BEFORE THE U.S. DEPARTMENT OF AGRICULTURE ------------------------------x IN RE: : : ADVISORY COMMITTEE ON : BIOTECHNOLOGY AND 21ST : CENTURY AGRICULTURE (AC21) : : EIGHTH PLENARY MEETING : : FEBRUARY 7-8, 2005 : : ------------------------------x Monday, February 7, 2005 USDA South Building, Room 1623 USDA/NFC Training Center Lincoln Rooms 1, 2 and 3 1400 Independence Avenue, S.W. Washington, D.C. 20036 BEFORE: DR. MICHAEL SCHECHTMAN Designated Federal Official, USDA DR. PATRICIA LAYTON Chairperson A P P E A R A N C E S CYNTHIA SULTON, HW&W ABBY DILLEY, RESOLVE DARYL BUSS. ELIZABETH MILEWSKI MICHAEL D. DYKES JUAN ENRIQUEZ-CABOT RANDAL W. GIROUX DUANE R. GRANT DAVID HOISINGTON GREGORY JAFFE JAMES MARYANSKI MARGARET MELLON RONALD D. OLSON JERRY SLOCUM LISA W. ZANNONI BERNICE SLUTSKY CAROL TUCKER FOREMAN TERRY MEDLEY RICHARD CROWDER LEON CORZINE VINCENT VILKER P R O C E E D I N G S (8:21 a.m.) MR. SCHECHTMAN: Good morning. This is the eighth 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. I'd like to welcome our Committee members, a good number of whom are here now, but I think all or nearly all should be here by within a couple of hours. I know we're -- a couple of people are a little under the weather, and most of the people are -- perhaps everyone is -- will be here. We're not entirely sure. We're hopeful that everyone will be here. We know a couple of members will be arriving a little bit late today. We will -- we expect to welcome a new ex officio member to the Committee today, Madelyn Spirnak from the Department of State, who replaces Peter Chase as special negotiator for Biotech for the State Department. I'd like to thank you all for making it here to our meeting today down in this maze. We apologize for having a new meeting room that's a little hard to find. We got bumped from our original location by the new Secretary of Agriculture's first press conference on the occasion of the President's -- release of the President's budget. This room gives us more space and better acoustics than otherwise we would have had. Can you hear me well enough back there? That's good, because I don't have more voice than I'm putting out right now. I'll also note we donÕt have microphones. Our transcriber -- for amplification, our transcriber will be able to pick up the sound from the microphones on the center tables that we didn't have room to move out of the room when we were organizing it earlier yesterday. Everyone will need to speak up. To my left is our AC21 Chairman, Dr. Patricia Layton from Clemson University. To my left and right are our facilitators, Ms. Abby Dilley and Ms. Angela Agosto from the organization RESOLVE. And two seats over is Cynthia Sulton from the organization HW&W, who are our partners in helping us make the Advisory Committee process work. Also joining us today will be USDA Special Assistant Secretary for Biotechnology, Dr. Bernice Slutsky, who will be helping us out as well and should be providing us a few remarks shortly. As usual, we'll have a very full agenda, so we ask that when the meeting is in session, conversations will need to be limited to those between members. The public will be invited to provide -- to participate by providing comments to the Committee and USDA this afternoon between 2:30 and 4. We'll be preparing the minutes of this meeting, and a computer transcript of the meeting also will be available within a few weeks. The Website address for this Committee is www.usda.gov/agencies/biotech/ac21.html. For any members of the Press, if they should manage to tear themselves away from the Secretary's press conference, you're welcome to speak to whomever you wish during breaks of our 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. Ms. Layton, our Chair, and I will be available for questions and comments at the end of each day of the meeting. I'd like to request that all members of the AC21 as well as all members of the audience and the press please shut off your cell phones and beepers while in the meeting room. We may actually have a few phone calls coming in as we try to shuffle in the last few members into the room. Bathrooms are located just outside and to the right. In the back of the room there are tables with meeting documents and background documents on them. For members -- for the information of -- the public, let me indicate that the AC21 is charged by the Secretary of Agriculture with preparing two distinct reports. First, a report on the impact of the proliferation of traceability and labeling regimes in other countries and how industry is addressing those requirements. And, second, a larger report on the likely impacts of biotechnology on agriculture and on the work of USDA over the course of the next 5 to 10 years. Now I'd like to turn to the official meeting documents and background documents. First, the background documents are the following: The official AC21 Charter; the AC21 Bylaws and Operating Procedures; a package of biographical sketches of all of the AC21 members; and the draft meeting summary prepared from the sixth AC21 meeting held on September -- excuse me, held on December 9th and 10th of this past year. Specific with this meeting we have the following official documents: First, the provisional agenda for this meeting; second, a full draft of one of the reports this Committee is charged with preparing, entitled Global Traceability and Labeling Requirements for Agricultural Biotechnology-Derived Products: Impacts and Implications for the United States. It is, we hope, near enough to final that we can iron out the kinks and get consensus on it by the end of today. I'll say more about that in a few minutes. The remainder of the documents, the 3rd, 4th, 5th, and 6th, that are on the table, are the same documents we distributed for the last plenary, which we plan to devote more time to at this plenary. They are third, the most current draft version of the Issues to Consider, chapter, fourth a document containing the two draft introductory chapters to the report. The document contains -- that package contains an outline from the first chapter and revised text for the second. Third, the latest draft, must of the chapter entitled, Preparing for the Future, which contains an analysis of certainties and uncertainties driving the future as well as three informative scenarios for thinking outside the box about what the future might look like. And, sixth, a draft definitions list based on the work -- definitions of work group. Were any of the documents distributed by AC21 members? If there are any, please be sure and provide me or the facilitators copies of those documents. For members of the public, you may speak during the public comment period. If there are any public comments, I'll need hard copies of your remarks. On the right table among the official handouts you will find copies of the detailed meeting agenda, as I indicated. We'll go over it in a few minutes, but please note that there are breaks scheduled in the morning and afternoon. For members of the public who wish coffee, coffee is available in the cafeteria on the First Floor in the Third Wing of this building, if you can negotiate that little journey. Also on the agenda, let me note that we are again preparing for a period of up to one and a half hours for public comment from 2:30 to 4 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. Any speakers will be allotted five minutes of time. Members of the public, if you wish to make a comment and you have not done so already, please be sure to have signed at the door so we can plan that time period. Now from USDA's perspective, there are three main objectives for this meeting. They are first, to finalize the submission by the Committee to the Secretary, the draft report on Other Countries' Traceability and Mandatory Labeling Regimes for Biotechnology-Derived Products. Jim, why donÕt you come up to the reporter here. I don't think we have a -- Excuse me. Traceability and Mandatory Labeling Regimes for Biotechnology-Derived Products, the implications of those regimes, and how U.S. industry is addressing the requirements for products shipped to those countries. Second, to review and make progress towards finalization of the other report, examining the impacts of agricultural biotechnology on American agriculture and USDA over the next five to ten years. The Committee will review in further detail the progress made by work groups between the September and December plenary sessions, looking at documents that weren't changed since the December plenary sessions. In essence doing some of the work that we were not able to get to at our December meeting, but which we will get to on schedule tomorrow. And, finally, determine any additional processes for finalizing the reports. I'll have a few more words to say about the status of each of the documents as we turn to them on our schedule. Let me first give you a couple of status updates. First, and most -- and very importantly, the new Secretary of Agriculture, the Honorable Mike Johanns has been sworn in, and as I indicated, is today conducting his first press conference related to aspects of the President's budget being released today. Second, with respect to this Committee, the charter for the AC21 has been renewed for another two years. Third, the process of selecting members to serve on this Committee to fill the spots of the Committee members whose initial terms expired -- are expired, rather, is still underway. We hope that the Secretary will have completed the processes fairly soon. One general point. We have been working since late spring in 2003 with the initial goal of producing a pair of reports by the end of 2004. There's a great deal of work, difficult, collaborative work by Committee members in getting us to where we are now. Obviously, we haven't met the initial time lines, but we are at the point of finishing up one very significant effort of the two that are underway. Taking the last step on the first report is going to require the good will and the positive and constructive participation by all. It will help set the tone that will enable us to succeed on the second report as well. Let me now turn the meeting over to our Chairman, Dr. Patricia Layton, for your words of welcome and -- MS. LAYTON: Thank you, and welcome everyone. It has not been quite two years since I was sitting in a hotel in a blizzard in Denver and got a call from David Hegwood saying I'd like you to be on this Committee. And it was a complete surprise, certainly warmed my heart in that very, very cold day. It's one of Denver's -- it's a memorable event. It was one of Denver's worst blizzards in their history, and I really got tired of eating food at the hotel there because you couldn't even get out to a restaurant. It was very memorable. And since then, I've had the opportunity to work with each of you in this Committee, and I don't think there was a single one of you I knew beforehand, and I feel very proud and very honored to have been chosen to be on this Committee and to work with you for the last two years on this, almost two years. It's really a year and three-quarters almost that we've actually come to meetings. In the, in the beginning, we were charged with one charge, and that was to prepare our major document, which is the one where we're not quite as far along at. And David Hegwood asked us to do the second document on labeling and traceability. And as I look over that, it has been -- that was, that was really an awesome charge to add that on top of our original charge, and to really see it sit here today and be as far along as we are on those documents, with one at point of final revisions and at the second one very, very far along in a difficult - - and difficult topics in terms of looking out into the future. It's always hard in taking on the concept of scenarios development, which was not normally done in advisory committees. We're chartering new ground. And I think we should at this eighth meeting consider and look at ourselves and feel very, very proud of how far we've come. It has been a, a considerable piece of work to get to this point, and I think we should all be very proud. It's also going to be the last meeting for at least four of our members, who have decided not to renew, and I would like to have us begin our thanks to them this time at the meeting. And they are Terry, Keith, David Hoisington and Juan Enriquez-ENRIQUEZ. And I believe that both Keith and Juan are both scheduled to be here. So at some point in time as we go through the meeting today, I'd like us all to say a very, very hearty thank you to you who have been here and who are moving on to new challenging assignments, which Terry has already moved and David is about to move in two weeks, that prevent you from staying with the group. And as we meet next time hopefully we're going to all -- most of us will be back and with new members in their place, and move forward in this. I think that Michael is outlining a process -- will be outlining a process for us to complete the work today that we need to complete, and I think to move forward tomorrow so that we can do as much as we can as a group. When we get new members, there is always a new dynamic and a new feeling out. So I think it's very important for us to get our contributions at a point that all of the four members who are leaving us feel that they have -- they can recognize the document, the documents when they're out, and that we've really accomplished something that's a salute to the hard work of the last two years. It is a significant achievement. I -- while this is not the 9/11 commission, you know, with lots and tons and tons of staff and professional writers, there has been a lot of extremely hard work involved and a lot of writing by each of you. This is not a document of the staff. This is a document -- these documents are documents of the committees, and it's something to be very proud of. And so I hope that as we step through the next two days, we do so in a sense of what we've accomplished and also in a sense of we have a new Secretary of Agriculture, and we want -- or at least I want to be able to bring a document to him very shortly that shows the depth and the hard work of this Committee, and to promise him the second document as rapidly as we can so that he is up-to-speed on what we're doing and the state of biotechnology now and in the future, ag biotechnology, and I think, you know, for me the challenge was I still want to talk about natural resources and Daryl probably still wants to get -- really go to the animals before this is all over. And when we started this process, we planned that that would be another stage down the road, and so I'm hoping we can still get to that. Because these issues are still in the forefront. There is still much work to be done, and I would love to see this Committee work as a well-oiled machine when we move with new members forward as we have for the last two years the group has been here. So today I ask that we work hard with the idea of moving through this process, of listening to each other, of making sure that we understand each other and of arriving at consensus on this document so that we do have something in hand to hand to the new Secretary as soon as possible, and with the promise of completing the second report within the year. I think that's a very admirable task and an overwhelming accomplishment really in terms of what we've had to do for the last two years. It's been an incredible ride. I mean literally we are not in our second year meeting -- I mean our second -- the anniversary of our first meeting yet, and we've accomplished a tremendous amount. And I feel like I have a whole group of new colleagues and friends that are one of the people who I respect, and I truly appreciate having worked with you in the last two years. So again, thank you. And let's just get busy and do our jobs today and tomorrow and see how far we can accomplish our task. Thank you. MR. SCHECHTMAN: Bernice. MS. SLUTSKY: Just 30 seconds, because I think you have a lot of introductory remarks, and there's a lot of work to do. But just to reiterate something that I think that Dale Moore said to you last time that you met in that both of these reports will be read by the Secretary, and both of these reports are extremely important to the Secretary's office and to USDA, and that we are looking forward to seeing the first report and the second report, and it will actually fit in very nicely with, you know, overall briefings that we'll be doing to the Secretary on biotechnology. And also just one other point that I wanted to raise. Between now and next meeting, what we would like to do is think about ways that you can interact a little more with the coordinating group that we have in the Department on biotech, and we'll be thinking about a mechanism by which you can do that, and I think that would be useful for both this Committee and certainly for that group. So that's something that we are going to exploring between now and our next meeting. And just have at it, I guess. MS. SULTON: If we could just quickly review the minutes from the December meeting, and I will elicit any corrections or modifications to them; and if there are none, then we'll prepare it for release to the website. The Seventh Plenary Session of the AC21 was held December 9th through 10th of 2004. It began with welcoming and opening comments from Mr. Schechtman and Ms. Layton. There was a review of the September 13th and 14th meeting minutes and the agenda for the December meeting. Dale Moore, as Bernice has just said, Chief of Staff to the Secretary, gave remarks to the Committee expressing his and the Secretary's appreciation for the work that had been done on both reports, and cited them as cutting edge documents forming a foundation for the new secretary, at that time Secretary-Designate. And he also expressed interest in examining the existing biotech framework at USDA. The meeting proceeded then to review the work of the Labeling and Traceability Work Group and specifically the draft report. The general comments ranged quite widely with one member -- several members talking about reservations about sending only the Traceability and Labeling Report to the Secretary, and agreement made that we would work very strongly to get the second report in soon thereafter. There was discussion of issues such as the role of the U.S. as an exporter of biotechnology versus the potential role in the future of the U.S. as an importer, and an agreement that we would focus on the export issue as was originally agreed for this particular report. The issues that -- it was an agreement among the Committee that the issues identified in the report are equally relevant for major and minor crops and for grain and grain products. Distinctions were made -- it was asked that careful distinctions be made within the report between issue statements and recommendations. Then there was discussion of the countries' differential traceability and labeling requirements impact on consumers, and a small group was established to draft a section on the various labeling regimes and their impact on consumers. Discussions ranged on the use of various terms in the report such as transgenic-free versus GM-free, the word risk, grain, grain products, et cetera. It was agreed that the introduction be revised to include descriptions of the scope of the report, the process of developing it, and key definition therein. Small groups then drafted the text of subsections of the introduction to include process, scope, and definitions; but time did not allow for the full AC21 to review all the text. Discussion of Section 3 of the report, the policies and issues raised, included minor revisions on three issues, the combination of other issues, the deletion of text on three issues; and remaining issues were assigned again to small groups that broke out in the meeting to revise the text. However, again, insufficient time was there to consider all the new text that was developed during the plenary. And there was a question as to addressing the role of international organizations within the text. A new issue was added on labeling requirements and public attitudes, and it went on to Sections 2 and 4 -- 2 and -- I'm sorry, 1 and 2 on the national and international requirements with respect to traceability and labeling, the labeling commercial impacts realities, and basically this was editorial and language changes. However, unresolved is how to characterize the factors influencing tolerance levels of the various countries set for AP, and it was agreed that the Executive Secretary would provide some options in the text. In the discussion of new consumer impact section, which was prepared by the small group for the Committee consideration, it was agreed to add this section to the report with the final designation of its placement still pending. There was also discussion, but not complete agreement on text for new issues within Section 3 to address the consumer implications of different labeling regimes. The Committee went on to discuss the progress of the work group on issues to be considered, focusing on three issues; adventitious presence, asynchronous, and coexistence. The issue of the proliferation -- easy for you to say -- of staff events, including definitions, compliance, and enforcement was discussed. There was an ongoing effort to frame an issue around consumer acceptance, and that was noted. There was support for structuring the section as a neutral issue statement and a collective articulation of issues. The work group was to continue to develop issues after the next plenary session. Went on to discussion of the work group's progress on the scenarios development. A summary was given of the current section, current structure of that chapter, entitled, Preparing for the Future, and it had basically five framing implication questions for each scenario relating to economic impact, natural environment, various issues regarding USDA, public acceptance, food sufficiency and security. The discussion ranged fairly widely but mostly on terms, definitions for such things as food sufficiency and food security, asking that they be defined in more detail. It was also prioritizing of the implications for the different scenarios, but no objections were made to the drafting of the implications section as outlined. There were on members of the public there to offer comment during the public comments period. The meeting ended, drew to a close with a discussion of a work plan and next steps, and there was agreement that we would advance our first meeting this year from our usual March date to sometime prior to the expiration of the charter for the Committee and the expiration of several of the members' terms, and thus we are meeting today. The next steps for the traceability of labeling report were for Mr. Schechtman to revise the report based on the comments provided at the December meeting, and for members to review the new draft that Mr. Schechtman would then provide prior to the meeting, focusing on the sections of old or new text not discussed during the plenary. And then those comments would be incorporated and a new draft sent out prior to this meeting. The next steps for Chapters 1 and 2 were to review them, the outline and the revised text, since we had not gotten to them in the meeting; and the next step for issues to consider again was to discuss the three issue statements and associated text. The next steps for preparing for the future was for the scenarios work group to continue reviewing the three draft scenarios and completing drafts of implications for the three scenarios. As regard to the final reports, it was agreed that when finalized by the Committee, the reports would be submitted by the AC21 Chair to the Secretary, posted on the AC21 website, and that a small representative group of the members of the AC21 would meet with the Secretary to formally present the reports. With the closing remarks from the Chair, the meeting was adjourned at 3:30 p.m. Are there any amendments or corrections to the minutes? (No response.) MS. SULTON: With no corrections or amendments, then the minutes will be ready to be posted on the website. Abby. MS. DILLEY: Okay, just briefly, because we're running a little bit behind schedule. Basically the agenda builds up off what Michael and Cindy have identified as the objectives for this meeting as well as building on the last conversation we had December 9 and 10, and that's namely to move both reports forward as much as possible. Today being dedicated traceability and labeling report and tomorrow being dedicated to the other report. There has been some interest expressed in terms of focusing more of tomorrow on the scenario discussion given that the four members that Pat identified as rotating off are -- happen to all be members of the Scenarios Group. So potentially taking a portion of tomorrow to really look at that particular portion of the second document to have the benefit of those Committee members still being at this meeting. So just briefly for today, the way we've organized today is to look at the introduction first. As Cindy mentioned, that section was reworked during the December 9 and 10 meeting, but we didn't have an opportunity to come back and look at those edits and modifications that were made during the last meeting. I we thought we'd start there, and then move into a discussion of some of the new text, which includes Adventitious Presence, which is on Section 3A that was redrafted by Randy and Greg, as well as Market Segmentation, which the Committee requested some additional language to help clarify some of the definition issues and provide a little bit more information on that. That's the -- that's Section 3G. And then also, which is not on your agenda, but had conversation about it, Section 3H, Consumer Implications of Various Labeling Regimes. So we know we need to get to those three sections as part of the discussion today. And then the policy issues, concerns issues raised by the analysis of the current situation. That again was re-worked at the last session, but we didn't have time during the plenary session to look over the edits and changes or modifications to that. So we anticipate spending the bulk of the conversation. Hopefully the other changes that have been made in the document, Mike will go through those in terms of just introduction to the text. We're more editorial in nature, and we've highlighted those changes to make sure that our assessment of what's editorial is also consistent with what your assessment of editorial changes were. So if there are comments, we'll provide an opportunity to talk about that, if there are any. And then, lastly, which we have not discussed before is the Executive Summary, which we didn't go over at all during the December 9 and 10 session, and it just made sense to us to tackle that last because usually you write the Executive Summary when you have the rest of the report finalized. So that is the last portion of the report that we propose for discussion in terms of just laying this out as to what we take first. We do have public comment period scheduled for 2:30 to 4. If in the event that we don't have public comment or we don't take all of that time for public comment, then we'll use that portion to come back and finish up details of that discussion, if there are remaining issues to be addressed., and then we'll adjourn. We're scheduled to adjourn by four. Originally, we were scheduled to start early and end early because the room we had before we had to be out of there by four, as I recall. UNIDENTIFIED SPEAKER: Yes. MS. DILLEY: Right. So for tomorrow, we are scheduled to again start early because we -- I think it's become routine as we -- and try to end early so those of you who travel, have to go other places, can catch your airplanes on time. And the way we had originally thought of the agenda or addressing the second report was to come back. As Cindy had mentioned, we had talked about the other document. Really the schedule is predominantly focused on the Traceability and Labeling Report, and the Committee made that decision to do that, to move that forward and try to finalize it. What we did talk about was basically the appropriate to the other sections, just to make sure that we were tracking with the full Committee how each of the working groups were making progress on their respective sections, and so it as hoped that tomorrow potentially we would get to a little bit more in-depth discussion and actual substantive discussion of these sessions. As I've mentioned, people have expressed an interest in maybe focusing more of the discussion tomorrow on scenarios portion given that the members who are taken off are from that working group. So we need to figure out exactly the agenda for tomorrow, but that is the overall approach to the agenda. I just wanted to see if there were questions or comments, and, yes, we do. Greg and then Michael. MR. JAFFE: Yeah, Abby, I'd like to at least make a proposal that we spent some time today on the Scenarios Chapter, at least introduce what we mean by finalize matters or what we mean by moving that along further, for people to at least think about it. You may know that Abby and I had a discussion on Friday afternoon, and I thought up the possibility of potentially actually finalizing that chapter as well as the Traceability and Labeling Report at the same time during this meeting. My reading of that was that it was near final. And so I'd at least -- I don't want to wait until tomorrow to have at least a discussion about that because I -- people want to think about it overnight, maybe review the chapter in a -- review that in a different way. MS. DILLEY: Different way. MR. JAFFE: So whether we do that during the public comment period, if there's no public comment period or something; but I would like to propose that we have some period of time, half hour, an hour, something to discuss the Scenarios Chapter, because -- MS. DILLEY: And what that means. MR. JAFFE: And what that means. Otherwise, I think we, we would get in tomorrow morning and people would be -- it would be a shock. There might -- people might have some ideas, I have some ideas, but some people might have other ideas. MS. DILLEY: Sure. MR. JAFFE: And we wouldn't be able to complete it because we wouldn't have the time to think about it. MS. DILLEY: I would imagine that we could hopefully at least spend some time talking about how we want to move through the discussion tomorrow so that people do have an opportunity to look at the document tonight and prepare for that. Michael. MR. DYKES: Yeah, I won't be here tomorrow, but I just wanted to make sure I understood where we were on scenarios. I have sent in comments on scenarios, and at the last meeting my recollection was that the Scenario Committee had evaluated my comments on two of the three sections within scenarios. And I just wonder -- I've not seen anything new. Has there -- MR. SCHECHTMAN: Let me indicate. There were comments from several people on scenarios that were not yet -- that have not yet been incorporated, and there were indeed sections of the chapter that were not yet fully gone over by the Scenarios Work Group. They only went through two of the three scenarios, and only discussed implications for one of them. So there's been a huge amount of progress made on the chapter, and I think it's perhaps fairly close, but there are -- certainly the work group didnÕt feel that their work was yet done on it. MR. DYKES: I guess that's my question. We have nothing new from the work group since the last time we met? MS. DILLEY: No. MR. SCHECHTMAN: That's correct. The work group has not met. MR. DYKES: Okay. So -- MS. DILLEY: So a part of the discussion may be to bring some of the comments that you had to offer to that discussion. Is that what I'm hearing? That you, they've gone through some of your comments, but not all of them, and so -- MR. DYKES: Well, I mean I guess -- MS. DILLEY: Along with everybody else's comments as well. MR. DYKES: -- scenarios, I sent those in several months ago, whenever that was. So I won't be here tomorrow. I'd like to have at least a chance to make sure that those aren't just gone. UNIDENTIFIED SPEAKER: Michael, I think in terms of the comments that were sent in, there is more which needs to be done on the scenario, but I think it's fair to say that the scenarios working group did in fact look through all of your comments, and they were discussed, and there were some changes made and some not. So it's not like there wasn't -- so the draft you will see does respond to some of the issues that were raised and the comments that were sent in. There were others that were not changed accordingly, and then as Michael said, the section on implications, I think what's really key is we agreed on the format of the question we would want each of the scenarios to address to bring some symmetry to them in that way. So there's a lot of work, but it's not to say that your comments that were extensive that were sent in were not passed on or looked at by the group, because we did. MR. DYKES: I guess to that point, not into semantics, but my sense was the one I thought we heard at the last meeting, two of those sections they were reviewed and decisions by the work group they were either in or out. The third one was not done.- MR. SCHECHTMAN: One scenario, there was not time to finish -- MR. DYKES: Yes. MR. SCHECHTMAN: -- going over that at the final meeting of that work group prior to the, the last plenary session. MR. DYKES: Okay. MS. DILLEY: And back to Greg's suggestion. If we decide to move in that direction towards finalization of that particular section, we need to talk about exactly what does that mean and how do we gather -- is there any additional information than what we've already provided to the Committee that we need to have and how we want to set up that conversation. So I think doing that later this afternoon if we could do that, depending on public comment or making sure that we spend time talking about how we want to have that conversation and what that might look like before we adjourn for the day. If no one has objection to that, I would propose we do that this afternoon. Carol. MS. FOREMAN: Thank you. I have a specific comment, and then in a minute or so, I will make a more general one. Since Michael can't be here tomorrow, and since we are losing the key members -- virtually all the members of the Scenarios Working Group, I would propose -- not Margaret. She said -- (Laughter) MS. FOREMAN: It seems to me that we might change the agenda and deal with that first and then come back and finish labeling and traceability. The scenarios chapter is shorter. We could find out pretty quickly if we're going to be able to get agreement on it; and then we could move forward in doing the traceability and labeling. I wasn't a part of the Committee during its first year, but it has seemed strange to me that the one -- that we are not putting out the material that the charter asked us to produce, and we are finishing something that wasn't in the charter. MS. DILLEY: Actually just background, because it was actually the Committee that asked -- requested by the Secretary if there were some pending issues given that the original charge was for future -- if there were some things more immediate that the Secretary wanted the Committee to address that we would do that in parallel with the other report. And so I think it was always anticipated that the second report in fact would probably be produced first because it was a more immediate issue. Just for -- that was not during your initial tenure. MS. FOREMAN: It remains that that was an add-on. MS. DILLEY: It was, that's correct. MS. FOREMAN: And it, as you know, I'm uncomfortable about going forward with pieces of this. It just seems certain that with the kind of turnover we've had on -- committee that we are going to have a major period of adjustment while new members get up-to-date, while we go back through and repeat all of the discussion that we've had before. I'm concerned, as I've said before, that we're not dealing with the Issues Chapter at all. But because the scenarios people are going off the Committee to a larger extent, it just seems absolutely essential to get that piece done or for all practical purposes acknowledge that it's not going to go forward. If that's going to be the case, let's just find out if that's the case. And by dealing with that first, I think we could get a pretty good idea of whether or not there is support for going forward with it. MS. FOREMAN: Michael and then Randy and then Dick. MR. GIROUX: Yeah, just one thought. I certainly take the point about the large number of members who were on the Scenarios Group who will not -- will certainly not be continuing on the Committee. At the same time, I think we can do a fair amount. Everyone on this group has paid close attention to what's in the scenarios, and we can do a certain amount of rearranging of composition of membership on the work groups, so that while we won't have the same people there who were involved in the drafting, we can at least have people who have been experienced in discussion of the process and who have familiarity with the documents to sort of back-stop some of that. So I think while the point is -- your point is clearly well taken that there's going to be some transitional pains, I think we can do some things to try to soften them as much as possible. MS. DILLEY: Randy and then -- MS. FOREMAN: Let me -- just let me -- one last thing on this. It just seems to me based on more years of sitting in advisory committees that I would like to acknowledge, that anybody who thinks that we're going to get that document out if it doesn't go out before the close of this meeting thinks that the Eagles won the Super Bowl. (Laughter.) MS. DILLEY: Randy, Dick, Mardi, Greg and then Terry. MR. GIROUX: Thank, Abby. Just to follow-up on your comment, Carol. I think that's probably true to say of the traceability and labeling document today, that when we met last, I believe that we moved this meeting to this period of time specifically for this group to deal with the traceability and labeling document for the fact that it was so close to being completed that we wanted to have this meeting before the charter of the Committee ended. And I think we would be remiss as a committee to now change the agenda at risk of not finishing the traceability and labeling document. It's the main reason that I'm here today. Not that I'm not interested in finishing the other documents, of course, and I can tell you that I commit to finishing the second report. No interest in not finishing that second report. I think we have a fair amount of work in front of us to deal with the traceability and labeling document. I think we have some people here that cannot be with us tomorrow. And so if we do not finish this document today, I have a feeling that it won't get finished. So I don't agree to changing the agenda to fit the traceability and labeling document most likely in tomorrow's session and replace it with talking about the scenarios document. Can't support that. MS. DILLEY: Dick. MR. CROWDER: Well, a couple of thoughts. (a), I wasn't here last time, and I'm like Michael -- I'm not like Michael -- I'm going to be in Kansas. But -- I've got -- well, two thoughts. First of all, we don't know when the new group is going to work. I mean the tracing and labeling people going to be back or not be back because we can't presume what's going to be there. So we've got some uncertainty around what's going to be in the tracing and labeling also. Number two, with respect to the scenarios. Even if we were fortunate enough to finish the scenarios, we still couldn't do anything with it. It's part of another document, and we have no chance of getting any of them completed if we focus on the scenarios and not tracing and labeling. And while we've got a document that we're as close to on agreement as possible, I think we ought to focus on getting one thing off the table and coming back in the next time rather then with a newly constituted body having two things to look at, to have one thing to look at, I think the transition would be much better. And I would suggest that we keep the agenda -- work for the day as we have heard earlier this morning. MS. DILLEY: Mardi. MS. MELLON: I think the Scenarios Chapter is really quite far along, especially if we were to make some decisions perhaps about -- could abbreviate some of the components of it. And it does seem to me that the, that the constitution of that group was -- worked very well, was unique, and it's not going to be that easy to replicate. So I would like to see us move ahead to get that done. I think of the, of all of the parts of the big chapter that are, that are on our plate, that's the one that we ought to focus on, and leave all the others until the next meeting with the new, with the new folks. I think we could, you know, we could get quite far along on that, and I agree with Carol that it's -- this is going to be a hard thing to duplicate if we don't, if we don't come to some agreement and sign off. MS. DILLEY: Greg, Terry and then Carol. I know you want to comment. MR. JAFFE: First the realist in me, and I want to comment on what Michael said. And I just have to disagree with you. I think that the, the one reason we've gotten the scenarios has been the uniqueness of that Committee and some of the people on it, Juan and Keith and Mardi and others who have done a tremendous job. And as a full member of the Committee, I have deferred to them a lot, and I've reviewed the chapter, yes, but I think that that committee can't be duplicated with the people around the room and people who come in, and I don't think that we don't move further along with that. I don't think it's as easy for us to pick it up as you said. That's my own personal view. I would find it hard to -- I've worked on the other committees and deferred a lot to that committee as to what they've done. I think they've done a great job, and I think that chapter is near complete, and I think it could be a stand-alone -- that goes to the Secretary or as finalized that's left in abeyance for the rest of the report that isn't -- negotiated with new people coming on. So I think there are creative ways to complete that. Now the optimist in me says that I think we can get both done in the next two days, both the scenarios, given the fact that I think it's near complete, and the traceability and labeling, because I think that is near complete. And maybe I'm too much of an optimist but I think they both can get done. I do have some worry about doing only one today and not the other one -- the other one tomorrow because Michael is not going to be here tomorrow, and I think Michael has some issues or things with scenarios, and since I think it can get done, I'd want to see somehow split, somehow split the baby. Maybe spend this morning on labeling and traceability, but leave an hour or two this afternoon to do on the scenarios, come back the next morning to whatever needs to be done with labeling and traceability and then go back to scenarios. But I think given the makeup of the Committee after this two-day meeting, I think that those both can get done. I have -- I don't have a lot of comments on either one, major comments on either one of them. So I'd like to try to figure out a way to compromise and do them both. MS. DILLEY: I was thinking in terms of just -- turn to Michael and say can you have us here until five, and maybe again depending on public comment we just extend the meeting longer today, and to the degree that we can get to scenarios as much as we can, at least a couple of hours, maybe even -- I don't know, do as much as we can on that, and maybe that's the way to try and get both pushed along today, given that some folks are not going to be here tomorrow. I didn't realize how many people are not going to be here tomorrow. Terry and then Carol. MR. MEDLEY: I want to say add my name to the list of not being here tomorrow. I have to go to Chicago. But I was thinking along the lines that you had just talked about in terms of since we -- based upon past precedents, we haven't had a long line of public commenters seeking to talk in those periods. I think if we can just go through our agenda and then look at that time as being able to have a discussion about the scenarios, and then, I'm pretty optimistic also in terms of what we might be able to accomplish. The other thing I think about the scenarios, this is an area where I believe that we're doing the report that science and things are changing so rapidly that some of the things are going to be almost out-of-date by the time the report is issued. The whole idea about the scenario piece is how does the Department get beyond that box in terms of looking at things that might happen, and not predicting, but how do you then deal with those? So I think it is a way of trying to keep current in an area that there are some unknowns and there's a value in that. MS. DILLEY: Carol. MS. FOREMAN: Yeah, just a final thing. You know at our last meeting scenarios was on the agenda first, and then we changed it to be labeling and traceability, and then didnÕt get around to doing scenarios. So it, you know, everything else keeps getting moved back and moved back and moved back to deal with this one issue, and I'd be perfectly happy if we decided to spend maybe up to 1:30 or 2 o'clock on labeling and traceability, and then go over to scenarios. Scenarios chapter is pretty short. MS. DILLEY: Yes. I mean in terms of I think just chronologically we need to do it that way, because I donÕt think -- I know I didn't come prepared to talk about scenarios this morning. So I would anticipate that probably other people are in the same boat. So maybe having that lunch break or some time to at least review it and then come back and commit to a couple hours on scenarios, and us reassess when we come back from lunch where we are on the traceability and labeling document. And then if we can push that towards finalization and then see where we are after lunch break -- MS. FOREMAN: Might also push us to finish labeling and traceability. MS. DILLEY: Yeah, yeah, I think that's right. I mean I think they go hand-in-hand. So can we commit to that? And for those of you, if you did not bring your papers for today -- I mean for the scenarios piece that remember there are copies in the back, and when you pick those up, there are a couple of pieces. There's a meeting summary and there's the preparing for the future draft chapter, and you need both because that continues the discussion that's not currently in the preparing for the future draft. So, please, if you haven't read it in