UNITED STATES DEPARTMENT OF AGRICULTURE WASHINGTON, D.C. - - - - - - - - - - - - - - - - - -X : : USDA ADVISORY BOARD MEETING : : : - - - - - - - - - - - - - - - - - -X The USDA Advisory Board Meeting was held on Thursday, December 9, 2004, commencing at 9:10 a.m. at the Economic Research Service, Waugh Auditorium, 1800 M Street, N.W., Washington, D.C. APPEARANCES Ronald Olson Carol Tucker Foreman Duane R. Grant Randal W. Giroux Vincent Vilker Elizabeth Milewski Daryl D. Buss Michael D. Dykes Gregory A. Jaffe Terry L. Medley Bernice Slutsky Cindy Sulton Patricia A. Layton Michael Schechtman Abby Dilley Angela Agosto Margaret Mellon Keith T. Triebwasser David A. Hoisington Leon C. Corzine Lisa W. Zannoni Carole L. Cramer Jerome B. Slocum Juan Enriquez-Cabot James Maryanski P R O C E E D I N G S MR. SCHECHTMAN: Good morning. This is the seventh meeting of the U.S Department of Agriculture's Advisory Committee on Biotechnology in 21st Century Agriculture or AC21. My name is Michael Schechtman and I'm the Executive Secretary and designated federal official for the AC 21. I would also like to welcome our committee members. I believe we have about 13 of our members here at this point. I know at least one more will be here a little bit later. Two more should be here a little bit later during the day today. To my left is the AC 21's Chairman, Dr. Patricia Layton from Clemson University. I'd also like to welcome our ex-officio members. I think we have two of them here thus far, and since I can't see them all particularly well, there could be others sitting there hidden from me by this post. To my right are our facilitators, Ms. Abby Dilley and Ms. Angela Agosto from the organization Resolve, and to my left, two seats over, is Ms. Cindy Sulton from the organization HW&W, who are partners in helping us make this committee process work. Also here today is USDA Special Assistant to the Secretary for Biotechnology, Bernie Slutsky, who is the Secretary's point on biotech and she's located at this corner to my left, and she'll help guide us to about around 9:30 we'll have the USDA Chief of Staff, Dale Moore, come in to offer a couple of words. This is our last minute addition to our agenda, so that's why it's not there. We're going to have a very full agenda, so we ask that when the meeting is in session, conversations need to be limited to those between members. The public will be invited to provide comments and participate in that way to the committee and USDA this afternoon between 3:30 at 5:00. We will be preparing minutes of this meeting and a computer transcript of the meeting will also be available within a few weeks. We hope to get all the minutes and all the meeting announcements up on the web. The website address for the committee is www.usda.gov/agencies/biotech/ac21.html. For any members of the press, you're welcome to speak to whomever you wish during the 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. Dr. 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. For your information, bathrooms are located down the hall and just out the door in that direction. In the opposite end of the room there are two tables with meeting documents and background documents. Please take only one copy. For the information of the members of the public, let me indicate that the AC21 is charged by the Secretary of Agriculture with preparing two reports. The first is a report examining the likely impacts of biotechnology on agriculture and on the work of USDA over the course of the next five to 10 years. And second, a separate report on the impact of the proliferation of traceability in labeling regimes in other country and how industry is addressing those requirements. Let me emphasize that these are two separate reports. Work groups have been set up to move these processes along between meetings, and they've made much progress through lots of hard work. We'll say a good deal more about the work groups and their work as we go along. Let me mention briefly the official meeting documents and backgrounds to this meeting. First the background documents. They are (1) the official AC21 Charter, (2) the AC21 Bylaws and Operating Procedures, (3) a package of biographical sketches of all of the AC21 members, and (4) the draft meeting summary prepared from the sixth AC21 meeting held on September 13 and 14th of this year. Specific for this meeting we have the following official documents: first, a provisional agenda for this meeting, second, a package of draft summaries from the work group sessions from each of five work groups since the last plenary. For the first report there were four work groups that meet. One on the issues to consider chapter, another on a chapter on preparing for the future via examination of the force and shaping the future plus development of some educational scenarios, three, a work group upon definitions, key definitions for the report, four, a new group on the reports introduction. Finally, there was a fifth group that worked on preparing a draft of the second separate report on traceability and labeling impacts. With all these work groups there are a lot of documents. The work groups have met differing numbers of times since the last plenary. Some once, some twice, one, three times. Some you'll need to look carefully at the package of summaries which is combined in that one stapled thing on the official document table to see who did what. We had lots of work groups meetings and preparation for this last week, and for this