preparation for today, be sure and do that at the lunch break, and then we'll turn now to the traceability and labeling document and work on that, and assess where we are after lunch. Leon, did you have a question before we get going? MR. CORZINE: Yes, I -- this agenda that was sent out previous, I think we should stick to it. If we -- I don't -- I wouldn't be in favor of saying at 1:30 we're going to switch. I understand it would be good to talk about scenarios later in the day, and maybe you can check and see if we can run later today. MS. DILLEY: We can run later today. MR. CORZINE: So I think that would be good. So let's get rolling. I just don't -- I wouldn't agree at 1:30, we're going to switch. MS. DILLEY: At 1:30, I said we will reassess where we are. MR. CORZINE: Okay. MS. DILLEY: But we are going to commit to at least a couple of hours on scenarios. After we get this done. I think we've just got to make that decision to take advantage -- particularly I didn't realize so many people were not going to be here tomorrow. So that, I think that makes it even more imperative that we get to that discussion today. Whose -- who can stay late today? MR. SCHECHTMAN: Who cannot? MS. DILLEY: Who cannot stay late today. I'm sorry: Terry has a train. MR. MEDLEY: A plane. MS. DILLEY: A plane. How late can you stay, Terry? MR. MEDLEY: I'm going to leave -- I have to leave about 3:30. MS. DILLEY: Okay. And but Keith should be here by then and Juan should be here by then, right? UNIDENTIFIED SPEAKER: Juan is supposed to be here at 10 this morning. MS. DILLEY: Okay. UNIDENTIFIED SPEAKER: I don't know what -- MS. FOREMAN: Have you heard Keith is definitely coming? I donÕt think he is? UNIDENTIFIED SPEAKER: I'm not sure. MS. DILLEY: We'd better -- if he's not, if he doesn't show up by the morning break, we'll call his office. MS. LAYTON: And who is not going to be here tomorrow MS. LAYTON: Terry, Leon and Michael. MS. DILLEY: Potentially three. UNIDENTIFIED SPEAKER: And Juan for maybe part of the day, not -- MR. SCHECHTMAN: Yeah, Juan will be here part of the day tomorrow. MS. DILLEY: Okay. Turn to Michael to just provide some of the preliminaries before we actually dive into the chapter and turn it over to Cindy for facilitating a discussion of the introduction. MR. SCHECHTMAN: Okay. The aim of today's efforts on the traceability and labeling of the document has on the document, as you heard, is to complete work on the report and finalize it for transmittal to the new Secretary of Agriculture and -- something to the just outgoing Secretary of Agriculture. Before I talk about the draft, its status, and how it was developed, let me for the benefit of the pubic, spend a moment or two going over its general structure. The document, as you've heard in bits from the summary, has -- from Cindy's summary-- has an executive summary followed by the bulk of the report. The report as a whole starts with a brief introduction describing what happened, why of the report, then dives into descriptions of different approaches that countries have adopted in setting out biotech labeling and traceability policies, which are described fairly generically, and associated with each one is some description of how industry is attempting to address the stated requirements. Then there's a description of different international agreements, treaties that bear on the use of labeling and traceability rules of trade. Following that, there's a large section entitled, Commercial Impacts and Realities. This section addresses more specifically particular concerns, market tools and trends. There are a series of pieces in there. They are adventitious presence, identity preservation systems, traceability systems, contracting and liability, testing associated risks, discrepancy between regulatory and true commercial requirements, impact and market segmentation, and a new section on consumer impacts. Following this, there's a policy section -- a final section, rather, which -- in which is highlighted certain policy concerns and issues raised in the report for the Secretary or for both Secretaries to consider. The report was originally developed by a work group composed of Randy Giroux, Ron Olson, Leon Corzine, Lisa Zannoni, Greg Jaffe and Dick Crowder. There's been extensive discussion of the document by the work group, and as you've heard, in plenary as well. We spent the bulk of our last two-day meeting in December going over the document. We made a lot of progress at that time. We went over at that point nearly the entire document, except that work was not completed on the first section, the Executive Summary, and the last, the Policy Concerns and Issues Raised. As I mentioned, one whole new section was added on Consumer Impacts, and discussed fairly quickly last time. Additionally, there were new pieces of text developed to go into various places in the document, notably in the introduction, including text on process and scope as well as definitions, and also some on policy concerns and issues raised that were not discussed at the meeting -- written but not discussed. And there was a call for a couple of pieces to be written, to be rewritten, rather, an adventitious presence portion of the text in Section 3 was worked on by Greg Jaffe and Randy Giroux, and also a small section of the impact of market segmentation also in Part 3. After the last plenary, just before the Christmas holiday, a revised version incorporating agreed-upon text, plus new text developed at the meeting, was circulated for the full Committee for comment. After that, the facilitators and I worked to prepare a new very annotated draft based o the comments received. It was sent out to members on January 28th. It was developed based on the following approach: For the entire text, suggested changes that were deemed by the facilitators and me as being strictly editorial and that clearly improved the readability of the document were included. If any of those proves to be the subject of discussion and at all controversial, in sections that were agreed to at the last plenary, weÕll revert to the original text without any delay. For sections of the text that were not discussed at the plenary or for which revised text as drafted by small groups at the plenary but not reviewed during the meeting, all suggested changes were provided. If those change altered the meaning rather than merely clarifying the text, they are provided as bracketed options. Sometimes there are nested options, so there are a whole bunch of forms of alternative brackets, squares, squiggly, greater than, lesser than signs. For portions of the text on which agreement was reached at the last plenary, only editorial changes were included, with apologies to those who provided more substantive changes to those portions of the text. This approach was taken to reinforce the process adopted by those present at the last meeting. We recognize that some portions of the text still engendered comments of substance, some of which will come up undoubtedly here today. Nonetheless, we would ask all Committee members to strive to adhere to this approach as much as possible in these discussions in order to be able to move forward. However, please note two exceptions to how we've approached this draft and would like to move forward, and the reason why -- and the reasons why. First, note that in Section IIA(3)a3, page 9, lines 40 to 41, in the second paragraph under labeling requirements triggered when modifications result in compositional novelty, a change is noted in the text where a question of fact has been raised about whether a particular example fits the case described. Second, we need to remember that one member of our Committee, Dick Crowder, was unable to attend the last session. While the new text does not include any of the substantive changes he proposed and comments for sections discussed at the December plenary, it is appropriate and necessary that he is offered the opportunity at the plenary session to raise issues of importance to him. The text also includes, as I mentioned, the new, redrafted Adventitious Presence Section prepared by Randy Giroux and Greg Jaffe. They at this point have mostly, but not completely, agreed on the text put before you, so there are a few extra brackets in what's provided. Additionally, please note that I provided some suggested text in the section on Impact of Market Segmentation, my attempt to address deficiencies and concerns noted in the last discussions. First, the definition for market segmentation was requested; and, after looking at a number of them on the Web, one was provided. Second, I took a stab at redrafting the text describing the range of attitudes towards transgenic products among different groups. I hope these are seen by Committee members as improvements. Finally, please note that I very occasionally made a word change or two on my own, generally to fix grammar or to fix clarity; never with the intent of making substantive change. I tried to italicize all those changes for transparency, and I hope I remembered to get them all, but I might not have. And also the ability of the tracking system on the computer to track things and things that were already changed is limited, as are my skills. WeÕre at the point now where there needs to be a final push to review the document. First, the pieces that have been not looked at yet, which we need to look at in greater depth, and then in going over for the rest of everyone's -- of the rest for everyone's comfort and to get input from Dick Crowder to round out our perspectives in order to move to get the final blessing for the report. What will the final report look like? This is to be -- we certainly want it to be a consensus report. That means everyone needs to sign off on it. That means further that it's not going to look like anyone's individual idea of what the report should look like. It probably also implies that there will be different things in it that each member won't like. It's going to be a consensus that is a compromise. Something that may be individually difficult in spots for each of you, but I think it's important for each of you to reflect on the big picture, and the value of this report as a whole in order to decide on your bottom-line messages and your overall bottom lines as we attempt to polish this effort off. As you all jump in now, I would encourage each of you in these discussions never to say such and such text is unacceptable, but rather provide an explanation of a concern that you have that's raised by a particular statement and actively seek a solution that everyone can agree upon. So with that, I will turn it over to Cindy. MS. SULTON: Okay. With the goal of getting through this report and coming up with a consensus agreement that we have talked about, I propose that first of all we take a rolling break and not stop for a formal break. And also to reiterate what Michael said, we want to focus on the parts of the text that were not discussed in the December meeting, parts that were drafted by small working groups at the plenary but not reviewed in the December meeting, and those bracketed changes that in fact altered the meaning rather than merely clarifying the text. And with that, I'd like -- Greg. MR. JAFFE: I guess given the importance of all of us being in the room for all the discussions, I would request we don't have a rolling break, but a defined 15- minute break, because I really don't want to miss the discussion. I do -- check into my voice mail and so forth. So I guess I would request -- see whether the other Committee members see about that, but do the break as scheduled in the agenda. MS. SULTON: I see pained looks that people want a break. All right. MR. JAFFE: What? MR. SULTON: I see that people seem to want a break, is that right? To have a formal break? Okay. UNIDENTIFIED SPEAKER: -- 15 minutes. UNIDENTIFIED SPEAKER -- 10-minute break. UNIDENTIFIED SPEAKER: Say 10 it will be 15 minutes. MS. SULTON: -- have a 5-minute break -- Okay. We would like to start with the introduction and that section is relatively short and has a statement of the charge, a description of the process. MS. LAYTON: working off January 28th -- MS. SULTON: we're working off the January 28th version of the text that Michael referred to, that gives you all the -- MR. CROWDER: So we'll come back to the Executive Summary? MS. SULTON: We'll come back to the Executive Summary after we've been through everything else. At any rate, the introduction has the charge -- by which the report was prepared, the scope of the report, and the terms. It runs on my copy from about page 3 to page 6. UNIDENTIFIED SPEAKER: -- we have comments -- page-by-page? UNIDENTIFIED SPEAKER: Coming back to the Executive Summary. MS. SULTON: Yeah, but -- no, we're not -- we're going to do the Executive Summary last. UNIDENTIFIED SPEAKER: Okay. MS. SULTON: After we have agreement on the body of the report, and then make sure that the Executive Summary does in fact reflect the body. MS. LAYTON: And in some places we -- to make a decision, because there are three suggested alternatives or -- MS. SULTON: That's correct. I don't know if you were able to print it out in color, but I have it in color so I can see where there were alternatives suggested. Michael. MR. DYKES: Just -- what's the difference in mine? I don't have it -- in color. I have blue and I have red for those. Could you just refresh my memory? Is blue what you put in is editorial and red content? MR. SCHECHTMAN: Red were things put in in the previous draft. MR. DYKES: By discussion of the Committee? MR. SCHECHTMAN: Yeah. MR. DYKES: Okay. And blue was? MR. SCHECHTMAN: Blue are subsequent changes. MR. DYKES: Either that you put in as editorial or comments from other Committee members? MR. SCHECHTMAN: Yeah. Most of mine, yes, most of mine should be italicized. A couple may not have shown up that way. MR. DYKES: Okay. Yeah, I do see some italics. Okay. MS. SULTON: So red are the changes immediately after the December meeting, and the blue are the changes after we got comments and -- MR. DYKES: The red should reflect the conversations from the last meeting. MR. SCHECHTMAN: Yes. MS. SULTON: That's correct. MR. DYKES: Okay. Now I'm with you. MS. SULTON: Okay. In the general sense of the introduction, do you think that we -- what was agreed to? MR. CROWDER: I've got questions and comments, if I might. MS. SULTON: All right, Dick. MR. CROWDER: Just a quick one underneath charge, should that be the United States food and feed Supply Chain? It says food and feed Supply Chain? I don't recall what the charge was, but I think it might have been U.S. UNIDENTIFIED SPEAKER: Yes, it is. MR. CROWDER: Okay. MS. SULTON: So insert U.S. in between the and food. UNIDENTIFIED SPEAKER: Yes. Yes. MS. SULTON: Okay. And as you turn to what is page 4, we do have a lot of bracketed items in that first paragraph, so there are choices to be made. In the last meeting we used the term snapshot, some people. Description, report were also mentioned. So the bracketed items in that paragraph that begins to draft the snapshot description report. Michael. MR. SCHECHTMAN: I would think, I would suggest report -- referred to. MS. SULTON: The next bracket is a little bracketed item on that same sentence. MR. SCHECHTMAN: Let me just say I think at least in my copy at least the colors are doing different things here. The old text on my copy is the blue. MS. SULTON: Yes, mine too. MR. SCHECHTMAN: Uh-huh. And the new text is red on mine. So I'm not -- they reflect different times, but I'm not sure that they do the same thing based on the computer -- MS. SULTON: But the -- and the brackets -- UNIDENTIFIED SPEAKER: Are changes. MS. SULTON: -- are changes. MR. SCHECHTMAN: Yes, brackets are both printed and text. MS. SULTON: So then there is an alternative text there but in brackets? MR. SCHECHTMAN: Yeah. If I can, the suggestion was made in comments that it really wasn't necessary to talk in great detail about who was on the work group as much as talk about the time, what kind of information they got, what the mandate was. So that the red version -- MS. DILLEY: Is more detailed. MR. SCHECHTMAN: So that the suggestion had been to eliminate starting half of line 2, going through the line 6 and removing that section, and then continuing the rest, the rest of the text, except perhaps the other comment was to change what was in lines 8 and 9. That was the, that was the suggestion from a -- comment -- more information in that, so I did. UNIDENTIFIED SPEAKER: You're going to have to put the language because everybody's computer I think printed out the lines differently. MR. JAFFE: I have them on different pages. UNIDENTIFIED SPEAKER: Unless you have drafts back there that we all should get. MS. SULTON: There are copies back there. It's just not in color. UNIDENTIFIED SPEAKER: It's not in color, I'm afraid. UNIDENTIFIED SPEAKER: Mine is not in color anyway, so -- MS. DILLEY: But then we'd all be on the same line on the same page. MS. SULTON: Should we take a moment to get -- just pass them out and make sure we're all on the same line? Michael. MR. DYKES: I would suggest that we stop after December 4th, 5th, 2003. I believe the next two bracketed text would take -- the next sentence the traceability and labeling -- bracketed text. So I think everybody here knows what AC21 Committee was. MR. SCHECHTMAN: Okay. Everyone fine with that? MS. DILLEY: Okay. MS. SULTON: No objections. MS. LAYTON: So deleting consisting of -- including representatives -- MR. SCHECHTMAN: Yeah. MS. DILLEY: Terry. MR. MEDLEY: I guess I'm just struggling a little bit with what we're trying to do. MS. DILLEY: Who needs a draft? MR. MEDLEY: In this process. UNIDENTIFIED SPEAKER: I do. MR. MEDLEY: Section here. Looks like we're just restating how the group worked, the number of calls we had. I mean I'm just not sure of what adds to value of what we're trying to do in the very beginning. I mean you had a charge which is very specific, and the fact that in response to that charge, you know, a group was set up to do the report. Then we kind of get into all these -- I'm just not sure of why this is necessary and what we're trying to achieve. MR. DYKES: I guess my sense was, Terry, I can agree where you're coming from, because I was just trying to follow this process, that's why I was deleting more rather than adding. I don't think you need much here other than -- MR. MEDLEY: In an introduction -- MR. DYKES: -- very succinctly -- MR. MEDLEY: on this report to have, you know, first thing you read is kind of -- it just doesn't go to substance. MS. FOREMAN: -- stop breathing. MR. MEDLEY: Okay, yeah, I mean -- MS. SULTON: Greg and then Pat. Greg. MR. JAFFE: I mean I guess I think it's helpful to talk -- I don't know how much process we need. I thought that the process that was written wasn't very well written. Some of the comments that Michael is suggesting were comments that I made in the draft. So I would kind of clean it up and make it more substantive in terms of talking about -- but I guess the point I wanted to get across somewhere in this document, and whether it's here or somewhere else, that I do think it's important that this report is based on the experiences of people around the table. And that doesnÕt -- it means that is primarily where it came from. We got -- we had a couple of experts, outside people make some presentations, but it is the thoughts and experiences of the people around the table. And so that to me is the one sentence or something that's got to be put in here. Because it isn't -- we didn't -- this isn't a report where we took lots of other evidence or we did an extensive literature search. It is what the people around the table, the experiences they've had with the traceability and labeling things. And so it isn't -- I don't want somebody to come back and say, we got Greece wrong or we got some country wrong in here. It's based on what we knew around here. And so that's what I wanted to get into the report for this paragraph. MR. DYKES: So the next two sentences go -- Greg, which one is yours, the blue one? MR. JAFFE: I don't have blue. MR. DYKES: Okay, number three on both are own experience. MR. JAFFE: Experience and expertise as well as information provided by outside experts, ex-officio members -- and experience. MR. DYKES: I'm fine with that. MS. SULTON: So we're suggesting the direct sentences before that be deleted in their entirety? MR. JAFFE: Right. MS. SULTON: Is everybody all right with that? UNIDENTIFIED SPEAKER: Uh-huh. MS. SULTON: Great. So we get down to the spirit of it rather than the step-by-step. Okay. MR. DYKES: So -- MS. SULTON: -- the same copy that you gave him. MR. DYKES: I would suggest we delete the next sentence, presentations. MR. JAFFE: Fine. MR. DYKES: And that -- work group met eight times. MS. SULTON: So delete everything down to the work group met eight times? MR. JAFFE: That's my suggestion. UNIDENTIFIED SPEAKER: Are you saying from beginning of Line 9 to the middle of line -- UNIDENTIFIED SPEAKER: Line -- MS. SULTON: Wait a minute. We've got -- we're going to have official lines, and I'll read -- MR. DYKES: Delete the bracketed presentations and ending with -- grain exporter. MR. JAFFE: That's why I suggested everybody have the same draft. MS. SULTON: It really would help. MR. SCHECHTMAN: Okay. I'll work with my black and white instead of my color one. (Simultaneous comments.) MS. LAYTON: All right, could I interrupt? Can I just -- I just want to remind everybody that this whole section was added in December, if I remember correctly, by a small work group that was charged -- UNIDENTIFIED SPEAKER: Right. MS. LAYTON: -- to go out and write the process, so -- UNIDENTIFIED SPEAKER: Right. MS. LAYTON: -- it has only been seen really this one time, so I think it is appropriate to do this. I think that there was a feeling that we did need a process piece in here. UNIDENTIFIED SPEAKER: Right. MS. LAYTON: So I just want to reiterate -- UNIDENTIFIED SPEAKER: Right. MS. LAYTON: -- we do need the -- MS. SULTON: And I think Greg was a member of that group. I'm not -- and the purpose was -- okay, well somehow it was expressed at that meeting we just needed to say how this was done, much as Greg said previously. So, Greg, I do now have the document that you're using which is -- we're going to use as the official document. So what line are you -- was that last change? MR. JAFFE: Michael was suggesting, Michael Dykes was suggesting that we -- Lines 9, 10 and the beginning, first four words of Line 11 be deleted. MS. SULTON: So beginning with presentations? MR. JAFFE: That's right. MS. SULTON: To the Committee, that whole sentence is gone. MR. JAFFE: Right, and everybody had agreed to keeping in the bracketed text that started the end of Line 6 and moved to the end of Line 8. MS. SULTON: So the text that begins members drew? MR. JAFFE: Essentially the work group members. It would delete the first bracket from the third word on Line through the -- near the end of Line 6. MS. SULTON: So it would then read beginning with Line 5, Work Group members drew on -- is that correct? MR. JAFFE: Yes. UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: That's correct. MS. SULTON: Okay. MR. DYKES: And then the next section starts with the Work Group met -- eight times. UNIDENTIFIED SPEAKER: Line 11. MS. SULTON: Which is Line 11 on the official text? UNIDENTIFIED SPEAKER: Right. UNIDENTIFIED SPEAKER: Yes. MS. SULTON: So nine is gone? UNIDENTIFIED SPEAKER: Yes. MS. SULTON: Okay. MR. DYKES: And I would suggest we keep the last -- well that's not bracketed, so we have finished the process. MS. SULTON: This was on the text though that we had not previously reviewed. So it's okay to look at all of this. MR. DYKES: Got one more sentence or one more -- three more sentences. MS. SULTON: Right, two more sentences. MR. DYKES: I thought they were bracketed, but they're not bracketed. So I'm fine with the way they are. MS. SULTON: Okay. Then move to scope. MR. MEDLEY: So are you going to read that or? MS. SULTON: You want me to read that? Okay. UNIDENTIFIED SPEAKER: Reading from two different -- MS. SULTON: To draft this report, a Work Group was formed after the AC21's third plenary session on December 4, 5, 2003. The Traceability and Labeling Work Group also benefited from the participation by ex-officio members of the AC21 and USDA staff. The -- MS. DILLEY: I think you have to take out the word also. That okay? MR. DYKES: Fine. MS. DILLEY: MS. DILLEY: No also. MR. DYKES: That's fine. MS. SULTON: So the Work Group -- UNIDENTIFIED SPEAKER: Members. MS. SULTON: -- members drew on both their own experience and expertise as well as information provided by outside experts, ex-officio members of the AC21 and employees of USDA with relevant expertise. That's a little bit redundant, isn't it? We said that before. The Work Group met via conference call eight times to discuss the mandate of the Committee and draft the report that would address the Secretary's charge. Okay. And then the last paragraph is accepted, is that correct? So moving to Scope. UNIDENTIFIED SPEAKER: Comments on Scope. MS. SULTON: Any comments on Scope? MR. MEDLEY: I think just the comment that Dick raised earlier when you say they -- putting it to the U.S. The report focused on the impact and implication on U.S. agriculture -- isn't that what we had said, we wanted to be very specific? Because it doesn't just fall to the U.S. agriculture. MR. OLSON: That's kind of covered there at Line 32, 33. MS. SULTON: Yeah. MR. OLSON: Impacts on U.S. agriculture and -- earlier MR. MEDLEY: I don't -- MR. OLSON: The next paragraph. MS. SULTON: It's the second paragraph. The paragraph right below. UNIDENTIFIED SPEAKER: Below that? MS. SULTON: In the second line, Line 32 on the official copy. MR. DYKES: I think, Terry, I'm with you, but I think if we put that up as we did in the very first line of the -- wherever we put it -- charge, introduction -- charge. I don't know if we have to go through and put U.S. -- MS. SULTON: -- very -- MR. DYKES: -- every single time when we refer to it. MS. SULTON: Right. MS. LAYTON: Should that second paragraph just move to the top? MS. SULTON: No. We've already said it in the, in the -- MS. LAYTON: Oh, okay, you're right, in the charge. MS. SULTON: Okay. Any other -- UNIDENTIFIED SPEAKER: We have a bracketed word in the first word in the first paragraph -- MS. SULTON: Michael -- UNIDENTIFIED SPEAKER: -- want that or not. MS. LAYTON: That's correct. MR. SCHECHTMAN: It's just -- strike it. MS. SULTON: Strike likely? UNIDENTIFIED SPEAKER: Strike likely? MS. DILLEY: Everyone okay with striking likely? MS. SULTON: So -- 37. Anything else on Scope? MR. HOISINGTON: A minor step. MS. SULTON: David. MR. HOISINGTON: In that second paragraph we say Advisory Committee and every place else we just say AC21, infer that those are the same. Wouldn't it be better to continue to use AC21? UNIDENTIFIED SPEAKER: Okay. UNIDENTIFIED SPEAKER: Yes, okay. UNIDENTIFIED SPEAKER: Either that or wherever we say AC21 the first time we put Advisory Committee -- MS. FOREMAN: That -- (Simultaneous comments.) MS. FOREMAN: -- gives us a little more flexibility of language. MS. SULTON: So going back to beginning of the text, the first time we mention it, we'll fix that. MR. SCHECHTMAN: Go back, and if no one will have objections, we'll try to make all that work. UNIDENTIFIED SPEAKER: All the same. MR. SCHECHTMAN: That will be, that will be a non-substantive change. MR. DYKES: We'd like to calculate it that way. UNIDENTIFIED SPEAKER: I'm sure you would. MS. SULTON: Okay, Greg. MR. JAFFE: Page 40 -- Line 41 on page 4, where underlined is this section. I think it should be changed to that section. On Line 43, I think it should say Section 3, comma, of the report delves into. I'd would delete the following section -- UNIDENTIFIED SPEAKER: Okay. MR. JAFFE: It's not the following. Section two is the following. UNIDENTIFIED SPEAKER: Okay, that's -- MS. SULTON: Thank you. MR. OLSON: Do we need to -- Section 2, 3, and 4 -- say the next section, do we need those descriptions? Can't we just say Section 2, Section 3, Section 4 -- UNIDENTIFIED SPEAKER: Right. MR. OLSON: And just eliminate the -- UNIDENTIFIED SPEAKER: Okay. MS. DILLEY: I like that too. Thank you. MR. JAFFE: And then on Page 5, Line 6, says the final segment. It's not a segment. Final section. MR. SCHECHTMAN: Well, we're going to get rid of that entirely. MR. CROWDER: Section 4. MS. SULTON: Okay. So we've cut that down, made it a little clearer. Any other comments on Scope before we move to Terms Used? Moving to Terms Used. The first one being approved products. It's red in mine. It means that wasn't in the December. MS. DILLEY: Yeah, it was not in the December, no. MS. SULTON: Was not in December. It was put in after the meeting, correct? UNIDENTIFIED SPEAKER: Correct. MR. CROWDER: I guess I, I guess I'm not comfortable with this definition, the second clause of the definitions. UNIDENTIFIED SPEAKER: And have been? MR. CROWDER: And have been granted authorization for food and/or feed use in a particular country or region. My memory, and I could be wrong, and if I'm wrong, then I wouldn't have an objection, but my memory this definition is used for not just products approved in other countries but also approved products would be considered something in the U.S., and the U.S. does not grant authorization for feed or feed use in an approved way. And so I'm comfortable with the first part we talked about having passed the necessary regulatory requirements, but I guess if we're just going to say just doesn't include the U.S. system, the I'm comfortable with it, but if it does include the U.S. system, I'm not comfortable with using the word approved products and the current definition that's been proposed. MR. SCHECHTMAN: Greg, could you just put a slash and/or have been granted? UNIDENTIFIED SPEAKER: In a particular country. MR. SCHECHTMAN: Are allowed? MR. JAFFE: They're allowed -- the point is n the U.S., they're allowed without having to go through the federal -- at least part of the regulatory system for food and feed. They can go without anything. So they don't need to -- this suggests if approved, it suggests that they went through something. I'm comfortable with it for all other countries. I'm saying but I think that we've used this term approved products especially in the adventitious presence and other sections as saying it's approved in the U.S., but not approved somewhere else. I'm comfortable with saying they passed the necessary regulatory requirements. To me that's ambiguous enough to say that some of those are mandatory requirements, some of them aren't mandatory requirements. MS. DILLEY: How about -- MR. JAFFE: I'm not comfortable with saying granted. The word granted to me authorization for food and/or feed suggests -- with the approval would suggest that. MR. DYKES: Why donÕt we change and to or. Does that take care? Does that fix you? UNIDENTIFIED SPEAKER: No. Greg. MR. JAFFE: What does that add? What's the difference with saying -- passed let's say regulatory requirements or granted authorization? MS. DILLEY: So just stop the -- MR. JAFFE: I'm suggesting just stop it after requirement. MR. DYKES: Oh, okay. I was just trying to find some solution to your -- MR. JAFFE: No, I'm just suggesting to stop it. MS. DILLEY: Dick do you have a -- MR. CROWDER: I was going to ask Greg about stopping there but going back and add regulatory requirements for food and feed use. MR. OLSON: Just cross out -- MR. CROWDER: Just cross out the approval. They passed the necessary regulatory requirements for. MR. DYKES: Food and feed -- MR. JAFFE: That's fine. MS. DILLEY: Okay. So -- UNIDENTIFIED SPEAKER: The whole -- clause and add -- (Simultaneous comments.) MR. JAFFE: Just those six words, just those five words, those five words. That's fine. MS. DILLEY: Okay. UNIDENTIFIED SPEAKER: That's fine. MS. DILLEY: Okay, got it. MS. SULTON: Moving on then. Anything in the biotechnology definition? Greg. MR. JAFFE: Okay. Well, my comments are the ones that were on the side here. I'm -- I still donÕt understand this definition. I wasn't in the group that came to it, but you -- it goes between -- biotechnology refers to the use of a range of tools, but then it says, we'll focus on a subset of these products. Tools and products are two different things -- and so -- MS. DILLEY: Okay. Can we just change that second word to tools instead of products? MR. JAFFE So is biotechnology the tools to make living organisms? Because -- and I don't have a solution to this because I really donÕt -- it just doesn't seem consistent to me. It says refer to range of tools, including -- to use -- tools to use living organisms. To me it's not the living organisms that's biotechnology. It's the tools. So it would be the technique. But then -- MR. SCHECHTMAN: Would it do it to say the AC21 will focus on products produced using the subset of these tools? UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: Yes. MR. DYKES: I would suggest, I don't know that we need all that. To me I thought we had three or four lines more than what we needed in there, of all the tools and all the different things in the first four lines. I would suggest we change it. Take -- put the word biotechnology in front of products and modern biotechnology and transgenic or genetically organism or their products are used interchangeably to refer to the use of genetic engineering or recombinant DNA processes, develop new varieties of plants or strains or microorganisms or animals. And delete those first five lines. MS. DILLEY: So you start on Line 20? MR. DYKES: I need to look at this. Where are we? Okay, yeah. Start on Line 20. MS. DILLEY: Would be -- MR. DYKES: And insert the word biotechnology. Delete in this report the terms, insert the word biotechnology, pick up the rest of that, and then use interchange -- refer to and insert the words the use of genetic engineering or recombinant DNA processes to develop new varieties of plants or strains of microorganisms or animals. And then keep that last sentence. MR. SCHECHTMAN: Can you repeat that again? MR. DYKES: On Line 20. Delete in this report the terms. Insert the word biotechnology. MS. DILLEY: In other words, pick up biotechnology in bold. MR. DYKES: Right. MS. DILLEY: Delete everything down to the word in italics products of modern biotechnology. MR. DYKES: Yeah. This is my suggestion. Of modern biotechnology and transgenic, parentheses, or genetically-engineered organisms, are used interchangeably to refer to, and then insert the words the use of genetic engineering or recombinant DNA processes to develop new varieties of plants or strains of microorganisms or animals, period. Delete the word organisms and then keep the next sentence, the term -- except where they're part of specific label indication. MS. MELLON: Well, I think, it seems to me that we couldn't write it like that, but we could, I think we could deal with Greg's problem by just, by just deleting the word these from Line 18. For the purposes of this report, the AC21 will focus on the subset products, namely those produced through genetic engineering or recombinant DNA processes and the derivatives of those products. I like including the notion that, that the focus is going to include the derivatives of the products. I mean that is a big part of the international debate, that you're not just looking at the organisms themselves, you're looking at the products, at the derivatives of those products, what they produce. And then it seems to me that we could, you know, we could go on. The rest of it seems, you know, useful to me to mention that there are several terms that are used interchangeably and that we're going to -- MR. SCHECHTMAN: Would you be okay, Greg, with deleting the word these? MR. JAFFE: No. I guess my proposal would be to -- it's -- would be it's so much more that first sentence. It refers to a use of a range of tools. I would say that alter, living organisms -- MS. LAYTON: It's the to use that's making -- MR. JAFFE: That's right. It refers to the use of tools to use living organisms to make or modify products, improve plants. I mean I like -- actually I like Michael's version of it, which was I was fine with Michael's version of it. The only thing Michael's doesn't capture is that biotechnology -- I mean I think his captures everything that needs to be captured. He could add in the derivatives. But I think what it doesn't capture is if you want to say that biotechnology includes traditional breeding. He's just limiting it to modern biotechnology. And that's what this report talks about. We don't talk about traditional breeding. So I'm comfortable with that. So if -- comfortable with not including traditional breeding, I think Michael's is fine, but I would either, if we're going to keep it the way it is, I think the first sentence would either have to refer to the use of a range of tools, including traditional breeding that alter living organisms to make products. Or I would just say -- or I would say is a range of tools including traditional breeding techniques that improve plants or animals or microorganisms, which is sort of what Michael was trying to get at. MR. DYKES: I was just trying to shorten it and be succinct with what the reports deal with. MS. SULTON: Terry. MR. MEDLEY: I think the -- in this definition, I think it's important to look at the range of tools. I mean obviously these terms genetically modified and how they are used normally. I mean the last -- report was very clear that that included broad-range and not just recombinant. I thought what we were trying to do in this definition was to give the readers that sense of the breadth of this, but that we were going to focus just on a subset with the specific modern biotechnology. And to me that sets a very helpful context for when you're looking at this. If you now delete that, I think that context is gone in terms of that. And for instance if we were looking at I guess Canada just an example, then Canada would say, yeah, I mean novelty is our trigger. So where are we? I think this context is important. I think you can do it with the suggestion, Greg, that you made in terms of just the lead-in that refers to the use of and get it out and just say it, you know, biotechnology is -- and come up with I guess -- language just so we keep that in. I mean I think the context is important. MR. JAFFE: So if we said biotechnology is a range of tools including traditional breeding that, colon, one, alters living organisms to make or modify products, two, improves plants or animals, or three, develops -- you have to have a verb there. You can't say develops microorganisms but some other -- to be parallel. Uses microorganisms for -- I don't know what it would be, but something like that might work. MS. LAYTON: Well, I think it's in plants, animals are microorganisms. MR. JAFFE: No. I think what it does is includes plants -- MS. LAYTON: Okay. MR. JAFFE: -- or animals, and I think any -- if you want to say includes plants, animals or microorganisms, you could do that, but -- MS. LAYTON: Yeah. MR. JAFFE: -- what it says here is develop microorganisms for specific uses. That's -- it's not referring to plants and animals there at least as written. It was -- MS. LAYTON: All right. Why don't you think that -- see, I'm not sure that it doesn't mean that you can't improve plants for a specific use. For example, Carol's work, I mean Carol's work was to put like things in tobacco, so that would be altering the specific use of that plant. MR. JAFFE: I'm not saying it doesn't. MS. LAYTON: Oh, okay. MR. JAFFE: I'm just saying -- improving plants and animals is I think sufficient in and of itself. You don't have to say for specific uses. MS. LAYTON: Okay. MR. JAFFE: I'm saying the way it was written, the sentence, it talks about develop microorganisms. I think that is referring only to the phrase specific uses of -- and the word developed there was put it. I'm not sure why it was put in, but it's confusing to me develop. What does it mean develop microorganisms? MS. LAYTON: So the alter living organisms or parts of organisms to make or modify products, improve plants or animals or microorganisms, period. UNIDENTIFIED SPEAKER: Plants, animals or microorganisms. MR. JAFFE: Yes. MS. FOREMAN: Would you read the whole sentence, please? MS. SULTON: Biotechnology refers to the use of a range of tools including traditional breeding techniques to use living -- MS. DILLEY: No, that alter. UNIDENTIFIED SPEAKER: That alter. MS. SULTON: That alter. You read it. MS. LAYTON: Biotechnology refers -- MR. JAFFE: Is a range of -- UNIDENTIFIED SPEAKER: Okay. MS. LAYTON: Is a range, is a range. Biotechnology is a range of tools, including, including traditional breeding techniques that alter living organisms or parts of organisms to make or modify products, improve animals, plant -- improve plant -- it would be and improve plants, animals and -- or microorganisms. UNIDENTIFIED SPEAKER: For specific uses? MS. LAYTON: No. MR. CROWDER: That changes the meaning of that. I mean I don't understand, not -- scientist to understand, but that does change the meaning of developing microorganisms for specific uses. UNIDENTIFIED SPEAKER: Right, that's a -- MR. CROWDER: I don't object. I'm just saying I just -- I'm pointing out something that will change the meaning of that sentence. MR. JAFFE: I'm having -- I have o problem having 3, 1, 2 and 3. MR. CROWDER: Yeah. MS. LAYTON: Okay. MR. CROWDER: But I think three was what was -- someone intended three when they wrote it -- changing to two. MR. JAFFE: I donÕt have a problem with that. MS. SULTON: Terry, did you want to comment? MR. MEDLEY: No. MS. SULTON: Okay. So the question is are they two -- MS. LAYTON: Okay. So you're -- let me go back. I think it would be then biotechnology is a range of tools, including traditional breeding techniques that -- UNIDENTIFIED SPEAKER: Colon. MS. LAYTON: Colon. MR. JAFFE: One. MS. LAYTON: One. MR. JAFFE: Alters living organisms to make or modify products; two -- MS. LAYTON: Products. MR. JAFFE: Two. MS. LAYTON: Comma, two. MR. JAFFE: Improves plants or animals. MS. LAYTON: Plants or animals. MR. JAFFE: Or three -- MS. LAYTON: And or three, develop micro -- develops microorganisms for specific uses. MR. JAFFE: Yes. MS. LAYTON: Okay. Everybody with that? All right. MS. SULTON: Three points. MR. SCHECHTMAN: Then in the next sentence, delete the word these. MS. LAYTON: Yes. MR. BUSS: Actually you could delete the -- you could just say this report will focus on the -- UNIDENTIFIED SPEAKER: Sure. MS. LAYTON: Okay. So starting the word -- the sentence with this report? UNIDENTIFIED SPEAKER: Right. UNIDENTIFIED SPEAKER: This report will -- MS. LAYTON: Of the AC21 -- UNIDENTIFIED SPEAKER: This report will focus. MS. LAYTON: Will focus. UNIDENTIFIED SPEAKER: Right. MS. LAYTON: And the next one do we need in this report? MS. SULTON: No. We suggested that that just say biotechnology products, no just, just products, start with the word products. MS. LAYTON: Products of modern biotechnology and transgenic or genetically engineered organisms or other products are used interchangeably to refer to these organisms. The terms genetically modified or genetic modification, GMO are avoided except where they are part of a specific label indication. Okay. UNIDENTIFIED SPEAKER: Okay. MS. LAYTON: Moving on. MS. SULTON: Any other -- oh, expansions, corrections, modification of terms. MR. DYKES: There are some square brackets in commercial risks. MS. SULTON: Commercial risk. In commercial risk. Okay. Dick. MR. CROWDER: My comments, the way it was originally written, the commercial risk was a, was a definite -- UNIDENTIFIED SPEAKER: Thing. MR. CROWDER: Term. Risk is an indefinite term by definition, and so I think it referred -- my comments were, and I'll read it as -- commercial risk refers to the financial exposure undefined and all potential losses undefined associated with the sale, transport, shipment or use of the grain or grain products resulting from contracts or other mechanisms. Which when you, when you enter into a contract, you accept certain risks, you pass certain risks on or whatever under mechanism -- MS. LAYTON: So you're suggesting to just release the first bracket, contractual liabilities and let it go from -- MR. CROWDER: No. Contractual liabilities, if there's contractual liability basically you know what they are. I mean -- MS. LAYTON: Yeah. MR. CROWDER: -- it's a specificity. MS. LAYTON: So just eliminating the bracketed term -- MS. SULTON: The bracketed term liabilities. And with that the definition is sufficient? Okay. UNIDENTIFIED SPEAKER: Is everyone okay with that? MS. SULTON: Everybody all right with that? Okay. I donÕt' see any shaking -- There's also bracketed text in the grain and grain products definition. MR. SCHECHTMAN: And there's a comment on that one too. MR. JAFFE: These were my comments. MS. SULTON: Yes, Greg. MR. JAFFE: One, I thought that this was too restrictive. It doesn't seem to, it doesn't seem to include corn flakes, and seems like seems like on the labeling system we talked about permanently labeling of finished products, not of commodities. We're not talking about commodity shipments. We're talking about things that the EU and things like that that get on the consumer shelves, and this didn't seem to cover that. Secondly, I didn't like the way it was defined where it said -- I mean grain and grain products, we talk about them relating to conventional grain and grain products throughout the report. We're not talking about them in this definition. Only talked about it as -- in terms of biotechnology products. So it seems to me the definition should sort of say something along the lines of grain and grain products, referring to canola, corn, wheat, soybeans. If there are any other commodity grains that I'm missing, we add them in, and the products or ingredients derived from them, including finished foods, and leave it at that. MR. SCHECHTMAN: Yes. Those were the -- those words were the bracketed words that -- some of the bracketed words that are in there are things that I meant to italicize that I had added in response to your comment. MR. JAFFE: Right, but I would delete any mention of biotechnology in this definition. I donÕt think there's a need for biotechnology in this definition, and I wouldn't, I wouldn't limit the grain and grain products to canola, corn and soybeans, but there are others. Wheat is I know a grain product, and I donÕt think cotton is, but, but if there's other ones that could be considered -- there are farmers around the room who know better than me what we would consider grain and grain products. MR. DYKES: Why donÕt you reread that, Greg. What did you delete? MR. JAFFE: I would, I would say grain and grain products would be first to I believe the majority of current biotech products. MR. SCHECHTMAN: To products? MR. JAFFE: To -- well, grains are -- refers to corn, canola, soybeans, wheat. MR. DYKES: Why donÕt we just say et cetera? Can we do that? MR. JAFFE: That's fine, but I would include wheat. I mean if we know them, if we know -- MR. DYKES: So canola, corn, wheat and soybeans, et cetera? MR. JAFFE: And products or ingredients derived from them, including finished foods. MR. DYKES: Agree. MR. CROWDER: Just a minute before you go to -- if you know the products, and you know we can list lots of grain in here, sorghum -- that goes on forever and ever. I -- MS. SULTON: That's what we said -- MR. CROWDER: Well, but I think you wanted to, you wanted to specifically list -- MR. JAFFE: I don't care. We can put an et cetera in there, but we know one, wheat. I mean I don't think it should just be listing the biotech ones because they're -- we're not referring here. The definition is not referring solely to biotech. By only putting corn, canola and soybeans, you suggest that it's -- even if you don't -- the word biotechnology. MS. LAYTON: Why don't you take out canola and just put corn, soy -- wheat, corn and soybeans. UNIDENTIFIED SPEAKER: Et cetera. MS. LAYTON: Et cetera. MR. JAFFE: That's fine. MR. DYKES: And then we're going to drop current biotechnology products. MR. JAFFE: Right. MS. LAYTON: So it refers to products with food or feed uses on the market. UNIDENTIFIED SPEAKER: Plant-derived products? MR. JAFFE: No, I just -- I wouldn't say that. MS. DILLEY: Wheat corn -- MR. JAFFE: -- refers to wheat, corn and soybeans and the products or ingredients derived from them, including finished foods. We donÕt need food and feed uses. MS. LAYTON: Refers to wheat, corn, soybeans, et cetera, and products or ingredients derived from them, including finished foods. MR. JAFFE: Period. UNIDENTIFIED SPEAKER: Period. UNIDENTIFIED SPEAKER: Period. MS. SULTON: Is everyone okay with that? UNIDENTIFIED SPEAKER: Let's see how it plays in the rest of the report. UNIDENTIFIED SPEAKER: Yeah. MR. SCHECHTMAN: And because it seems to me like we specifically had arrived to this grain and grain products definition and put brackets around it to define our discussion. UNIDENTIFIED SPEAKER: Right. UNIDENTIFIED SPEAKER: So let's see how it plays in the report. I -- but I -- we may be coming back to this. MR. JAFFE: That's fine. MS. SULTON: Okay, so moving -- if necessary. The next definition also has bracketed in it the word participants versus companies and individuals. Beginning on Line 38 on the official copy. UNIDENTIFIED SPEAKER: Which was originally? MS. LAYTON: It originally was -- first of all the players that are involved in bringing food and feed products to the consumer. MR. DYKES: I think we changed the participants at the last meeting. MS. LAYTON: Meeting, right. MR. JAFFE: The December 28th draft -- individual. MS. SULTON: The January 28th document. MR. JAFFE: No, the December. UNIDENTIFIED SPEAKER: The December. MR. JAFFE: 22nd maybe it was. But the -- UNIDENTIFIED SPEAKER: Yes. MR. JAFFE: -- December 22nd draft that came out after the meeting. UNIDENTIFIED SPEAKER: Yes. And then there was a suggestion -- MR. JAFFE: I guess somebody else suggested changing that to participants. Not me. UNIDENTIFIED SPEAKER: Right. MS. SULTON: So is companies and individuals fine or do we want to change it to participants? MR. BUSS: The alternative of just reordering the sentence saying industry or the food, feed supply chain refer to all of the technology providers, seed breeders and producers -- wholesalers and retailers that are involved in bringing food and feed products to the consumer. MS. LAYTON: Okay, so move that phrase that are involved in bringing food and feed products to the end, and so industry or the food and feed supply chains refers -- MR. BUSS: Refers to all of the technology providers, seed breeders, and just continue on where it says retailers, and then bring down that are involved in bringing food and food products -- UNIDENTIFIED SPEAKER: Okay. So I deleted participants, companies and individuals and the word including, and I moved that are involved in bringing food and feed products to the consumer to the end. Much easier? UNIDENTIFIED SPEAKER: Fine. MS. SULTON: Okay, everybody all right with that? Yeah, Daryl. Thank you, Daryl. UNIDENTIFIED SPEAKER: Traceability. MS. SULTON: Do you have something on that one, Randy? MR. GIROUX: Square brackets around -- given in the -- example. MS. SULTON: Right. MR. CROWDER: I've got a question on that. Are we mixing -- I ask the question because I wasn't part of the discussion last time. Are we mixing apples and oranges when we make an analogy between the living requirements of bioterrorism for security purposes versus tracing and labeling required for something else? MR. DYKES: I guess my -- I would kind of concur with Dick. I think we should delete the example. I don't think that the example -- UNIDENTIFIED SPEAKER: I agree. MR. DYKES: I don't think it's in context. MS. SULTON: You concur with that, Randy? MS. MELLON: -- but I think it's relevant that traceability requirements are not biotech-specific. And we say that in a number of cases, and that in fact they are out there -- that the U.S. is imposing traceability requirements for other reasons, some on the grain, and that does offer some opportunities, I think, to the Department to think about how, you know, what tools it has available to it to think about how to address traceability challenges in the biotech context. I wouldn't, you know, I don't know whether the concern is simply that you don't want bioterrorism in the same kind of report with biotechnology, but I think that in general the point is a very sound one, that there are other reasons out there that traceability requirements are being imposed on the very system we're talking about. MS. SULTON: So is the issue that we put too much emphasis here as opposed to just listing a series of instances where traceability might kick in? Randy? MR. GIROUX: This is the definition section. I think there is in the report a -- that there is a section in the report that talks about -- that addresses all of those things. This is just supposed to be the general definition for traceability and not I donÕt believe -- UNIDENTIFIED SPEAKER: So we -- MR. GIROUX: -- in the report. So I would just reiterate we strike this example because if we're going to start talking about examples, we've got to list a whole bunch of examples. MS. SULTON: Right Terry. MR. MEDLEY: I had two comments on first sentence. One, the word reconstruct; and, two, if required. I'm just wondering how that discussion came about, because it seems to me that everything that's here would be traceability refers to the ability to document a history of the origin of participant steps handling involved in the production of food or feed products. UNIDENTIFIED SPEAKER: That's true. MS. LAYTON: To document instead of to reconstruct it? MR. MEDLEY: Yeah, yeah. MR. CORZINE: I concur. MR. MEDLEY: You're going to reconstruct it, but you're going to use documentation to do that. MS. SULTON: And you also objected to if required. MR. MEDLEY: Yes. MR. OLSON: It's traceability whether it's required or not. MR. MEDLEY: Exactly. MS. LAYTON: Okay, and then if this example is needed back there in that section, because I'm like Randy. I remember that section. If we needed something like that, that would be a more appropriate place for putting this rather than in the definitions. MR. DYKES: Yeah, or to Mardi's point going through several examples. MS. LAYTON: Several examples. UNIDENTIFIED SPEAKER: At that point. MS. LAYTON: At that point. UNIDENTIFIED SPEAKER: Here you would just see a very short traceability -- MS. SULTON: Mardi, you okay with that? MS. MELLON: Fine. MS. FOREMAN: We're through with that section? MS. SULTON: Yes, Carol. MS. FOREMAN: I think because this is going forward as a separate report and because -- and then labeling, talked about information appears on products offered to consumers, I think we need a brief definition of consumers so there's a separation between the word customers and consumers, and we came up with one in the Issues Group, and I was just looking to see if I can find it with just a quick -- customers and consumers -- retail and -- I'll find it in a minute. MS. DILLEY: So adding a new definition to the -- MS. LAYTON: While you're looking for that and we're at that section change, it is 10:15 and we are late for our break. I recommend that we take a five-minute break and hope that you will be back here in 10 minutes. Carol has a -- wait, Carol has a -- MS. FOREMAN: David says that in the definition section -- there is a definition for retail consumer which is -- MS. LAYTON: So that's a definition document. (Simultaneous comments.) UNIDENTIFIED SPEAKER: So is the person who personally uses or consumes a good or service from a retail establishment. UNIDENTIFIED SPEAKER: That's a retail consumer. UNIDENTIFIED SPEAKER: That's a retail consumer. UNIDENTIFIED SPEAKER: And then customers -- customers are individuals or groups who purchase, are provided with or use products and services. So that would be those two definitions. UNIDENTIFIED SPEAKER: Yes. So moving the retail consumer -- (Simultaneous comments.) UNIDENTIFIED SPEAKER: So is everyone okay with adding those two definitions? Any objections? Okay, 10 minutes. (Whereupon, a brief recess was taken.) MS. LAYTON: I have section on adventitious presence. That section is on page 15, I think. It's Section 3 beginning on 15 on one document. I'm looking on the other document. UNIDENTIFIED SPEAKER: ItÕs here, 15. MS. LAYTON: 15. So if everybody can join us, get those -- page 15, Section 3, Adventitious Presence. MR. OLSON: And we're coming back to the other one sometime too, right? MS. DILLEY: We'll go back. This is the new stuff so. MS. DILLEY: WeÕre taking a circuitous path. MS. LAYTON: This is the stuff that has not been discussed totally. It was new material that Randy, you and Greg, Greg and Randy. MR. JAFFE: Primarily Randy. I'll give him the credit. He did a great job. No, I don't mean that negatively. I mean -- UNIDENTIFIED SPEAKER: Raise your hand and salute to Randy. MR. JAFFE: It's good. (Simultaneous comments.) MS. LAYTON: Okay, Cindy. MS. SULTON: Actually Abby. MS. LAYTON: Abby's going to do it. Sorry. MS. DILLEY: So if you turn to page, what's page 15 on at least the draft -- at the back table, 3A was adventitious presence. And for those of you who were not in the room, yes, we will come back to Section 2, but we want to go to Section 3 first because this is new material, so per the -- the request was after discussion of this section during the December 9 and 10 meeting, there was an assignment requested to give to Greg and Randy to rewrite the section per the discussion. So that's what you have before you. And so if you'll turn to that and see what comments you have. It goes from page -- page 14 through 19, and then what that section is replacing is 19 through 21, I think. Yeah. MR. GRANT: Can I ask one question? What are we doing with the comments in between -- MS. DILLEY: We'll come back. MS. LAYTON: We'll come back to it. MS. DILLEY: Randy. MR. GIROUX: Just one comment. When Greg and I went to rewrite this section, we took the original material and all the ideas and suggestions that people had wanted to see in the section, and you'll see it's a complete rewrite. We took a lot of effort to make sure that none of this -- none of those notions or ideas are lost, and they are all in here somewhere as to the best of our ability. Nothing was added. It's just reorganizing what -- MS. DILLEY: Heavy editing exercise. MR. GIROUX: Heavy editing. MS. DILLEY: Okay MS. DILLEY: people have comments on that section? Terry, you want to start? MR. MEDLEY: Yeah. I think that under adventitious presence, the term adventitious presence in the context of plant biotechnology -- that last sentence, we say the key components of the definition are small and unintended. Small is nowhere in the definition. I would propose we say the key components of the definition are low levels and unintended. Because small is a new term that we are introducing. MS. LAYTON: Should those be in quotes? I'm sorry. Should the word low levels and unintended be in quotes as -- MS. DILLEY: Yes. MS. LAYTON: -- they are used in that key component sentence? MS. DILLEY: Yes. DR. SCHECHTMAN: Unintentional -- MS. LAYTON: And unintentional. MR. CROWDER: Well then, not to be jumping around, when we get back to executive session, the word small and so forth is in the definition -- executive session. MS. DILLEY: You mean in the executive summary, which we haven't done yet. MS. SULTON: But we'll make a note to make sure we're consistent. Mardi. MS. MELLON: I just had a question on page 16, lines 3 and 4, there are references made to how did they call -- allowances for adventitious presence in the current grain system. Now the examples are for foreign material and grade number one corn and grade number five corn. I don't think that that's the relevant -- UNIDENTIFIED SPEAKER: Example. MS. MELLON: Example. I mean you want -- what are -- what -- I think you need to -- it would be better to know what are the tolerances for, you know, for soybean and corn or for other varieties of corn in some situation where you're making representations about variety. I mean this -- what foreign materials, like grain -- UNIDENTIFIED SPEAKER: Rat pellets. MS. MELLON: Yes. Well, that doesn't seem to me to be what you're looking for here. UNIDENTIFIED SPEAKER: Material includes everything. UNIDENTIFIED SPEAKER: Corn includes everything. UNIDENTIFIED SPEAKER: Includes everything, soybeans, canola, rat turds, the whole -- UNIDENTIFIED SPEAKER: A non-variety, variety, anything. UNIDENTIFIED SPEAKER: Broken kernels. MR. GIROUX: It includes everything. It's the general term, includes everything that's not dust. MR. JAFFE: -- not grade one corn or is it just any kind of corn? (Simultaneous comments.) UNIDENTIFIED SPEAKER: It's never zero. UNIDENTIFIED SPEAKER: Right, but I thought -- I understood -- and I'm not knowledgeable about this one, says number one grade corn. It's not just the amount of foreign material, but also it's a certain kind of corn. Or it's not? UNIDENTIFIED SPEAKER: No. UNIDENTIFIED SPEAKER: No. UNIDENTIFIED SPEAKER: Only difference is the amount of foreign material. UNIDENTIFIED SPEAKER: Correct. MS. MELLON: Isn't there yellow corn number two? Isn't that a standard -- how much white corn can you have in yellow corn number two. UNIDENTIFIED SPEAKER: It doesn't break it out that way. MS. MELLON: It doesn't? UNIDENTIFIED SPEAKER: There's a certain amount of foreign material could be in yellow number two. UNIDENTIFIED SPEAKER: Which could be -- it could include soybeans. MS. DILLEY: So is the terminology foreign material, it's not, it's not -- doesn't go into enough detail to make that a good example? MS. MELLON: I just -- I don't know what it means. UNIDENTIFIED SPEAKER: What page is that on? MS. MELLON -- certainly isn't, you know, 7 percent foreign material in yellow whatever it is in number five grain, I don't think that that's relevant to trying to decide, you know, what sort of tolerances might be appropriate in the situations that we are discussing. MS. DILLEY: Are there other examples you wanted to -- MS. MELLON: Well, I don't know about -- MS. DILLEY: -- explaining foreign materials. MS. MELLON: Maybe you need to explain foreign material. Maybe I just misunderstood the kinds of tolerances that are out there. MR. DYKES: That's what I was going to -- I think what Mardi's suggestion is incorporate in the definition the foreign material. It's just not in this document. So we need to describe, that's what I'm hearing, to describe the foreign matter, foreign material includes such things as soybeans, other grains, cracked kernels. MS. MELLON: And I think the other thing we need is who sets those standards? I mean are these GIPSA standards, are these conventional and agreed-upon standards? Who sets the standards for -- MR. OLSON: USDA -- MS. MELLON: Okay, these are US -- these are USDA established allowances for foreign material in grain commodity grain. MR. DYKES: For example, USDA number one, yellow grade corn and USDA number five grade corn. MS. DILLEY: So the, so the two things we need to add into this definition or example is to explain foreign material and what that may include, and then also that they're established by USDA -- MR. OLSON: I just wonder if it would be better to make a broader -- tolerances for insect fragments or tolerance for various -- rather than just corn. Because corn you can make FM. MS. MELLON: What's FM? UNIDENTIFIED SPEAKER: Handling it, to create -- just by handling -- without -- MS. MELLON: What does FM mean? MR. OLSON: Foreign material. UNIDENTIFIED SPEAKER: I thought it was a radio station. UNIDENTIFIED SPEAKER: That too. Actually -- MR. OLSON: -- broken kernels, foreign material, so but when you handle corn, you create broken kernels every time you handle it, so your FM goes up and from a grading standard. You can make number two corn into number three corn just by handling it. MR. GRANT: So I'm curious, Ron. I think that maybe a better example to use that might be more relevant to the discussion would be the -- an example around contrasting classes versus foreign material. Contrasting classes has a tighter parameter as defined -- at least in my experience. MS. LAYTON: Doing what would that look like then -- MR. GRANT: If you're selling -- MS. LAYTON: -- example? MR. GRANT: -- hard red wheat and you get white wheat mixed in, that's a contrasting class, and the tolerance is tighter, and it's defined. UNIDENTIFIED SPEAKER: Want to come up with a sentence for us, Duane? MR. GRANT: No. MS. DILLEY: Well, I mean I -- better example because I think it's trying to -- if it's the example that's confusing, it doesn't really help to explain what -- MR. GRANT: Well, to me it's a better example because it's wheat versus wheat. You know, in my example it's wheat versus wheat, it's not wheat versus rat turds, somebody else's example. I don't want to get that on the -- UNIDENTIFIED SPEAKER: Too late. MS. DILLEY: So maybe change it to wheat, a wheat example where you're talking about red meat and some wheat meat -- UNIDENTIFIED SPEAKER: White wheat. That will be chicken or pork. MS. DILLEY: Gets mixed in. Can you come up with a couple of sentences or -- MR. GRANT: With Dick or somebody who is in the trade we could. I'm actually not sure what those tolerances are. I know that they're different than foreign material, and they're, they're defined. MR. JAFFE: I don't think you need the number. I think you just -- don't have to say it's 3 percent -- to say that in order that to market red wheat, there's a limit to how much -- the tolerance set as to how much white wheat can be in it or something like that. MS. DILLEY: Wait a minute. Let's get Juan and then -- Daryl -- MR. ENRIQUEZ: You know, I don't think this is one size fits all. One of the things that you don't want to happen is to set a tolerance and then have something that doesn't work, because then every system suddenly doesn't work. Therefore, I'm jut thinking through -- we set a tolerance and then there's a horrible incident in canola or whatever and what you don't want is the next day to have everybody say we're going to put 00000.1 percent tolerance across the entire system. I think what you want to do is you want to set a tolerance that reaches a general tolerance level and then a tolerance level for things that you're worried about. So it's almost -- so for in general for these things the tolerance level is this or these types of things. Call it StarLink. Are you going to say that there will be absolutely no StarLink in the system for the next 10 years. Let's set that as your standard for all grains. Are you going to set it won't be more than 1 in 10,000 or 1 in 100,000. And then for something that is different than that, even for -- chemical industries -- I think it's important not to say it's a 1 percent tolerance but for this type of stuff it's 1 percent, for this type of stuff it's 1/10th of 1 percent, for this type of stuff it's 1/1000th of 1 percent. Because otherwise you're -- situation where something goes wrong one day and then the tolerance level for everything comes down overnight, if you set one tolerance level. MS. DILLEY: Yeah, I think this is -- recommendation for a policy -- trying to give an example of, and it sounds like if we can come up with a red wheat, the red wheat example and just in terms of is that again GIPSA, the USDA sets a tolerance -- UNIDENTIFIED SPEAKER: Yes. MS. DILLEY: -- for hard red wheat to allow how much -- is found in that. MR. GRANT: We can come up with an example. DR. SCHECHTMAN: The point that was taken, are the numbers really critical as much as -- MR. GIROUX: I'd like to make a recommendation. Just drop the numbers and perhaps use a sentence with respect to grain for example USDA grade standards -- respect to grain USDA has set grade standards for no more than -- grade standards for foreign material. Foreign material includes things such as broken kernels, grains of other types. I don't want us to spend too much time on just -- MS. DILLEY: Right. MR. GIROUX: -- an example. MS. DILLEY: Right. Okay. MS. LAYTON: Okay, so where you're starting is with respect to grain the USDA has set grade standards for foreign material. Foreign material includes such things as, and then give a few on the list and end that paragraph. MR. GIROUX: With respect to grain, for example, the USDA has set -- DR. SCHECHTMAN: And such things as broken kernels, grains of other types, et cetera. MR. GIROUX: Grains of other types, et cetera. MR. DYKES: Does grains of other type mean corn and soybeans or is that grains of other species? MR. GIROUX: Grains of other types. MR. DYKES: Other types? UNIDENTIFIED SPEAKER: Both. MR. DYKES: Why don't we use GIPSA's definition of foreign material. Just use their definition. It's there. DR. SCHECHTMAN: Okay, we'll get GIPSA's definition. Everyone will be okay with just getting the text verbatim and sticking it in? We can -- UNIDENTIFIED SPEAKER: Yes. MS. LAYTON: Can we figure out what we're doing on the first page though on 15? There's a bracket on it also occurs due to the biology of plants. Is that in or out? MR. JAFFE: I think it should be in. UNIDENTIFIED SPEAKER: Yes. MS. LAYTON: Okay. In? Nods. Yes. Okay. MR. BUSS: Not on that point so -- UNIDENTIFIED SPEAKER: I know. MS. DILLEY: Okay, next. MR. BUSS: Well after getting back to -- discussion, I -- play the devil's advocate and say how valuable is the example anyway, because if you look at page 15 from lines let's say 39 to 43, I think it does a pretty good job in terms of talking about adventitious -- different products, allowances, et cetera, et cetera -- that establish allowances -- do we, do we really need the example at all? MS. DILLEY: So question whether we need an example, and if we do have the example, then we go Randy's route of just taking out the numbers and going to foreign material? So any reaction to -- MR. DYKES: I guess I'd just add one. I think if we look at this Committee and the confusion here about the fact that soybeans can be in corn shipments and some of those kinds of things, I think it is important for the readers of this document to realize that even in our current system -- MS. DILLEY: Right. MR. DYKES: -- it's okay to have 2 percent or 5 percent something else in corn and still be corn or wheat and still -- red wheat and still be red wheat. MS. DILLEY: So the example serves a purpose and let's go the route that Randy had suggested. MR. DYKES: That would be my suggestion. MS. DILLEY: Okay. Dick, any further -- anything further on that point? MR. CROWDER: Well -- MS. DILLEY: So that's what I would suggest we do at this point. MR. CROWDER: If we're, if we're -- okay. If we're going to use examples, I need to check some language because the seed example is not certified seed. It's labeling consistent with the Federal Seed Act. MS. DILLEY: Right. MR. CROWDER: Bottom of page 15, line 44. MS. DILLEY: Okay. MR. CROWDER: There's, there's a -- MS. DILLEY: So can you take that -- is there a need for that example -- it's a different example on the bottom of page 15, which is 5 percent of corn seed is allowed, that -- MR. CROWDER: You can have all types and still label it as corn seed and don't have to label it as mix or anything else. It's labeled as corn seed. You can have 5 percent off-types, but that seed is -- does not necessarily mean it's certified. Certified is a specific process that we don't use in the U.S. as much as -- MR. JAFFE: -- label as corn seed then? MS. DILLEY: So take the word certified? MR. GRANT: Not only corn seed. It's a specific variety of corn seed. MR. CROWDER: Yes, it's a hybrid. I mean it's -- MR. DYKES: Labeled as a specific corn variety. MR. GRANT: 3223 has to have 95.1 percent, 3223 can have 4.9 percent -- or whoever. UNIDENTIFIED SPEAKER: Or soybeans or whatever. UNIDENTIFIED SPEAKER: Specific corn variety. MS. DILLEY: Is still labeled as a specific corn variety seed. UNIDENTIFIED SPEAKER: Hybrid seed to start with. MR. GIROUX: Seed corn variety. MS. DILLEY: seed corn variety. UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: And that's required by the Federal Seed Act. MS. DILLEY: Got it. All right, got it. Okay, so I think we fixed that in both examples. Greg, I think you were next, and then Dave. MR. JAFFE: Just my -- this is sort of in that -- same paragraph. I would -- I'm the one who -- the reason the language says adventitious commingling in some places and adventitious presence in other places. And so I think that that allowance for -- on the top of page 16 in the first sentence, it should say allowances for adventitious commingling also exists in grain and food, and what comes behind this, and I've talked to Randy about it, is I mean I just -- we've defined AP as biotech, and so when we're talking in these introductory paragraphs more generally, I have to have a different term. And so I came up with the term adventitious commingling. MS. DILLEY: Okay. MR. JAFFE: So by -- there plus in the next paragraph where it says some amount of AP, again it's got to be some amount of adventitious commingling. we're talking about a generic statement not about biotech. We're talking about -- MS. DILLEY: Right. UNIDENTIFIED SPEAKER: Right. MS. DILLEY: You're talking about commingling broadly. MR. JAFFE: Broadly. And then -- MS. DILLEY: And not -- MR. JAFFE: And then once we get into the 1, 2, 3, 4's, I think we're fine to use AP because then we're talking specifically about biotech events. MS. DILLEY: Right, got it. MR. JAFFE: And that's what our definition is in the first -- MR. CROWDER: I've got some reservations about that. MS. DILLEY: Why? MR. CROWDER: Commingling to me is an active act. MS. DILLEY: Can you come up with a different term? You see what Greg is trying to -- MR. CROWDER: Well, I have a problem going back way back when adventitious presence is defined as biotech only. Biological processes are -- is not commingling. And we've defined that in here. MS. DILLEY: Well, I think what we're trying to do though, Dick, as I -- is to define the term as it's used in this report and that this report only addresses adventitious presence, but adventitious presence or commingling is broader than just biotech. So we need to sort through that so that we're clear we're talking about what we're talking about when we're talking about -- MR. CROWDER: Well, as long as we don't talk about commingling because that -- MS. DILLEY: Then what's a different term? I think Greg, not -- to commingling, it just has to be -- UNIDENTIFIED SPEAKER: Presence. UNIDENTIFIED SPEAKER: Presence. UNIDENTIFIED SPEAKER: Presence. MS. DILLEY: Okay. MR. JAFFE: But then you've got to redefine -- I'm fine with them. Dick, I've never liked the definition being biotech specific either. MR. CROWDER: I don't, I, I -- MR. JAFFE: But I agreed to it as long as -- DR. SCHECHTMAN: Can I make a suggestion that instead of saying commingling, which is active, that we just say adventitious material? MR. CROWDER: We're talking about adventitious presence. Why don't we call it adventitious presence? I mean we're trying to make something out of something that -- MS. DILLEY: I think it's because we're -- adventitious presence, for my understanding is a much broader issue than not just biotech-related, and we're defining it specifically for when we're it to presence of biotech material in this report. Is that right? MR. CROWDER: I would like to make a -- I'd like to go back and define adventurous presence. in the broad sense like we had it in the original AP section. In the case of biotech it refers to, is what it was said, and then you've got both of it covered. UNIDENTIFIED SPEAKER: Yeah, yeah. MS. DILLEY: Okay, so -- MR. JAFFE: I hade no problem with it back then. MS. DILLEY: Okay. MR. JAFFE: We didn't like it back then because we used the word I think it was unwanted, and people didn't like the fact that we had to differentiate between adventitious presence for biotech and non-biotech. And so that's how we got rid of -- MS. DILLEY: Okay, so now -- MR. JAFFE: I was very comfortable with the original -- MS. DILLEY: If everybody is comfortable -- does anybody have an objection to going back to the broader definition then? UNIDENTIFIED SPEAKER: Unwanted for any reason? MR. CROWDER: My understanding of what we changed was -- and then we came back and we dropped the broader definition, is that some members of the group did not want to use the word unwanted, and I said from that -- and some other people also said, unwanted to drop it is okay. But I didn't recall the discussion at that time being that we were going to drop the broader definition of adventitious presence. That we were just going to drop the unwanted from the broader and the narrow, narrower definition, with the unwanted dropped out. That was my understanding, and then we've gotten to the point now where we've dropped the unwanted and limited only to biotech, which I don't think is -- somebody may disagree with -- MR. JAFFE: I'm not sure what you're proposing. MR. CROWDER: To go back to the original definition of adventitious presence is small amount of unintended material in -- I don't recall the exact words. DR. SCHECHTMAN: Feed, grain or -- MR. CROWDER: Seed, grains, feed, what -- MS. DILLEY: So it would start -- MR. CROWDER: -- in the case of biotech it refers to. MS. DILLEY: Okay. So in this -- MR. JAFFE: I think you need that unwanted or something there in it, because it's -- MS. DILLEY: Okay. MR. JAFFE: -- unintended. It is something that somebody doesn't want there. So I'm comfortable with it. When we say it's transgenic, then that's the -- that, defining -- what it is in the case of biotech, it's -- MS. DILLEY: Okay. MR. JAFFE: -- not -- you need something else in here. So I'm comfortable going back to that, but you need to put something in there for the general one that talks about it's more than just unintended. It's something that isn't supposed to be there. You have to have -- you have to somehow describe it that way. MS. LAYTON: Okay, how would you go back to page 31 and let's take a look at that, line 31 on page 15. MS. MELLON: I would argue that you could use the word unwanted and it's not pejorative. I mean you -- the fact that you don't want soybeans in your corn does not -- is not a slur on soybeans. Some things are simply not wanted in certain places at certain times for all kinds of great reasons. MR. VILKER: Are we confusing unwanted and unaccounted for? MS. DILLEY: So if you go back to line 31, the term adventitious presence and then refers to unintentional low levels of material in seed, grain or food and feed products the -- UNIDENTIFIED SPEAKER: If it's -- MS. DILLEY: -- or low levels -- (Simultaneous comments.) MS. DILLEY: Wait a minute. And then in the case of biotech, and then you need some qualifier in terms of biotechnology, is that what you're -- MR. JAFFE: No. We need a qualifier for the general one. The biotech one is automatically it's unintended low levels of transgenic materials. You know what the defined thing is. To say the general one is unintended low levels of material. UNIDENTIFIED SPEAKER: Foreign material. MS. DILLEY: Foreign material. MR. JAFFE: You have to have some -- but it's not just foreign. It could be corn in corn. It's unwanted. It's -- MS. DILLEY: That's -- but you've already -- you can define foreign. (Simultaneous comments.) MS. LAYTON: Okay. Could we have a little group do this at lunch and come back with some language? MS. DILLEY: -- no. MS. LAYTON: No? UNIDENTIFIED SPEAKER: We're so close. MS. LAYTON: We're so close. Okay, so what do we suggest? MS. DILLEY: So go with then the term adventitious presence refers to unintentional low levels of foreign material and define it up there what foreign means? MS. MELLON: We donÕt really want -- do the biotech folks here really want their products considered as foreign material? MR. JAFFE: The transgenic one is just foreign, but the specific kind of foreign just being transgenic. want MS. MELLON: I mean I -- you know, if I were on your side of the fence, I would not want my product -- I'd much rather have it say unwanted for some reason than have it encompassed in the term foreign, along with the other things that we now know are in foreign -- MR. DYKES: Did we take the word transgenic out from the materials? MS. DILLEY: What I'm trying to resolve is talk about adventitious presence or confining that particular to biotech, and then if we're not -- because commingling is not what people want. So what we're trying to figure out is how are we defining it, and then what do we need throughout the documents to distinguish -- if we do need to distinguish it, to distinguish it. MR. CORZINE: Isn't the term unintended is pretty universally used in definition of adventitious presence, I think. DR. SCHECHTMAN: Unintended is not the problem. It's the unwanted is the -- MR. CORZINE: And you know what, I have trouble with unwanted because I'm not -- it's kind of a given if you have some adventitious presence where there are tolerances or thresholds, it's, it's there. It's not -- MR. HOISINGTON: Could we not just say low levels of unintended material? MS. DILLEY: We do. UNIDENTIFIED SPEAKER: Yeah, but then not have foreign materials. UNIDENTIFIED SPEAKER: Right. UNIDENTIFIED SPEAKER: Define foreign materials as unintended materials. DR. SCHECHTMAN: Low levels of unintended materials. MS. DILLEY: Okay. And then we were -- wait, wait, Greg. And then you were suggesting using adventitious commingling, that's what we would use, low levels of unintended material? MR. JAFFE: I donÕt want to use just commingling at all, so I'm -- MS. DILLEY: I know. MR. JAFFE: -- problem with that. MS. DILLEY: I know, and so what I'm suggesting is an alternative to where you're talking more broadly, not just biotech. So example page 16, line 6, some amount of, and this is where you would -- commingling, so some amount of low levels of unintended material is to a large extent unavoidable in grain and grain products based on realities of plant biology. It's talking about it in a more broad context. So we take Dave's suggestion and use that instead of the commingling piece, and then that seems to resolve the problem. MS. MELLON: If you define adventitious presence broadly, when you don't need any other term for its use -- so then the, then the commingling just falls out. The question was only how would you broadly define adventitious presence outside the context of biotech? So you would either say it's low level -- unwanted for some purpose, I would say, and in the case of -- in case of biotechnology, it means transgenic varieties of grains -- you know, that's what it means. But if you do that, then you don't need -- the commingling issue just falls out. You don't need it as a separate term. And it's -- the only sticking point is whether you want to simply -- as you want to be explicit about the fact that it's unwanted for some reason or that you want to just -- MS. LAYTON: Okay. So I heard the term adventitious presence refers to unintentional low levels of materials in seed, grain or food and -- feed and food products. MR. JAFFE: Foreign materials. DR. SCHECHTMAN: I thought it was low levels of unintended material. MR. JAFFE: That was one proposal, but another proposal was low -- unintended low levels of foreign materials. MS. LAYTON: Yeah, but I heard somebody say -- Mardi say she didn't like the word foreign, so that's why it was -- MR. GRANT: I like unintended better, but -- MS. LAYTON: Low levels of unintended materials. MR. JAFFE: You need, you need something else in there. You're missing one of the key characteristics. DR. SCHECHTMAN: The unwanted? MR. JAFFE: Yeah or foreign. I mean it's not just -- DR. SCHECHTMAN: Can I just make one observation? I don't know if people will agree with this, but my sense is that AP is sometimes a problem and sometimes a fact of life. And it's always a fact of life that it's sometimes a problem. So that whether or not it's a problem depends on whether or not it's something that you can deal with or something that is unwanted. MR. JAFFE: It's always unwanted, whether it's a -- I mean it's -- not only a problem because of certain levels. MR. GRANT: It's always measurable, but not necessarily always unwanted. MR. JAFFE: I don't think unwanted means you don't care, it just means -- you didn't, you didn't make the product to have it in there, but it got in there. I mean nobody affirmatively makes the product to have it in there. It is unwanted. I mean you want to grow 100 percent wheat. The fact that you grow 98 percent wheat because something else gets in there, you didn't want it in there. It's not a problem because you're under a certain level, but nobody -- you didn't intend, you didn't want it. (Simultaneous comments.) MS. DILLEY: Terry -- Terry. MR. MEDLEY: Yeah, I think -- I'm really struggling with our discussion here, because I thought what we were going to do is we have a transgenic or biotech specific definition for AP that was there. And now what we're talking about is having a general definition so we can eliminate the adventitious commingling. And in this general definition, we've been talking a lot about unintended or unwanted. I guess the point is, if it's the unintended presence of that material, why doesn't that cover the definition? Why does it have -- why does it have to be something more, but then the fact -- and we talk, we talk in this paper about the numerous ways that that can happen, but I don't understand with the definition why we have to go beyond that. MS. DILLEY: What I'm stuck on, Dick, is whether we -- you're really uncomfortable with an adventitious presence specific to biotechnology definition for the report, because I thought that's why we were going through -- MR. CROWDER: No, no. We're trying to solve the commingling. MR. MEDLEY: Right. It was the commingling. So it's really a two-step process what I was listening to, and it seems that we are there on the biotech, and we had it, because we're being very specific about what's unintended. That's necessary for AP discussions here. But in terms of AP in general, we give this introduction of how it occurs -- occurs, and so the important thing is you have, you know, the unintended low levels. MS. DILLEY: So can -- so what I hear you saying is what I suggested before, which is to keep the definition from 31 through 35 as modified, it would be low levels and unintentional. MS. LAYTON: No. Refers to low levels of unintended material. MR. DYKES: Right. MS. LAYTON: In seed, grain or food and feed products. And the next one would be the key components of the definition are low levels and unintended. UNIDENTIFIED SPEAKER: Right. UNIDENTIFIED SPEAKER: Period. MS. LAYTON: No. Unintended. We changed it to unintended. Okay, and then you can drop commingling and use the term adventitious presence in the next sentence on line 36. DR. SCHECHTMAN: No, but then you'd need the sentence that says in the context of plant biotechnology this refers to -- UNIDENTIFIED SPEAKER: Transgenic material. MS. LAYTON: Right, transgenic material. And add that into that first paragraph. MR. MEDLEY: That's -- yeah, so the first definition, and we already have that. The term adventitious presence in the context of plant biotechnology refers to unintended low levels of transgenic material in seed, grain or feed, food products. And that one's very specific. I thought what we were talking about was coming up and having a general definition of adventitious presence, because the whole first examples after that really you're talking about general AP not biotech -- UNIDENTIFIED SPEAKER: Right. MS. DILLEY: Correct. MR. MEDLEY: And so that's what triggered the need to have a broader definition. MS. DILLEY: Absolutely, correct. MR. MEDLEY: So what you have to say is in a broader context adventitious presence is, and then you'd say adventitious commingling of material has always existed. I mean isn't that what you were discussing? Or do we need it? MS. DILLEY: It's page 16, line 6, some amount of something is to a large extent unavoidable because you're talking about it in the larger context. So what we're struggling with is that language right there. UNIDENTIFIED SPEAKER: But in line 6 on 16 that is presence because all that stuff is biology. UNIDENTIFIED SPEAKER: Exactly, right, that's right. UNIDENTIFIED SPEAKER: On line 36 on 15, that is -- where it says adventitious commingling, that is an active man, man does those things in that sense. MR. CROWDER: So just leave everything like it is -- commingling on line 6. (Simultaneous comments.) MR. JAFFE: General AP or something because it's not biotech AP we're talking about there. MS. DILLEY: -- general AP then. MR. JAFFE: That's what I'm -- I donÕt want, I donÕt want the document to read -- says some amount of AP is unavoidable, and people are going to say, we're saying that biotech AP is unavoidable. I'm not sure I'm comfortable with saying that. I am comfortable saying that generally AP is unavoidable. MS. DILLEY: Okay. So if we add general AP and we define that up front, is everybody okay with that? MR. MEDLEY: Wait a minute. I -- if we're talking here about what is a biological certainty or something you can't, then why would it be wrong to have it apply to biotech products? I don't understand. I mean I thought that was the whole point. MS. LAYTON: -- or moves -- on bees or something, but it moves. MR. MEDLEY: Because otherwise we'll be saying for biotech we can do what we've said here is biologically impossible. MR. JAFFE: Well, this is -- this sentence is generic. It's not specific to biotech. It's just saying -- MR. DYKES: It still fits within the definition of AP. MR. JAFFE: It should. If you say the adventitious presence of materials in food and feed supply has always existed based upon different things, that to me seems that it's self-defining. Adventitious presence of material has existed. MR. DYKES: I think all we need to do is delete the word commingling -- MS. DILLEY: Okay, and the, and the parens. MR. DYKES: And we're fine. MS. LAYTON: Okay. Do we need to change 31 through 34, page 15? MS. MELLON: I thought we were going to have a general definition. MS. LAYTON: We agree to, I think, which was the term adventitious presence refers to low levels of unintended material in seed, grain, or food and food products. The key components of the definition are low levels and unintended. In the context of plant biotechnology, this refers to transgenic material or specific transgenic events. MR. MEDLEY: But it seems that we're really getting confusing here. I mean the definition where we would have the letters AP should refer to our special definition for biotech. In other contents where you see it written out adventitious presence small, it should be self- explanatory. Why would you need to definitions? MS. LAYTON: We didn't. MR. MEDLEY: No, but I thought you were just now rewriting. If you're -- the one you just read out did not have in the context of plant biotechnology. MS. LAYTON: Actually that was the last sentence in that paragraph. I took in line 31 the term adventitious presence, delete from in the context of plant biotechnology, at that point, refers to low levels of unintentional materials in seed, grain, or food and feed products. The key components of the definition are low levels and unintended. Add new sentence. In the context of plant biotechnology this refers to transgenic materials or specific transgenic events. MR. BUSS: In that context, I wonder if that second sentence or whatever it is, the last thing you just read wouldn't more logically fit on page 16 immediately before what is now line 17. Because all of that -- all of that discussion being conventional AP, and then make the definition -- then it logically flows into line 17. No, I think that makes it -- MS. LAYTON: Could be. UNIDENTIFIED SPEAKER: Good idea. MS. LAYTON: Okay? MR. DYKES: That's what I had suggested in my own text as moving this specific reference to biotech down to in front of those -- MS. LAYTON: Okay. DR. BUSS: in that context, logically flows into MS. LAYTON: could be. MS. DILLEY: -- out? UNIDENTIFIED SPEAKER: Yes. MS. DILLEY: Mardi? MS. MELLON: I'm okay with that. MS. LAYTON: So in the context moves to line 17. MR. JAFFE: But I would just leave it in. I think in the context of plant biotech adventitious presence refers to unintended low levels of transgenic materials is - - MS. LAYTON: Repeat those sentence. MR. JAFFE: Repeat -- MS. LAYTON: Okay. UNIDENTIFIED SPEAKER: I would say seed, grain or feed. MR. DYKES: Move those three or four lines -- move those three or four lines and move them down to just before adventitious presence can occur four different ways. MS. LAYTON: Okay. Got it. Way to go, Daryl. Okay. MR. MEDLEY: That then gets very specific to biotech AP. MS. LAYTON: Okay. And then I heard remove the word leave commingling on 36 on 15 but use the term AP on 6, correct? MR. JAFFE: Yes. MS. LAYTON: Not adventitious commingling. MR. JAFFE: Right. MS. LAYTON: Okay, and somewhere we defined AP as -- we put in the initials AP. MR. DYKES: So some amount of AP is to a large extent unavoidable in grain and grain products. UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: Okay. MS. LAYTON: And somewhere on that page after the word adventitious presence, I think you put in parentheses AP. MR. DYKES: I think it's actually being done earlier in the document. MS. LAYTON: Whatever it is. Make sure it's done. MR. DYKES: It's been done earlier. MS. LAYTON: Good enough. MR. CROWDER: Excuse me, Pat. Where was the -- where was the word -- MS. DILLEY: Page 15, line 