meeting, and we have summaries for all of those except for the last two, which were on Thursday and Friday of last week. Their work product, however, are all captured in the official documents. So some of those are the next documents. The third official document is the most current draft version of the issues to consider chapter. The fourth is a document addressing the two introductory chapters for this report. That document contains an outline for the first chapter and revised text for the second. Fifth, the latest draft of much 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 about outside of the box about what the future might look like. Sixth, there's a draft definitions list based on the work of the definitions group, and finally, a full draft of the second report the committee is charged with preparing which is entitled, Global Traceability and Labeling Requirements for Agricultural Biotechnology Derived Products: Impacts and Implications for the United States. This report has had extensive work from the work group and during the portion of the meeting devoted to discussing it, we'll talk about how close various parts of it are to completion. A key goal of this meeting is to see if the committee can identify what's needed to bring it to closure at this meeting or the next. 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 later, but please note that there are breaks scheduled in the morning and afternoon. For members of the public who wish coffee, coffee is available downstairs and across the street, there's a coffee shop. Also on the agenda, please note that we're planning for a period of one and a half hours for public comments from 3:30 to 5:00 p.m. today. We want to be responsive to the needs of the public and we'll see as the meeting progresses how we need to structure that time. Members of the public, please be sure if you wish to make a comment, please be sure that you have signed up at the door if you've not already done so, so that we can plan that window in the afternoon. Now from USDA's perspective, there are three main objectives for this meeting. They are for the committee to finalize for submission to the Secretary or identify the clear path for finalization, the draft report on other countries traceability and mandatory labeling requirements for biotechnology derived products, the implications of those regimes and how the US industry is addressing those requirements for products shipped to those countries. Second, to review and move closer towards finalization of the other draft report examining the impacts of agricultural biotechnology on American agriculture in USDA over the course of the next five to 10 years. And finally, determine processes for finalizing the committee reports. We'll have more to say about the status of each of the documents as we turn to them. Let me indicate though right now that I think the committee is in an important period of transition. This is not only because there will be a new Secretary of Agriculture, but also in a number of other ways. The Charter for this committee is in the renewal process. We've started the process for soliciting nominations for places on this committee and the terms of half of the members on the committee expire in February 2005. And finally, we're at a point where we really need to see what kind of progress you all have made on your two major reports. Let me make one general point. We've been working since late spring 2003 with the goal of producing one then two reports by the end of 2004. There's been a great deal of work, difficult work, by committee members in getting us to where we are now. We here have worked you all pretty hard and we're grateful for your willingness to let us do so. Obviously the initial aim of getting two reports finished by the end of 2004 is not going to be met. But the work is going to continue. Now in preparing the materials and focusing discussions of this meeting, in a couple of instances the work groups have opted in the documents you've received to err in the direction of less is more. The work groups in some instances are presenting only those pieces of work that have been gone over by them in a bit more detail and asking you to focus on those rather than carry over other pieces from earlier discussions and maybe lose a bit of focus. That's not true in all the documents, but in several of them it is. Now let me turn the microphone over to our Chairman, Pat Layton, for your words of welcome and thoughts for the committee. Pat. MS. LAYTON: Good morning, everyone, and happy holiday to you all too. It's hard to believe that it's almost December 25th. But it's here we are in the middle of December. I want to reiterate what Michael has said. This is a major meeting for us because of the fact that we are nearing completing of one report and working very hard on the other report. I've listened in on some of the committee meetings, although I've not participated in all of them. And I know there's been a tremendous amount of work done. I also know who the half of the committee is that are about to either be renominated or who may be leaving, and some of you I know I've spoken to, so most, at least a couple of the members may not be back with us at our next meeting. So I think it's very important, because we are a group that have worked very hard on these reports, to get as much done so that the folks who are not going to be with us can feel that their participation has been valuable and feel completed. I know that's always