36. MS. LAYTON: And that was the active piece that Ron I think suggested. Was it Ron or somebody suggested that in the handling system that is active. MS. DILLEY: So -- that's a correct term used as -- is that right? MR. SLOCUM: The problem is the next sentence -- also occurs, it also occurs. MS. DILLEY: Can you say adventitious presence also occurs? MR. SLOCUM: Yes. MS. LAYTON: But you know what you talk about that in the next paragraph about that part. So take out that bracketed sentence, and it's covered in the paragraph on page 16. MR. HOISINGTON: That whole paragraph is covered in the next paragraph. MS. LAYTON: There is also a bracket at the bottom that allows -- that establish allowance for these materials on page 15. Is that stay or go? MR. HOISINGTON: I have -- MS. LAYTON: Yes, David. MR. HOISINGTON: I mean the second and the third paragraphs in terms of how mixtures occur are identical, far as I'm concerned. The only thing that is different is the second part of that second paragraph, which refers to numbers and examples. So I would rather have -- and think the third paragraph that goes into a great detail of how you can actually have commingling and adventitious presence is sufficient in my mind to explain the different ways, man- made and natural, biological -- MS. LAYTON: So you would say delete the whole second paragraph. Dick is shaking his head. MR. DYKES: Where are you? MS. LAYTON: On the bottom of page 15, line 36, David is suggesting and Dick has nodded -- MR. CROWDER: The question do you need the examples? MR. HOISINGTON: I have a different comment on the numbers. UNIDENTIFIED SPEAKER: Not numbers but -- MS. LAYTON: That you might delete that entire paragraph? MS. FOREMAN: The second paragraph. MS. LAYTON: The second paragraph that runs from line 36 on 15 through line 4 on 16. MR. JAFFE: That does talk about that there are laws and regulations and standards on it. I donÕt think they completely overlap. I think it does set out -- that second half of that paragraph that you want to keep in, once you specifically make this distinction between material intentionally introduced and things that you can mix to get out of, changes -- versus things that you can whereas biotech you can't. First discussion -- biotech, that's good to put in there, but I think you need the previous paragraph as it helps explain why it's there. MR. DYKES: I donÕt see any problem. To me I thought where we were going, we had taken care of this commingling issue and so we were just going to change adventitious commingling to AP and leave that paragraph in there as it is, and just refer to AP instead of adventitious commingling. The AP of materials and food -- is always -- I mean I think it provides a context. MS. LAYTON: Okay, so -- MR. CROWDER: The intent was to leave commingling in that paragraph. Only to change commingling in the next paragraph. MR. JAFFE: We can call it presence in that paragraph then. MR. DYKES: I thought we could call it AP now that we changed the definition. UNIDENTIFIED SPEAKER: I donÕt have -- MR. DYKES: Why is it that on -- let me sure I've got the right place, page 15, line 36, the AP of materials and the food and feed and just change adventitious commingling to AP, because we fixed that when we fixed the definitions. MS. LAYTON: Okay. Do we leave the statement in there about biology plants? (Simultaneous comments.) MS. LAYTON: That's in the third paragraph, so you don't need it in the second paragraph. MR. JAFFE: Well, I don't see why it hurts to have it there. MR. DYKES: Yeah, I don't think it hurts anything. MR. JAFFE: I mean if you're talking about structure, the reason is -- DR. SCHECHTMAN: It was a problem when commingling was there and it's not a problem when commingling is out. UNIDENTIFIED SPEAKER: Right. UNIDENTIFIED SPEAKER: Right. MS. LAYTON: So AP on line 36 and also on 39 were all adventitious presence can be minimized instead of adventitious commingling? MR. DYKES: And on 41. UNIDENTIFIED SPEAKER: Yeah. MR. DYKES: And on 41. So adventitious commingling is replaced with AP in all, in all that paragraph. MS. LAYTON: And then you're set? Then you're okay with this paragraph staying in? MR. DYKES: And with the changes we made on a specific seed corn variety earlier -- Jerry Slocum. MS. LAYTON: And did we also leave in USDA has set grade standards for foreign material at the back end or are we going to delete that? MR. DYKES: I thought we left that in. We're going to pick up the definition of -- MS. LAYTON: And we're going to use the GIPSA definition? UNIDENTIFIED SPEAKER: Correct. MS. MELLON: The point that we ought to, to delete the reference to organic. That has nothing to do with grain standards. That's the -- requirement -- MS. DILLEY: The 5 percent -- MS. MELLON: -- on page 16. MS. DILLEY: -- non-organic substances. MS. MELLON: USDA's organic standards allow up to 5 percent non-substances. MS. DILLEY: So strike that sentence. MS. MELLON: That's in processed food in order to label it as either organic or made with organic materials. MS. LAYTON: I had deleted all of that in favor of the GIPSA definition. MS. MELLON: That's fine. Thank you. MS. DILLEY: Okay. Juan. MR. ENRIQUEZ: The process suggestion. You know, we go over these things, we ask for edits. The edits come in. The work groups go over the edits, then we get them again and have the other edits, and you know there are probably a series of things that are really important that we discuss as a Committee, but if we set a limit to the amount of issues that are really important to any one human in the Committee, and simply as a matter of process, if we suggested that people said over the course of two days, here are 15 issues I want to bring up. That doesn't mean you can only comment 15 times in this Committee. You can comment as many times as you want on issues that people bring up, but you know people could come in here with a 15-point agenda and say, here are 15 things I really want to change. Because otherwise we're going to try and get a perfect document that everybody agrees on, and I'm not sure if that's going to happen. I don't know if the right number is 15 or if it's 20. I mean if you want 20 interventions per person per day to bring up issues that are important. DR. SCHECHTMAN: Can I make a comment on that? I think that may be something -- those sorts of limits may very well make sense on pieces on which we really thought that the Committee had agreed on, but this is text that no one has, that no one has seen yet. MR. ENRIQUEZ: Fair. Simply on pieces that -- DR. SCHECHTMAN: But I think, I think -- MR. ENRIQUEZ: -- gone over in work groups. DR. SCHECHTMAN: Yeah. I think the point emphasizes the need to focus on what's really important, folks. MS. LAYTON: Absolutely. DR. SCHECHTMAN: And not, and not do a lot of editing that's not, you know, really very important to you. MS. DILLEY: So to that reminder -- the AP section, the rest of the AP section, and then I'd like to get to the other parts of 3, Section 3 before we break for lunch, if at all possible, which includes the market segmentation and the consumer -- the last two parts of that. MR. DYKES: I'd like to come back to the organic standards. I'd like to keep that sentence in there, if I can because I -- MS. DILLEY: We got rid of that. MR. DYKES: Huh? MS. DILLEY: Why? I'm sorry, Michael, I -- MR. DYKES: Because I think it's consistent with all of the, the rest of that paragraph talking about how certain standards are there, but they have exceptions for things that aren't a part of that definition. MS. DILLEY: I thought we got rid of that in place of -- UNIDENTIFIED SPEAKER: GIPSA. MS. DILLEY: -- the GIPSA definition. So the rest -- all that number 1, number 5, all that's been deleted to go to how GIPSA establishes allowances. MR. DYKES: I think it's important to raise the point about the organic being up to 5 percent non-organic, but I'm fine with it, if other people think that's a problem. I think it's just another example other than the GIPSA definition. MS. DILLEY: I think unless you really want to argue about it, it's gone. It was deleted with the rest of that paragraph. Okay. MR. HOISINGTON: Can I just ask in the GIPSA definitions are there percentages that are indicated or is it a generic idea. MS. DILLEY: I have no idea. DR. SCHECHTMAN: There are hundreds of percentages. So I think what might make sense is just define foreign material and not put in a whole lot of percentages, because -- MR. HOISINGTON: As I see it, there are two things you can use that example for. One is to show to that there are many things that could be unintended. MS. DILLEY: Right. MR. HOISINGTON: And that's a good reason for having examples. But the other option to use that -- specific numbers is low levels. See you put a figure like 7 percent and you're basically defining what do you imply by low levels in our previous definition of adventitious presence, and I'm trying to figure out, are we trying to say both of them or are we simply just trying to say there are a lot of things that have already been defined as unintended and we deal with them. Or are we trying to deal with what is below level? MS. LAYTON: Could we give a website that would actually list the definitions, GIPSA -- MR. DYKES: I was going to go to something like that. Kind of leave the -- because I thought we were again generally speaking we were fine with the text. What we were struggling with based on Mardi's comments was what is the real definition of foreign material. So maybe we can make a footnote, and down below two lines about a website or reference GIPSA's definition of foreign material or foreign matter or however it's referenced, leave the text we have here, make it USDA number one, USDA number whatever we reference here, leave the two or three examples we have here and make a footnote back to a website or something where if you want to look up what GIPSA's definitions and percentages are for all different kinds of foreign material, you can. Is that another way to do it, so you donÕt have all that text in here? MS. DILLEY: Not our decision. It's yours. MR. DYKES: Oh, I would recommend that. And we keep the text that we have here. Otherwise you're going to get off into a whole discussion and -- because I think when you start looking up GIPSA's definitions of these things, you're going to find them to be rather extensive. MS. DILLEY: Terry. MR. MEDLEY: Again I guess just calling a check, I thought on this discussion on adventitious presence and the comment I heard about moving the definition over to 16, page 16 around line 17, was to accomplish two things. One, we'd have a general discussion as a lead-in here of adventitious presence. And it would talk about the fact that, you know, how it occurs, has been existing, and then right before we get into biotech, we would have specific definition as relates to biotechnology. And then we would start using the letters AP. And if you do that, the last part of the second paragraph on page 16 starting with I guess its' line 13 or line 12. That tries to go specifically to biotech and the fact that you cannot blend it back to compliance. That doesn't fit. UNIDENTIFIED SPEAKER: Right. MR. MEDLEY: Now in the general discussion. So that would have to be moved to come after the biotech specific definition. I also -- UNIDENTIFIED SPEAKER: Yes. MR. MEDLEY: -- am not exactly sure that this is correct. I mean if one had IP systems, IdP systems and you had a threshold level set for biotech, then one could in fact, you could bring it back. So this isn't accurate. MR. GIROUX: It's not adventitious presence if you blend it back. MR. MEDLEY: But the point is, if there is either contractual regulatory -- a level set, i.e., if there was, then you could met that level by blending back the -- MR. JAFFE: A labeling level. MR. MEDLEY: Yeah, from -- MR. JAFFE: For labeling but not for adventitious presence. MR. MEDLEY: That's -- I guess what I'm saying is because of this, I'm no sure that this -- what this adds to this discussion. I think it raises some questions, but I'm not sure. Now you have to say, yeah, from a labeling perspective, and I don't think that this is additive. MS. DILLEY: What this adds, you mean that last sentence? MR. MEDLEY: Well, this, this concept here of I think it's important to say in practice material introduced into seed, grain or food does not meet the definition of AP. Fine. That's very accurate. But then the next part of this, which I -- tolerance, I donÕt see what that adds. MR. DYKES: Yes. I had the same -- I had not raised it yet, but I had the same, I had the same concerns about that. MR. MEDLEY: Yeah. I mean the first part of it is an accurate statement. That's what we're trying to get to. So I would suggest that we just say that, and then you're going to have -- right, and then you're going to have the definition. MS. DILLEY: So you stop the sentence, add AP. MR. MEDLEY: Yeah, but I would say in practice material introduced -- intentionally introduced into seed, grain, feed, or food does not meet, and I wouldn't say the definition, because we haven't given the definition yet. UNIDENTIFIED SPEAKER: Yeah, we did at the first -- UNIDENTIFIED SPEAKER: Yeah, we did. UNIDENTIFIED SPEAKER: Yeah, we did. MR. MEDLEY: We didn't move it. MS. DILLEY: We did specific to transgenic biotech, but the general one is still up there. MR. MEDLEY: Well, then let's just put the general definition and write out adventitious presence. MS. DILLEY: Okay. UNIDENTIFIED SPEAKER: Okay. MR. MEDLEY: And only use AP after we've gotten into biotechnology. UNIDENTIFIED SPEAKER: Yeah. MR. DYKES: Okay. So that should be definition of adventitious presence. MR. MEDLEY: Definition of adventitious presence, right, exactly. MS. DILLEY: And still, you're still suggesting to move that to -- MR. MEDLEY: No, no, no, I'm fine. You can leave it there. MS. DILLEY: Okay. MR. MEDLEY: And then delete the rest of that sentence. DR. SCHECHTMAN: Did I understand you, Terry, that to say that we should not use the abbreviation until we use the term with respect to biotech? That's a very nonstandard way of using abbreviations. UNIDENTIFIED SPEAKER: You might want to say ABP or something. MR. MEDLEY: Well then why are we using it? UNIDENTIFIED SPEAKER: I just think that's more accurate. UNIDENTIFIED SPEAKER: Absolutely. DR. SCHECHTMAN: I mean I think it's just -- UNIDENTIFIED SPEAKER: Okay. DR. SCHECHTMAN: -- an acronym for adventitious presence. MR. MEDLEY: All right. DR. SCHECHTMAN: And then later on, you know, when you're focusing in on the context, that's what you're referring to, and the context will be gotten from the text. MR. MEDLEY: Well, we use it, I mean even in this specific discussion, we have AP and then we have the abbreviation AP, and I'm just trying to get some sense of what's the rhythm here or what's the rationale as to when you use it and when you don't? MR. DYKES: I'm kind of where Mike was. I think the rationale is is that it's just an acronym. So you have adventitious presence, paren AP, and then throughout the remainder you use AP. UNIDENTIFIED SPEAKER: AP. MR. DYKES: Yeah. DR. SCHECHTMAN: I think the only time -- MR. MEDLEY: So everywhere we have adventitious presence? MR. DYKES: That would be my sense, because I donÕt think there's any difference in them. I guess the fundamental question is do you think there's a difference between AP and the words adventitious presence? MR. MEDLEY: Well, what I see here in terms of these events, one through four, I mean we're talking about biotech-specific. MR. DYKES: Well, that's why we moved the definition of in the specific case of biotechnology and then right before these four different examples. MR. MEDLEY: Okay. MR. DYKES: So we have a broader definition of adventitious presence. MR. MEDLEY: Right. MR. DYKES: And then we make a specific reference to in the case of biotechnology -- MR. MEDLEY: Right. MR. DYKES: -- and then we go on to these four examples. MR. MEDLEY: Right. And within these four examples, when I see adventitious presence written out or AP, I'm referring to the general definition or the biotech- specific? MR. DYKES: I would think the biotech specific. MR. MEDLEY: Well, that's why I said what I said about we were referring to the biotech-specific. MR. DYKES: But I guess the reason why I said the biotech-specific, I don't think you can make a distinction whether you're writing the words out or whether you make it AP. MS. DILLEY: Yes. MR. DYKES: I think that's just, in my view, that's just standard formatting. I think the reason that those four examples are biotech is because we make the reference in the preceding sentence that in the context of biotech it means such and such. And then we go 1, 2, 3, 4. So it's relative to biotech because of its location in the document relative to where the definition is. ` MR. MEDLEY: Well, no, no, I -- well so that we don't keep pushing this, on page 16 under one, we say the adventitious presence of approved events, we use adventitious presence. We drop down to the third paragraph, and we say that in the case where complete avoidance is required, AP, and we use the term AP. I'm just saying how do we decide when we're using it? DR. SCHECHTMAN: We'll fix it and make them all AP. MR. MEDLEY: Okay. MS. DILLEY: We know what the concern is that you -- that we're confusing between -- MR. MEDLEY: Yeah. MS. DILLEY: -- talking about broadly and talking about specific to biotech. We'll just -- MR. MEDLEY: Right. MS. DILLEY: -- make sure that the text addresses that problem. MR. DYKES: I think the question for the Committee is, is they donÕt -- they're the same whether you spell out adventitious presence or you write AP. I think if we agree on that, then I think you just go back and you -- MS. DILLEY: Fix it. MR. DYKES: -- fix it the first time and you move on through with AP thereafter. MR. MEDLEY: Okay. MR. DYKES: Does that take care of your -- MR. MEDLEY: Yeah, just consistency. Because it looks like there is a special meaning when we use it -- MR. DYKES: But there's not one intended. MR. MEDLEY: Okay. MS. DILLEY: Okay, I just wanted to -- MS. LAYTON: It's an unintended acronym. MS. DILLEY: How many people have comments in Section 1? So it's the line on 16, page 20. Do we have comments in that section? UNIDENTIFIED SPEAKER: On page -- MS. DILLEY: 16, starting line 20. I guess we have a -- MS. LAYTON: There is a bracket there. MS. DILLEY: Parens, yeah, Michael -- they're in parens. DR. SCHECHTMAN: Yeah, line 28? MS. DILLEY: Yes, line 28, and it was DR. SCHECHTMAN: Labeled product to suggestion, food containing biotechnology-derived ingredients. MS. DILLEY: So we're needing to -- DR. SCHECHTMAN: Just decide among those two. MS. MELLON: I vote for foods containing biotechnology-derived ingredients. It's clear. MS. DILLEY: Okay, any problem with that? MS. LAYTON: So deleting -- MS. DILLEY: Okay. MS. LAYTON: -- labeled products. MS. DILLEY: Right. MR. CROWDER: Are they separate, are they alternatives or are they both? Are they two alternatives? MS. SULTON: Just same way, describing the same thing. MS. LAYTON: There were two alternatives. MS. DILLEY: Two alternatives. MS. LAYTON: Weren't they? MR. CROWDER: That's -- MS. DILLEY: I think that was confusing in terms of -- MR. CROWDER: There's two different questions here, if you really want to know. Do you want to avoid products with that or do you want to avoid labeling products that contain that? They're addressing two separate questions, it seems to me. DR. SCHECHTMAN: Well, it was about consumers who wanted to avoid those products. It wasn't -- this wasn't the question about industry. MS. LAYTON: Yeah, all right, is it the -- do the consumers wish to avoid labeled products or do the consumers wish to avoid foods containing biotechnology ingredients? MR. OLSON: You could put a period there after marketing reasons, and then consumer starts a new sentence. Separate the thought. MS. LAYTON: Okay. UNIDENTIFIED SPEAKER: We need a verb. UNIDENTIFIED SPEAKER: Yeah. MR. CROWDER: You clarified my question. MS. LAYTON: Okay. UNIDENTIFIED SPEAKER: Okay. MS. LAYTON: Okay, leave it like it is. Okay. So we're -- and we're deleting labeled products. MS. DILLEY: Any other comments on one? So that goes all the way to the top of page 17. Anything else on that? MR. DYKES: So just so I'm clear. I don't want to -- but just to keep -- on process. We came back to this foreign material. Did we conclude that we're going to have a footnote? Is that how we left that? MS. SULTON: We're going to use the GIPSA definition. DR. SCHECHTMAN: Yes. In the footnote I -- MR. DYKES: Keep the text as we have it, put a footnote there that -- DR. SCHECHTMAN: -- not keep the text as we have it. UNIDENTIFIED SPEAKER: No. MR. DYKES: Not the, not the -- DR. SCHECHTMAN: Not the numbers. All the numbers are gone. MR. DYKES: Not the examples. DR. SCHECHTMAN: There's going to be USDA has set grade standards for foreign material, footnote, foreign material is defined by USDA's Grain Inspection Service as such and such. For information on detailed standards, see this website. Is that okay? MS. DILLEY: Okay. Can we move on to two then? That starts on line 8. MR. HOISINGTON: Wait a minute. MS. DILLEY: Okay, Dave. MR. HOISINGTON: I donÕt know -- since I don't have the late copy, it's under the number sub-three -- elsewhere, but not -- MR. JAFFE: We're not there yet. MS. DILLEY: We're not there yet. We're on one. Anything else on one? MR. GIROUX: Way ahead of us. MS. DILLEY: Randy. MR. GIROUX: We're -- you donÕt need both of them. (Simultaneous comments.) MS. DILLEY: Where are you? UNIDENTIFIED SPEAKER: Where are you? MS. DILLEY: Line? MR. GIROUX: Second line of the first paragraph, number two, adventitious presence -- processing United States. Oh, no, I guess it does belong there. Forget it. Never mind. UNIDENTIFIED SPEAKER: Where are you? MS. DILLEY: He's, line 10 or 12 or 11 on page 17. (Simultaneous comments.) MS. DILLEY: Closing out number one. Now we can move to number two. Is there -- is there anything else? Randy, you were talking, but I didn't get to hear the point. MR. GIROUX: No, never mind. MS. DILLEY: Okay. Anything else on number -- on two? And that goes from -- on page 17 from line 8 to line 30, anything else? Any other comments? MR. MEDLEY: Eight and nine, the sentence, the last sentence in one, and it's a question, what are we seeking to, to make with that statement, and it begins with -- MS. DILLEY: Terry, where are you? UNIDENTIFIED SPEAKER: Where are you? MR. MEDLEY: Page 17, lines 5 and 6. It's the last sentence in one. MS. DILLEY: So in both cases the presence of AP -- biotech -- make the product -- include in feed supply chain. MR. MEDLEY: Yeah. I'm just trying to -- what is the -- what was the purpose of that sentence and what are we trying to do with regard to this paragraph? MS. DILLEY: Randy or Greg. MR. JAFFE: I'll defer to Randy. MR. GIROUX: This was a statement that was in the original text. I just restated it here. There was no purpose for it. MR. MEDLEY: Because it seems to me that the, the ending of the paragraph above that is the really one we have to deal with in terms of, you know, this acceptable zero, et cetera, and then we just kind of throw in the sentence, and it just hit me. MS. DILLEY: Any problem with deleting it? (Simultaneous comments.) MS. DILLEY: I think it's picked up in the -- MR. MEDLEY: Yeah. MS. DILLEY: -- other discussion of contracts anyway. UNIDENTIFIED SPEAKER: Delete. MS. DILLEY: So Mardi, any problem with that or -- MS. MELLON: No. MS. DILLEY: Okay. Okay, anything in Section 2? That's what we're focused on now. Mardi. MS. MELLON: I think we -- I think Greg and I have both raised this issue of approved. I don't think we want to use that term. MS. DILLEY: Okay. Where are you? Regulatory approval? MS. MELLON: The events approved in the U.S. but not elsewhere. Events are not approved in the U.S. They meet regulatory requirements in the U.S. MS. DILLEY: Okay. Okay, so Line 29? MS. LAYTON: Actually it's line 8. MS. DILLEY: Line 8. MS. LAYTON: Line 8. MS. DILLEY: Okay, oh, okay. Thank you. UNIDENTIFIED SPEAKER: Where are we at now? MS. DILLEY: Line 8 -- UNIDENTIFIED SPEAKER: Title of number two. MS. DILLEY: So products meeting regulatory requirements. MS. MELLON: Yes, in the U.S. but not elsewhere. We don't want to, we don't want to imply that products in the U.S. are formally approved. MS. LAYTON: Okay. MS. DILLEY: So it would now read products meeting regulatory requirements in the U.S. but not elsewhere. MS. MELLON: Yes. MS. LAYTON: Do we want products or events? We've used the term events. MS. MELLON: You want to do events? They don't -- MS. LAYTON: I donÕt know, but all four of them are events. MS. MELLON: Events meet regulatory requirements. MS. LAYTON: And number one, is number one any different? Mardi, I would ask you also because it's events approved in the U.S. and the importing countries. So we have to probably look at this. MS. MELLON: I think we need to look at it in all of these circumstances. (Simultaneous comments.) MR. CORZINE: Question. MS. DILLEY: Yes, Leon. MR. CORZINE: Question on approved. I guess I'm not clear. I, I -- because I donÕt agree. Okay, in the FDA sense it's a voluntary and they give a pass or they donÕt formally use the term approved, but the other parts of the regulatory system as far as in the USDA part and in the EPA, you do have to have approval. MS. DILLEY: That's right, so that's -- I think that's Mardi's point, is that -- MS. MELLON: You could have approved or -- MR. JAFFE: We're talking about food here. We're not talking about -- MS. DILLEY: Leon, go ahead. MR. JAFFE: And even then -- MR. CORZINE: I'm not sure that -- MR. JAFFE: -- regulated. MR. CORZINE: I don't think, Greg, this doesn't just say food here that we're talking about now. MS. MELLON: These are events -- MR. JAFFE: We're talking about adventitious presence here. We're talking about -- MR. CORZINE: We aren't just talking about food so you do get approvals. MS. LAYTON: So it's adventitious presence events? MS. MELLON: No. We're talking about -- UNIDENTIFIED SPEAKER: No. UNIDENTIFIED SPEAKER: No. MS. LAYTON: That's what I, I donÕt understand now. I think we're a little -- MR. CORZINE: -- approval. That's what I don't understand why -- MR. SLOCUM: Talking about biotech events. MS. LAYTON: Okay, that's what I want to make sure. MS. MELLON: We're talking about biotech events where the biotech events accrue when they appear they are unintended their appearance is unintended in a, in a, in a batch of grain. There are distinctions to be made between events that are approved or have met regulatory requirements and those that have not even been reviewed much less have met regulatory requirements. MS. LAYTON: So is it events approved or meet or that -- MS. MELLON: -- regulatory requirements, and that's -- MS. LAYTON: Regulatory requirements? MS. MELLON: Yes. MS. LAYTON: So it's both. It could be one or the other. MS. MELLON: It could be one or the other. I agree. MS. LAYTON: Okay. UNIDENTIFIED SPEAKER: But, but -- MS. LAYTON: So it's events approved or that meet regulatory requirements -- MS. MELLON: Regulatory requirements in the -- MS. LAYTON: -- in the U.S. MS. MELLON: -- U.S. but not elsewhere. MS. LAYTON: Right. MS. MELLON: Because they're not approved. MS. DILLEY: Isn't that correct, a correct statement? MR. MEDLEY: No. MS. DILLEY: No. MR. MEDLEY: I donÕt think so. I mean you can turn that around and you can say that the question can be what do I need to do to put something on the market, and you can have regulatory requirements that say you either do A, B, and C or you can have it say if it doesn't hit this trigger it doesn't have to go on. And you are then marketing consistent with that. If we're going to change events approved, we need to come up with a term. Because now this is starting to get very, very complicated. MS. ZANNONI: How about if you put events that may be sold in the U.S. Take out approved and all that stuff because -- MR. MEDLEY: Yeah, I mean -- MS. ZANNONI: -- your point it's marketable. MR. MEDLEY: -- you can market that. You looked at what the requirements are. They lay it out. MR. HOISINGTON: Why not use the word marketable? UNIDENTIFIED SPEAKER: Why donÕt we say that. MR. JAFFE: That can be marketed. UNIDENTIFIED SPEAKER: Yeah, that, can be marketed. UNIDENTIFIED SPEAKER: Yeah. UNIDENTIFIED SPEAKER: Okay, that would work fine. UNIDENTIFIED SPEAKER: Approved for marketing? (Simultaneous comments.) MR. CROWDER: I just wanted -- excuse me if I'm - - if before I go to the government, I cannot put these on the market, and I know I cannot before put them on the market, and then if I go to the government and go through EPA, go through the USDA and so forth, I can't put them on the market. Seems like to me that somewhere between time I ask mother may I go to play with Johnny -- MS. MELLON: You don't have to ask mother. MR. JAFFE: The problem is you don't have to ask FDA. You don't have to ask FDA. MR. CROWDER: Well, you have to ask someone. I donÕt think this -- MS. MELLON: -- if you make your own decision about your own product and, and how it meets the FDA's -- MR. JAFFE: For certain biotech -- MR. CORZINE: That is only in the case of FDA. We're not talking -- you talk about EPA and USDA. You get approval. MS. MELLON: but you only need to go to EPA for those products that meet the definition of pesticides. That's a very narrow set of the biotech events that are out there. MS. DILLEY: I think you either have events that can be marketed in the U.S. or you have to the -- approved or meet regulatory requirements. DR. SCHECHTMAN: That have met regulatory requirements. MS. DILLEY: That have met, that have met. Those are technically correct. So it's either marketable or -- MR. MEDLEY: So you're saying, so you're saying it's something that's met regulatory requirement. MS. DILLEY: Yes. MR. MEDLEY: Is not something that is considered something that is approved from -- MS. DILLEY: That's correct. UNIDENTIFIED SPEAKER: That's right. MR. JAFFE: Approval is active, meeting regulatory requirements is passive. I mean the company can -- MS. DILLEY: We spent -- (Simultaneous comments.) UNIDENTIFIED SPEAKER: -- drive 55 miles an hour. MS. DILLEY: Right. So people have a strong preference for either marketable or that have met? UNIDENTIFIED SPEAKER: That have met. UNIDENTIFIED SPEAKER: That have met. MS. DILLEY: That have met. Okay, and that really goes either -- that goes in number one and number two? MR. JAFFE: And number three. UNIDENTIFIED SPEAKER: We'll make them all fit. MS. DILLEY: And number three. And number four, that will get fixed. Thank you. So back to number two. Anything else in number two? DR. SCHECHTMAN: And similarly I presume that the places where it says regulatory approval all through the text it will be fixed to reflect the same, the same thing. MR. GRANT: -- requirements. DR. SCHECHTMAN: Yes. MS. DILLEY: Such as lines 29 and 30 would be -- UNIDENTIFIED SPEAKER: Or line 12, yes. UNIDENTIFIED SPEAKER: Or line 12. MS. DILLEY: So can we move on to Section 3? Okay, can we move on to three? MS. LAYTON: Yes. Very small. MS. DILLEY: Okay. Greg. MR. JAFFE: Number three in the last sentence, I would say currently the U.S. EPA maintains a zero tolerance specification for events -- not completed the regulatory policy. MS. DILLEY: Okay, so specific to EPA? MR. JAFFE: Other agencies don't have a specification. MR. GRANT: Where are you at, Greg? I'm sorry. MR. JAFFE: The last sentence in -- MS. DILLEY: 37. MR. JAFFE: -- number three. It's line -- UNIDENTIFIED SPEAKER: 37. MR. JAFFE: -- 37. MS. LAYTON: And instead of USA, he wants to -- MR. JAFFE: -- EPA maintains a zero tolerance specification. MR. MEDLEY: So what do you consider the import requirements coming in under USDA? What is that standard? If it doesn't -- if it isn't in the book, it must be zero by definition. UNIDENTIFIED SPEAKER: Huh? MR. MEDLEY: I mean because it does cover imports. MS. LAYTON: So Terry's extending it to USDA imports. MR. MEDLEY: It covers imports into the U.S. I mean currently right now if you don't have something specifically setting whatever it would be zero. MS. LAYTON: Actually, you're right, Terry. I think this is not about things in the U.S. This is about things approved elsewhere. MR. MEDLEY: That are coming into the -- MS. LAYTON: And so this is all about imports. MR. MEDLEY: Right. MS. LAYTON: And is the U.S. EPA the only person that -- MR. MEDLEY: No. MS. LAYTON: -- that limits imports? UNIDENTIFIED SPEAKER: Okay. MS. LAYTON: And Terry is saying no. UNIDENTIFIED SPEAKER: Correct. MS. LAYTON: It is U.S.A. MR. MEDLEY: And I don't know, maybe Jim could tell us, I donÕt know what you do in terms of imports coming into the U.S. There's testing of products, but I know USDA would have to be added to EPA. MR. JAFFE: I would also ask that we just put import in the sentence then. (Pause.) MS. DILLEY: The rest of you, if you could please make sure that you review the scenarios, preparing for the future, and the other conference call summary, so that we're prepared to talk about the scenarios piece when we get to that point of the agenda where we're going to do a check-in of how we're going to use the rest of our day when we come back, okay. Briefly, before we dive back into the discussion. MR. DYKES: I have none of my scenario stuff with me. MS. DILLEY: It's back there. MR. DYKES: All right. MS. DILLEY: Pick up a copy. UNIDENTIFIED SPEAKER: Michael, I have your copy. MR. DYKES: Thanks. MS. DILLEY: Okay. Be back here at one then. (Whereupon, a luncheon recess was taken.) A F T E R N O O N S E S S I O N [1:29 p.m.] MS. LAYTON: At lunch we discussed that we might talk a little bit more about how we were going forward. MS. DILLEY: Yeah, so here's what's going on. We have a group upstairs that's trying to work on the consumer -- consumer, let's see we're talking -- calling that consumer implications for varying labeling, varying labeling regimes. And we think that that conversation could at least get going fairly productively in a smaller group as opposed to doing it in a larger group. So we're going to give them some time to work on that. Again, half an hour, 45 minutes, we'll go check and see how they're doing. In the meantime, one option was to go through other parts of the report. The problem with that is that Dick is the one person who it would be nice to get. Okay. We hadn't heard his comments because he's the one person who wasn't with us when we were all together. So where we thought we would start when we got back here while that group is working is talk about the guidelines for the scenarios discussion for a little bit and get that squared away and then move back to the document on the traceability and labeling. So if we could do that for a little bit because we have, we do have some of you who have been involved with the scenarios discussion and just figure out how we want to approach this moving it forward. Because I know, Terry, you have to go at -- did you say 3:30? MR. MEDLEY: Uh-huh. MS. DILLEY: So if we could at least start, set that conversation up and have any input by those who have to leave a little bit early to do that, and then we'll move back to going through the traceability and labeling document at about two. Does that sound reasonable to people? MR. SCHECHTMAN: It probably makes sense, and since we've talked about a lot of this -- before, before your plane arrived this morning, it probably is -- backing up for a moment to talk about what we were saying earlier -- that there was some thought that there was a possibility to move the scenarios chapter more quickly and see what could be -- see what the possibility was of actually getting some version of the scenarios document actually out of this meeting. MR. ENRIQUEZ: Would anybody have any major objections to scenarios as they are currently placed? MR. SCHECHTMAN: Well, they're -- you mean placed in the full document or -- MR. ENRIQUEZ: Yeah, in the whole document. I mean edits, edits are different, I think, specific edits are different from major -- MS. DILLEY: In the overall -- MR. ENRIQUEZ: Any major blocks to how it's currently structured? MR. SCHECHTMAN: No. I think if we could, if we could hold off on the discussion of the content just for -- talk through how we're going to do this, if that's -- MR. GIROUX: What are we going to do with them? Are we going to do -- MS. DILLEY: Well, I think we could, we could entertain that question that Juan put out. I mean why not, because that may help shape what we want to do with the -- UNIDENTIFIED SPEAKER: Okay. MS. DILLEY: So why not broach that. And we recognize we're still missing people, but let's entertain that question and then come back to how do you want to set up this conversation. Because that's as far as -- we wanted to get before we actually have the conversation with more of the Committee members here. MR. SCHECHTMAN: Yeah, because I did want to just make the one point in addition, Juan, that a couple of folks had mentioned that there were comments that they had provided on that section that -- that were never incorporated into the document. MS. MELLON: Plus the entire implication section that we wrote for last scenario. MR. ENRIQUEZ: We didn't do -- so the implication section will be the work of -- MS. MELLON: The future -- UNIDENTIFIED SPEAKER: The next committee. You know, this Committee goes as far as -- UNIDENTIFIED SPEAKER: -- do that. MR. ENRIQUEZ: -- first two sections, and then the next group can design and sign off on implications, if they wish. My understanding is four of the six people on the Committee are leaving. MS. DILLEY: Six? UNIDENTIFIED SPEAKER: Four. MS. DILLEY: Dropping like flies. MR. ENRIQUEZ: So my suggestion would be that we don't deal with implications at this meeting because I don't think we'll get through. MS. DILLEY: Mardi. MS. MELLON: I agree that we probably won't get through the implications. I'm also quite interested in moving this forward to some sort of completion. I guess I would put on the table the, the possibility that we might just have to not have implications, that we could have the scenarios, and they could kind of, you know, stand as thought provokers, but that we wouldn't need to have the implications in order to sign off on the piece as it's currently -- as it's written. I am -- I mean I'm reluctant to kind of divide it into -- divide the piece into kind of two tasks, and give a whole new committee, you know, with four new people, the challenge of writing implications as a whole or even maybe implications for one of the scenarios. Just it seems to me that people are not going to want to -- they're either going to want to go back and reopen the whole thing or they are going to have a difficult time kind of getting back with the program to know what the implications ought to look like. So as hard as it is for me to say this, I think one of the things that we have to entertain is the practicality of getting this done in two days is the possibility that we might just not have implications for the scenarios. We would have the drivers, you know, the future, the purpose of the scenario -- not, not -- they're not predicting the future and then kind of let them, let them do what they do. MS. LAYTON: And there would be also the questions. UNIDENTIFIED SPEAKER: No. MS. LAYTON: In other words, you've done something in the work group that I actually liked, which was -- UNIDENTIFIED SPEAKER: Yes. MS. LAYTON: -- you talked about what are the implications and what is the economic impact of the scenario, what is the economic impact of the scenario on the natural environment, what are the implications of the scenario for USDA, and you listed some, what are the implications of scenarios for public acceptance, and what are the implications of scenario for addressing food sufficiency and food security. I thought those were wonderful questions. MS. MELLON: Yes, they are, and -- MS. LAYTON: That are working questions for a group -- any group -- UNIDENTIFIED SPEAKER: Yes. MS. LAYTON: Even the group within USDA to use. UNIDENTIFIED SPEAKER: Sure. MS. LAYTON: Without even us -- so you know I think that's one of those things that those are the kinds of questions that would be posed after each scenario. I think that's also a very valuable tool. That's just my opinion. Greg. UNIDENTIFIED SPEAKER: I think that -- MR. JAFFE: Yeah. I mean my view is this is a great document, been put together. I think it reads very well as it is, a stand-alone. I think you could add a conclusion and take as Pat said, these and incorporate that into a conclusion or next steps or whatever you want to call it. I don't think we should do as Mardi said, I don't think we should do implications at this stage. We won't get it done. My view is that because some of the members of that Committee are leaving, they spent two years, they'd like to show something for their work. I think they've done a great job. I think we should, you know, what comes out of these next two days' meeting -- transmittal to the Secretary saying, you've given us this charge and what we've completed to date is a scenarios chapter, part of the one -- Part A and Report B, and put them in as final documents together. And I think we should spend time this afternoon and tomorrow to the extent people have edits on this as Juan said the edit-type things, and put those in. And I note not everybody's comments have been taken, but I think what Terry said was that they've all been at least analyzed. We don't always take everybody's comments. We -- I mean they're analyzed. Not everybody -- this is a consensus. We, you know, weight everything. So I think that Terry did say that the Committee has at least reviewed everybody's comments and considered them. MR. SCHECHTMAN: They didn't quite review all of them. MS. DILLEY: So the proposal on the table is to take out the implications section, do the scenarios document up to the point over the next couple of days to get it to how everybody is comfortable, and I think then we come back to Juan's question of just how off are we from everybody feeling comfortable, and then present that to the Secretary as well for something to consider along with the questions, I guess. Terry. MR. ENRIQUEZ: I think the questions could be phrased as you may wish to build your own scenarios based on your own knowledge, and here are some of the questions you may want to ask in terms of how these scenarios affect you and your business. MR. MEDLEY: Well, I guess I have just a, maybe a slightly different slant on this. I have to admit that when we first started working on the scenarios, this group I think we came together at a certain point really under -- kind of semi-understanding what we were working on and what we were trying to do, and I think we were then able to make some progress. But what I see that's really critical in the scenarios is the language we worked on trying to respond to the concerns raised by the full group in terms of, you know, whether a scenario was likely to occur or how much are we trying to predict and what is unreasonable and what -- and so I think the language that was in the document, especially on page 8, which tries to go through the fact that each scenario is intended as a coherent description of what the world might look like if after events driven by the certainties, uncertainties play out. But then we go on to say they're not predictions -- it's probably not going to be accurate. But I think at the end, which is not bolds, what's really critical to me, it says, however they demonstrate the sensitivity of agriculture and the food system to events that can tip the future in different ways and look -- altogether provide an opportunity to extract additional knowledge about broader impacts into the future. And to me it seems that from the Department's perspective, it's okay to give some scenarios and to give this out. But what's really the critical tools are the things you should start looking at that really make a difference? In my opinion get into the time we spent trying to develop questions about impacts. I mean what are the things you want to look at from the standpoint of economics, competitiveness, science. And so it is really providing a document that's not trying to say here's an answer, but here's a pathway that one can go down to try to be prepared for the changes that could occur. And so we spent a lot of time on the certainties, the uncertainties. They're in bold. I do believe that the strength of the scenarios is providing a document that hopefully the Secretary of the Department would say, okay, this can help us as we're trying to get prepared to carry out our duties in an area where certain things are certain, certain are not, and there are going to be new developments. And so it's hard for me to see trying to pull that -- MS. DILLEY: It's hard for you to see -- finish that. MR. MEDLEY: It's hard for me to see pulling I guess the impacts out. MS. DILLEY: I don't think anybody suggested that. MR. MEDLEY: Okay. MR. SCHECHTMAN: No. There was the thought of putting in the categorization of the kinds of impacts, you know, the key that you came up with for -- UNIDENTIFIED SPEAKER: The structure. MR. SCHECHTMAN: -- for the structure of analysis of implications. Putting that in and saying -- MR. MEDLEY: Okay. MR. SCHECHTMAN: -- you may want to do that on these scenarios -- MR. MEDLEY: I see. Fine. Fine. MR. SCHECHTMAN: -- or others which you may devise. MS. LAYTON: So not answering -- MR. MEDLEY: Right. MS. LAYTON: -- not answering by the providing the questions. MR. MEDLEY: Okay. MS. LAYTON: Because of one the things we learned early on was that -- MR. MEDLEY: Yes. MS. LAYTON: -- when you get scenarios, you're also given the questions to answer about those, and then you go into work groups and you work through those questions. MR. MEDLEY: Exactly, okay. MS. LAYTON: And so that may be the most valuable -- that may be what we really need to do is the scenarios and those questions so that then the Department can answer them from their different points of view. MR. MEDLEY: Okay. No, I'm fine. I just through I must have -- MS. LAYTON: Bernice. MR. MEDLEY: -- wrong. MS. LAYTON: No. I mean I think that that's actually a very -- that could be, you know, very useful, and you know, we may want to at some point, you know, once you finalize this, have you explain to, you know members of our coordinating group, you know, what, what you, you know, what you mean by the scenarios and how they can be used by the Department and have that kind of physical interaction as well as, you know, just putting it down on paper. MR. SCHECHTMAN: We won't hesitate to try to bring you back to that discussion, even if you're off the committee. MR. MEDLEY: Okay. MR. SCHECHTMAN: Whether we'll succeed or not is another matter. MS. DILLEY: I think we have Michael, Lisa, Greg, and then Juan. UNIDENTIFIED SPEAKER: Well, no, I'm not on that. MS. DILLEY: Okay. Michael and Lisa and Juan. MR. DYKES: I guess I'm a little -- I thought the last time we had a meeting we were going to meet one more day to finalize traceability and labeling, and the first day was going to on the T and L paper. MS. DILLEY: Correct. MR. DYKES: Two specific requests from the Secretary. One was the document, the two or three chapters, which includes a chapter on scenarios; and then one on traceability and labeling. So I guess I'm a little confused as to why now we want to pull -- I understand the argument about four of the members are leaving, but we had another member leave us before when their term -- and we -- the committee is set up so that people are going to rotate on and rotate off. We happen to have four this time. We had Magnus rotate off on the first time. I think we should continue on the process -- I'm fine with -- I'm not prepared to discuss scenarios today because I thought that was going to be on day two's discussion on the agenda. And I'm not prepared to discuss it, but I mean I can read my comments, and I will discuss it. But I think we should still stick to what we agreed in the last meeting was to try to finalize traceability and labeling, get that out the door. MS. DILLEY: I think one of the key pieces of information, we're still committed to finishing the traceability and labeling document. This is not taking over from that. This is trying to do it in addition to. The key piece of information that was missing in the December 9- 10 meeting is who was rotating off, and the fact that I -- I donÕt think anybody was aware that four people that just happened to be in the Scenarios Work Group, are rotating off the Committee, which is a huge piece of -- issues we know we're going to keep talking about because the majority of our -- of that working group is still going to participate. We're going to integrate additional members into that conversation. But to have a much more dramatic turnover on the scenarios, I think a lot of people are concerned that it would not -- it may not have the same benefit of consistency of membership. So that's why the proposal is on the table in terms of trying to finish it -- MR. DYKES: Well, I don't think -- I think we have, and we've talked about it in the work group, but we've also talked about scenarios as a larger committee. So to say that part of the work group has gone, I don't think that detracts from where the rest of the larger committee is. I think it's a chapter within the other section. So I think we should complete the T and L. We should work on the scenarios today, if that's what we want to do with some of our time while people are out. But the other report should remain and scenarios should remain a part of the other report and to give credit to those committee members who worked on that, and I recognize their contribution. We should -- and when we finalize the second report, we should, we should comment on those committee members that have been participants throughout this process, even those that have departed. Doesn't say that they -- they're in consent with them, but they were part of the discussion and development of it. MR. MEDLEY: Rotate off, not departed. MR. DYKES: Their term, they rotated off. (Simultaneous comments.) (Laughter.) MR. DYKES: They rotated off. That includes -- and before this time and maybe even more are going to rotate off before the other report is done. MS. DILLEY: Lisa and Juan. MS. ZANNONI: I think on the scenarios, when we review them, whenever we review them, we should concentrate on the questions. And we did this internally in our company, the value was in the questions and how broad or narrow or out of the box they let you -- they thought. And the scenarios just fell away, because the end product, if the Secretary does this, is what comes out of those answers to the questions. Because that's, that's their product on what, what areas they have to look at, that type of thing. So the scenarios, as long as the facts are such that you look at the questions differently, it -- that's fine. If we get into you know making edits on the scenarios, I donÕt think that's where the value is. I think it's really in the questions and making sure that the scope of the questions are what we think the Secretary should be looking at when they use it as a tool. MS. DILLEY: Juan. MR. ENRIQUEZ: If you bear with me. You know, in the time that we've been working, there have been three sort of quasi-scenario things published. One was on 9/11, which is a report on 9/11 that people got through which was kind of complicated. The National Intelligence Council put out a report called 20/20, which addresses some very thorny issues. It's full of scenarios, potential intelligence counseling, what the world looks like 50 years out. And then the FDA last week put out this little biggie, and the first chapter -- MS. LAYTON: Can you read the title so that it will be in the record? MR. ENRIQUEZ: Sure. It's the Innovation/Stagnation: Challenge and Opportunity on the Critical Path of New Medical Products." If we read the first paragraph of this, if you indulge me for a second, might have something to do with what's happening in agriculture. "Many of the new basic science discoveries made in recent years may not quickly the yield more effective, more affordable, safer medical products for patients. This is because current medical technology development path is becoming increasingly challenging, inefficient, and costly. During the last few years, a number of new drugs and biologic applications submitted to the FDA has declined significantly. The number of innovative medical device applications has also decreased. In contrast, the product development costs have soared over the last decade. Because of rising costs, innovators often concentrate their efforts on products with a potentially high market return. Developing products targeted for important public health needs like counter terrorism plus common diseases prevalent Third World diseases. Prevention indications on individualized therapy are becoming increasingly challenges, challenging. In fact, with rising health care cost, there is now concern as to how the nation would continue to pay for even existing therapies. If the costs and difficulties associated with new medical product development continue to grow, innovation will continue to stagnate or decline and the biomedical revolution may not deliver the promise of better health." If you change those words to agriculture, I would argue that you would have a very effective scenario development plan for this, and you see that in USA Today last week, biotechnology apparently -- food source. Two of our Board members here are quoted in the particular article, and you see some issues evolving that have -- in our scenarios, which is the issue of avian flu and animal flu. Now if you're talking about what's going to happen to agriculture in the 21st Century and actually over the next decade, my argument would be things like traceability and labeling are very important, and they are a small piece of the puzzle. And if the Secretary wants to look at what will truly change over the next year, 2 years, 4 years and 10 years, we'd better get those scenarios out quickly. This is not a process to go for another two years. I think two years has already been too long. But the way you prepare a farmer, the way you prepare a country, the way you prepare a business for what's coming is you try to figure out what's going to happen if you have techola (ph.), mad cow, reaching in this country, because that's what's been happening in Asia and -- when you get a case of mad cow in Japan last week, then beef imports disappear again for the next five years in Japan. How do you prepare for stuff like that that you don't know is coming? You put out scenarios, and they may not be perfect, they may not be right, but you get them out, get them into people's hands, and you do it quickly to try and get people thinking, what happens if the world starts looking like this? It may not be the world I look like, but we can spend the next five years talking about scenarios. I would argue we have to get something out the door, even if it's rough and dirty, and that's -- I think as important as anything this Committee is doing. If you're looking at what this stuff looks like, you know, in the 21st Century. That's one, one person's point of view. MS. DILLEY: Greg. MR. JAFFE: Yeah, I mean I would agree totally with what Juan said. We have talked about four people not coming back on the Committee because they haven't actually applied. I'm one of the people who has applied. I don't know if I'll be on this Committee a week from now or not. So, you know, my -- and five other people or something around the table will feel that way, and I'm not asking Michael to give me a call on that. MR. SCHECHTMAN: I don't have -- MR. JAFFE: He can't give me a call on that. That's not important. But I guess when I read the documents over the weekend, I said the issues document isn't anywhere near complete. It's barely an outline of anything. MS. DILLEY: -- just three issues. MR. JAFFE: The scenarios document, in my mind, read as a complete document. It may need some editing and may have some comments from people, but I thought we could get it done and get it to the Secretary. Our charge was not a report on scenarios or a chapter on scenarios. We came up with the idea of part of the -- one of the reports was to do a scenarios piece. There's nothing that says it has to wait for the rest of the report. I mean it was something that our Committee as a group said. This would be a useful thing to include in it. We can -- and, therefore, we can as easily say it's a useful thing to separate it out and give to the Secretary now as Juan has said. So I donÕt think we need -- it fits within our charter as something the Secretary we think is interested in, there's nothing that says we can't give it to him tomorrow with the traceability and labeling, and my view is we should finalize as much of our total workload as we can finalize, and I think we can finalize it. So I think we really need to ask the question, Juan's question, which is, is there anybody here who thinks we can't? Is there major heartburn with the substance of what's in these 14 pages that we can't get the editing done and write a conclusion that includes the questions in the next day and a half in addition to finishing -- which I think we only have a few more sections left of the traceability and labeling. We have one page on consumers. We've got the implications things, 7 or 8 of those, and executive summary. We've pretty much gone through everything there. So I think Juan has asked the right question. MS. DILLEY: I think that is the right question, and I think we need to do that in full group is the problem right now, I think. MR. ENRIQUEZ: I think that's fair, and I think the answer is there are no major blockages to this thing. MS. DILLEY: Right. MR. ENRIQUEZ: I think I should sit down with whoever has a -- their half an hour just in the back during a break, if you want, and we'll go through the edits as anybody who has got edits come, and let's see if we can't get those edits in tonight, and get a document out by tomorrow so we donÕt spend more than an hour on scenarios, so people don't have major blocks on. We -- MR. SCHECHTMAN: I'll just put a little caveat on that, which is I think that some of the text suggestions are -- some are more substantive than others, and I don't know that it's -- which is not to say that you donÕt' try. MS. DILLEY: I think that's a great offer. I think we should field that question. UNIDENTIFIED SPEAKER: Yes. MS. DILLEY: When we have a full committee. Get a sense of it, and then if it works, I love it, because you're doing our work for us. It's just -- fantastic. So if we can agree to do -- to field Juan's question when we're all here, I think then we'll get a better sense of whether it's doable and if, and try to get it done. Mardi. MS. MELLON: One fact, factual question. How many comments are there that would -- that would -- that we know of that would need to be dealt with in the process Juan's described? I mean Michael's -- you got a few comments that were not considered at all on, I think on the third scenario, is that correct? MR. SCHECHTMAN: Yeah, some comments that weren't considered at all, some comments that weren't included, but that he nonetheless may feel strongly about. So they are not comments that have gone away. MS. MELLON: But is -- are there other sets of comments that are not -- MR. SCHECHTMAN: There were some from you. MS. MELLON: There were some from me, yes. MR. SCHECHTMAN: And I believe that there were some comments that came up at the sixth plenary that there was not time to get into this document. Not a large number and not very -- and I don't have them. I donÕt have them here with me. I didn't think we were going to be at this point. MR. ENRIQUEZ: We could do it tomorrow morning. MS. DILLEY: You would have to decide. MR. ENRIQUEZ: -- things that you'd like to do today. MS. DILLEY: We'd like to field that question today. MR. ENRIQUEZ: Put a time limit on the stuff. If you're -- traceability -- for this thing, can't -- so we'd like to do traceability and labeling. By all means, let's spend all afternoon on traceability and labeling, and then tomorrow morning we get on scenarios seriously. And if people have edits, please give them to Mike, and we'll look through them. MS. LAYTON: I think there was a question there are people, there are a couple of people who are not going to be here tomorrow. And so if -- and there was some point that if we could get to -- if we could get tracing and labeling, traceability and labeling up to a certain point that we could then ensure that we got the scenarios comments from those people who weren't going to be here tomorrow, given that people felt comfortable that we could get somewhere on that. MR. ENRIQUEZ: Fair enough. MS. LAYTON: So I think that there was some idea that we might have to piece the afternoon in, piece in a section of the afternoon for working on those scenarios. Now Michael said he did not bring his comments with him, but does this Michael have them? MR. DYKES: I -- I made comments in I guess according to this August 16th. I have not read the scenario section, not looked at it since I turned in these comments. That's not to say that I can't sit here and read it, but I assumed that today's session was traceability and labeling and tomorrow was on the rest, on the other parts of the report. So I'm fine. I'm not going to be here tomorrow. I'm fine with -- you have my comments. You want to discuss them tomorrow, proceed with the discussion, I'm fine with that, but I'm as of this afternoon prepared to sit here and talk about scenarios. I mean I can read, I can read my comments, but I mean I'm not even -- not thought about it since August. MR. SCHECHTMAN: I guess the question really that we have is will we then proceed if people discuss your comments, you're not here? That creates a procedural problem for us in finalizing something tomorrow. MR. ENRIQUEZ: Could we ask a similar question on the traceability and labeling? Does anybody have major objections to the traceability and labeling? MS. LAYTON: I think, I think that there are on the consumer segment, and I think that's what's being worked on right now. MR. ENRIQUEZ: Other than the consumer section? MR. SCHECHTMAN: It's not a question so much of major objections. There are choices that haven't been made yet by the Committee. MR. JAFFE: I think -- I mean Michael we have the same -- we have, we're already missing two people today. Doesn't look like Keith or Carole are showing up today. I'm not sure if they're showing up tomorrow. MS. LAYTON: Carole has bronchitis. We're not sure on her status. MR. JAFFE: And so we're going to be missing three additional people tomorrow. The same question about the traceability and labeling as we are going to have about scenarios in terms of can you finalize a document if people aren't in the room. So I think we have to broadly address that question, not just link it to only one of those reports, but to both of those, because we're not going to have the final document on traceability and labeling today either necessarily. MS. LAYTON: Mardi. MS. MELLON: No. MS. SULTON: Well, Abby has gone to try to get the group that's working on the consumer report. Maybe when they come back, then we will return to the traceability -- report. It had been our intention to continue with the sections identified on the agenda, I guess Mike's annotation and the consumer piece and go to issues and come back then to the executive summary. Is that -- Yes. MR. JAFFE: I thought the agreement was at 2:30 after public comment we would move to scenario. MS. SULTON: No. MS. LAYTON: No. 1:30 we would discuss it. MR. JAFFE: But we also said that we would leave at least some time -- MS. LAYTON: At the end of the day. MR. JAFFE: Well, we had talked about -- Well, I'd like -- MS. LAYTON: We have to get to this consumer section, have to get to -- MR. JAFFE: We can get to consumer, but not exactly -- MS. LAYTON: Well, I'm asking. I wasn't stating that -- MR. JAFFE: Okay. MS. LAYTON: -- was the way we were going to do it. I'm saying that was the way we had it in the agenda, and the -- question how -- would we still approach it in that order. Correct. MR. JAFFE: Okay. I would propose that we could do the consumer section and do that, but then I would propose that we move on to scenarios since we have people leaving today who will not be here tomorrow and discuss the question Juan and others have said, because I think that that is very important. MR. GRANT: So just to kind of the group on what's going on since -- but if this works all right, Pat, with you and the group, we're trying to come up with a clean draft of customer section, and then we'll print that off and bring it back down to you, if that works. MR. MEDLEY: How long? MR. GRANT: I'm guessing 30 minutes maybe. MS. LAYTON: Can we start then from other issues? (Simultaneous comments.) MS. LAYTON: Are you comfortable if we go over the few other edits? That would be my next question. MR. GRANT: It's the bottom line. We're going to either hash through the consumer thing up there or down here so -- MS. LAYTON: Or down here, right. MR. GIROUX: So are we going to -- right. So just a process question. MS. LAYTON: Yes. MR. GIROUX: I mean your guys going to come up with something, you're going to bring it down, and then we're going to have to re-discuss it as the whole Committee? MR. GRANT: So I -- MS. SULTON: We will have to. MR. GRANT: Yeah. MR. GIROUX: So I'm just -- you know at some point if you -- we're going to all -- I mean it's one thing if you come down and say everybody here at the table says whatever they come up with, that's okay with us, but it's different to -- for everybody then to have to chime in again on it and maybe change everything you guys have done. So I need a -- maybe a pulse check from the people that aren't in that discussion, you know, what's going to happen when they bring it down. MS. LAYTON: Who is upstairs? MR. GRANT: There's Carol, Dick. MR. JAFFE: Leon and Duane. MR. MEDLEY: I mean I -- to me I understand what Randy is saying, but it seems to me that there's a difference between this group I think rehashing or looking at something that, you know, is kind of a more consensus that addresses some of the questions then trying to write that anew in this group. MS. LAYTON: Yes. MR. MEDLEY: That would take much, much longer. It's much easier to go through something, and we're only talking about a page, right? MR. GRANT: Right. MR. MEDLEY: We're only talking about a page that we would be able to look at. MS. SULTON: Hopefully to vote up or down, I guess. MR. MEDLEY: Because otherwise, if we try to draft it down here this whole -- MS. SULTON: It won't work. What we've done is take the people who had questions, specific questions, and they are the ones actually working on resolving some compromise language. MR. SCHECHTMAN: So are we hearing the thought of having an up or down vote on the new piece that comes in? MR. MEDLEY: No. We're hearing not going to complete the process. UNIDENTIFIED SPEAKER: Pardon me? MR. MEDLEY: -- take the 30 minutes that they said it would take to bring it down. MR. JAFFE: One proposal is while they are doing that, for the scenarios people to get together and whoever - - have major edits and things with Juan, and start that or at least start putting together what might be the conclusion, taking those questions or something like that. That may be one valuable breakout group at the same time. MS. SULTON: Can we have -- people were saying they don't have their questions with them. Michael. MR. DYKES: Another suggestion maybe. Could we continue to go through the T and L paper, look at the particular edits, the bracketed text, when the people come back go through the sections that they have and tell them what we've talked about and discussed, and if they have other particular comments, we could bring those up. If they're fine with what we've done, then we've done everything except the one page on consumer, and we look at what they did and we do that, and we get traceability and labeling by 5 o'clock today. MS. SULTON: Greg. MR. JAFFE: I mean I, if I was in that group upstairs, I don't think that's fair. Traceability and labeling is supposed to be something we're putting our final changes in. Even this morning when I, when we talked about a rolling break people -- I and it was agreed by everybody, people all wanted to be in the room to hear that stuff because it's something they're going to be asked at the end of this two-day meeting are they comfortable with. So I don't think it's particularly efficient if they're only going to be a half hour to start going through this, and then it will take us almost as long to explain the changes that we made, and they'll all have the right to have a comment just like Dick has the right to have a comment when he wasn't here last meeting. I think it would be much more productive to the extent that there are -- people have things with the scenarios to break up in a group and do that at the same time for the half hour. MR. MEDLEY: But didn't we have -- I thought the comment was we were going to through and in those bracketed areas we were going to make some choices. So, therefore, what happened is everyone would still have an opportunity when they come down. Simply -- you would simply read -- MS. SULTON: These were the choices made -- MR. MEDLEY: These were the choices made by this group. And then if you disagree, then that person can say, well, no, I don't like that. If they say, okay, that's fine, then we've completed. But everyone has an opportunity both on the consumer and on this to express their particular view about the language that was chosen. I agree, we're not trying to -- MR. JAFFE: Are we talking about bracketed language or are we talking about people's comments? Because we still have -- the executive summary people are going to be providing comments. MS. LAYTON: I don't think we want an executive summary -- MR. JAFFE: So we're just talking about -- UNIDENTIFIED SPEAKER: Market -- MR. JAFFE: No, not market -- sounds like -- I'm comfortable if we're just going to go through Section 2 and go through places that people have the bracket. I don't think we should go through new text. MS. SULTON: Okay, then let's do Section 2 to be productive. MR. JAFFE: I still think we're much better ff spending the time -- (Simultaneous comments.) MR. DYKES: Things that are not new text. I totally agree. Things that are what we should focus on. MS. LAYTON: Daryl has a question. MR. BUSS: I don't have a question, but the concept of dividing into two breakout groups with one group breaking out -- (Simultaneous comments.) MS. LAYTON: Both get back reports. UNIDENTIFIED SPEAKER: Correct. (Simultaneous comments.) MS. LAYTON: Okay, so are we -- do we want to do this off-record? UNIDENTIFIED SPEAKER: What are we doing? MS. LAYTON: Section 2. Section 2, page 6. MS. MELLON: Can I make just one more general -- UNIDENTIFIED SPEAKER: Yes. MS. MELLON: -- observation? And that is follow- up on what Greg said. And we're going to get to the end of today, and we're not going to have enough people here to sign off -- so whether it's at the end of today with regard to the traceability and -- labeling. UNIDENTIFIED SPEAKER: Traceability and labeling. T and L. UNIDENTIFIED SPEAKER: I can't say -- MS. MELLON: -- what was in my coffee. Or with regard to the scenario. We're going to have to have a process for getting final approval that is going to have to be something like this is as close as we could get. People who were not here for any reason, that includes because they're leaving, you know, today -- they're here today but leaving tomorrow will have one last opportunity to look at this, but there has to be some sort of a -- you know if this -- if we are to get sign-off on anything there has to be a process that kind of presumes that by the end of the two days we're pretty close to there, and unless you have major substantive objections that this thing is going to go forward. MS. LAYTON: Correct. MS. MELLON: But that will be true of -- I mean we'll need a single process that will deal with both of the pieces. MS. LAYTON: Comfortable? MR. ENRIQUEZ: Let me be more specific on that comment. If after two years of work you lose a significant part of this Committee, the only thing that you bring out in this Committee in two years is the issue of traceability and labeling? It's going to look like this was driven by the specific interests that are interested in traceability and labeling. If the only thing after two years that we can have a consensus on or that we come up with that's traceability and labeling as what we're suggesting for the Secretary for 21st Century agriculture, I think you should think long and hard about what that report means. MS. SULTON: Abby, while you were out of the room, there was a suggestion made also that we go into a breakout to get the people's comments on traceability -- on scenarios. Michael, did you -- MR. DYKES: Yeah, I was just going to say what I understand about scenarios being important, but I -- MR. ENRIQUEZ: I'm not just talking about scenarios. I'm saying -- MR. DYKES: But I'm not -- MR. ENRIQUEZ: -- this is a group that has spent more time editing this particular document and working on this particular document than any other issue. It's a very important issue to what our charge is 21st Century agriculture. If this is what's going to come out after two years, at least I'll have something to say about that because you know I donÕt think this reflects the work of what's going to happen. We have in essence a day and a half for -- folks are going to rotate off after two years to say this is what we worked on for two years. And if the only outcome is this, well, you know, we might say, well, perhaps reflect it, that's all. As important as this is. This is a committee on 21st Century agriculture. MR. DYKES: I hear you, but I don't -- I think that's mixing what the request was with what's coming out of the meeting. I don't think anybody is ascribing any more significance of one to the other or saying that the Committee failed or the Committee succeeded or any of those kind of comments. MR. ENRIQUEZ: A statement of fact as we have it. MR. DYKES: A statement of fact as we have it as -- Secretary asked for two reports. Asked for one report and then came back and asked for a special report on traceability and labeling. That's the way it was presented to the Committee. MR. ENRIQUEZ: That's all the Committee is responding to. MR. DYKES: So to comment that that's all we come out of here with, I don't think that's exactly true. We have done a lot on the rest of the reports. The other reports just not finished -- just -- traceability and labeling. MS. DILLEY: So I think we have a commitment to work on both pieces and advance both pieces. I think if we don't get on with it, then we're not going to get either report done. So let's do it, and start with Section 2 of the Traceability and Labeling Report and move forward with that, and then we'll get back to hopefully Section 3 by the time that other group comes back, and make sure we get to scenarios for a portion of today. I don't - we still did not have any public sign-up, so if there are people in the audience who have -- are interested in providing public comment, please do that so we can organize our time this afternoon as best we can. Okay. Cindy, I'm going to for Section 2 then. MS. SULTON: All right. If we were to just go forward with looking at bracketed text, there is not a lot of bracketed text until page 10 as I look at it. Section 2 actually begins on page 6. There's a lot of editing. There's one place in -- on page 6 in line 3 -- get the right line -- I'm sorry, on page 10. In the -- MR. SCHECHTMAN: Now there's some on page 9. MS. SULTON: -- 9. MR. SCHECHTMAN: Yes, 9, lines 39 to 42 or 40 to 42. UNIDENTIFIED SPEAKER: We needed a correction on that. There's an issue on that. MS. SULTON: It's on the word it? Is that where you're looking? (Simultaneous comments.) UNIDENTIFIED SPEAKER: For example. MS. SULTON: For example, okay. This is a question of fact with -- UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: Yes. MR. SCHECHTMAN: This is in Section 3, labeling requirements triggered when modifications result in compositional novelty under the scope portion, and this is the example -- MR. MEDLEY: What page are we on, Michael? MR. SCHECHTMAN: This is page 9, lines 40 to 42. This is your -- MR. MEDLEY: Okay. MR. SCHECHTMAN: -- the issue that you had raised about -- and I think, I think your suggestion was just to eliminate the example. MR. MEDLEY: Yes. MS. SULTON: Yes. MS. LAYTON: And this is in the e-mail that was sent to you. This one is highlighted. Sorry, I just -- UNIDENTIFIED SPEAKER: So the sentence reads: in the case where the new product mimics a conventionally bred product, it may or may not be exempt from labeling depending on the country. UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: Right. UNIDENTIFIED SPEAKER: Right. MR. DYKES: I'm fine with that. MR. SCHECHTMAN: Everyone okay with eliminating the example? MS. LAYTON: The country? MS. SULTON: You talking about eliminating the example in its entirety? MS. LAYTON: Yes. And then the answer is should we use the word on the country? UNIDENTIFIED SPEAKER: Sure. MS. LAYTON: The. UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: Okay. UNIDENTIFIED SPEAKER: Going to use the word -- or it? MS. ZANNONI: It. MR. SCHECHTMAN: It. UNIDENTIFIED SPEAKER: It. UNIDENTIFIED SPEAKER: It being the product? UNIDENTIFIED SPEAKER: Yes. MS. SULTON: Michael, the next I see is on page 11 in line 6. UNIDENTIFIED SPEAKER: Yes. MS. SULTON: Variety of factors, including detectability of -- why was this bracketed, Michael? Can you give us a little -- MR. SCHECHTMAN: This was a case where there was not agreement on how to characterize the whole range of factors that might enter into this decision. And I know in fact a good number of the folks who are actually off in discussion had views on this particular piece. I was just trying to give -- to capture the various comments that people had provided and give a whole lot of different things you could cross out if -- to suit yourself and see how people felt about the most appropriate text. MR. GIROUX: So, Michael, is there three choices here to finish that -- it looks like there's choices, four. MR. SCHECHTMAN: There's some nested, there's some nested stuff in there as well so -- MS. LAYTON: Read it, you know, you think the choices -- MR. SCHECHTMAN: Maybe based on a variety of factors, including detectability, level of testing and political considerations, the level of testing detectability or balance of domestic factors, including consumer and political considerations, and then the, and then the last one has several different possibilities nested within it. There's nothing sacred about any of these possibilities. David. MR. HOISINGTON: I guess the question in my mind seems like tolerances are based on politics and things like that, not science (maybe I'm wrong), and our ability to actually meet those tolerances as a scientific consideration -- measure activity and all that. It seems like to me this section confuses both of those in my mind. I think everything is there, but -- that's how I review it. MS. SULTON: I'm sorry, Randy. MR. GIROUX: So in my conversations, I think it's all of the above, all countries save different things. Some trade, you know, trade or use detectability or testing capabilities or what the marketplace, what they believe the marketplace can achieve in setting a tolerance. I've yet to see a country say they're using it as a political tool. So I would like to see us come out with -- I think we've got three options. I think some are better than others, but I think it's important that we would list all those considerations. MS. SULTON: Terry. MR. MEDLEY: There just seems to -- it just seems like it's a little bit of overkill. It's, you know, and so it seems that there are areas that would be good for providing examples so you can simply say that tolerance set for AP are often country-specific and may be based upon a variety of factors, including detectability, you know, a required level of -- well, I was going to say a level of testing and marketplace considerations, but I was just trying to -- it just seems that we should be able to characterize it in a few examples, and not have to repeat this over and over again. And what I've heard from this discussion is the detectability -- we'd have to probably say level of testing would have to be clarified a little bit, and then if there are other -- just used the term marketplace considerations or something. But if there's a way we could just do that. MR. DYKES: -- level of testing, testing capabilities. UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: How about test method performance? UNIDENTIFIED SPEAKER: Okay. MR. DYKES: So you could say tolerances set for APR from countries may be based on a variety of factors, including detectability, testing, performance, test method performance and considerations in the marketplace. MS. SULTON: When you say test method performance, are you talking about the quality of the tests, the -- I'm not sure what that denotes. MR. GIROUX: Yes. MS. SULTON: Yes, okay. How well -- the sophistication of the test. MR. GIROUX: Right. So if certain countries say we will test at Level X because we know our methods are validated and we can do them to this level. MS. SULTON: So is it -- MR. GIROUX: And that's the level that we chose. And so it's the performance of the method as they validated. They say this is what the method can do and, therefore, this is the tolerance. MS. SULTON: Right. MR. JAFFE: To me I mean the issue is the last one which was this idea that sometimes these are not set scientifically, and they're not as I said -- on the marketplace. I mean there's that -- Europe will say we balanced the consumer groups or the green groups and we did a political or consumer -- and that's not marketplace. So I think it's wrong to call that marketplace. There is a political -- and other countries just randomly pick a number that they think that their consumers will live with or that they think they can say they've done the best they can do or something along those lines. I mean I think that -- MR. MEDLEY: Consumers aren't a part of the marketplace? MR. JAFFE: I'm not saying consumers aren't a part of the marketplace, but the decision is not based -- it's not a marketplace decision. It's not -- it's based on other -- it's based on other -- it's based on the judgment of what politically people -- UNIDENTIFIED SPEAKER: Acceptable. MR. JAFFE: -- acceptable to people, not based on what is market acceptable to them. MR. DYKES: How would you suggest changing it, Greg? What would be your suggestion? MS. ZANNONI: Just add marketplace and political considerations? MR. JAFFE: Yeah. I mean -- MR. DYKES: So how would you say it? MR. JAFFE: I don't have a problem with any of these, to be honest. UNIDENTIFIED SPEAKER: I don't either. UNIDENTIFIED SPEAKER: Michael said there are others in the room who aren't here -- more problems with this. MS. DILLEY: Well, I thought it was based on a variety of factors, including detectability and test method performance, marketplace and political considerations. MR. MARYANSKI: Marketplace consumer. MS. DILLEY: And political? MR. MARYANSKI: Yeah. MS. DILLEY: Marketplace consumer. UNIDENTIFIED SPEAKER: I mean consumers have a huge impact on that number, way more than the marketplace. MS. ZANNONI: The political situation is responding to the consumer, so I would just put consumers like you're suggesting and not -- MS. DILLEY: Okay, so marketplace and consumer consideration. UNIDENTIFIED SPEAKER: Right, because I'm -- considerations, I mean it's so -- MS. ZANNONI: Yes, if you put consumer. MR. SCHECHTMAN: Marketplace and consumer consideration -- marketplace or consumer considerations. MS. MELLON: Put in all three, marketplace, consumer, political. UNIDENTIFIED SPEAKER: Just put all -- MR. MARYANSKI: The truth is it's all -- MR. DYKES: I donÕt really care. Just long as we put something, I think we can close -- MS. SULTON: Okay, so -- MR. DYKES: So tolerances set for APR may be based on variety of factors including detectability, level of testing, marketplace, consumer and political considerations. MS. MELLON: Yes. MS. SULTON: But test methods performance, okay. MR. SCHECHTMAN: Yes. Is that okay? UNIDENTIFIED SPEAKER: Sure. MR. DYKES: Yes. UNIDENTIFIED SPEAKER: What he said. UNIDENTIFIED SPEAKER: Got it. MR. DYKES: I think we've captured all the words on the next two or three sentences. (Simultaneous comments.) MS. SULTON: And the next is D4. No, we scratched what was bracketed. MR. SCHECHTMAN: That's because we didn't introduce any of the -- any substantive changes in these sections -- UNIDENTIFIED SPEAKER: Right. MR. SCHECHTMAN: -- that people had were not, were not put in this text. MS. SULTON: So we didn't -- the next thing we put in is -- trying to find -- MR. DYKES: I don't see any more bracketed text up until AP. UNIDENTIFIED SPEAKER: That's right. UNIDENTIFIED SPEAKER: That's right. UNIDENTIFIED SPEAKER: I don't either. MR. SCHECHTMAN: So we can continue along in sections that we've already reviewed post AP. MS. SULTON: So the next thing is -- MR. DYKES: I have one question. I'll just ask the question. I'll leave it to whoever -- that ad hoc task force on biotechnology, what are the officials titles? That is -- MR. SCHECHTMAN: Where are you? MR. DYKES: It's under Codex. MR. SCHECHTMAN: I believe that is the official title. MR. DYKES: Okay. Ad Hoc Task Force on Biotechnology? MR. SCHECHTMAN: Yeah, I -- UNIDENTIFIED SPEAKER: It is. MR. DYKES: That's fine. That's fine, that's fine, that's all I had. Okay. MS. SULTON: So if we -- MR. DYKES: Intergovernmental I think we in there as well. MR. SCHECHTMAN: Oh, I missed intergovernmental? Sorry. UNIDENTIFIED SPEAKER: Where is it, Michael? MS. DILLEY: No. We didn't have any brackets. It's Ad Hoc Inter-organizational Task Force? MR. MARYANSKI: Ad Hoc Intergovernmental Task Force. UNIDENTIFIED SPEAKER: I don't know where it is in -- MR. MARYANSKI: It is under Codex. It's under the last paragraph. It's about five lines up in parentheses. MS. ZANNONI: What's the number? MS. SULTON: It's page 13 number 29. (Simultaneous comments.) UNIDENTIFIED SPEAKER: Intergovernmental. UNIDENTIFIED SPEAKER: Intergovernmental, between -- MR. DYKES: Page 13, line 29. MS. SULTON: So it's Ad Hoc Intergovernmental Task Force? MR. DYKES: Yes. UNIDENTIFIED SPEAKER: Sorry. UNIDENTIFIED SPEAKER: Is that food derived from biotechnology, Jim, or is it just biotechnology? MR. MARYANSKI: If you want the whole name, it is food derived from biotechnology. MR. DYKES: I think it is Ad Hoc Intergovernmental Task Force on Food Derived from Biotechnology. UNIDENTIFIED SPEAKER: That's correct. MR. DYKES: I believe that's technically the correct name of it. MR. SCHECHTMAN: Okay. MS. SULTON: Okay, all right. MS. DILLEY: I guess they donÕt read titles from novels. MR. DYKES: Just trying to -- MS. SULTON: So that brings us pretty much through that section. The next section with text -- changes is in the Issues Section. Begins around page 35, but I -- MR. DYKES: I thought it was on identity preservation -- (Simultaneous comments.) MS. SULTON: Are we going to do that section? I thought we were going to -- (Simultaneous comments.) MS. SULTON: Thanks. I'm sorry. I didnÕt mean to point. UNIDENTIFIED SPEAKER: That's okay. MS. SULTON: We're sharing text here. So that would be preservation systems. MR. DYKES: I had a comment on preservations in that second paragraph. MS. SULTON: Okay, Michael. MR. DYKES: Page 21, line 23. We use the word segregated biotech varieties, and I really think we are talking about biotech products instead of varieties. MR. SCHECHTMAN: What -- where again, please? MR. DYKES: On page 21, line -- UNIDENTIFIED SPEAKER: Line 24. MR. DYKES: -- 23 and 4 -- maybe 24, yeah. I would suggest we change varieties to products. I don't think -- UNIDENTIFIED SPEAKER: Great, great. MR. DYKES: -- we're talking about varieties as in -- MR. JAFFE: I thought we were -- this is where -- now it seems like we're doing other questions, not going through bracketed text. I'm still -- UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: Oh, okay. MR. JAFFE: -- I'm still -- UNIDENTIFIED SPEAKER: Yes, all right. MS. SULTON: Okay, moving along with bracketed text. MR. SCHECHTMAN: There shouldn't be much because it was -- MS. SULTON: no. MR. SCHECHTMAN: -- because those things were not included. MS. SULTON: -- not finding bracketed text. MR. SCHECHTMAN: The next place is on impacts of market segmentation. MS. SULTON: Well, we were going to MR. SCHECHTMAN: the next place is on impacts MS. SULTON: we were going to wait for that one, is that correct? And because that's new text, and -- yeah. So again it brings us back to the policies and issues, policies, concerns, and issues raised by the analysis. MR. JAFFE: I donÕt' think we should be doing that. MS. SULTON: Right. MR. DYKES: So the impacts of market segmentation is all -- that's all new text? MR. SCHECHTMAN: The only pieces that are new are first sentence and the replacement text that is on page 31, which is -- that I drafted, which is Lines 5 through 9. The rest of it is entirely -- that replaces the stuff that's crossed out below it. MS. SULTON: And begins on page 30 in the official text. MR. DYKES: And the first sentence was merely put in there as I recall the conversation to kind of key up what -- MR. SCHECHTMAN: That's right. There was a desire for definition. UNIDENTIFIED SPEAKER: What page are you on, Michael? MS. SULTON: Page -- MR. SCHECHTMAN: This is 30. MS. SULTON: -- page 31, begins, line 21. MS. DILLEY: Just clarifying what's new text. MR. DYKES: The first sentence is new. MS. SULTON: Against market segmentation is the process. MR. SCHECHTMAN: And I suspect not terribly controversial. MR. DYKES: I'm fine with that first sentence. MS. SULTON: Okay. UNIDENTIFIED SPEAKER: Just need a few -- MR. SCHECHTMAN: Yeah. We'll clearly need to get feedback from the other folks on the other piece, but maybe we can just take people's temperature here and see where we are for just a second. MR. DYKES: I'm fine with both the first sentence and the -- over on the other page, the -- most current future -- MR. SCHECHTMAN: Greg, Mardi. MS. MELLON: Substantially equivalent? We want to use that -- MS. SULTON: Where are you reading? MS. MELLON: I'm reading on page 31, line 5. Just in terms of taking the temperature. It seems to me that the view that most current and future products are likely to be substantially equivalent to traditional products, I just -- I don't think -- I would just advise that we wouldn't want to use that word. It's -- it carries a lot of baggage, and a lot of people don't, you know, take the position that in fact none of the products are substantially equivalent. So I don't think you would, you know, you might want to say very similar to. MR. DYKES: I was wondering what you were going to -- I almost suggested the same reason, Mardi, but I didn't -- but change from substantially equivalent to similar to or very similar to. I think I agree with Mardi. The two words substantially equivalent have significant -- MS. MELLON: I would definitely draw a line on that. MR. JAFFE: How do you make a difference between most current and future. I mean future is supposed to be things that aren't similar to traditional products. That's the whole point. So I don't think it's true for -- you can say that for current products. I don't think you can say that for future. UNIDENTIFIED SPEAKER: Jim. MR. MARYANSKI: I didn't raise substantial equivalence in the section on labeling, but I really was sitting here groaning over it because it really isn't the correct terminology to use there. And Mardi's right. There's been a lot of different views about what the term means. So I think it would be better to use something other than that term in this -- and labeling you know we talk about significant composition -- changes in the product, but we've never used substantially equivalent at FDA to refer to labeling changes. It has now a very precise meaning, but I think, you know, for this document, I would agree it would be better just not to use it. Because people will read it differently. MS. SULTON: So significantly similar is -- MS. DILLEY: To Greg -- I think to Greg's point is that the case, I mean are some future products intended to be not similar to but maybe it's the emphasis is more on although the promise -- MS. SULTON: But this is the range. It says that they range from, and that's one, that's one end of the range. MS. DILLEY: But it's not a comment on the products themselves. It's just that they -- MR. SCHECHTMAN: Would this address it, Greg, that a view that most current products are likely to be very similar to traditional products and that future products offer the promise of addressing -- UNIDENTIFIED SPEAKER: Why, why do -- MR. JAFFE: Current products aren't likely. Current products are. MR. SCHECHTMAN: Okay. MR. JAFFE: -- likely to be -- MR. SCHECHTMAN: Okay. MR. JAFFE: They either -- I mean you're talking about a view here. People who are -- technology say the current products are -- MR. SCHECHTMAN: Okay, okay. MR. JAFFE: -- or are like future products -- I mean -- MR. SCHECHTMAN: Okay. MS. MELLON: And my other comment is why we would need to make -- market segmentation is further complicated by attitudes. I'm not sure that the attitude that products offer a promise