important when you've worked very hard to feel a sense of completion and a sense of accomplishment, and I want to thank those people now for their service and to pledge my support in helping to move us along as quickly as we can, but as thoroughly and as thoughtfully as we can during our two-day session. I encourage all of us to be very constructive as we move through the next two days and to work very hard to have a very constructive process for dealing with issues and accomplishing our goals. I know that we have a hard two days and that we can work very hard during the next two days to get those things accomplished, and I encourage all of you to please, you know, speak with me offline if there are things that I can do to help move this along in a more efficient and effective manner. I think it's important to get everyone's issues on the table at this point in time and to understand why they are issues and to understand what solutions might be available to those issues. So encourage you when you bring an issue up, that you talk about the why and the how. So with that in mind, I welcome you all here today, both our public, our ex-officio members and the members of our committee, and I hope that we have a very, very productive meeting so that we can all finish the year of 2004 feeling we've done our best to accomplish as much as we can in this year. Thank you. MR. SCHECHTMAN: Thank you, Pat. Now perhaps I'd like to turn over to Bernice Slutsky, the Secretary Special Assistant for Biotech, who will offer a couple of thoughts as well, as we get started. MS. SLUTSKY: Thanks, Michael. And again, I'd like to welcome everyone here. You'll be hearing more from Dale Moore in just a few minutes, but this is going to sound like a broken record, but I too have tried to at least listen in and participate on as many of the working groups as I've been able to and I can't tell you how impressed and appreciative we are of really all of the hard work and creative work that's going into these documents, and I've been involved in many advisory committees before and I've really never seen a group, you know, try to be as constructive and produce reports that are clearly going to be very valuable to the department. As I said before, the issues that are addressed in these documents are ones that will continue to have an impact across the department. And beyond the importance and usefulness of these reports, we will also be discussing future areas of work for the committee. I think as you know, biotechnology is of interest to virtually every agency in the department. I've said before, if ever there was a cross-cutting issue in the department, this is one, and I think that it will be important as the committee moves forward in finalizing the traceability and labeling document and moving towards finalizing the other report, and as we discuss in the department and with you new areas of work for the committee, that we try to determine how to have more interaction between the groups in USDA that are coordinating this issue for the department. As I believe I mentioned to you a couple meetings ago, we have two different coordinating groups in the department. One at the senior staff level, and these are the people that deal with these issues every day within their respective agencies, and then one at the policy level consisting primarily of Deputy Under Secretaries. I imagine that these two groups are going to consider, can continue to be functioning through the transition and with the new Secretary of Agriculture when he is confirmed, so I think it will be important for that interaction to take place as we move forward in the committee. With that, I'm going to turn it to Michael, and I believe Dale will be here in a few minutes. MR. SCHECHTMAN: Let's then move on while we are waiting for the Chief of Staff to arrive. Maybe we can just have a very, very quick review of the meeting from September 13th and 14th from Cindy Sulton. MS. SULTON: A very brief summary. The sixth plenary session was held September 13 through 14, 2004 and focused almost entirely on the two reports that Michael referenced earlier, the long-term report, as well as the one on traceability and labeling. The meeting began with opening remarks by Dr. Schechtman and Dr. Layton, followed by a review of the minutes from the June 3rd through 4th meeting and a discussion of the agenda outline. The meeting then turned to a discussion of the progress on the traceability and labeling work group and of the report that they had generated. The members discussed and offered comments and suggestions both on the first and the second day of the deliberations and offered a lot of direction to the work group who went back, were charged to go back and revise part and expand parts of the report. The next area of discussion was the work group progress on scenarios development. The committee discussed the draft chapter entitled Preparing for the Future, focusing on the three scenarios that were intended to depict various possible futures and not intended to predict the future, as well as on the driving forces of what do we know and what is less certain. Again, the committee gave a great deal of direction to the work group for their future efforts. The discussion then turned to the progress of the work group on issues and concerns, and again, the chapter developed by this work group was discussed during sessions over the two days of the deliberation. In addition to raising issues and giving direction to the work