of addressing future needs in the U.S., I mean how does that, how does that bear on the, on whether market segmentation is complicated? I think, you know, a lot of people believe that that might be the case, but that, you know, what really differentiates the ends of the spectrum is, is how they -- whether they consider things to be inherently different or not, at least I -- MS. SULTON: Greg. MR. JAFFE: I think Ron wrote this. He had a -- I mean he had -- he comes from the industry and -- market segmentation, he wanted to capture this. I think it would be better -- UNIDENTIFIED SPEAKER: Okay. MR. DYKES: May we just say we have a question about the use of the word substantial -- MS. SULTON: So we'll hold this -- MR. SCHECHTMAN: Why don't, why donÕt we table this piece and then move on. MS. SULTON: Right. MR. SCHECHTMAN: Move on. MR. SCHECHTMAN: I think we've hit the end of the pieces that we can do until everyone comes back. MR. DYKES: So the next piece is a consumer piece, and then the policies and the issues. MS. MELLON: Are we getting copies of the comments that Michael and I made on the, on the scenarios so that people can look at them? MR. SCHECHTMAN: We haven't done that. I have, I have -- MS. MELLON: It might be useful to have copies made of those so that people -- MS. SULTON: We have comments on so many sections, that's why we didn't do that, but we were hoping that people would present their comments, the ones that -- had strong feelings about. MS. MELLON: But we can't memorize -- MS. LAYTON: Can I suggest something? It's 2:30. The cookies are in the back. Why donÕt we take a five- minute break while Abby runs upstairs. Get your cookie, make your phone calls. UNIDENTIFIED SPEAKER: Blood sugar. MS. LAYTON: Get your blood sugar up, and let's be sitting here at no later than quarter till. MR. GIROUX: Will the rest of the Committee be back -- MS. LAYTON: I'm hoping -- MR. SCHECHTMAN: That's what Abby is checking. MS. LAYTON: -- that's what Abby is going to see. MR. GIROUX: Because we need to -- MS. LAYTON: We need to move. And were there any public comments that came up? Just want to check one more time. (No response.) MS. LAYTON: Okay. (Whereupon, a brief recess was taken.) UNIDENTIFIED SPEAKER: So the small group is still working. What we want to do is come back -- and they're working productively. They're not just going out for ice cream or something like that. And what we thought we'd do is come back here and start the conversation on scenarios. Obviously we table Juan's question completely because we want to do that with full committee, but we're going to go forward with the discussion within time of trying to do as much on both documents as possible, hopefully completing both documents between today and tomorrow and start, just get a sense from the people who are in the room in terms of your comments on the scenarios as has been described in terms of how we would move that document to completion, which is to take out answering the questions, but leave it at posing the questions, with drivers and the three scenarios as an exercise that the Department can consider or whatever. We can draft a cover note when we're close enough to finishing that, but just see where people have more than editorial comments. Basically are there -- is there anything in these that really is major cause for heartburn and what are they? Are they in the drivers section, are they in the scenarios section or the questions? And start that conversation so that we can be productive while the other group is still working. When they come back, we'll come back to the traceability and labeling, and we hope to do that by about quarter to at the latest, right? Yeah, quarter to. So that's what we're proposing. So and then we can table the questions to the larger group for the 15 minutes -- traceability and labeling -- Is that comfortable to people? Okay. So -- Angela, you want to -- well do we want to just take this section-by-section or step back and just get overall comments? UNIDENTIFIED SPEAKER: You want to introduce it? UNIDENTIFIED SPEAKER: I think we've done that. MS. LAYTON: I think it's been introduced. Juan I think is hopefully going to be back here at quarter after three for the discussion, but -- so why donÕt we just take the -- what we know or think we know section and see if there's any major substantive comments on where that is. MR. SCHECHTMAN: Let me just add one point. I know there were comments that were sent in to improve the text from various people that are not in here. Particularly I know Mardi and Michael. And I guess the question is not so much all the comments that might improve the text, since I think if we're trying to really get something out, it's not just for the small improvements, but it's for things that are really, really central. MS. MELLON: Well, I mean for what it's worth, I can't remember what my comments were. I join Michael. Sorry, but it was a long time ago. MR. SCHECHTMAN: We're printing them out. MS. MELLON: Thank you. But I can say that I, I did not, I know that my comments were not of a major -- UNIDENTIFIED SPEAKER: Heartburn variety. MS. MELLON: Yes, heartburn variety. I was quite happy with the way the scenarios had developed, and so I think I did have some comments, but I do think that they were either minor or editorial. MS. DILLEY: Anybody else have comments? Michael, did any of your comments go to the first section? MR. DYKES: Again, I'd jus like to reiterate for the record I have not read any of my comments. I've not read anything on scenarios because scenarios was not on today's agenda. But having said that, as I recall from August, I didn't think that the scenarios, and I think they were drastically improved as I'm recalling from the last plenary where we had as I recall looking at the first two scenarios we had picked up some of the, the drivers and incorporated those into the different scenarios so that I thought we had broadened the scenarios out so that they fit a broader range of issues. I also thought, and again I'm going from recall here, so I also thought that on many of the drivers were all the negative drivers, but I think when the work group got together prior to the last plenary I thought they had also looked at both positive and negative drivers. So I guess I -- as I recall of the two scenarios that we had from the last plenary, I thought they had been drastically improved, and I don't recall major, major problems that I had with either of those two. So that's kind of if I had to summarize for my own mind, I am on those, that's where it is. And I guess I'd add one more, optimistic that if the work group had worked on the third scenario and had made commensurate adjustments to that as they did with the first two probably be fine, but again I'm going from August so. MS. DILLEY: So the only one just for my recollection, only one that has not been incorporated into the document has been -- the work group didnÕt get a chance to really work through in the same manner on scenarios one and two or three, right? MS. LAYTON: Can I as a question? When I look at the document, it is -- it talks about, you know, note to Committee members on what we know or think we know. That section had been reviewed by the work group. We worked very hard on that, I know several times in. Is that section pretty well done? And then if you move to the next section, which was what we don't really know, the notes in there say what is much -- certain needed to review -- that needed a review, and then a question I would have is was there a section in the scenarios work group conference call thoughts that indicated that they have reviewed it, and that they were more comfortable with it? And, Angela, you were on those conference calls. Did a lot -- did much changes go into or was there much to change and what is much less certain? MR. SCHECHTMAN: What is much less certain was not -- there were not huge numbers of changes, but it was not reviewed. The last work group did not go back and look at those. MS. LAYTON: Okay, so that still has not been done. MR. MEDLEY: To look at what now? I'm sorry. MS. LAYTON: What is much less certain. Your notes on the -- UNIDENTIFIED SPEAKER: Page 5. MS. LAYTON: -- it's page 5, and your note on page 5 says the work group needs to further review this section. So I guess I would feel comfortable with having a feeling of where the work group is on that based on all the work that was done. And I think that was for the October 2nd -- 22nd conference call or any subsequent work on that. MR. SCHECHTMAN: Yeah, and I think, I think that intent to further review that section was really to see further in response to your question, Michael, about some of the drivers being negative. MR. MEDLEY: You mean in the last -- MR. SCHECHTMAN: In pages 5 -- UNIDENTIFIED SPEAKER: Through 7. MR. SCHECHTMAN: -- through 7. MR. MEDLEY: Of the scenario document? UNIDENTIFIED SPEAKER: Yes. MR. SCHECHTMAN: Yes. MR. MEDLEY: What is -- MR. SCHECHTMAN: Okay, the two parts that have been less reviewed apart from implications, which maybe are going elsewhere, is the What is Much Less Certain and the third scenario. And the question about the What is Much Less Certain piece was, as I recall the discussion, really going mostly towards ensuring that some of the uncertainties were positive uncertainties as well as negative uncertainties. MR. DYKES: That squares with my recollection as well. MS. LAYTON: So my question is, do we feel -- how do we feel about those from the Committee? UNIDENTIFIED SPEAKER: Do you want to give people a couple of minutes to look it over? MS. LAYTON: Yeah. Can we do that? MR. DYKES: How do we feel about it in this document -- MR. SCHECHTMAN: Yes. UNIDENTIFIED SPEAKER: Uh-huh. MR. DYKES: -- that we are now, the November -- what we -- the November 29th document, is that the document -- MR. SCHECHTMAN: Yes. MR. DYKES: We are dealing with three documents. The November 29th document, is that the document? MR. SCHECHTMAN: Yes. MS. LAYTON: That's it. MR. DYKES: And then we are dealing with -- when we keep talking about questions, are we dealing with scenarios work group conference call October 22nd? MS. LAYTON: Yes. MR. SCHECHTMAN: That was largely for implications, which we are -- UNIDENTIFIED SPEAKER: Not going to -- MR. SCHECHTMAN: -- not going to talk about except for the list of the questions that are in that. (Simultaneous questions.) MR. SCHECHTMAN: The questions, not the implications. UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: -- conclusions of this paper or -- MS. DILLEY: Terry, you are looking puzzled. MR. MEDLEY: Yeah, I -- MS. DILLEY: Why? MR. MEDLEY: If we're looking -- if the concern is -- positive as well as negative for what's -- what is much less certain, that section is written in terms of questions that can go either way. UNIDENTIFIED SPEAKER: Right. MR. MEDLEY: It's just questions. It doesn't say either negative or positive. MR. DYKES: Well, I guess -- MS. DILLEY: It was more tone then. MR. MEDLEY: Yes. MS. DILLEY: So what we're asking is take a couple of minutes to read pages 5 through 7, and see is that section -- UNIDENTIFIED SPEAKER: Good. MS. DILLEY: -- good, yeah. MS. MELLON: Could I just, since we've got Jerry here, can I just ask one factual question about on page 5 about soybeans? It says enormous new agricultural commodity production areas will -- in South America, particularly in Brazil and Argentina. There will be tremendous pressure and structural change in the soybean market. This could have implications on sourcing soybeans given that this is the only large open commodity market for the U.S. in the European Union. That just doesn't make any sense. UNIDENTIFIED SPEAKER: That doesn't make any sense at all. UNIDENTIFIED SPEAKER: Mardi, where are you? MS. MELLON: I'm on page 5. UNIDENTIFIED SPEAKER: The second to last -- MR. SLOCUM: No. It's the second bullet. The big bullet at the top of the page. MR. MEDLEY: Oh, I see. MS. DILLEY: -- enormous new agricultural commodity production areas -- MS. MELLON: What's the concept here? MR. SLOCUM: The concept is that, is that we don't sell any corn in Europe because of biotech issues. They donÕt want to import any U.S. corn into Europe anymore because of biotech issues, and they still import a lot of soybeans. UNIDENTIFIED SPEAKER: Right. MR. SLOCUM: If you look at commodity trade between U.S. and Europe, it's a big chunk out of the soybeans. UNIDENTIFIED SPEAKER: Right. MR. SLOCUM: So the statement is right that there will be huge new areas -- Argentina -- structure, structure changes -- so we just need to reword that last sentence. I think what we want to point out is the importance of the European soybean market to U.S. growers. Because it's the second largest market that the U.S. sells -- the European Union is. MS. MELLON: Okay, so the new soybean acreage, what it could mean would be that there would be an increased supply of non-transgenic soybeans that could go to the European Union? MR. SLOCUM: There's an increasing supply of both transgenic and non-transgenic. MR. MEDLEY: Right. Yeah, I mean because from what I review -- over the last year or so, if you take the combined soybean production yields in Argentina and Brazil, we're getting to a point where those yields were meeting and then exceeding the yields here in the U.S., and Europe is a major market for soybeans, especially for animal feed. And so the way I read this is that with those increased capacities in Brazil and Argentina, there is then this issue of competition for that European market, whereas those from Brazil and Argentina could be sourced to replace what's currently now coming from the U.S. UNIDENTIFIED SPEAKER: That's right. MS. LAYTON: I think we all -- I remember having that discussion before, and you all said that was what was going to happen so. MR. MEDLEY: It could. MS. LAYTON: It could. Could happen. MR. SLOCUM: -- should be that this could have, this could have implications on exports of soybeans given that this is -- MS. LAYTON: This meaning EU? MR. SLOCUM: What's this? MR. MEDLEY: No, I think that -- MR. SLOCUM: This is EU. MR. MEDLEY: -- this could have implications on the U.S. export of soybeans. MR. SLOCUM: Right. MR. MEDLEY: Given that this is the only -- UNIDENTIFIED SPEAKER: That's better. UNIDENTIFIED SPEAKER: That's much better. MR. MEDLEY: It's the U.S. export of soybeans. UNIDENTIFIED SPEAKER: That's right. MS. LAYTON: On the U.S. -- UNIDENTIFIED SPEAKER: Export of soybeans. MS. LAYTON: -- export -- UNIDENTIFIED SPEAKER: And then that can go either way. UNIDENTIFIED SPEAKER: Yeah. MS. DILLEY: And then does that -- the rest of it say the same, Terry, then given that this is the only -- MR. SLOCUM: That goes away. UNIDENTIFIED SPEAKER: Don't need that. MS. DILLEY: Okay. Just goes away. (Simultaneous comments.) MS. LAYTON: So the final sentence is just this could have implications on the U.S. export of soybeans, period. UNIDENTIFIED SPEAKER: That's right, because it doesn't -- MS. LAYTON: Absolutely. UNIDENTIFIED SPEAKER: Biotech is not the issue. MS. MELLON: Exactly. That's what I was trying to get to. UNIDENTIFIED SPEAKER: Exactly. That's what I was trying to get to, just that you've got this huge new soy source -- okay, great. Thank you. MS. DILLEY: Do you want a minute to look over the rest of it or you want ready to talk about it? And that is what is much less certain -- 5, 6, 7. MR. SCHECHTMAN: Could someone explain the documents that were sent out? MS. LAYTON: One is Michael Dykes' comments, and one is Mardi Mellon's comments. MM is at the top of Mardi's, and M -- Michael Dykes' name is at the top of his. MS. DILLEY: Randy, you have a question? MR. GIROUX: I'm okay for us to proceed as long as it's not -- is there anything someone is not happy with? If we can take it in -- MS. DILLEY: No. MR. GIROUX: -- bite size pieces so we could kind of skim and read as we're going through it, I think that would be a lot more productive. MS. LAYTON: So disruptive events. UNIDENTIFIED SPEAKER: One paragraph at a time. MS. LAYTON: Yeah, and then nothing on disruptive events -- I just got finished reading. Does anybody -- UNIDENTIFIED SPEAKER: Randy, slow down. MR. GIROUX: -- too quick. UNIDENTIFIED SPEAKER: So where are we reading? What page, which document? UNIDENTIFIED SPEAKER: Top of page 6. UNIDENTIFIED SPEAKER: Five, bottom of five -- six. From our -- MS. DILLEY: November 29th document. MR. BUSS: -- where it says current popularity of -- (Simultaneous comments.) UNIDENTIFIED SPEAKER: I'll tell you, there's a lot of people out there -- UNIDENTIFIED SPEAKER: If you just say low carb diet, I don't know that you need current popularity -- UNIDENTIFIED SPEAKER: Yeah, good. MS. LAYTON: So just low carb -- for example low carb diets. UNIDENTIFIED SPEAKER: Right. MS. DILLEY: Anything on democratic -- move to political uncertainty? MR. SLOCUM: Going too fast. MS. DILLEY: Okay. (Pause.) MR. DYKES: I think one of the things under political uncertainties -- the European Union a decade from now be granting access for -- I guess that's a question so you can't -- the kind of -- UNIDENTIFIED SPEAKER: Increasing? Increased -- MR. DYKES: Increasing. I think the point is it's there, although very limited, but -- UNIDENTIFIED SPEAKER: Increasing instead of granting? (Simultaneous comments.) UNIDENTIFIED SPEAKER: Or just increasing access. MR. MEDLEY: That's true, but that's a -- hopefully it goes in that direction. MS. LAYTON: That's why it's a question. UNIDENTIFIED SPEAKER: Yeah, that's why it was a question. MS. LAYTON: Terry, once again, thank you so much for your service on this Committee, and we really appreciate your being here. MR. MEDLEY: And I will continue and whatever is called upon, if it's another meeting or whatever, I'm happy to do that. MS. LAYTON: Thank you again, Terry. UNIDENTIFIED SPEAKER: Thanks, Terry. UNIDENTIFIED SPEAKER: Bye, Terry. (Mr. Medley exits room.) MR. SLOCUM: Maybe because that language was written while the moratorium was still on. It's -- maybe we ought to just say will the European Union continue to grant access. UNIDENTIFIED SPEAKER: Oh, yeah, yeah that's it. MR. SLOCUM: Because we, we wrote that sentence - - European Union in a decade be granting access. We wrote it -- MS. LAYTON: Right. So we changed it to will the European Union a decade from now be increasing access for transgenic crops and growing them as well. UNIDENTIFIED SPEAKER: Okay. MS. LAYTON: Anything else on political uncertainties? Okay, so people have moved on to technological. MR. BUSS: Under the technological, five lines down, the first part of that sentence needs to go away because it links into Chapter 2. So if you just start the, start of the sentence that says which products will make it to the U.S. access. MS. LAYTON: so MS. LAYTON: Yeah, that's one of my suggestions too. Also in the first -- second sentence, I think there's too many "wills." With an evolving regulatory system, it is uncertain how quickly will new applications will reach the marketplace here or in other countries. I think -- get rid of the first will was my suggestion. UNIDENTIFIED SPEAKER: Stick to her -- MS. LAYTON: No, that's editorial. I'm sorry. That wasn't substantive. MR. DYKES: Is that a violation? MS. LAYTON: Yes -- UNIDENTIFIED SPEAKER: Yes, it is. We'll take it, but let's not go in that trend. We're sticking with heartburn stuff. UNIDENTIFIED SPEAKER: Mardi is out of the room and she had a comment -- UNIDENTIFIED SPEAKER: What was her comment? UNIDENTIFIED SPEAKER: About the reference to the safety -- UNIDENTIFIED SPEAKER: Where is that? (simultaneous comments.) MS. LAYTON: Okay, Mardi had a comment I'll bring up under the question, will additional cases of food safety issues with organically grown produce continue or expand with the expanding organic market, and will consumers demand their -- demand other agricultural products. And Mardi's comment is, I'm not aware of any cases of food processing -- poisoning traced to certified organic production. But even if there were a few cases it is important enough -- is not important enough to mention here. MR. GIROUX: So I disagree. I think there are several cases where -- and whether it's organic food or whether it was -- there are a number of instances where organic produce has been removed the market. MR. SCHECHTMAN: Let me suggest that we wait until -- let's hold this when -- Mardi probably just went to say goodbye to Terry. And she'll be back in a minute. Let's come back. Let's come back to this. MS. LAYTON: Okay. I just want to mark that place though. MR. SCHECHTMAN: Okay. MS. SULTON: Any other comments on that section? MR. DYKES: I think that's also an issue in Hawaii with crops coming in under the organic -- to the environment that -- MR. SCHECHTMAN: Let's mention that when Mardi's back so we can have the whole discussion on it, if we can. MR. DYKES: I was just responding to the question. (Pause.) MR. SCHECHTMAN: Okay. MR. SLOCUM: Are we up to environmental uncertainties? MS. LAYTON: Yeah. We'll come back to that section when Mardi gets back in the room. (Pause.) MS. LAYTON: In that section, I don't think -- are we talking about transgenic animal products in the -- in this chapter or was that in an earlier chapter? There's a paragraph in here that says as discussed earlier in this report, these include transgenic animal-derived products, plant-derived food products engineered to offer specific health benefits to consumers and plant and livestock producing pharmaceutical or industrial compounds. Are these in the drivers piece? UNIDENTIFIED SPEAKER: No, they're in earlier chapters. UNIDENTIFIED SPEAKER: Earlier chapters. UNIDENTIFIED SPEAKER: So maybe we can just -- UNIDENTIFIED SPEAKER: I think that whole sentence is referring to -- UNIDENTIFIED SPEAKER: Yeah. MS. DILLEY: Or you can say increasingly novel products such as and put some of those in there and then close out the sentences. MS. LAYTON: So take out as discussed earlier in these -- in this report. MS. DILLEY: Yes. UNIDENTIFIED SPEAKER: Right. MR. SCHECHTMAN: And these includes such -- and just say such as. MS. LAYTON: Such as -- MR. SLOCUM: Such as. MR. SCHECHTMAN: And we'll just rearrange the sentence to make it -- UNIDENTIFIED SPEAKER: Yeah. MR. BUSS: In the first sentence in that paragraph -- large body who would argue that the effects of global warming are already apparent, and so would it be better to say the serious effects of global warming become more pressing within the within the next decade? MS. MELLON: I'd be glad to do that. MS. LAYTON: I have to say that some people in the world don't think -- MS. MELLON: Where are you? MS. LAYTON: -- they're there, though. MS. MELLON: -- serious effects of global warming -- MR. GIROUX: Take away the word more, will become pressing. MR. SCHECHTMAN: Will become pressing, okay, okay. MR. BUSS: That works. MR. DYKES: So you're replacing apparent -- the apparent with become -- MR. SCHECHTMAN: Becoming pressing. MR. DYKES: Become pressing. MR. GIROUX: That was a question, right? UNIDENTIFIED SPEAKER: Yeah. UNIDENTIFIED SPEAKER: That's right. UNIDENTIFIED SPEAKER: I'm happy. MS. LAYTON: I can live with that. MS. DILLEY: Is there anything else in that section? MR. BUSS: The second paragraph, the first sentence, will consumer opinion regarding the technology remain malleable, which means -- implies manipulation, and like I said earlier -- something like remain open or something to that effect. Do you see what I'm saying? MS. LAYTON: So in other words delete malleable and open -- MR. BUSS: Well, or something to that effect. MR. SLOCUM: The concept was that they're still being formed. MS. DILLEY: Flexible. MR. SLOCUM: Yeah. MS. LAYTON: Evolving? UNIDENTIFIED SPEAKER: Continues to evolve. MS. LAYTON: Actually I was thinking of the word na•ve. But that's not probably the right word either. MR. BUSS: Open-minded. MR. GIROUX: Changeable. UNIDENTIFIED SPEAKER: How about changeable? UNIDENTIFIED SPEAKER: Yeah. UNIDENTIFIED SPEAKER: I like that changeable. MS. DILLEY: Is there anything else in that section -- to come back? MR. DYKES What did we change then? Did we change malleable to changeable? UNIDENTIFIED SPEAKER: Yes. MS. DILLEY: Yes. MR. GIROUX: Then the last -- UNIDENTIFIED SPEAKER: So do -- MR. GIROUX: -- would have to go away, right, difficult to alter or -- (Simultaneous comments.) MS. LAYTON: Question mark, delete rest of sentence. MS. DILLEY: Uh-huh. MR. BUSS: So, Randy, in that context of using changeable, do you mean open to change or changeable plus, minus on a given day? MR. GIROUX: Yes. MS. LAYTON: Well, yeah, I think it's either one. UNIDENTIFIED SPEAKER: Okay, either one. UNIDENTIFIED SPEAKER: Long as you can read it either way and -- UNIDENTIFIED SPEAKER: Right. It's not hard to - - MS. LAYTON: Mardi's back. Before we progress too far, do we want to go back to her comment on page 5 under technology and regulatory uncertainties? Mardi -- page 6. And this is in the first paragraph, and it's about organically grown produce and food safety issues. MS. MELLON: We -- yeah. I'm not aware of any cases of food poisoning that have been traced to certified organic foods. I mean that's just -- I donÕt even know where that comes from. MR. GIROUX: So maybe I don't understand the context of the question. Is this organically grown certified food in the United States or is it food poisoning versus recalls? Meaning I'm not sure how broadly that you're trying to make that statement. Because we know there have been several recalls for vomitoxin not specifically tied to organic, but it's been organic produce that's been taken off the shelf. MS. MELLON: Right, but it's not -- I mean there's nothing that shows that we're any more likely to have a recall of anything coming from a certified -- coming from certified organic food. It just isn't -- there's just no -- there are simply no data. Yes, there are recalls that include conventional food, and there are recalls that include organic food. But why would you mention organic food as if it's something special? There are recalls all the time. UNIDENTIFIED SPEAKER: Is the issue about recalls? MS. MELLON: I would just suggest that we -- I mean additional cases of food safety issues with organically grown produce. I just think we should delete that. There are just -- there aren't any cases out there right now that have any meaning. MS. LAYTON: Could you live with that sentence gone, that question gone? UNIDENTIFIED SPEAKER: I'm trying to understand where it came from, and I guess there are some people that believe that, you know, that organic food is safer or better for you. And on the other side of the coin, it really isn't. So or may not be in some instances, and so I'm trying to -- I don't know where it came from. MS. MELLON: I don't either. MS. LAYTON: I don't either. It doesn't actually look like it fits. MR. GIROUX: So there is a perception or a -- not a perception, but a lot of people moving towards organic foods. So if something bad happened in organic like something bad could happen in biotech -- both sides the full picture, I'm just wondering if that's -- is that plausible that something bad could happen in organic food and people could say you know I'm really not going to eat the same way. MS. MELLON: I mean surely that could happen, but I'm just not sure why it would be in technological and regulatory uncertainties that's, you know, it just doesnÕt - - just seems to me like a, you know, like an outlier. It's clear there are people that, you know, I can name a few names, people making this case, but they are not -- it's not backed up by data that there is any -- that there are any more food safety incidents of any sort associated with certified organic or even just natural -- natural foods, organic foods and with conventional food. So I just think it's not -- and, you know, we don't -- this is not the, this is not an issue we're discussing. It's only an example. So I would just suggest that we do without it. MS. LAYTON: So anybody have heartburn if we delete that question? MR. DYKES: That may have come from me as I'm trying to sort through my comments here because I looked through two different texts. UNIDENTIFIED SPEAKER: What is underlined -- UNIDENTIFIED SPEAKER: That's -- on Michael, on your comments dated August 16th, it's underlined, which means MS. AGOSTO: On Michael, on your comments dated August 16th it's underlined which means that it was added. UNIDENTIFIED SPEAKER: Added. MS. AGOSTO: By you. MR. DYKES: Okay. So this probably came from me. So I guess maybe what I was trying to get at there, Mardi, is will there be changes, will there be unknown issues in the organically-grown produce that can somehow create uncertainties, regulatory uncertainties. So maybe it's too strongly worded. MS. MELLON: Well, I just don't think -- I mean we're -- MS. LAYTON: We're not talking about organics here. MS. MELLON: At all. I mean there are lots of alternatives out there, alternative foods that are, that are not, you know, transgenic. I -- just doesn't seem that it's a pertinent -- MR. DYKES: The previous -- says -- new products developed using the wealth of new genomic information be transgenic or whether it be non-transgenic developed through -- MS. MELLON: Maybe we could say well some of these, you know, turn out to have problems. MR. JAFFE: Couldn't you just say -- will organically grown produce continue and expand and will consumers -- or will consumers demand other agricultural products? MS. LAYTON: I don't think organic is an issue here though. UNIDENTIFIED SPEAKER: It's not the issue. MS. LAYTON: It's not the issue. I'd say just delete the question. MR. DYKES: All right. MS. LAYTON: Now the last question there about U.S. farmers, is that still a valid question there? UNIDENTIFIED SPEAKER: Yeah. UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: Yes. MS. LAYTON: Okay, so that stays. MS. MELLON: Michael -- I would argue it's a little redundant, but you know since we've already talked somewhat -- MR. JAFFE: I think I may have added that sentence as well. UNIDENTIFIED SPEAKER: You did. MR. JAFFE: I think where it's coming from is with the regulatory uncertainties in South America and with the technology in South America. That's why I put it there. MS. MELLON: Okay, I mean I'm happy with that. MS. LAYTON: That seems logical. MR. JAFFE: As I recall. MS. MELLON: That sounds good. MS. LAYTON: Okay, back then to agricultural and food system uncertainties. MR. BUSS: Could I just back up to -- MS. LAYTON: Yes. MR. BUSS: -- environmental uncertainties? MS. LAYTON: Yeah. MR. BUSS: I guess in the discussion we just had prompted me to notice that other than global warming, we don't really talk about the environment very much under environmental uncertainties. I was wondering if it was worthwhile having an additional question that might read something like will pressure for reduced fertilizer, water or chemical use drive support for biotech products? UNIDENTIFIED SPEAKER: I as I -- I'm trying to get my thoughts together. I thought there was a whole missing piece on the problems of water availability. Yeah. So I'm kind of -- where you are, I think -- MS. LAYTON: Actually, water availability is in a certainty and it is water issues will become increasingly important domestically and international. There will be increasing pressure on fresh water supplies and less water will be unviable for agricultural purposes. Overall world fresh water quality will decline. Linkage between water conservation, new agricultural technologies and -- agricultural will become increasingly important. So those are incertainties not uncertainties. MR. BUSS: Only the water fee. MS. LAYTON: The water -- what else were you asking about? I'm sorry. MR. BUSS: I had lumped actually three of them, fertilizer, water or chemicals. So we could take water out as an uncertainty, and we -- MS. MELLON: Should they really be added to certainties the concerns about that there will be increasing concerns about the use of fertilizers and -- MR. MARYANSKI: Much less certain, isn't that -- UNIDENTIFIED SPEAKER: What's your question again, Daryl? MR. BUSS: Well, I don't know. I was posing the question of should we add in that section under environmental uncertainties, the question of will pressure for reduced fertilizer or chemical use drive support for biotech products? It could be turned around as a certainty. MS. MELLON: I mean I'm happy with that. MS. LAYTON: The certainty -- I'm sorry. The certainty on fertilizers is in the increasing price and diminishing supply of fossil fuels will become an ever more urgent concern for U.S. agriculture, and it says, and I'm continuing the sentence, in addition high energy prices could constrain the use of synthetic fertilizers in the U.S. and also pose a challenge for the long-term viability of new agricultural lands that are dependent on large fertilizer inputs. That's -- MR. BUSS: But that would be determined entirely by economics. MS. LAYTON: That's an economic certainty and not an environmental point. I'm looking. I'm continuing to look. MS. MELLON: I mean I guess since we've mentioned it in certainties, we probably donÕt need to raise it. It really is a certainty, you know, that the -- I would say that these things are, are -- that's the direction they're headed. I think the question -- MS. LAYTON: The uncertain -- MS. MELLOW: -- might be to look and make sure that it's reflected in the scenarios. MR. BUSS: That it's somewhere. MS. LAYTON: And that's why I was looking. The uncertainty that I thought about on the environmental side might be something about animal waste products or byproducts. Animal waste products, increasing -- if you've got a lot of feed animals, how do we deal with the waste products from those animals, but I donÕt think that's a transgenic issue, so I think it's -- MR. GROUP: I think one of the issues that's missing here is sustainability under environmental uncertainties. I think the court's still out. Some people say that it is more sustainable, other people say that it's really not more sustainable. So what is the uncertainty then if biotech will, will demonstrate that it's a more sustainable farming system, and then what does that -- what are the impacts of that? That was -- f it's not true something happens. If it is true, something happens. MS. MELLON: I donÕt know. I guess I wish that was, that was true, but I think I'm not -- MS. GIROUX: You don't agree it's true? MS. MELLON: No, I just -- what my -- where my, my concern is, is that the word sustainable is a mushy word that the notion that people would agree that that anything is sustainable or is not. I have a hard time seeing that that actually kind of has ramifications. MR. GIROUX: Could we say improved sustainability over convention agriculture? Could we qualify it and say that it's improving, improves the sustainability -- MR. SCHECHTMAN: As a question. MS. MELLON: So you would want to have a question that would say, you know, will biotechnology turn out to improve the -- MR. GIROUX: Demonstrate. MS. MELLON: -- or be seen to improve the sustainability of (Simultaneous comments.) MR. GIROUX: -- production agriculture. MS. MELLON: Okay, production agriculture. MR. SCHECHTMAN: But that should go in the last section, right? MR. GIROUX: Yeah. MR. DYKES: But I think he's talking about from an environmental -- MS. LAYTON: The environmental -- MS. MELLON: No, it actually is better in the environmental -- UNIDENTIFIED SPEAKER: Okay, okay. MS. LAYTON: Can we, can we read that again then? MS. MELLON: Well, agricultural biotechnology -- MS. LAYTON: Will ag biotech, abbreviated. MS. MELLON: We want to say be seen to improve or -- MR. GIROUX: Demonstrate that it improves -- MS. MELLON: demonstrate -- MR. GIROUX: -- sustainability of production agriculture. MS. MELLON: That it -- MS. LAYTON: Will ag biotechnology demonstrate improvements that -- MR. GIROUX: And the sustainability of production agriculture. MS. MELLON: Or the sustainability of -- MS. LAYTON: In sustainability in production agriculture. MS. MELLON: In the sustainability of production agriculture. MS. SULTON: In the sustainability of production agriculture. UNIDENTIFIED SPEAKER: Would you repeat -- UNIDENTIFIED SPEAKER: Hang on. MS. SULTON: Will agricultural biotechnology have demonstrable improvements in the sustainability of production agriculture? MS. MELLON: I would actually say will agricultural biotechnology demonstrate improvements in the sustainability of production ag. MS. LAYTON: In the sustainability of production ag. That's what I thought, uh-huh. MR. BUSS: That works. MS. LAYTON: As a question, and that goes in the second section, second paragraph or the first paragraph? UNIDENTIFIED SPEAKER: First paragraph, end of the first paragraph. MS. LAYTON: Okay. First paragraph. UNIDENTIFIED SPEAKER: -- first paragraph. MS. LAYTON: Okay. (Pause.) MS. LAYTON: Yes, and this, and the U.S. agriculture -- you can mention Wal-Mart specifically. MR. GIROUX: So I'm afraid that -- I'm afraid that adding that line that I just mentioned may create -- MS. LAYTON: Havoc? MR. GIROUX: Create havoc, and maybe I broke the rules when I said that because -- UNIDENTIFIED SPEAKER: We're only supposed to be working on the text so -- UNIDENTIFIED SPEAKER: This is true. MR. GIROUX: So I will rescind that if that's okay, because I don't want us to create more issues then we have. MS. LAYTON: Okay. Thank you, Randy. MR. SCHECHTMAN: Take out the whole -- MS. LAYTON: -- of a question. MR. GIROUX: I just don't want us to -- MR. DYKES: You've got a lot of buzz words in there. There ought to be a red flag. MR. GIROUX: I was just thinking about the people -- UNIDENTIFIED SPEAKER: I agree, I agree. MS. MILEWSKI: I wanted to just ask a question. That next paragraph that begins with consumer opinion regarding the technology remains changeable. Why are questions about consumers in the environmental area? Wouldn't it seem more logical just to have -- MR. SCHECHTMAN: I wonder if there was just a missing heading. MS. LAYTON: Yeah, that is a consumer section and not environment. UNIDENTIFIED SPEAKER: Consumer uncertainties. MS. LAYTON: Consumer uncertainties? MR. SCHECHTMAN: Yes. UNIDENTIFIED SPEAKER: Yes. MS. LAYTON: Thank you, Elizabeth. MS. MELLON: Yes. I think that must be a missing heading. Thank you. MS. LAYTON: Let's make sure that we -- make sure that Mardi -- I mean that -- MS. DILLEY: Supposed to be back -- I'm locked out of the cafeteria, so I cannot get the doors do not open. MR. SCHECHTMAN: I hope they are not locked in. MS. DILLEY: I didn't see any faces pressed up against the windows so -- (Simultaneous comments.) MS. MELLON: I'd like to go back to the question, will there be consumer backlash against large conglomerates or will this not be an issue for the majority of consumers? Do we really need the second -- UNIDENTIFIED SPEAKER: Either it is or it isn't. UNIDENTIFIED SPEAKER: Not really. MS. MELLON: I mean will there be a consumer backlash against large conglomerates? MS. LAYTON: Question. MR. SLOCUM: As they renew their Sam's cards. UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: Which one -- MS. LAYTON: We dropped the phrase, or will this not be an issue for the majority of consumers after will there be consumer backlash against large conglomerates. UNIDENTIFIED SPEAKER: Where are we? MS. LAYTON: Consumer uncertainties. UNIDENTIFIED SPEAKER: Oh, I got it. MR. GIROUX: Do we have to mention Wal-Mart specifically? MS. LAYTON: Oh, I really wanted to. Well, I love them but I hate them. MR. DYKES: I'm trying to figure out what was dropped. (Simultaneous comments.) MS. LAYTON: Under consumer uncertainties. MR. SLOCUM: Talking about Wal-Mart reminded Mardi of large conglomerates. Imagine that? MR. DYKES: I don't know why Mardi would jump to such a conclusion. (Laughter.) MS. LAYTON: And you really could take out like Wal-Mart. I think mega-retailers are sufficient. UNIDENTIFIED SPEAKER: Sufficient. People will visualize. UNIDENTIFIED SPEAKER: Right, right. MR. SLOCUM: We could put i.e., Wal-Mart. Be more accurate. MR. GIROUX: I don't understand this one. Will there be consumer backlash against alleged conglomerates. MS. LAYTON: Well, in my town there was a huge backlash against building a Wal-Mart in our town -- UNIDENTIFIED SPEAKER: In Loudun County and several places. MR. BUSS: Certainly -- UNIDENTIFIED SPEAKER: They still build them. MR. SLOCUM: They still build them. They build them and the parking lot fills up and they stay. MR. BUSS: So they actually are modifying their, their -- UNIDENTIFIED SPEAKER: Yeah. MS. MELLON: That was one of my suggestions. MR. GIROUX: What was that? MS. MELLON: Well, this was I was in my Juan mode. Is that the end of the -- is at the end of the paragraph beginning down the food chain, it talks about Wal- Mart, you know, how they look, conglomerations, how much consolidation or expansions will there be, what will be added to its work product containing transgenic-derived ingredients. And then I ask whether the convergence of the interest of Wal-Mart, the world's largest retail, and China, a major U.S. competitor, will emerge as a problem or an opportunity for U.S. agriculture. I think the most interesting thing out there is that the world's largest retailer, Wal-Mart is requiring its suppliers to go to China, which is our largest competitor. UNIDENTIFIED SPEAKER: More than half of the non- food stuff in the store is made in China, more than half of non-food stuff in the store is made in China. MS. MELLON: But it also raises a whole new set of questions. MS. LAYTON: Okay. MS. MELLON: And if there were even the slightest disinterest in it, I think -- MR. JAFFE: I don't think that we need it. (Simultaneous comments.) MR. JAFFE: We could -- gets into a whole area that's a little far a field in terms of merchandising and -- MR. SCHECHTMAN: Interesting nonetheless. UNIDENTIFIED SPEAKER: Interesting, but let's go. MS. MELLON: That's part of the discussion between the coordinating committee and our committee, committee. MR. JAFFE: Right. MS. LAYTON: Okay. So in the absence of your dying on the heart there, we're going to drop that. MR. DYKES: So all we changed in that last paragraph was, delete like Wal-Mart. MS. LAYTON: Like Wal-Mart, yes. Okay, next. Envisioning -- this is just an opening paragraph under envisioning a -- possible future. UNIDENTIFIED SPEAKER: So the question do you want to keep going in this mode and wait for the other group or -- MR. SLOCUM: Keep going. UNIDENTIFIED SPEAKER: Okay. Okay. MR. BUSS: Use the time. UNIDENTIFIED SPEAKER: Yeah. MS. LAYTON: I would ask one more question. If this were to go out on its own, is there something that should be added to the beginning, and how would we come up with that? MR. JAFFE: Page 1 you're talking about or -- MS. LAYTON: Yeah, I just went back to think about that, and I didn't know if there was -- MR. DYKES: Think about that now? MS. LAYTON: No. But I want us to not forget that. It's a question. I'm posing a comment. Because there may be something from like Section One, the introductory section that needed a little pre-paragraph or something that may have to come in. I just want us to make sure we get to that point at some point in time. MR. JAFFE: Actually the beginning reads fine. UNIDENTIFIED SPEAKER: Pretty good. MR. JAFFE: Maybe we can just say to the Secretary, you know, you asked us to do task one. Here's that paper that we did that supports part of task one. MR. SCHECHTMAN: A cover letter. MS. LAYTON: A cover letter will do. Cover letter will do. MR. JAFFE: I think this is good. I actually think -- the beginning paragraph says we were charged to do this, and here's what we did. MS. MELLON: Can we at least have one paragraph, I mean one sentence that says that we hope that the USDA will -- MS. DILLEY: Want that in a cover note, cover letter or -- MS. MELLON: Yeah, cover note I -- but that they will consider using scenario development and planning, and we encourage them to, you know, look at the questions that we offered for implications and see if those, you know, wouldn't be useful guidelines for the USDA as it moves forward. MS. LAYTON: Okay. I'm back, okay, sorry. It's there. MR. ENRIQUEZ: If you want to be specific about it for those staying on the Committee, this is the type of document that's like to get the Secretary to want to come and sit down, talk about -- particularly over the next three weeks as he's trying to figure out what he's going to -- this is the kind of thing that would bring him here to say, that was interesting, tell me more. MR. SCHECHTMAN: Yeah. I mean I think we, we hope -- we would like to see if we could get the Sectary to come to the next meeting, but you know obviously there's no promises on this yet. He's still figuring out where he is, and it may be that some of you might want to hear that conversation even if you're not on the committee. MR. ENRIQUEZ: This is the kind of thing that landing on his desk in the first month in office could lead him to ask more questions. MS. LAYTON: Okay. Are we gong to say here are the titles of the three scenarios as a separate sort of paragraph all on its own? MR. HOISINGTON: -- paragraph out of that. MS. DILLEY: So title and description, is that what you're suggesting doing? MR. SLOCUM: Why don't we say the three scenarios we decided to look at are, and make that part and then make that part of the paragraph, and then -- each scenarios -- description of what the world might look like. MS. LAYTON: So start with the titles of the three scenarios, delete, colon, are, something and Rosy Future, Continental Islands, and Biotech goes Niche. No paragraph. Each scenario is intended as a coherent description of what the world might look like after events driven by the uncertain -- the certainties and some of the key uncertainties listed above -- UNIDENTIFIED SPEAKER: All one paragraph. And then does that next thing go in that same paragraph, these are not predictions of the future or is that a separate paragraph? UNIDENTIFIED SPEAKER: That's a separate paragraph. MS. LAYTON: Okay. UNIDENTIFIED SPEAKER: Separate paragraph. MS. LAYTON: I think it's an important piece, so I want -- I think standing it out is okay -- MR. SLOCUM: Well we, you know, we think all those -- the bolded things -- MS. LAYTON: Should stand out. MR. SLOCUM: Yeah. And in fact Terry thinks that the sentence starts with however should be bold. I speak for him. You know, he -- that's the sentence he read to us earlier in the day. MS. MELLON; We could bold the whole paragraph. UNIDENTIFIED SPEAKER: Yeah, why don't we just do the whole paragraph bold and make it all -- MS. LAYTON: Actually does that paragraph end? I'm wondering if there's a missing space there or -- UNIDENTIFIED SPEAKER: No. MS. LAYTON: -- if there's a missing -- there is an additional return that needs to be changed. (Simultaneous comments.) MS. LAYTON: It's all one paragraph. UNIDENTIFIED SPEAKER: All