group, it was suggested and agreed that the work group would be expanded in its composition. On the afternoon of the first day of the meeting there was time allotted for public comment, and we had before us Ms. Kari Ann Powell of the National Association of State Public Interests Research Groups (PIRGS), and Ms. Powell spoke for a short time with the committee asking that when evaluating cost, AC21 consider the true cost of labeling when using true data and urging the committee to operate with transparency to provide information to the public when needed and to encourage FDA and EPA as well to hold discussions around labeling and policy in the United States. The committee discussions continued and focused in on the revised draft introduction to the report. As regards Chapter One, the committee agreed to the overall purpose of the introduction and deliberated on specific elements on the introduction outline and then supported an outline for this first chapter. The second chapter, Current and Future State of the Art was discussed in depth with great discussion of the scope of future products to be included in the report, and as a result of the discussion there was developed a proposed outline for the chapter, however without consensus on all its parts. It was agreed that its next steps there would be a drafting group to revise chapters one and two, and a small group to collect and draft definitions for the terms contained in the report. There was then discussion of the work plan and next steps where we spent some time addressing the issue of the period of transition for the committee acknowledging that the terms of half of the members would end in February, and also the fact that the USDA Charter renewal process would begin and there would be a Federal Register notice for member nominations. The definitions work group was constituted and members were asked to submit suggested definitions or terms needing definition in advance of a conference call. The drafting work group was also constituted and it was proposed that there be two conference calls to organize and write the next draft of those chapters. The committee members were again asked to provide their comments in advance of that meeting. The work group on issues to consider agreed to have an additional set of conference calls, and again, the committee members were asked to provide additional comments in advance. The work group on preparing for the future was to convene to revise the chapter and to consider whether making the chapter an appendix to the rest of the report or to address other steps to clarify better how the scenarios are storytelling tools. The traceability and labeling work group asked that the committee members provide them with any additional editing suggestions in advance of their next work group conference call and then agreed to develop a new draft of that report incorporating the explicit suggestions made during the meeting and any additional comments that might be provided subsequently. That group was to convene to consider the executive summary and implication sections and to draft the provisional final draft of the report. The meeting then came to conclusion with Dr. Layton thanking the committee members for all of their hard work and the meeting was in fact adjourned at 3:30 p.m. This obviously is a summary of the minutes. Does anyone have any questions or any modifications they might want to make to the full summary? Without such comments, can we assume that we have a summary ready to be posted on the website, and we'll do this subsequent to the meeting. Thank you. MR. SCHECHTMAN: Thank you, Cindy. Since we are still waiting for Dale to get here, let me just talk perhaps just for a minute about the status of the Charter and membership nominations. As you all know, the Federal Register notice announcing solicitation of nominations was published, I believe it was November 23rd, it was the 22nd or the 23rd, and half of the current committee members' terms expire. Since nobody has served on the committee for six consecutive years which is the limit established by the Charter, all of the current members whose terms expire are eligible to resubmit a nomination to be considered to continue on the committee. That process is going forward when the nomination closes on the 23rd. We'll gather all of the things up through the normal departmental processes to categorize the nominations and group them according to the various kinds of expertise that are here, provide the information to the Secretary's office so that they can move forward on making the choices. The Charter is in the late stages of going through the rechartering process. I guess that sounds a little funny but -- and hopefully that will be done pretty soon. In terms of member appointments, I can't say exactly how fast or slow the process will be with the change of Administration. If we can get it done before the current Secretary leaves, we will certainly do that. It takes a little bit of time and often there's transition time is a little bit confused. MS. DILLEY: Will the rechartering process be completed before the Secretary? MR. SCHECHTMAN: The rechartering process should be completed by the end of the year we hope. To aid the members who are on the committee whose terms expire who may wish to reapply, just in case you do, I have copies of the AD-755 form here and if you wish one you can just catch me at a break and I'll provide it to you. MR. JAFFE: Do you have electronic copies also? MR. SCHECHTMAN: They're certainly available electronically as well. This was for those who wanted to have a piece of paper in their hands. Otherwise, we can send it to you if you request it. And our timing was just great. We welcome Dale Moore who is the Chief of Staff for the Department of Agriculture, and he'll offer a few words. MR. MOORE: Good morning everybody. I apologize for running a little behind. I forget this isn't southwest Kansas and there's traffic on the roads or streets, I guess a better way to put it. And particularly with our good friends and advisory committee on the Hill in session this week. That always adds a little bit of excitement to the process because I've learned, while I thought I'd been following all of their advice throughout the year, I realized that the last couple of days that there was a lot of it that I'd missed, at least according to the phone calls I'm getting. So I've been kind of catching up on that. In visiting with Bernice I had, my good fortune, I guess David's as well because he's living in Italy now, but when David moved on, Bernice and Michael were asking how do we keep the Secretary posted on, you know, in particular what you all are doing, but what's going on also in the world of biotech and the developments there. So once a week, whether she thinks I need it or not, Bernice comes in and gives me an update and I've noticed that like any good teacher she, we sometimes have the same thing on the agenda for two or three weeks in a row just to make sure I'm understanding what we're talking about. And I know that there are a couple of items in particular that the Secretary has been extremely interested and very appreciative of the work that you all collectively are doing and that's these reports. I know that there's been, you know, from some of you, you know, through Michael, through Bernice and a couple of you have contacted me directly, a little nervous about the time frames that you have on the reports that you're working on. And I want to assure you that while we are in, and we being the Secretary's office, are in a period of transition. Those reports are both timely. The work that you all are doing is very much needed. While those of you not familiar or perhaps seeking some assurance that the process hasn't changed, as Governor Johanns goes through his confirmation process in anticipation that some of you might ask a question or two as to what his position is on things relative to matters involving biotechnology, the answer is we will find out when the Senate has its confirmation hearing. If you don't particularly like that answer I've got the White House number you can call and explain to them you didn't like my answer. But, we have a very firm policy, and I think a very important policy that it is the right and purview of the Senate to ask those questions and I have little doubt knowing some of you sitting around the conference table here are very much already engaged in visiting with your favorite Senator or two or three to make sure some of those questions get asked at the appropriate time. I am encouraged that, you know, as we look back, you know one of the first issues that I got to work on as I came on board for the President and the Secretary was to StarLink. You know, like any form, you know, I sort of figured well, I've kind of grown out of that phase of my life, but then that's not true. You never grow out of it. And it has been, you know, the work that you all, you know, have been doing and have continued to do throughout that process, I think last, I've kind of lost track. Was it this past summer in Burkina Faso? It's kind of been one long Monday for the past four years, but this past summer in Burkina Faso as we got the reports back from Dr. Pinn and the team that was over there visiting with, not just, you know, sort of our collective counterparts and particularly that of the African countries, but the leaders of those nations who stopped by and visited and made it clear that from the Secretary's Science and Technology Conference in Sacramento, which again, I know several of you participated in and contributed to the success of that particular meeting, the growth just in understanding and in interest and in desire to learn more about how we in the United States work with biotechnology, how we're addressing, you know, some very real, you know, conundrums that the solutions, you know, tease us now and then with presenting themselves and then kind of slipping back and hiding in the weeds and kind of forcing us to dig a little deeper or go a little sideways or sometimes just back up and take a look at something we may have already bypassed to find that solution that works the best in terms of, you know, what the mission is. We've got a lot of wonderful technology that, you know, can address, in some cases solve, a lot of problems. At the same time there is a responsibility to assure public health, environmental health, and frankly understand that our regulatory process which we believe is second to none, and I'm not just talking about at USDA. We're looking at, you know, our co-workers and friends and colleagues at EPA and FDA and certainly at the White House, these opportunities to, you know, make some progress forward they're going to rest on the work that you all do. Not that we're looking for somebody else to blame if everybody's like where did that come from, but as one of my former mentors, not former mentor, but former bosses and mentors made the observation that, when I