one paragraph. UNIDENTIFIED SPEAKER: Just one paragraph. UNIDENTIFIED SPEAKER: The whole thing from beginning to end. MS. LAYTON: Just bolded. MS. MELLON: I actually would suggest that we take out the titles of the three scenarios move them from where they are to, to after the paragraph that ends visions for the future. I think we could just go from on page 7, all the scenarios share the certainties but uncertainties play out differently. Each scenario is intended as a coherent description. These are not predictions of the future, dah, dah, dah. And then here then are the three scenarios for the future, and we could say we, we've decided to call them, we've entitled them Rosy Future, Continental Islands, and Biotech Goes Niche. MS. LAYTON: I like that. Here then are the three scenarios we've selected -- UNIDENTIFIED SPEAKER: Created. MS. LAYTON: We have created? UNIDENTIFIED SPEAKER: Created. MS. LAYTON: Created. We have -- we have decided -- we have entitled them -- MS. MELLON: Yes, we have entitled them. UNIDENTIFIED SPEAKER: Given them titles. MS. MELLON: I mean I think that kind of gives the idea that it is somewhat -- arbitrary. We've entitled them Rosy Future -- MS. SULTON: Creating them. MS. LAYTON: Okay, here then are the three scenarios -- here then are the scenarios we have created. We have entitled them Rosy Future, Continental Islands and Biotech Goes Niche. And then, boom, that's the end. MR. BUSS: -- make a suggestion on that preceding page -- MS. LAYTON: Yes. MR. BUSS: -- on page 7 toward the bottom. MS. LAYTON: Uh-huh. MR. BUSS: In that last paragraph we now say however the AC21 believes that it is useful to provide a few examples, think we ought to say three examples. Because about two sentences down we typically say three scenarios. MR. SCHECHTMAN: Okay. UNIDENTIFIED SPEAKER: Just examples. MR. SCHECHTMAN: Right, examples. MR. BUSS: Three examples. UNIDENTIFIED SPEAKER: Just examples. UNIDENTIFIED SPEAKER: Opposed to a few or -- MS. MELLON: Well, I think just examples. MS. SULTON: provide examples. UNIDENTIFIED SPEAKER: But then you say later -- MS. LAYTON: I think it's these three scenarios then share the uncertainties, but -- okay. That's editorial. Never mind. Not substantive. Okay, so Rosy Future. Michael, I think you said you felt pretty good about the first two. Is Rosy Future one of the ones that you felt pretty good about? Because we went through that one before. MR. DYKES: I think so. I think some aspects of -- MS. LAYTON: Okay. Anybody else had any heartburn? MR. DYKES: I've not read it since August. I hate to keep reiterating that point, but it's hard to say I'm okay with something that I haven't read since August. MS. LAYTON: Can you kind of look at your comments and make sure. MR. DYKES: Yeah, I have been trying to do that as we go along. MS. LAYTON: Yes, Randy. Randy. MR. GIROUX: Did I just hear you say that we're going to talk about the three individual scenarios now? UNIDENTIFIED SPEAKER: Yes, we are. MS. LAYTON: They're not back. Do you want to move to the questions instead? MR. GIROUX: -- general comment? MS. LAYTON: Uh-huh. MR. GIROUX: These scenarios are -- they're not right and they're not wrong. They're simply ours. MS. LAYTON: Right. MR. GIROUX: We spent a lot of -- are we going to debate the scenarios or what's in the scenarios? What exactly are we talking about here? MS. LAYTON: Heartburn, any heartburn on -- MR. SLOCUM: If you violently object. MR. JAFFE: There's something in there that is -- tremendous heartburn. MS. LAYTON: Because they're not right and they're not wrong, they're just -- MR. JAFFE: -- everybody is going to differ on whether they think the likelihood of one scenario is 90 percent versus 0 percent, that's my understanding. But we're not -- document says in several places that it's not an attempt to -- not ascribing a likelihood of these. We're just giving three potential scenarios. Everybody will differ on what the likelihood of them occurring is, and then -- have a whole series of facts, you know, statements in them that might not happen so. MR. GIROUX: All right, so what we're trying to do is understand what the scope of our discussion is going to be -- what are we, what are we trying to -- are we looking to say that they're wrong? Are we looking to say there's some inconsistencies with the drivers? What are we going to do? And I just want to set some ground rules -- MS. DILLEY: Good idea, very good idea. MS. MELLON: I think that we should look at them for -- one is for tense. I mean we, you know, these are all presented as kind of in the past tense, so we don't want to have would do this or would do that. They all ought to be in the straight past tense. And I think we, you know, we might want to look at them just to see whether they -- the - - whether they're as descriptive as they might be. So for example Michael added -- small family farming became profitable. I think small adds -- it's a nice little descriptor, and so I would say we would leave it, but I wouldn't want to, you know, take on the whole issue. MS. DILLEY: I think, just an amendment to that, I wouldn't worry so much about tense, because I think we can do that subsequent to the meeting. I think it's really does the -- do the three meet the task at hand, which is to set up descriptions of possible futures to raise these questions. I mean that we're basically saying let's forward this to the Secretary for an exercise to consider, right. So I guess the question really is are there -- are these three scenarios, do they meet that in terms of presenting three different possible scenarios that help flush out some of these questions or make it interesting to pose those questions. And the other piece of that is not only interesting, but is there just anything plain that completely freaks people out, gives them serious heartburn? Because I think tense stuff we can deal with later. MR. GIROUX: What do you mean freaks people out? MS. DILLEY: I -- that you just completely object to have that piece in there. Am I off base or -- MR. SCHECHTMAN: Well, no actually -- MS. SULTON: -- is it well framed. MR. SCHECHTMAN: Let me try one thing on one of the scenarios, and this is really trying this out on Michael. (Laughter.) MR. SCHECHTMAN: This is noticing that you had a number of comments on the second scenario, which in your comments you had called staying the course, which reflected to me that the scenario was intended to be a description of what the current situation is, and that there was a difference of view maybe on current -- different people thinking different things about current trends. And I wonder if we disconnected the second scenario from the idea that this is the trend that is happening right now if that would ease some of the concerns about that scenario. Do you understand what I mean? UNIDENTIFIED SPEAKER: I would get rid of the first sentence. MR. SCHECHTMAN: Get rid of the first -- MR. JAFFE: The logical argument, you have a problem with the logical flow of it and is when you look at a logical flow of this, there's something radically missing or something -- MR. SCHECHTMAN: That's right. GREG JAFFE: the logical argument; flow MR. SCHECHTMAN: so that if you got rid of the first sentence of that scenario -- UNIDENTIFIED SPEAKER: It wouldn't be a -- MR. DYKES: I can't comment on your question. I guess, Michael, because -- I'm not trying to be difficult. I mean I haven't even read any of these. I haven't. So I mean I could sit here and try to read it and respond to that, if you like. MR. ENRIQUEZ: I think it makes a lot of sense -- MR. GIROUX: Because then it's not judgmental. MR. JAFFE: It's just saying this is the second scenario. It doesn't say something that we're doing today is being continued and it's a question about whether people agree that that's the state today, so -- MS. MELLON: And we might want to deal with in the fourth sentence of the paragraph continued to increase the amount of biotech crops planted at a 15 percent CAGR. What does that term mean? MS. LAYTON: I -- where are you reading from? UNIDENTIFIED SPEAKER: Reading from Michael's -- MS. MELLON: I'm reading from Michael's. MR. DYKES: I don't think that got picked up though, Mardi. MS. MELLON: Oh, okay, well then -- I'm sorry, that's, that's probably why -- MR. SCHECHTMAN: Let me make a little suggestion now, which is that we may really need just to have a couple of minutes talking about process on what we're going to be doing -- what's going to -- what could come out of this meeting and what's going to be need to be done wit it after we leave today or tomorrow, because clearly it's the case that some folks have already left, some people aren't here. Some people are leaving in -- at the end of today and will not be here tomorrow. I think -- and, and while it's -- while we're talking about scenarios, it is also clearly the case that it's been something that not everyone was equally prepared to come in and talk about. So I think we just need to have some discussion on -- and we have just on time people coming back into the meeting. UNIDENTIFIED SPEAKER: Yeah, they're back. UNIDENTIFIED SPEAKER: We think they're back. UNIDENTIFIED SPEAKER: They're smiling. MR. SCHECHTMAN: So we sort of need to talk about -- (Simultaneous comments.) (Laughter.) MS. MELLON: Well really we -- I mean I just want to note that Michael doesn't really have a lot of -- he didn't really have a lot of suggestions on the third scenario, and that was the one that we really hadn't gotten to. So that suggests that -- (Simultaneous comments.) MR. SCHECHTMAN: Are people okay with five? UNIDENTIFIED SPEAKER: Five is fine. UNIDENTIFIED SPEAKER: Five what? UNIDENTIFIED SPEAKER: O'clock. UNIDENTIFIED SPEAKER: Five o'clock. UNIDENTIFIED SPEAKER: I've got to leave at five sharp, because I've got to get to the airport. MR. SCHECHTMAN: Okay. UNIDENTIFIED SPEAKER: And I've got to get tickets before I get to the airport. MS. LAYTON: Then five o'clock it is. MR. SCHECHTMAN: Well, let's talk sort of briefly about what is doable and what our sense of consensus means in the view of people coming and going and documents going to people for whether it is thumbs up or thumbs down or things that are -- thumbs up or thumbs down or major questions of fact that might need to be adjusted. Is that a reasonable criterion for dealing with sending out the documents after this meeting? Because we will -- obviously a lot of people have been off working very hard, and I think I see white smoke coming out of every one of their heads. UNIDENTIFIED SPEAKER: That's hair. UNIDENTIFIED SPEAKER: The gray ghost over here. (Laughter.) MR. SCHECHTMAN: And you look like you're ready to say something. UNIDENTIFIED SPEAKER: No, you finish first. MR. SCHECHTMAN: I'm trying to figure out in -- you know, there obviously is going to need to be some kind of process to accommodate having people see the document after this meeting. Seeing both documents in their entirety. And the question is what is the nature of that process? I think that's a really important thing that we need to answer while as many of us are here as can be. Greg. MR. JAFFE: I just think it should -- I mean people that just came in missed the long discussion we've had about -- you say the document -- they understand what document we're talking about, what we're trying to -- at least what some of us talked about as proposals we're trying to accomplish in these two days. May just want to elaborate a little more. MR. SCHECHTMAN: Okay. MS. DILLEY: Sure, both documents meaning the traceability and labeling document, which we will discuss shortly, and then the preparing for the future paper that would go both of which would go around for review and just - - I think you guys were in the room but maybe not. They were taking the implications section out of that and trying to work through, had been working through and will continue to do so tomorrow, working through comments on what we know the uncertainty -- the -- what we -- what is much less certain, and then the three scenarios and put that forward as -- MS. LAYTON: With the questions. MS. DILLEY: With the questions, sorry, with the questions that are contained in this. So merge those together as a separate document what would -- both the -- so both the traceability and labeling and that document as outlined would come back for review by the Committee and then we'd need to set a date certain by which people need to respond as to whether they're -- they would -- are supporting both documents, and then they would go forward to the Secretary, be submitted to the Secretary. So we need to have a date certain. And I think what you suggested in terms of a bar for any kind of comment was statements of fact, right? MR. SCHECHTMAN: Statements of fact. MS. DILLEY: So we need to set a date for -- and I think then the issue is date certain. What date certain are we talking about. MR. ENRIQUEZ: Seven days after receiving the document. Is that reasonable? MR. SCHECHTMAN: Whether it's 7 or 14, people are on travel, et cetera, but a very, a fixed date not far in the future that we can decide on. MR. JAFFE: I guess I'm just a little confused. This would -- my understanding is everybody would be agreeing at the end of the meeting that subject to their re- reviewing of it they would be comfortable with both of these documents going forward to the Secretary, give them a chance to review it, reiterate their comfort or raise any questions of fact that they might have a question with. MR. SCHECHTMAN: Yes. MR. JAFFE: Is that what you're -- MR. SCHECHTMAN: Yes. The only caveat to that is that there will be a number of people not here at the end of the meeting. MR. JAFFE: Right. MR. SCHECHTMAN: So that -- MR. JAFFE: Right. The question I have then is what happens if somebody said they weren't comfortable with the -- in other words, we've always talked about this being a consensus document. So what happens -- everything works with that scenario. That's why so -- everybody say when they leave this meeting that they're comfortable with it subject to obviously reviewing it and making sure it's -- but I guess my question is what happens if somebody comes back and says they're no longer comfortable with it or on review they're no longer comfortable with it, one or both of the documents or something like that? How does that play into this? MR. ENRIQUEZ: -- that second for one question. We've been sitting here for two years. Every discussion has been public, every working group has had a summary put forth. Everybody in this room has had two years to review these documents and has had three months since the last meeting. If you did not review the documents of the last meeting and this and that, that's your trouble. At this meeting we should know where we stand on this thing, and if you've got a major heartburn. What you can't do at this meeting is say, you know what, I didn't do my homework, and I'm going to hold the thing up. I don't think that's a reasonable position, because all of these discussions have been public. All the working group meetings have been public. And you know everybody here has had two years to think through these issues, to comment on working groups, to comment on these things. If there are major statements of fact that are wrong in the stuff brung forward, let's put them out on the table. If there are major disagreements, let's -- if there are factual issues which are wrong, by all means let's change them in the future document. But I think we're getting pretty close to a thumbs up or thumbs down on the series of documents. Because otherwise we're going to be reviewing this stuff for months. I mean we -- I guarantee -- for five years --traceability and labeling for five years. MR. CROWDER: I agree with Juan, but I'd like to -- I am not comfortable with the documents right now because I've not gone through them. I have read them and said comments in every one at one time or the other, but I don't know where we are in terms of -- MR. SCHECHTMAN: And your comments -- MR. CROWDER: On tracing and labeling on -- MR. SCHECHTMAN: Scenarios. MR. CROWDER: Scenarios. I was probably more comfortable with that than something else, but there also -- Juan not only issues a statement of fact and what's in there, but there are some things that -- we just spent several hours going through how things are represented and whether they represented, you know anything acceptable, acceptable way. So I guess that I'd like to -- and I know that on tracing and labeling there are some things that I've not had a chance to comment on that were postponed from this morning, in addition to the consumer side. But I'm willing to -- I mean I think this idea of a drop dead date is, is worthwhile, but as far as I'm concerned, the rules got changed for me today when I walked in here, and if I had known that the rules -- known what the rules were I would have prepared differently. I mean I came to take a history test. I didn't come to take a history and English test, and I didn't study for the English test. But I'm willing to look at it and be as accommodating as I can. But if there's something that is, you know, in a different place, then I'd like to have a chance to have input into it. But other than that, I don't have any problem with moving both documents along, but -- to see where the language is before I come to saying I'm going to -- MS. LAYTON: And that's why I think it's send it out, get it done, get it revised, send it out. MR. CROWDER: -- and I'll get it back in. MR. SCHECHTMAN: Randy. MR. GIROUX: Just a question of process. So what happens if somebody comes back and says, I can't sign off on this document unless this substantial change is made or I won't sign off on this document? What happens? MR. SCHECHTMAN: After the, after -- MR. GIROUX: Because it's too late. MR. SCHECHTMAN: -- member terms expire? MR. GIROUX: Right. So what happens? Just so everybody in the room understands if they say no or yes what is the implication of that. I just want to know. UNIDENTIFIED SPEAKER: I do too. MR. SCHECHTMAN: What are people's views? MR. GRANT: We thought you had the answer. MS. DILLEY: I think you got a couple of options. I think you either say okay, by this date either it -- the documents will go forward, and we'll either have everybody's name on them or they'll have some portion of the names of people on them. That's one option. I'm not saying that's the answer. I'm saying that's one option. UNIDENTIFIED SPEAKER: All right, one option. MS. DILLEY: Another option is to take a tally at the end and if there are say two people who are disagreeing on two -- each of the documents, you can try and put another timeline on that to address concerns or and then at the second date certain again they either go forward or they don't go forward. So you can either put a clause in there that there is a little bit of time to try and get -- reach consensus or not. MR. GIROUX: Two members of the Committee can't work separate from the rest of the Committee. MS. DILLEY: No, no, no, no. So you would have a timeline on it, just addressing the particular thing, whether it was by conference call or however you try and resolve it. That gets complicated. I'm not saying it's not. I'm just laying out options here. It's a lot more complicated because then it becomes more of a moving target. So the third option, I guess, is to say well if those people are not supportive to submit a letter of -- along with the reports going forward of why they have concerns or minority report I guess, if you will. MR. CROWDER: But are we not bound by the terms we were chartered under? MR. GIROUX: -- the bylaws. MS. LAYTON: I pulled them. Decision making -- or it's under Section 3, Decision Making Consensus. We, the AC21 will seek to operate via consensus and recommendations made to the Secretary of Agriculture. On occasion the Chairperson may request a motion for a vote. Any member including the Chairperson may make a motion. Recommendations or other documents can be considered to -- consensus if there is no consent by any member of the AC21. MS. FOREMAN: I'm sorry. We had a little crisis over here. Would you start again? MS. LAYTON: Referring to Section 3 of the Bylaws there on the back panel. And so it's talking about we can vote. Then it says the USDA believes there is a value in the Committee articulating the range of desperate views -- UNIDENTIFIED SPEAKER: Disparate. MS. LAYTON: Disparate. (Laughter.) MS. LAYTON: Okay, so why don't I explain how to pronounce that word. Of its members even if consensus is not reached. Therefore, if consensus on specific substantive proposals is not possible, the AC21 will make every effort in any recommendations or findings provided to the Secretary to articulate both the reasons of both the areas of agreement and disagreement and the reasons why differences continue to exist. In striving to achieve consensus AC21 membership should consider all relevant public and private sector perspectives and the interests and concerns of all AC21 members. If recommendations or findings are given to the Secretary that are not based on consensus, those AC21 members not joining in consensus should be afforded the opportunity to provide to the Secretary in a timely manner a minority report. The AC21 will also strive to achieve consensus on significant procedural issues such as -- and that's what -- so I think that's it. MR. JAFFE: So it seems to me one thing we could do would be to leave this meeting with that, give everybody still the opportunity to that everybody comfortable with going forward but giving the opportunity to look at the last one, and if there's a -- I mean I -- coming from Dick, having not studied for the English test, if there's a problem, I like Abby's idea of sort of trying to work it out first. It seems to me, it may not be as big a problem as one thinks. But then, if it can't be worked out, then whoever is in those groups -- the concept would be that these two would definitely go forward to the Secretary but there might -- if there needed to be a minority report -- UNIDENTIFIED SPEAKER: Would not be a consensus document. MR. JAFFE: Small number of people that might be in either one of those, but the concept would be leave this day that both of these would go forward and trying to work out any distinctions, and then if need be it sounds like a minority would be the way to solve it. MS. LAYTON: And, or you could put both, you could put both opinions. We could not achieve consensus on this questions. These are the two few points, and that document could then reach consensus and move forward. Having the two sides in there. MR. SCHECHTMAN: It's a little dangerous to start the process of doing that because then -- MS. LAYTON: Absolutely. MR. SCHECHTMAN: -- opening the whole thing. MS. LAYTON: I agree. MR. SCHECHTMAN: But I think, you know if there are very small, you know, small but important points that members feel will prevent them from reaching consensus articulating those, you know, not as a minority report of the whole report, but, you know, articulating those little points of problem are not -- I don't see where it would be particularly problematic. MS. DILLEY: So people are comfortable with that process? Date certain, see where we are, try and work any lingering issues out and then if we can't, then we go to a non-consensus format versus trying to work it out and getting it done. MR. DYKES: Are we saying that we have to have non-consensus? Are we separating the two issues, one on traceability and labeling. If we get a green on that one, that one goes; if we don't get a green one on the other one the other one doesn't go? Or are we saying have agreement on both. I just want to make sure I'm clear on this process. MS. DILLEY: The goal is to get both. MR. DYKES: So if we don't have agreement on both, neither goes? MS. DILLEY: No. MR. JAFFE: No, no. I think what it's saying is we're using the same process for both of them. So they're both going to go to the Secretary. The question is are they both going to go as consensus or with a minority majority, but we're going to leave the -- we're not going to -- MS. LAYTON: So it's process and timeline is the same. MR. CROWDER: -- parallel track. MR. JAFFE: They're on parallel tracks. They're not linked in the sense of that -- consensus of both of -- but they're both going to go in the same both on the same track. MR. DYKES: They're both going to go -- depends on how they're going to go. MS. LAYTON: Right. MR. DYKES: That's the only question. UNIDENTIFIED SPEAKER: Right. UNIDENTIFIED SPEAKER: Right. MR. SCHECHTMAN: And we're going to do our best to get them both out of here. UNIDENTIFIED SPEAKER: Right. MR. SCHECHTMAN: Obviously the consensus that we will reach at the end of tomorrow is going to be of the people who are here. MR. JAFFE: Right. MR. DYKES: And have we talked about the process for the two people that aren't here today? MS. DILLEY: You mean Carol and Keith? MS. LAYTON: I will be happy to call them and walk through what we've done, and then hopefully -- and they will see everything we've done and have the time frame that we have. But I could call them, you know, I can even call Carol tonight because she's just suffering from bronchitis. Is here in D.C. And get a feedback on her. Keith, I don't know about, but we could certainly call him Wednesday. MR. DYKES: My reason for asking the questions is just process. So we make sure we have down and we follow what we say we're going to follow so we don't -- UNIDENTIFIED SPEAKER: Uh-huh. We're following that. MR. DYKES: So they donÕt change the rules during the day and during the, during the -- MS. LAYTON: Okay. So do you want to write that process down formally so everybody sees it in writing or are you comfortable? MS. DILLEY: Pat's opening line is here's the deal. MS. LAYTON: Here's the deal. MR. DYKES: I just think it should be reflected. MR. GIROUX: I'd like to hear it. MR. DYKES: I'd like to see it reflected in the minutes. MR. SCHECHTMAN: Let's write it down. MS. LAYTON: Let's write it down. It's always important. Because this is it. We should have consensus MS. LAYTON: let's write it down. MR. JAFFE: One other thing. I think that's great, Pat, that you're going to do that, but there will be three more people not here tomorrow. However you want to call MS. LAYTON: Absolutely. MR. JAFFE: I donÕt know whether -- Michael is going to kill me for this suggestion, but -- going to take a week or whatever I think to turn these documents around, I don't know whether one can get a unofficial transcript of what's gone on in these two days in a similar time frame to sort of get back to the people who also weren't here so they could actually have what they wanted to be able to sort of actually go through and see what was done by the Committee on those two days. MS. LAYTON: The master is in the -- MR. SCHECHTMAN: Yeah, that -- you know we can't guarantee exactly when we will get our transcript. I know, you know, we've worked with folks to get us transcripts quickly, but that takes awhile for us to get. I can't promise when you're going to get them. MR. JAFFE: I'm saying for people who weren't here either one or both days, even if that's gotten later on when they're doing the review, the 14-day review period, it would be able to give them the -- for what happened then. MR. SCHECHTMAN: We will try to turn them around as quickly as we get them. That's -- we can certainly do that. MS. LAYTON: Okay. So the first was the documents will be -- all comments will be taken during these -- this two-day period, and we will deal with the issues as we can. The staff will then incorporate all changes as outlined during this two-day process, hopefully within a week, 10 days, a week to 7 to 10 days. The documents will then be E-mailed to every member of the Committee current member of the Committee, since we don't know the new members of the Committee, so we're just dealing with the old members of the Committee. Because at this point in time, if we feel consensus walking out the door, without any, you know, without seeing the revised version, that's what we're talking about, based on the tomorrow as we leave or today as you leave -- then we would have a review period of 10 -- 7 working days? Seven working day review period? MR. DYKES: I donÕt know if that's going to be sufficient time. When are you going to get them to us? Seven days -- MS. LAYTON: If they're out in 10 days, one week to 10 days. MR. DYKES: Oh, okay. MS. LAYTON: Okay. MR. DYKES: And the seven days after that. MS. LAYTON: Seven days after that. MR. DYKES: Seven days after that. So you're looking at -- MR. SCHECHTMAN: Seven work days. MR. DYKES: -- 14 to 10 -- 14 to 17 days. UNIDENTIFIED SPEAKER:: I think instead of workdays or 10 days? MR. JAFFE: I would say 10 working days. MS. LAYTON: 10 working days. Okay, 10 working days, 10 working days. Hopefully everybody will do it sooner, especially if we've got a problem. MS. DILLEY: And at that point -- MS. LAYTON: At that point in time -- UNIDENTIFIED SPEAKER: Responses are? MS. LAYTON: Via e-mail. MR. GIROUX: And what are, what are the potential responses? MS. LAYTON: Accept, and -- sorry. No, up, no, up, down, factual check, fact check needed and put in fact check needed. MS. DILLEY: You can't abstain. If we donÕt hear from you, you're okay. MR. GIROUX: Right. MS. DILLEY: We'll assume that's a yea. MR. BUSS: That was what I was going to say. It seems to me that no response -- MR. DYKES: No substantial changes. MR. CROWDER: So that means for those of us who won't be here tomorrow, we have no chance for input into -- on what we've already had into scenarios? I tell you, that's fine, but -- MS. LAYTON: I think we're going to try to -- MR. CROWDER: -- I think -- MS. LAYTON: Dick -- MR. CROWDER: I donÕt think it's very good given the fact the way it was handled. MS. LAYTON: Okay. MR. CROWDER: -- put on that on the table, that I can understand the reason for it where we're going, but I donÕt like the way it came about. I want that, that reported too. MS. LAYTON: I understand. MR. CROWDER: Okay. MS. LAYTON: I wasn't expecting to do this either. MR. CROWDER: Okay. MS. LAYTON: What I am going to say is that while you were working on consumer issues, we went through most of scenarios in terms of the documents and looked at comments that were there and made some decisions, and we want to take a few minutes and brief you on what we did at this time. So you can feel comfortable with where we are. And then have you all do the same for us on consumers. MR. JAFFE: Let's finish the process. MR. SCHECHTMAN: Yeah, I think we haven't quite captured -- MS. LAYTON: Okay. MR. SCHECHTMAN: -- everything, because there was this, there was some -- go ahead Greg. MR. JAFFE: So what happens if -- so you need number four, so if there's the not, the question is work out by -- MR. SCHECHTMAN: If -- MS. LAYTON: If there's a no, the DFO -- UNIDENTIFIED SPEAKER: What am I going to do? MS. LAYTON: By facilitators or by secretary. The DFO will facilitate a process of seeing if there's a way through it, quick way through the issue. No. Okay, what were you saying, guys? I'm trying to repeat what I heard. MR. ENRIQUEZ: Can I make a suggestion on that? MS. LAYTON: Yes. MR. ENRIQUEZ: There has been working groups on each of these things. If there is a strong no, then that person goes into a conference call with the working group, and the working group decides, yeah, we'll make this change or we won't make this change. And if the working group says that's a valid point, let's do it, then they'll recommend to the Committee as a whole that that change be made. MS. LAYTON: How does that sound? MR. SCHECHTMAN: The person still has to be able to sign off on it. I mean the issue is that -- MR. ENRIQUEZ: If the work group says no, then it goes into a minority report. MR. SCHECHTMAN: Okay, all right. MR. ENRIQUEZ: If the working group says we don't agree with you, put it in as a minority, go for it. If the working group agrees with it, then it will recommend to the Committee as a whole that that change be made. MR. GIROUX: So it's not just no. It's no with a reason. MS. LAYTON: Reason. Yeah. If you're going to say no, please say no with a reason. MR. JAFFE: Right, that's what I'm saying. I wanted to get down there that if somebody says no, then they realize eventually they may have to do a minority report. It's not, no, I get to veto this report from going to the Secretary. It's, no, leads to a minority report. So number -- MS. LAYTON: No reason for it. MR. JAFFE: -- five would be if you can't work it out with the work group, I like Juan's thing, then five is minority report. MR. ENRIQUEZ: Dick's point, it's hard to put changes into monologue. I have to say two things. One is we've been working on implications for the past thing that is not going in this report. This language has been in here, and I don't think it's changed for five, six months. So we've had five or six months to prepare for this thing. And tomorrow is a regular scheduled meeting. And you know those of us who can make it, great. MS. FOREMAN: There's one other thing, and that is that on at least two occasions when we were scheduled to deal with scenarios, we didn't do it at the time the agenda said we were going to do it. We switched and did labeling and traceability. So this got put off in favor of something else on several occasions. It doesn't seem more reasonable that now we're pushing it to get it finished. MS. DILLEY: Does the work group then -- is that the traceability and labeling work group addresses the traceability and labeling comments and the scenarios work group addresses -- UNIDENTIFIED SPEAKER: Yes. MS. DILLEY: -- the -- UNIDENTIFIED SPEAKER: Okay, clarified. MR. CROWDER: On your points -- except for the fact that I scheduled one thing this week and got another thing this week, and that, that caused -- that had some consequences even though -- MR. ENRIQUEZ: My concern on this is the next meeting that this group has is going to have a whole new membership, and trying to go through this process again with a whole new membership, it ain't going to happen. MS. LAYTON: Okay, let's focus on the process then so -- MR. SCHECHTMAN: Let me reiterate what I think the last two steps were that I heard. That will be when the document is sent out, it will go out to people via e-mail either accepted or not with the reason saying what the problem was or questions of fact. No response will mean agreement. If there are nos, then there will be a quick consultation with the work group, notwithstanding the fact that the date may be after the date of the membership, and then if the work group doesn't agree to put it in, it will either go into a minority report or the person will have the opportunity to -- the person will have the opportunity either to do a minority report or to indicate acceptance. Yes. MR. JAFFE: Can I just add one thing I guess. I would just say that at this stage at least we should at least give the rest of the people who were not on that work group the opportunity to participate in that work group -- if MR. ENRIQUEZ: Absolutely. MS. LAYTON: Yes, absolutely. MR. JAFFE: Should be limited to the work group, but it's obviously scheduled for the work group and people who have that disagreement. MR. SCHECHTMAN: People okay with that? MR. GIROUX: If that small work group comes up with a solution -- MR. CROWDER: I don't think we've got much choice in terms of where we go from here. I mean I don't -- MR. GIROUX: If that small work group comes up with a solution to the problem, they solve the problem, it doesn't go back to the greater committee again. MS. LAYTON: I think there has to be a review by e-mail from the work group to -- UNIDENTIFIED SPEAKER: An explanation to the Committee. MS. LAYTON: Has to, yes. (Simultaneous comments. MR. GIROUX: So then you agree with the report, but then in the end you may disagree with the report -- UNIDENTIFIED SPEAKER: And if you do then I guess -- (Simultaneous comments.) MS. LAYTON: Let me suggest this. If you say no and have a reason for saying no and have a reason for saying no, it needs to be communicated to the whole Committee. MR. JAFFE: Yeah, I think that makes sense. So if there is -- so if somebody doesn't accept the report and they forward a reason, then that should be forwarded to all the Committee. MS. LAYTON: Everybody on the Committee needs to know about it. Because then if it's going to work group, you need to know if you want to participate in that or not. UNIDENTIFIED SPEAKER: Right. MR. JAFFE: Yes, that makes sense. Full transparency. MS. LAYTON: Full transparency. MR. JAFFE: And then the solution for the work group would go out to the whole Committee, and I guess if somebody objected to that, then they could -- MR. SCHECHTMAN: Well, if they objected, they should be in the working group. MS. LAYTON: They should be, they should be in on the call. MR. JAFFE: Right. MS. LAYTON: So you'll know what's coming. You'll know it's going to either be solved or not solved on that call, and it should be -- in time for you to be on that call, even from India. MR. CORZINE: Does the process repeat itself if there's somebody that can say there is substantial change? UNIDENTIFIED SPEAKER: No. UNIDENTIFIED SPEAKER: No. UNIDENTIFIED SPEAKER: That's why you'd be on the call. MR. SCHECHTMAN: You have to be on the call. I'm not sure it's -- we're stretching our margins here a little, but -- MR. DYKES: Right. MR. SCHECHTMAN: But I think it's what we're going to have to do. MS. LAYTON: I think the work group has to feel that they -- I think they have a sense of the group to know they're pretty -- MR. SCHECHTMAN: May I get thumbs up or down on the process? May I get thumbs up or down on the process? MS. LAYTON: Carol. MS. FOREMAN: There's no linking between the two reports. MS. LAYTON: For -- UNIDENTIFIED SPEAKER: No -- but -- MS. LAYTON: -- on procedure to move them forward at the same time. MS. FOREMAN: Yeah, but what, what is there is, you know, objection to one MS. SULTON: They'll all go forward. MS. FOREMAN: They'll all go forward, just some of them may have a minority report. UNIDENTIFIED SPEAKER: That's right. MR. JAFFE: My understanding is they're not linked but they're both going on the same track. They'll be sent together, whether or not they have a minority report or not, they'll be -- both will be sent. MS. FOREMAN: Okay. I'm sorry. That was stated. I just -- MR. DYKES: So I think to be clear then, they are linked. They'll either go forward for the -- full Committee report, or they'll both go forward one with a full Committee, one without -- one with, one without. UNIDENTIFIED SPEAKER: Or both with. MR. DYKES: Or both with or both without. MS. LAYTON: Yes. MR. DYKES: I think to be clear. It's not fair to say they aren't linked. They are clearly linked. MS. DILLEY: They're linked in time frame. UNIDENTIFIED SPEAKER: In time. MR. DYKES: They're both going to the Committee. UNIDENTIFIED SPEAKER: Do they have -- MR. DYKES: They're both going to the Secretary. MR. CORZINE: Because you may not have any need to re-gather the work group, say T and L, there's no -- there's not a -- so it moves forward while the other is still getting resolved. I mean is that right or are you -- MS. FOREMAN: Same date. MR. CORZINE: It wouldn't -- unless then you're going to link them. MR. DYKES: They are linked. According to the process, they are linked. MS. LAYTON: And so what we're really looking at is a cover letter that transmits both of them the same day. Is that what I've heard? Chronologically they would, they would -- MR. CROWDER: Then I'm against the process. MS. LAYTON: That's what I asked. UNIDENTIFIED SPEAKER: When did we link -- MS. LAYTON: That's what I'm trying to find out. MR. CROWDER: -- because I -- we, we were given two different charges, and not only did we change the homework assignment, we changed the study hall period also. MS. LAYTON: Okay. MR. CROWDER: So I -- MS. LAYTON: Are you comfortable or is everybody comfortable if they are -- it's the same process. One may be 10, 5 days ahead of the other? MS. MELLON: No. MS. FOREMAN: Listen, there are days when we did not do scenarios. We changed the homework assignment. We changed the agenda in order to move tracing and labeling -- traceability and labeling ahead of those, and so I think it's -- you know, you just have to deal with the fact that now this time the -- Keith -- was able to come one day last time, and when we got to the meeting, we changed the agenda and moved scenarios off of the first day, the one day he was able to be here. So it's happened to everybody. MR. CROWDER: And, Carol, I've been coming to these -- I agree, it has happened to everybody, but it has not happened to everybody at the time we were trying to finalize reports. There's a difference. MR. ENRIQUEZ: I signed up for a committee on 21st Century Agriculture. If the only product coming out of this project is the traceability and labeling report driven mostly by concerns about traceability and labeling and that's the only thing that comes out of it, I would be very uncomfortable with that being product for two years. MS. DILLEY: I don't think there's a question of whether there's one or two products. MR. CROWDER: I would too, but -- as it may -- that I solved that by imposing an artificial restriction or condition on top of it. MR. CORZINE: That's what I see. I don't see, even with what you're saying, Juan, I don't see the need to combine them like that. I thought a long time ago we said that USDA asked and we moved T and L to the front. I mean that was done quite some time ago. MS. FOREMAN: I never for the record, I never agreed to that. UNIDENTIFIED SPEAKER: I donÕt remember that -- UNIDENTIFIED SPEAKER: Maybe that -- was that before you -- UNIDENTIFIED SPEAKER: No. MS. FOREMAN: I'm a member of the committee now and I don't remember. MR. SCHECHTMAN: I think there was an expectation that the one report -- MR. CROWDER: Let's get back to -- MR. SCHECHTMAN: -- might be easier to do than the other, and that, and that it might, it might very well get finished before. But I donÕt think it was made a higher priority, you know. I think it was thought of that because it was more a matter of fact than of issue development, it might be a bit easier to do. MS. DILLEY: I donÕt think there's any disagreement among the group that I'm hearing that two products are going forward. I think the question remains, is there a way to -- either we go with the date, the same date for both, whether one is finished before the other one, or we go with a way of linking the two in time frame, but they are submitted separately, and I, I -- there's no option that two reports aren't going to be submitted. So I guess that's the question to the group is whether we can find a way around this or not find a way around this. Greg. MR. JAFFE: I mean it seems to me -- maybe we'll put a time limit on number four, that if there is --so that they are both then together, but that there's not a major time lag. Again that conference call is to happen within two weeks of the -- everybody saying no, and so they are -- and then the reports will go, you know, so that, I mean I guess the concern here is if you link them to make sure they go, one doesn't go six months later because somebody holds up on a minority report or something, which I guess, I don't believe anybody would do, but we're playing off scenarios here. So why not again put a time limit on number four to get done, which would then -- UNIDENTIFIED SPEAKER: Yeah, I mean -- MR. JAFFE: -- make sure that they're both together but are also done timely. So they are being linked, but it's not line one is holding up the other. MS. DILLEY: So you're saying that a letter would go forward with one report that says the second report will not be -- will be submitted no later than -- MR. JAFFE: No, no. I'm saying -- MS. DILLEY: -- days or they're sent at the same time. MR. JAFFE: I'm still, I'm still saying that they are linked. MS. DILLEY: Okay. MR. JAFFE: But saying if the worry here is somebody saying that they don't want the fact that there's a disagreement with one to hold up the other, I'm saying let's make sure there's a time limit on the disagreement so that they both go at the same time. MS. FOREMAN: So they -- one may go and then -- report, but it has to go -- MS. LAYTON: Actually according to the Bylaws a minority report can come afterwards. MR. JAFFE: Right, so -- MS. LAYTON: In a timely manner. MR. JAFFE: -- they both could go and one could go -- first one -- second one is a minority report and then the person who is writing the minority report -- MS. LAYTON: Their minority report would be -- MR. JAFFE: -- and then it's under their burden to get it as quick or short, but it doesn't hold up -- MS. LAYTON: And that is in the Bylaws. We do not have to wait for a minority report to send it -- MR. JAFFE: So therefore if the conference call happens within two weeks, this idea of timing doesn't become -- it's not material in the two-year time frame. They both go, and the minority report is something that is left up to that person. MR. SCHECHTMAN: But I do want to check that we don't have to hold both calls on the same day. MR. JAFFE: Hopefully there will be no calls. MS. DILLEY: Hopefully there will be no calls. MR. CORZINE: So it gets back to the basic question. One can hold the other hostage for -- MS. LAYTON: No, they can't until -- UNIDENTIFIED SPEAKER: For two weeks. MS. LAYTON: For two weeks. UNIDENTIFIED SPEAKER: For two weeks. MR. CORZINE: I guess why I still -- is there a basic thing that I'm missing, why they are linked? MS. SULTON: Treating them the same. MS. DILLEY: So that both go forward as products of the Committee at the same time that -- MR. JAFFE: They're being linked because there are two products of this report that go to the issues we've been asked to look at by the Secretary, and at least in some members of the Committee, they're near enough done that they both should go. And one -- although believes everybody is working in good faith here, one doesn't see -- one is not more important nor more valuable to the Secretary than the other or goes to more to our charter than the other, and so if we're finishing our two-year charter, our products should go together that have been completed. MS. DILLEY: Daryl, you had a comment. MR. BUSS: I think aside from timelines, I guess I would see -- I would prefer that the documents go forward. I separately -- I'm assuming at a different time, but each with their own cover letter. To me combining the two implies that there may be a relationship between the two -- in other words, traceability and labeling document did not arise as a consequence of or was written in a way to reflect the scenarios, for example. I think they're -- you know, they're independent events. And so in my contacts with -- Leon we were trying to match these to get them forward, then