was working for him on the Hill the most important thing I could do was remember that as smart as I thought I was, there was usually somebody smarter somewhere else in the process, and you know, being a smart-alec didn't really count for much. We have a tremendous amount of faith, by we in the Secretary's office, her team up and down the subcab it has a tremendous amount of faith in the work that you all are doing. We put a tremendous amount of confidence in the work that you are doing, and whether it is a report that Secretary Veneman receives before her tenure officially ends or that Secretary Designate Governor Johanns receives shortly after his tenure begins, I can guarantee you two things. One, we need those reports. They are going to serve as tools and as foundations for ongoing work and moving the pegs forward on biotech, and the second thing is that I can promise you they will get read because you all frankly are the cutting edge on this process. We've got battles on the legal front with our dear friends on the European continent. We've got acceptance issues that, you know, as we learned with the StarLink process that the biotech community as well as the government has some responsibilities to help make that progress keep going, and frankly, I think the promise of what biotech holds in some of the regions or some of the arenas in terms of addressing, you know, health issues or nutrition issues, and frankly in some parts of the world just plain addressing economic issues, kind of puts a heavy burden on you all. I know you all are up to the task. On behalf of the Secretary, again thank you for the work that you're doing. I know that you probably feel overpaid but you just have to accept that and accept our gratitude for the hard work that you all do. I will be happy to answer some questions and I've got plenty of time because you all are my excuse for not being in the office this morning. At least at my desk. And if they are to hard answer questions, I'll just obfuscate and dance around them and the easy ones I'll, you know, answer in very short sentences. (Discussion off the record.) MS. DILLEY: Questions for Dale? (Discussion off the record.) MR. SCHECHTMAN: Maybe what we can do to make -- MR. MOORE: Observations. I'll take observations, how's that. MS. DILLEY: Here's Mardi. MS. MELLON: My name is Margaret Mellon, I'm with the Union of Concerned Scientists, and I've been interested for decades now in issues of biotech regulation, and it seems to me that, you know, while a lot of these issues have been kind of swirling around in the regulatory arena that not much has really happened to push the, first of all forwarded basically, we're still living with the now 25-year-old biotech framework that we, you know, that emerged in the mid-1980s and so this is a good one for obfuscation, but do you see anywhere in the federal government a kind of interest in, I mean really serious interest in kind of examining the biotech framework, reforming it, on kind of the same scale as was done in the mid 80's. MR. MOORE: Mardi, that's an excellent question and I would have to let that, to answer the first part of your question, yes, there is an interest and it's not an interest that you know folks who are concerned about biotech and what it may be unleashing, you know versus you know those that stand to profit from biotech. It seems to be a universal desire to, you know, examine the framework and you know, save the good parts and add a few wings onto it and all that good stuff. The challenge seems to be, from my perspective, and you'll forgive me if I throw in a few Delaney reform analogies, I had extensive experience on that front in a previous life. MS. MELLON: I was watching from the sidelines. MR. MOORE: Abby was keeping a close eye on me too. When we went through that process, I started on the Hill in the early 80's and over about a 10 year period there was this constant drum beat we need to reform Delaney. And what fascinated me is that over that time frame there's sort of a collective desire, you know, to fix it or fix something and when Pat Roberts became Chairman of the Ag committee and Tom Wiley became Chair of Commerce, you know those, politically those things kind of lined up and they had Mr. Dingle and we had Chairman de la Garza, and the balls really started moving, and what fascinated me was that within a week after we had announced, you know, full committee markup on Delaney reform, on something that for Mr. RobertsÕ perspective, I'll be very candid, we had worked very closely with the industry and the ag community. You know Mr. Dingle's folks had worked with their committee and Steve Garves (phonetic sp.) and so forth. We got to the point and we're just about ready to push all the buttons and lay out here's the Chairman's mark to get all the reaction and the chemical industry came in and said, you know we've worked on this for a long time but we really think we need to drop about two thirds of this section 3 cancellation stuff, and we're like okay, fine, but I thought that was sort of the cornerstone. Well, we've been thinking about it, you know, and so let us think about that and it wasn't but two days later that Administrator Browner and her team came in and had the exact same conversation. And we were kind of sitting back, it's like okay so everybody wants to fix it, but when it looked like we were, then everybody started pulling back saying, no, no, we're not sure we're there yet. That's the sense I get on biotech, that everybody runs up and, you know, grabs a hold of that wire and says okay we're all going to grab it together and hang on to it and they're ready to start moving forward and then the pieces start getting laid out, well we need to work on this and just one by one people start letting go of the wire and we back up again. And so, yes, there's a desire to fix it. Is reform just around the corner? I honestly don't see that as yet critical mass of all the political will, the policy solutions and that sort of balanced cooperative desire that on the ideological spectrum you've got, you know, everybody from the right field foul pole, the left field foul pole ready to move forward. It's still the fairly no channel down the middle. MR. SCHECHTMAN: That's a good answer. MR. MOORE: Is that obfuscating enough? MS. MELLON: No, actually that was much more forthright than the usual answer and I actually thank you. MR. MOORE: I'm a short-timer so -- that's me being a smart-alec. MR. SCHECHTMAN: Any other questions? Thank you very much, Dale, we really appreciate it. MR. MOORE: Thank you all. MR. SCHECHTMAN: Maybe we can extend your stay a little bit by taking just a few-minute break and if people want to talk to you individually. MR. MOORE: That would be cool, because my car doesn't come back for another 10 minutes. MR. SCHECHTMAN: Let's take a 10-minute break. MR. MOORE: Thank you all very much. (Whereupon, a brief recess was taken.) MS. LAYTON: Today's meeting, however, I've had significant conversations with several of you this morning and I'm going to opt to not review the agenda because I think we're going to have a floating with the one scheduled thing being that we break at 3:30 for public comment and that we begin on - - two scheduled things, one, we break at 3:30 for public comment and two, we begin by working on the traceability and labeling numbered document number one. Meeting objectives are the same. We are planning to finalize for submission by the committee to the Secretary the draft report on Other Countries Traceability and Mandatory Labeling Regimes for Biotechnology Derived Products, the implications of those regimes and how the U.S. industry is addressing the requirements for products shipped to those countries. To review and move toward finalization the other draft report examining the impacts of agriculture biotechnology on American agriculture and USDA over the next five to 10 years. So, with that in mind, and we're already a little behind schedule, we're going to work very hard and entertain how we get through traceability and labeling, but we're going to do it very thoroughly and with everyone working hard to meet the objectives of getting that report the way we discussed and everyone comfortable with it. So with that I'm going to ask Cindy to start, Mike, are you going to talk a little bit? Michael's going to talk a little bit of what we've gotten done so far and then we'll get started on the actual work that work product. MR. SCHECHTMAN: Okay. I'll shorten my normal wordy remarks. The work group on traceability and labeling composed of Randy Giroux, Ron Olson, Leon Corzine, Lisa Zannoni, Greg Jaffe and Dick Crowder have but in a lot of work on this report. They've gone back and tried to address at least most of the points raised last time and they're enthusiastic about seeing the end of the tunnel on this document. For the public, let me just mention briefly what the structure of the report is. It starts with an executive summary which is followed by the bulk of the report. The report as a whole it has a brief introduction, then dives into different approaches that countries have adopted in setting out biotech labeling and traceability policies. The policies are described very generically and associated with each one is a description of how industry is attempting to address the stated requirement. There's now a description on relevant different international agreements, treaties that relate to these things. Following that there's a large portion entitled, Commercial Impacts and Realities, and this section addresses more specifically a set of particular concerns, market tools and trends in seven categories that you'll hear about. Following that, there's a final section in which the work group has highlighted certain policies and issues raised in the report for the Secretary to take note of. What's the current status of the document as of the work groupÕs work? From the prospective of the group the document is pretty close, but the work group had not finished its last go-through of all of it, and the work group particularly recognized that the policies issues raised section may need a more thorough going-over, and I'm sure that'll happen here. Additionally, in the last conference call a week ago after extensive discussions, the work group members asked me to take a shot at reorganizing the existing text in one part, in section two on adventitious presence, and the group hasn't had a chance yet to review the reorganized version of that. So again, the ambitious goal for this discussion is to finalize this report for submission to the Secretary, or at least to identify the very clear path for how that will happen in the very near future. So before I turn the discussion over to Cindy, let me ask if work group members have any comments that they want to make before we start. MS. SULTON: On the proposal mode of attack on this that we ask the committee to give first your reactions to the document as a whole, the general