we seem to suddenly have evolved into bundling them together with a single cover letter, and I'm not sure that serves us well. MS. DILLEY: Okay. MS. LAYTON: So five, and then 6 I guess they go forward with individual cover letters. UNIDENTIFIED SPEAKER: That's fine. MS. LAYTON: Did I hear -- I heard Carol say yes. I'm looking -- yes, nods? UNIDENTIFIED SPEAKER: Fine. MS. LAYTON: Happy campers on that Dick? MR. CROWDER: Yes. MS. LAYTON: Happy camper -- okay. Happy camper on separate cover letters. MS. DILLEY: The time frame issue. Do we have clarification on that or not? MR. SLOCUM: We do now. It's fixed. UNIDENTIFIED SPEAKER: Fixed time. UNIDENTIFIED SPEAKER: Fixed time. MS. DILLEY: Okay. MR. SLOCUM: If you want your minority report, if there is one, to be included with the Committee report, you've got to submit it in that period of time, is that right? MR. SCHECHTMAN: Or else it will wind up being submitted on its own later. UNIDENTIFIED SPEAKER: Separate. MS. LAYTON: It says those -- AC21 not -- consensus shall be afforded the opportunity to provide to the Secretary in a timely manner a minority report. That's our Bylaws. And I think that's incumbent upon the individual to submit. UNIDENTIFIED SPEAKER: Does the Committee get to see that report before it's submitted or is it submitted just -- MS. LAYTON: I -- (Simultaneous comments.) MS. LAYTON: It's minority -- MR. SCHECHTMAN: I mean we'll circulate it to everyone, but no one else gets to comment on it, I donÕt think. I would just suggest that we build in here if there is permission for minority, if there is need for a minority report we will build in a couple of weeks from the point this is done to allow the minority reports to be written, to give folks an opportunity to provide them with the report, if they so desire. And if it comes in later, it comes in late, but just to give them a chance to -- MR. SLOCUM: Are you talking about two fixed times then? MR. SCHECHTMAN: We will get this done -- MS. LAYTON: Which is this. MR. SLOCUM: Which is this? MS. LAYTON: The working -- MR. SCHECHTMAN: The conference call in a, you know, in a brief -- MR. SLOCUM: 10 working days. MR. SCHECHTMAN: Yeah, and then we will allow, if there is not agreement, we will allow a fixed period of time for the person to decide if they're going to submit a minority report and to give it to us after which it will go forward with or without the minority report. MR. GRANT: Let's fix that time too then now. MR. SCHECHTMAN: Which is that time? MR. GRANT: So the minority report time. (Simultaneous comments.) MR. CROWDER: That's a reasonable period of time. (Simultaneous comments.) MR. SCHECHTMAN: Can always send it later. UNIDENTIFIED SPEAKER: Yeah, can always send it -- MR. SCHECHTMAN: How are people with the process? Michael. MR. DYKES: Just a comment on the process. Until we walked in here today, we have spent the last two or three meetings talking about getting one report done, and we set up this meeting today with agreement at the last meeting we'd spend one day to try to finalize the T and L document. We changed it to two days. And now we're changing -- and I'm not saying I foresee any issues here, but in terms of process, we're changing the process as we go. Without -- how do we get consensus of the Committee even on the process, because we're changing within the meetings themselves. So -- MS. DILLEY: You're right, that's not a great process, that's not, that's hard. And I think the thing that's driving us so much is that people are rotating off, which is a factor that we didn't know at the last couple of meetings. MR. DYKES: We did know. MS. MELLON: No. MR. DYKES: We did know terms were expiring and people did know whether they wanted to re-up for the Committee or not. We're going to have people rotate off. MS. LAYTON: I don't think we knew that. MS. DILLEY: I didn't know that. UNIDENTIFIED SPEAKER: Well, who is we? MR. SCHECHTMAN: And in point of fact, we don't know that people who are on the Committee and reapplying are going to be reappointed. UNIDENTIFIED SPEAKER: Right. MR. DYKES: That's right. So there's a lot of things we don't know about the makeup of the Committee. MS. DILLEY: That's correct, and -- MS. FOREMAN: But we do know one thing that virtually every member of the scenarios group has not applied to be reappointed -- two-thirds, four-fifths. MS. MELLON: Here I am, a potted plant again. (Laughter.) MR. JAFFE: I agree with you, Michael, that things have changed at this meeting, but I have to say that at the October meeting, Michael Schechtman got up there and said, you know, we're going to finish both reports. We're going to work real hard. The issues group, we tried to have an all-day meeting in November. It wasn't until even -- we were trying to get -- can't tell you for the last couple of meetings we've only worked on T and L. It wasn't until we got to the December meeting we made a decision at the beginning of that meeting that we couldn't get the other one done as a whole, and I have to say that I asked Terry at that meeting, and he hadn't decided yet. People didn't have to -- send in their things until December 22nd. He told he had hadn't decided. MS. LAYTON: He did not, I agree. He told the same thing to me. MR. JAFFE: I had asked specifically. So at the December 8th-9th meeting, I had asked different people, at least Terry, and he had not made a decision about whether he was going back. I hadn't made a decision yet. I hadn't made a decision yet. I hadn't talked to my boss. So -- whether I was even applying, whether I get on or not. So I donÕt -- I think there are facts that have changed. MS. LAYTON: Michael, you're leaving in five minutes, three minutes. You were here for the discussion that we've had so far on scenarios. We've not had this implications -- consumer implications. Can we get, can we get five minutes on this so that Michael is -- has heard what you all's thoughts are? MR. DYKES: You've got other sections you've not gone through the -- you've not gone through the executive summary. You've not done the last section on issues raised and concerns. MS. LAYTON: Okay. MR. DYKES: I mean I'm not saying there's a problem with -- I'm just talking about the process. MS. LAYTON: Yeah, I know. MR. DYKES: We've got a lot of other work when the other document -- MS. LAYTON: And we've got -- and we want to finish it. MR. JAFFE: -- able to get done tomorrow morning. UNIDENTIFIED SPEAKER: Tomorrow morning. MS. LAYTON: First thing in the morning. MR. CROWDER: I thought we were going to agree to stay late tonight. MS. LAYTON: I'm ready to stay late. Michael has to leave. MR. SCHECHTMAN: We've already exceeded by one hour. We were scheduled to go to four. I know Michael has to leave not to go catch a plane. MR. DYKES: Yeah. MS. LAYTON: I mean I'm willing to stay and work longer. But I just wanted to -- since this is here, Michael, you have -- you might think about it. MS. FOREMAN: It represents the hard negotiation best thinking and agreement of an odd group of bedfellows -- Ron and -- and me and Dick. UNIDENTIFIED SPEAKER: Also ran down batteries too. MS. FOREMAN: Yeah, not to mention -- (Simultaneous comments.) MR. GIROUX: So it's just the group that worked on this that had consensus on the wording of this document? MR. OLSON: Yes. MS. LAYTON: Yes. Leon. MR. CORZINE: Suits me. UNIDENTIFIED SPEAKER: Yes. MS. FOREMAN: -- with sweat. MR. GRANT: That consensus, that doesn't mean we're necessarily -- MS. FOREMAN: -- we do not love every word of it. MR. GRANT: -- the equivalent of what would go in the implications. MS. FOREMAN: No. MR. GRANT: Language -- MS. FOREMAN: No. (Simultaneous comments.) MS. MELLON: My question is why in the last paragraph the -- in the sentence beginning in the U.S. where there is no mandatory processed-based food labeling most grain-based foods. I mean I think they write -- MS. LAYTON: That's not the last paragraph though. There's a paragraph -- MS. FOREMAN: -- another paragraph. MS. MELLON: Oh, there is. MS. FOREMAN: But that's not relevant. MS. MELLON: Oh, because I think it's most processed foods contain low levels of genetically-engineered corn or soybeans and no health or safety issues have arisen. I don't think -- UNIDENTIFIED SPEAKER: What's a grain-based food. MS. MELLON: -- multi-processed foods as grain- based foods. UNIDENTIFIED SPEAKER: Do Mylo (ph.) -- peas contain it? MS. MELLON: Well, I'm saying they might, but I mean processed foods that contain low levels of corn and soybeans. That's what we're talking about. MR. JAFFE: But that's not what -- this says process-based food labeling. That you don't label according to the process. MS. MELLON: No, processed foods, for the foods in the, in the grocery store that are processed foods rather than, than in the produce department. If you go into the produce department, there's nothing that's genetically- engineered. UNIDENTIFIED SPEAKER: That's not true. MS. FOREMAN: The scope of the -- (Simultaneous comments.) MR. SLOCUM: Her question is grain-based foods. UNIDENTIFIED SPEAKER: What's a grain-based food? UNIDENTIFIED SPEAKER: Cereals, breads, pasta. MR. JAFFE: So corn in a can, sweet corn in a can. MS. LAYTON: Is a grain-based food. UNIDENTIFIED SPEAKER: Grain-based food. MR. JAFFE: I think what Margaret is saying is that usually when people talk about it, they talk about the fact that things have soybean oil and corn oil or corn syrup in them. So Coca-Cola is not a -- nobody would think of Coca-Cola as a grain-based food. It has an ingredient that people think has been genetically-engineered, derived. So I think that's the distinction she's saying. If you want to say here that it's corn flakes contains genetically- engineered ingredients or do we want to say that everything that has corn oil or corn syrup have it, and those are not grain-based foods, those are just processed foods. I think that's what Mardi is trying to distinguish between and what do we want to be saying. Because the grain-based food would be corn starch, corn flakes, corn meal, sweet corn in a can. MS. FOREMAN: So it's a question of fact. MS. LAYTON: It's a question of -- MR. CROWDER: What is Coca-Cola? MS. LAYTON: It's a processed grain. MR. JAFFE: It's not a grain-based food. (Simultaneous comments.) MR. SCHECHTMAN: May I interrupt for just one second. MR. JAFFE: Thinking more like Healthy Choice Salisbury steak dinner, which has -- MR. SCHECHTMAN: Just one process question for our afternoon. How late are we planning to stay? UNIDENTIFIED SPEAKER: Now? MR. SCHECHTMAN: Yeah. What are people comfortable with right now for continuing. UNIDENTIFIED SPEAKER: I want to be in bed by 10:30. MR. DYKES: I need to leave in a few minutes. MS. FOREMAN: Does anybody have a problem with saying most processed foods have at least small amounts? MS. MELLON: I would say most processed foods contain low levels of genetically-engineered corn or soybeans. UNIDENTIFIED SPEAKER: Not processed foods. MS. FOREMAN: It's not process-based. It's processed foods instead of grain-based foods. MR. CROWDER: I thought we did talk about that. MR. GRANT: I don't think so, Dick. No we -- UNIDENTIFIED SPEAKER: I think it was. MS. LAYTON: What? UNIDENTIFIED SPEAKER: The grain-based foods. UNIDENTIFIED SPEAKER: Yeah, but it's really -- UNIDENTIFIED SPEAKER: I donÕt know. I don't know. I don't think we know enough to say that most processed foods are --Your Honor MR. SCHECHTMAN: How about most processed -- most grain-based foods and many processed foods? Does that -- MS. LAYTON: So most foods contain genetically engineered ingredients? UNIDENTIFIED SPEAKER: No, because you want to say processed, don't you? You don't want to say most foods. UNIDENTIFIED SPEAKER: May we suggest this. Most grain-based foods and many containing plant oils. UNIDENTIFIED SPEAKER: No. UNIDENTIFIED SPEAKER: No. UNIDENTIFIED SPEAKER: No. (Simultaneous comments.) MR. JAFFE: -- wheat -- MS. MELLON: Sweet potatoes. Maybe it's -- MS. LAYTON: -- DNA in them at all. (Simultaneous comments.) MR. SCHECHTMAN: Can I just ask again the question of how late we're planning to stick around? UNIDENTIFIED SPEAKER: I'm going to be leaving pretty soon. MR. MARYANSKI: I have to leave within 30 minutes. MR. SCHECHTMAN: 5:30? UNIDENTIFIED SPEAKER: 5:30. UNIDENTIFIED SPEAKER: No, I have to go. MR. SCHECHTMAN: 5:15 or -- or do we -- 5:15. Okay. UNIDENTIFIED SPEAKER: I am really getting upset. MS. SULTON: So how are we going to fix this? MR. CORZINE: Does many foods do it? Forget -- take out processed, forget most, forget -- many foods. MS. MELLON: Yes. Many foods I would say contain low levels of genetically engineered corn or soybeans. Most foods do not contain any -- those are the only two things that are out there in the food system in any, in any amounts. MS. LAYTON: Okay. So what she has proposed is in the U.S. where there is no mandatory processed-based food labeling, comma, many foods contain low levels of genetically-engineered ingredients, and no health or safety issues have arisen. MS. FOREMAN: She said -- I wouldn't -- UNIDENTIFIED SPEAKER: -- soybean and -- MS. FOREMAN: -- or soybeans -- UNIDENTIFIED SPEAKER: -- instead of ingredients. MR. CORZINE: Well, I donÕt know that you want to mark soybeans out. Just say many of those foods, because you've got -- what are you going to do with papaya? UNIDENTIFIED SPEAKER: Yeah. (Simultaneous comments.) MR. GRANT: There's cottonseed oil, there's cotton -- UNIDENTIFIED SPEAKER: Absolutely. MR. GRANT: It's ubiquitous clear through the system. UNIDENTIFIED SPEAKER: Corn flour. UNIDENTIFIED SPEAKER: Okay. Are we -- UNIDENTIFIED SPEAKER: -- say corn flour. UNIDENTIFIED SPEAKER: This is not important. MS. LAYTON: Many foods contain low levels of genetically-engineered ingredients and no health or safety issues have arisen, okay. MR. OLSON: What's the low level? (Simultaneous comments.) MS. LAYTON: Okay, many foods contain genetically-engineered ingredients and no health or safety issues have arisen. MS. FOREMAN: I buy that. UNIDENTIFIED SPEAKER: Yes. MS. LAYTON: Okay. Going once, twice. The Committee and everyone agreed to take -- dropping most grain-based and putting the words many in. UNIDENTIFIED SPEAKER: Right. MS. LAYTON: Okay. Any other changes? I haven't read the back. MS. DILLEY: If not, then do you want to highlight, Dick, your -- the particular comments you have on other portions of the document so that we have those for further discussion tomorrow? MR. CROWDER: I -- UNIDENTIFIED SPEAKER: We're signed off on this. MS. DILLEY: Thank you very much for your hard, hard work. UNIDENTIFIED SPEAKER: Thank you. MS. LAYTON: Absolutely, tremendous work. Thank you. UNIDENTIFIED SPEAKER: This is wonderful. MS. MELLON: Very nice. (Simultaneous comments.) MS. DILLEY: Dick is looking for his comments for those of you who can stay, it's -- it would be good to give Dick some amount of time to put his comments forward because he's not going to be here tomorrow. So -- UNIDENTIFIED SPEAKER: That would be good. MS. DILLEY: -- if you can find them and at least put them on the table, and we can pick them up tomorrow, that would be helpful. UNIDENTIFIED SPEAKER: Dick, she has your comments. (Simultaneous comments.) MS. DILLEY: This is on labeling and traceability. MS. LAYTON: And I'm going to have to change that to say labeling and traceability, because obviously I can't say tracing and label -- UNIDENTIFIED SPEAKER: That's exactly the -- MS. LAYTON: So if you all could make that alphabetical in the title, I'd be happy. Absolutely. MR. CROWDER: Are mine the ones in the green? UNIDENTIFIED SPEAKER: Cindy? MS. SULTON: Are you green or are you red? I donÕt -- MR. CROWDER: I think I'm -- this one, yeah. MS. SULTON: Yes? Can you tell? MR. CROWDER: Yeah. MS. SULTON: Okay. UNIDENTIFIED SPEAKER: This is yours? MR. CROWDER: Yeah. I had a couple others too. Okay. Although the pages may be a little -- MS. LAYTON: So try to give us the section number so we can find -- UNIDENTIFIED SPEAKER: This is mine. MS. LAYTON: Are you in the executive summary now? MR. CROWDER: Yeah. Let's go to the executive summary. MS. LAYTON: Okay. MR. CROWDER: On the 1, 2, 3, 4th paragraph down. UNIDENTIFIED SPEAKER: First page? MR. CROWDER: First page. MS. LAYTON: Yeah. Starting additionally? MR. CROWDER: Yeah. The last sentence in that says, on the other hand the United States neither required - - or feed products derived from genetically-engineered organism indicate the method by which they were produced nor requires specific tracing of biotechnology products through the food chain. I've got -- it's a question I've got here. If a trait is novel or changes in composition does it not require labeling? MR. JAFFE: Not for the method by which the organism was produced. It will require according to the FDA guidance on FDA policy, they will require that the difference be labeled. So if it's high oleic soybean, they will require you to identify it as high oleic. They wonÕt require you to indicate the method by which it was produced, so they won't -- their policy doesn't require you to say it's -- UNIDENTIFIED SPEAKER: Genetically engineered. MR. JAFFE: -- genetically engineered high oleic soybeans. They'll just say you have to identify the difference, the novelty. You have to identify the trait, not how -- MS. LAYTON: Okay, so that's a back check -- MR. JAFFE: Result -- MS. LAYTON: Result. MR. CROWDER: Okay, I go from page 3 to -- I'm missing a page here. MR. SCHECHTMAN: Missing page 4? MR. CROWDER: I'm missing page 2. UNIDENTIFIED SPEAKER: Sorry about that. MR. SCHECHTMAN: Very well, there were no issues on -- I can, I can give you my page 2. Are you missing from your copy? UNIDENTIFIED SPEAKER: Yeah. Hold on. Hold on. MR. CROWDER: You didn't pick up my copy of this, did you? MR. OLSON: No. Check to make sure. MR. CROWDER: Oh, here it is, here it is. UNIDENTIFIED SPEAKER: Are we going through the -- MS. SULTON: No. Just -- (Simultaneous comments.) MS. SULTON: Okay. MR. CROWDER: Here it is. This is in the executive summary in the paragraph starting contracting requirements, the last sentence I would suggest changing to read: however, contract terms relative to liability transfer. MR. SCHECHTMAN: That's actually in -- we have contract terms relating to is what we have as a bracketed. We haven't gone over that yet, but that's actually included. All of your comments are included in sections that we haven't talked about yet. So there -- UNIDENTIFIED SPEAKER: So they're included in -- MR. CROWDER: All my comments? No. Some of them were not, I think. UNIDENTIFIED SPEAKER: Well, in the -- MR. SCHECHTMAN: Except that one. MR. CROWDER: It's in, it's in, okay, that's in, okay, that's fine. If it's there, okay. The one on the, on the charge was -- MS. LAYTON: We dealt with that this morning. MR. CROWDER: We dealt with that, we dealt with that one. MS. LAYTON: We dealt with all of the introduction. MR. CROWDER: And did we deal with -- what did we decide on commercial risk? UNIDENTIFIED SPEAKER: Where? Which one? MS. LAYTON: Commercial risk reads -- MS. SULTON: Refers to -- MS. LAYTON: -- refers to financial -- MS. SULTON: Financial exposure. MR. CROWDER: Okay, we did that one. Did that one. I -- I'm going to keep going. Page -- well, let's put it this way. On the exemptions for mandatory biotech specific labeling of -- I've got it on page 10. Then go to the next one, just above two, exemptions from requirements based on status of ingredients. UNIDENTIFIED SPEAKER: Yeah. UNIDENTIFIED SPEAKER: Yes. MR. CROWDER: Right above that, it says in addition, the potential for extension of liability related to either human, animal, plant, environment and social impact. What is a liability related to social impact, and how is social impact defined? MR. SLOCUM: It's not. Where are you, Dick? What page? MS. SULTON: It's page 11, line 20, 21, 20 or 21. MR. GIROUX: So I believe that may address some of the things that are being negotiated -- Biosafety Protocol. MR. CROWDER: Social impact? I don't recall that. UNIDENTIFIED SPEAKER: Doesn't fit. MR. CROWDER: I don't see how it fits either. MR. SCHECHTMAN: That's what the protocol -- I mean there are places, if I can clarify on this that there are places in the Protocol that enable countries to look at socioeconomic impacts. MS. LAYTON: Socioeconomic -- social -- MR. SCHECHTMAN: Social, socioeconomic. MS. LAYTON: But is social impact the right word? MS. ZANNONI: Or should it be socioeconomic impact? MR. SCHECHTMAN: Exactly -- the U.S. has a very clear view on what if anything should be done on liability. Liability is still being negotiated, and how the Parties, which we are not one, are going to resolve that. MR. SCHECHTMAN: I would just as soon to see that not in this report in terms of our own government position in terms of bargaining with that, see what I'm saying. It's in here and your own people recognize it. I just, I don't - - if somebody could pull it out and put it somewhere without a specific relation here to. I don't know why we should be creating that environment. MS. LAYTON: So strike and social -- so strike and social -- UNIDENTIFIED SPEAKER: And social. MS. LAYTON: -- so or environmental impact. Okay. Anybody have heartburn on striking and socio -- social? Keep going, Dick. MR. CROWDER: Okay, I'm going to go pretty fast now. UNIDENTIFIED SPEAKER: Love it. MR. CROWDER: Oh, page 18 or -- find out where it is -- reserve systems. MS. SULTON: That's page 21. MR. CROWDER: Okay, page 21 in the new one. Okay. It says that several, at least -- MS. LAYTON: And the paragraphs? How many? MR. CROWDER: Paragraph -- system 1, 2, 3, 4, 5, 6. MR. SCHECHTMAN: That starts several traditional agricultural organizations? MR. CROWDER: Several traditional organization. UNIDENTIFIED SPEAKER: Page 22, line 7. MR. CROWDER: Several additional -- have established producer certification systems. I don't know of any, and I'm -- it's a question. I don't know of any producer certification systems. MS. LAYTON: Leon, isn't that your section? UNIDENTIFIED SPEAKER: They are cited at the bottom of the page. UNIDENTIFIED SPEAKER: A footnote is for the -- UNIDENTIFIED SPEAKER: Okay. I was just trying to catch up -- MR. CROWDER: Right, but I don't know what they are, Leon. MR. CORZINE: I'm sorry. What, what part? MS. LAYTON: Page 22, line 7. MR. CORZINE: Okay. MS. LAYTON: The citation of footnote number four. MR. CORZINE: Have established producer certification systems. That's like -- producer certification systems like the ISO 9000 and those kind of -- they've got -- there are producer certification systems by - - Colorado corn growers have one, Illinois, Iowa corn growers have one. We had them listed before. UNIDENTIFIED SPEAKER: They're here. They're in the footnote. UNIDENTIFIED SPEAKER: They're in the foot, except there needs to be -- MR. CORZINE: But not there that you want the name or -- MR. CROWDER: No, no. I'm just trying to figure out what they are certifying. MR. CORZINE: They're certifying producers. MR. CROWDER: To -- MS. LAYTON: That have a higher level of education and are equipped to operate under various -- (Simultaneous comments.) MR. CROWDER: Okay, that's fine. MR. CORZINE: They're equipped to operate under various SOP -- MR. CROWDER: Okay. Okay, that's fine. That was -- okay, perfect. Because -- UNIDENTIFIED SPEAKER: Cancel that one. MR. CROWDER: -- we're going to need more -- just on the, the one offered by -- the footnote six offered by the American Seed Trade Association, I would prefer we put owned and offered because it is a owned -- MS. LAYTON: Okay, so the footnote should say owned and offered. MR. CROWDER: Yeah. MS. LAYTON: Okay. Footnote six on page 23 should say owned and offered by the American Seed Trade Association. MR. CORZINE: What's the line of boxes? UNIDENTIFIED SPEAKER: Pardon me? MR. CORZINE: The boxes. MR. GIROUX: Paragraph starts with National Corn Growers -- MS. SULTON: Page 23, footnote number six at the bottom of the page. MR. CORZINE: -- up on the -- MS. SULTON: Now reads owned and offered. MS. LAYTON: What's Randy asking about? MS. DILLEY: He's saying developed by the National Corn Growers Association, and that's that footnote. MR. CORZINE: The next paragraph down, maybe it's just in mine, I've got a line of boxes underlined. MS. LAYTON: Oh, we don't -- know before you go and know where to go programs have been developed, footnote seven, to better inform producers before they bother seeding, before harvest, as to who is willing to accept and channel specific transgenic -- in specific regions of the U.S. And that footnote is by the National Corn Growers Association. MS. DILLEY: You have a row of boxes, but nobody else has them. UNIDENTIFIED SPEAKER: No one has them. MS. LAYTON: No one else has them. UNIDENTIFIED SPEAKER: It's a bonus. MS. DILLEY: You're just lucky. (Simultaneous comments.) MR. CROWDER: Traceability -- you've got the changes under the seed industry operates today -- federal and state seed laws -- then in testing associated issues. MS. LAYTON: Okay, page 27. MR. CROWDER: -- to the paragraph that begins in the absence of international standards. MS. LAYTON: Okay, that is in -- MR. SCHECHTMAN: To of page 29. MS. LAYTON: 29. MR. CROWDER: The last sentence, I'll read the whole thing, but-- as such there are commercial risks associated with applying transgenic or non-transgenic ingredients. And I think the phrase on the end of that should be based upon testing results. Because all of that above there talks above the variability in testing outcome. So if you, if you sign a contract or one testing system and you send it to the market and test another, use another testing system, that's where the risk comes in. MR. OLSON: And we deleted testing where it shows here. Testing was deleted. It was in there between the word commercial and risk -- there was test -- the word testing was in there before. UNIDENTIFIED SPEAKER: But the words -- MR. CROWDER: Is commercial risk based upon testing results? MR. GRANT: I like that, Dick. I think that helps to clarify it. MS. LAYTON: Okay. So you're adding at the end of this sentence after the word ingredients based upon testing results. MR. CROWDER: Yes. In fact one of the things that we encourage growers to do is to make sure they know when they sign IdP contracts they know exactly what testing system is going to be used, what lab is going to do it and everything else. MS. LAYTON: Any other heartbeats on that one? Okay. MR. CORZINE: Testing results. MS. LAYTON: Based upon testing results, at the end of the sentence. MR. GRANT: Not methods. MR. CROWDER: No, just -- yeah. Okay, that's it. Thank you for your patience. UNIDENTIFIED SPEAKER: Dick, thank you. MR. GRANT: You did good. I think that's the model we should use from now on. MR. SCHECHTMAN: Can I ask you -- you didn't want to say anything about the issues, the policy concerns and issues? MS. LAYTON: The last section. MR. CROWDER: Yeah, I wanted to, but I was going to do that as I read them during the day and I just, I didn't get to it. MR. SCHECHTMAN: Okay. MR. CROWDER: I intended to cheat a little bit here today and do this. MS. LAYTON: Can I just ask you one question? MR. CROWDER: Okay. MR. SCHECHTMAN: There was a good deal of discussion at the meeting that you were not at last time about including this issue that we know was yours about the role of international organizations. There was -- I think you were -- there were a number of people who didn't think that it belonged as an issue. I want to just take your temperature -- MS. LAYTON: Because we're deleting. MR. SCHECHTMAN: -- on it since you're, since you're departing. MR. CROWDER: Which issue are we talking about? UNIDENTIFIED SPEAKER: Yes. UNIDENTIFIED SPEAKER: Yes. MR. CROWDER: In mine. MR. SCHECHTMAN: Number nine. MS. LAYTON: Number nine. It's in this, in the document that was on the back table, it's number nine, line 15. UNIDENTIFIED SPEAKER: It's not going to be on that one, Dick. MR. CROWDER: No, I've got it, I've got it. Delete question. I find that -- well, I guess what I'd like to hear is the other side of the coin as to why it should not be there. I mean what's the argument that says it ought not to be there? MS. LAYTON: I don't actually remember personally that it -- the reason why it came up as a delete, and it's just -- I donÕt personally remember that. MR. CROWDER: And we've gone through all these items in the adventitious presence and everything else today, and we've -- about the issues again and I just -- MS. LAYTON: Is that one that got combined? UNIDENTIFIED SPEAKER: No. MR. CROWDER: I'd like to leave it in unless there's a strong argument -- MR. JAFFE: I guess I'm comfortable with it if you delete the second sentence. MS. DILLEY: Some issues? MR. JAFFE: Because that -- I mean if you're talking about if it's a -- if it's a thing on international organizations, that's fine, there's a role, there's a potential role for -- the impact. It's unclear which organization. The U.S. Government should continue to -- explore different venues and approaches. Then to me that just means different international organizations, different venues and approaches. I think that bilaterally and multilaterally is not related to this, and so -- MR. CROWDER: Maybe it ought to be a separate issue then. MR. JAFFE: -- and I would -- I don't -- I'm not comfortable with us -- I mean there's already references to a Mexico thing that I think we're not necessarily properly factually describing, but I'm willing to, to not get into that and leave it the way it is. I've never seen that. It's not an official document. I'm not going to endorse it, and to me that second sentence indirectly endorses that, which I don't think there's a -- it's not even a policy of the U.S. Government. So I'm comfortable with I guess my reason for doing that was the second sentence. I'm comfortable with the first and third sentence saying then international organizations may have a role in addressing some of these things. I agree with that. UNIDENTIFIED SPEAKER: But I -- MS. MELLON: I just -- I mean my only concern about that, that one is that it has a recommendation that's not, you know, it's not an issue or a concern, it actually is phrased as a recommendation. The U.S. Government should continue to creatively explore -- MR. CROWDER: Okay, I thought that's, I thought that's what Greg was -- but I, Greg, I would suggest that we consider in that second sentence to put alternatives on issues, maybe -- MR. JAFFE: If we take out the references to the Mexico agreement in the report, then I'm more comfortable with it, but I'm not comfortable with both of those in the report because it is an indirect endorsement of the Mexico agreement, and I'm not comfortable with that -- bilateral that we discussed -- UNIDENTIFIED SPEAKER: Trilateral. UNIDENTIFIED SPEAKER: Trilateral. MR. SLOCUM: BSP -- MR. JAFFE: I think we're not describing that correctly. It's not a government -- MR. CROWDER: Well, let's describe it correctly and do it, but I mean I don't see why this group would have an issue given the importance of international trade agriculture to endorse one channel of approaching these issues at the exclusion of another channel. And I just -- I think that's not very kind to the wheat growers and soy bean growers, the corn growers, the pickle growers and everything else who are looking to see something, and if, if Argentina is a big market for U.S. alfalfa or Japan is a big market for U.S. alfalfa, I don't know why we shouldn't approach that bilaterally. MR. GRANT: We should leave all the options. I guess my question is, can we find the section on Mexico and look at that and see if -- MS. LAYTON: I have it. It's page 14, line 29. MR. GRANT: Greg, maybe you can describe how it's characterized incorrectly, because I don't see how it's described as government -- MS. LAYTON: Page 14, line 29, is where it begins. To that end. MR. JAFFE: It is not -- I don't know if it's a trilateral agreement. It's not between the governments. It's not a government document. It does not have any official status of the U.S. Government. It is a document that talks about if a private party sends grain to Mexico what the Mexican government will consider sufficient for purposes of the Biosafety Protocol. That's my understanding. It's not published in the Federal Register. It's not a guidance. It's not a policy of the U.S. Government. The U.S. Government hasn't signed it. So it's not between parties and non-parties because it's not -- MR. CROWDER: It was negotiated as I recall directly by the State Department. MR. JAFFE: On behalf of private parties. It's not -- I mean that's the problem. It is very unclear. But I went to, and I can't remember where was the presentation where somebody finally described it to me. There was finally a government person I felt described it accurately. MS. LAYTON: Someone is waiving their hand. MR. JAFFE: That's right, the person described it at the -- maybe we can get the transcript or something. But this doesn't describe it. I'm willing to leave this in, but I'm not willing to then link them. MS. LAYTON: Bernice is the expert. MS. SLUTSKY: I'm not the expert, but Greg is right. It's not a formal government-to-government agreement. It's -- we refer to it as a trilateral agreement, and so -- MR. OLSON: Why don't we just say that. Negotiated a trilateral arrangement. MR. CROWDER: Call it what it is, and then -- I donÕt have a problem with that. MS. LAYTON: So it's really not a bilateral agreement, government agreement. (Simultaneous comments.) MR. JAFFE: It doesn't say that. It doesn't belong here then. It -- MR. GRANT: I think it, I think it belongs because it facilitated trade, but footnote it at the bottom explain this is not a treaty. It's not between the governments. This is an arrangement, and explain what it is, if that's what we need to. But obviously it facilitated trade and continues to this day, so it met the purpose. MS. SLUTSKY: I think it's reasonable to say the government helped facilitate the -- MR. JAFFE: The beginning of the paragraph says the Protocol allows the Parties or non-Parties to enter in bilateral, multilateral agreements. I have no problem with that. This is not a -- described that's not what this is. MR. CROWDER: Then let's get it correct, and let's take out to that end, and start another paragraph and decide what this one is. MR. JAFFE: Well, I don't think it belongs here then. This is the discussion of what the Protocol does. It's not a discussion of how people implemented the Protocol. This is purely factual. I've always had a problem with this section here, but I've been comfortable with it. The whole point of the Codex and the Biosafety Protocol sections here was to talk about what other labeling and traceability requirements are out there, not how they're being implemented. We're not here to write a treatise on the different implementation -- MR. CROWDER: No. We're talking -- let me just, let me ask -- let's talk about the business and trade side of it and not the legal side. You say it's not associated with the Protocol. The Biosafety Protocol that never came into -- look, if the Biosafety Protocol had never came into existence, would this agreement have taken place? MR. JAFFE: I'm not saying it's not associated with the -- MR. CROWDER: Well, no, you did. MR. JAFFE: No, I'm saying if not -- it is not -- this section here -- for this section to describe what does the Protocol require, what is in the Protocol, not to discuss implications or how different countries are implementing it, which is this -- different thing. That's not part of our group charge. I've never seen the document. I'm not comfortable with -- MR. CROWDER: I've seen the document. I'll tell you what, others can say what they want, but if I had to take out one thing, and I don't think we ought to take out either, I would take out this because it's known in fact exists and leave the policy -- MS. LAYTON: So take out -- MR. CROWDER: No, I'm not -- I'm not saying -- if I've got to make a choice, I'm saying that the trade -- we've got to do everything we can to facilitate trade, period. And if we just leave it with this one document and don't suggest a broader approach later, we have not done justice to -- but I donÕt really -- I'll let you reflect on -- MS. FOREMAN: I, I -- we should do everything within reason to facilitate trade. We -- I can't buy the unalloyed endorsement of all trade, so -- MR. CROWDER: Well, I'm kind of against -- the legal approaches to it too. MS. FOREMAN: I'm -- there are a lot of trade things that we don't support, even though we're the most pro-trade of all the consumer groups, there's a lot of things we're not for. MS. SULTON: Jerry. MR. SLOCUM: It seems to me that you know Greg's issue is not with bilateral or multilateral negotiations. His issue is with the tacit endorsement it gives of this trilateral arrangement. MR. JAFFE: That's right. MR. SLOCUM: That's right? So what we really need to do then is clean up this paragraph on page 14 that you take exception to. MR. JAFFE: I'd love to eliminate that. MR. SLOCUM: That's what we need to fix. MR. JAFFE: And then you could rewrite the recommendations saying, you know, I mean you could write the issues saying, you know, there's a role for adjusting the impact internationally be it through -- organizations, through bilateral agreement, through multilateral agreement. MS. LAYTON: Or through arrangements. MR. JAFFE: The government should -- I'm not going to go into arrangements. MS. SULTON: Okay, okay. MR. JAFFE: Because then we're discussing -- UNIDENTIFIED SPEAKER: Right. MR. JAFFE: -- this other thing, which I donÕt think has a lot of legal validity. MR. GRANT: Greg, can you answer one question for me? Does the arrangement allow trade to continue between the participants to the arrangement and meet the requirements of the Protocol? MR. JAFFE: I don't know. MS. LAYTON: Could it be in footnote? MR. JAFFE It says what the Mexicans are going to -- my understanding is it says what the Mexicans will be comfortable with in terms of labeling for commodity shipments that are going into Mexico. I don't think we could -- if we -- if the trade was going the other way that it would be binding at all on our government in terms of saying that if somebody else was shipping something with -- adventitious presence, something that wasn't approved there, that we'd be particularly comfortable with the labeling of it -- approval of it. (Simultaneous comments.) MS. LAYTON: Mardi and then Leon. MS. MELLON: I would be in favor of having it described, because I think it's -- it's important to me that this is what is happening in the real world in response to a lot of these issues. Now I'm like Greg. I don't, I don't - - I think I don't like it because I think it cuts consumers out of the process more than I would like, but I don't understand it well enough to be sure that that's the case. But I would -- so I would be searching for some description of the fact that there's an informal agreement among three countries that, you know, that appears for the moment to be facilitating trade and then some -- but what I, what I would like it -- I don't like the idea that we would be necessarily endorsing it without fully understanding it. But I would like it to be described, because I think it's an event in -- you know, that's going on out there. MS. LAYTON: Could it be described under the auspices of while not -- while the U.S. is not a Party to the BSP, arrangements have been made that respect ongoing negotiations in the BSP to facilitate trade? And I don't know the answer to that, so I'm just asking. MR. CORZINE: I think it kind of starts right off that paragraph saying that, sub-Parties and non-Parties, and I think it shows a good example of in the real world of what has been done to move forward, and how they can use the 95 percent how they can use -- it's just an example. I guess if you don't like what -- maybe you donÕt agree necessarily completely with that trilateral agreement, it is there. It is real world, and this is, this is what -- MS. LAYTON: And I would say this. I think what it is saying is, is that the word agreement implies it is a government-to-government and it is not a government-to- government agreement. It is a business agreement arranged by the government. MR. JAFFE: It is not allowed for under the Protocol. It's not an agreement that -- there's a section of the Protocol that says specifically you can have arrangements between Parties and non-Parties. The U.S. Government has specifically said this isn't something that qualifies under that article. So it doesn't fit here. MS. LAYTON: Well that's why I'm saying is it could be described here and that it respects what's going on in the BSP, but it is a business arrangement that did include some help from the government in negotiating. I'm just trying to find a way around -- I understand why it's here with the BSP because it respects what's in the BSP, but it is truly not a formal-to-formal government agreement, and the word agreement I think does have implication of being a formal State-to-State agreement. So I think there's some need -- if we could work on some language, fine. MR. CROWDER: So all you need to do is change the word agreed to terms. UNIDENTIFIED SPEAKER: No. MS. LAYTON: I think it needs a statement ahead of that. UNIDENTIFIED SPEAKER: It's following a sentence that this is authorized by the Protocol and it isn't. MS. SULTON: Ron and then -- MR. OLSON: I think it needs to be in there, but it needs to come out of this paragraph. UNIDENTIFIED SPEAKER: I agree. MR. OLSON: I think it can be a stand-alone paragraph when you could just start at the beginning, alternatively, you know, a business arrangement or describe what it really is, but take it out of that sentence -- MS. LAYTON: Absolutely. MR. SCHECHTMAN: I think the language can be fixed. MS. LAYTON: Absolutely. (Pause.) UNIDENTIFIED SPEAKER: Are you comfortable with that, Greg? MR. JAFFE: I'll have to -- UNIDENTIFIED SPEAKER: I'll work on something myself. I'll get Ron to help me. MS. SULTON: Daryl and -- UNIDENTIFIED SPEAKER: Mardi, I'm okay with that. MS. SULTON: Okay, Daryl -- UNIDENTIFIED SPEAKER: That's not, that's not an issue. MR. BUSS: Okay, to avoid confusion with the Cartagena Protocol, why wouldn't we simply just insert between line 26, 27, a number three and head it as Informal Business Agreements or whatever you like outside -- MR. SCHECHTMAN: Because it's really, it really is related to -- (Simultaneous comments.) UNIDENTIFIED SPEAKER: Yeah. We wouldn't have done it without -- MR. SCHECHTMAN: I think itÕs a matter of how it's characterized. UNIDENTIFIED SPEAKER: Yeah. UNIDENTIFIED SPEAKER: I think it can be fixed fairly easily. MR. JAFFE: I'll have to see it. MS. LAYTON: Please let us work on it. Okay. Tomorrow. MR. JAFFE: I'm not committing one way or the other, but -- MS. LAYTON: Okay, tomorrow. MR. CROWDER: You might have to -- MR. JAFFE: What? MR. CROWDER: You might have to write up a report on that one. MS. LAYTON: He's kidding. (Laughter.) MS. LAYTON: He's kidding. But -- UNIDENTIFIED SPEAKER: Juan. MR. ENRIQUEZ: I think this discussion actually brings up an important issue here, which is when you talk about global traceability and labeling, there are going to be strict government-to-government agreements. There's going to be another level. There's going to be another level, and I think there should be a paragraph in here that says, if an organization -- if you don't want to call it Wal-Mart, like a mega-retailer on a global level sets its own traceability requirements, that could be just as important and have as much of an impact as a government agreement. Because I think your point is a very important point, which is there are going to be different things driving this, and it ain't just going to be government-to- government, and it ain't just going to be formal treaties. I think we should acknowledge that in this report. UNIDENTIFIED SPEAKER: That's in there. UNIDENTIFIED SPEAKER: That's in the section on government -- UNIDENTIFIED SPEAKER: In the section, just -- (Simultaneous comments.) MS. LAYTON: Okay, we'll work on that. All right, so -- MR. SCHECHTMAN: I think, I think we need to -- UNIDENTIFIED SPEAKER: adjourn? MR. SCHECHTMAN: -- to adjourn for the day. MS. LAYTON: Okay, now what we didn't -- before I got, before we leave, did we solve whether we were going to delete nine or not? UNIDENTIFIED SPEAKER: Keep nine. UNIDENTIFIED SPEAKER: -- we would keep nine. UNIDENTIFIED SPEAKER: What time are we starting tomorrow? UNIDENTIFIED SPEAKER: 8 o'clock. UNIDENTIFIED SPEAKER: 8 o'clock. MR. SCHECHTMAN: If -- will you be okay with leaving that sentence in, in that other policy concern if we can fix this, this part to your satisfaction? MR. JAFFE: Depends how it's written. I think if it's written as -- UNIDENTIFIED SPEAKER: Statement of facts. MR. JAFFE: -- statement or -- MS. ZANNONI: That is not in agreement. MR. JAFFE: I don't want it -- no, it can't be linked to -- MR. SCHECHTMAN: Yeah. MR. JAFFE: -- thing. If it's written as this report raises lots of issues that should be, should be addressed internationally via organizations multilaterally or trilaterally, I'm comfortable with it. If it has a specific sentence that sort of says the U.S. Government should go for multilateral or trilateral agreements, I'm still concerned about the linkage. MR. SCHECHTMAN: Okay. MR. JAFFE: So if it's -- laundry list of -- UNIDENTIFIED SPEAKER: Of alternatives. MR. JAFFE: -- of alternatives and we say the U.S. Government should pursue all of these, then I'm comfortable with it. MS. LAYTON: Okay. So we can work on number nine and have it back in. MR. JAFFE: All right, I've got to go. MR. SCHECHTMAN: Okay. MS. LAYTON: Okay, bye. We'll work on number nine and have it back in. UNIDENTIFIED SPEAKER: Why did I just agree to do that? UNIDENTIFIED SPEAKER: I donÕt know. UNIDENTIFIED SPEAKER: You okay with that? UNIDENTIFIED SPEAKER: Number nine. MS. LAYTON: Okay, all right. (Simultaneous comments.) MR. SCHECHTMAN: Thank you all for your appearance. MS. FOREMAN: Can we get excused for tomorrow now? MS. LAYTON: We'll adjourn until 8 o'clock. No. I'm sorry. Lisa (whereupon, at 5:30 p.m., the meeting in the above-entitled matter was adjourned, to resume at 8:00 a.m., on February 8, 2005.) CERTIFICATE OF REPORTER I, Dan Hawkins, do hereby certify that the foregoing transcription was Electronically recorded on audiotape by me and reduced to typewriting under my direction; that I am neither counsel for, related to, nor employed by any of the parties to the action in which these proceedings were transcribed; that I am not a relative or employee of any attorney or counsel employed by the parties hereto, nor financially or otherwise interested in the outcome of the action. ___________________________________ DAN HAWKINS, REPORTER FREE STATE REPORTING, INC. 2 44 FREE STATE REPORTING, INC. 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