approach, and then we would also ask if you have editing comments we would very much like to get them, but the best way we think to do that would be for you to submit those afterwards, and then we'll spend a great deal of time talking about the implications section before coming back and going section by section. Is that an agreeable way, Carol? MS. FOREMAN: Given the way that we're going to manage the session ahead, I think I have some comments that are more general. We'd like to go forward with only part of the report. I know this was requested separately, but given the fact that the Charter expires, that the committee has to be renewed and new members will be coming on, I think that there's a possibility that the momentum for the rest of the report will disappear and this will end up being the full product of this committee. That's a very serious problem for me. This chapter is acknowledged as being written from an industry point of view. It deals with very narrow, important but narrow set of issues and so I have real problems with going forward with it as a separate and independent document. Pat and I have discussed altering the executive summary so that it states very explicitly that this is the first of a three-part document, and that the new Secretary and the public can anticipate that the rest of it will be completed. I would prefer if we had a date on that, but I think that if we can do that and then I'm going to have some substantive suggestions. But as a matter of process, if we can do that I think that it would ease my concerns. MS. SULTON: What is the pleasure of the rest of the committee about putting something like that in the Executive Summary? Terry, did you want to start? MR. MEDLEY: I had another point, but I'll respond to that one. No, I think that the committee had two very distinct but yet connected charges. We were looking at completing those within a two-year period of time, and so I think I would support what Carol is saying in terms of somehow having language which makes it very clear that as a committee, you know, the first report which was the short term report we're responding, but also the second, the longer term, five to 10 years, that that also and maybe we could even say that, you know, we intend to complete that within that time frame before the Charter of this committee expires. so therefore we have kind of a time frame. Now, whether we can do that, I don't know. MS. FOREMAN: But a commitment always. MR. MEDLEY: A commitment, yes. Yes, I think. So, I'm supportive of that. As I said I had another point I want to raise so. MS. SULTON: Any other comments on that suggestion? MS. DILLEY: So would the proposal be that, to draft specific language to reflect that and have the committee, maybe we can do that at lunch or something and review that post- lunch, but the full intent of the committee to convey to the Secretary is this is the first of two reports that the committee fully intends and has made a commitment to complete. MR. SCHECHTMAN: May I just ask one quick thing, Carol. I thought that I heard you say first of three. MS. FOREMAN: Well, it's first of two. I was thinking other chapters. MR. SCHECHTMAN: Okay. MS. FOREMAN: I was thinking scenarios and issues and I know that -- MR. SCHECHTMAN: Okay. Thanks. MR. MEDLEY: Could I now ask my -- MS. SULTON: Yes, Terry, go ahead. MR. MEDLEY: I think that as you went through the only statement I'd like to make is, as we look at the policies and issue section to the extent something is really a recommendation, I would suggest that that's not responsive to the charge that we had. The charge was specifically looking at kind of the state of it and how industry is responding to that, not to necessarily make recommendations of what should happen. MS. LAYTON: So Terry, could you suggest which things you see as recommendations that -- MR. MEDLEY: Well, I mean, not being a part of the work group I just, you know, I can just give you an example and one of the issues where I think it's a recommendation. I mean, it's one that I support, but it's still a recommendation. You know, number five in the policy issues is very clearly is a recommendation. It says that, you know, we should establish an adventitious presence policy. Now, I support that and I think it's needed, but I think it's not responsive to what was asked for in this report. MS. LAYTON: So you would propose deleting number five? MR. MEDLEY: Yeah, and as we go through I think, yeah, that type of, anything which ends up that we feel is in fact a recommendation and not just a policy or an issue, but a recommendation of action, I think that, because otherwise I think it might adversely impact our ability to come to closure on the first report. MS. SULTON: So to be clear then, we're just talking about rephrasing things so that we clearly outline what the implications are without making recommendation, what that what you said? MR. MEDLEY: If that works or deleting if that works. Whatever is appropriate. MR. SCHECHTMAN: I might just suggest that if, you know, we certainly don't mind getting recommendations that the committee as a whole has consensus on, and maybe, you know, they can be individual ones might be left in if everyone agrees on them, but if they're stumbling blocks, that makes sense and we may possibly, you know, a possible bit of future work that could come out of this is if all the recommendations are stripped out of this, you know, there could be possible future work on recommendations if the group can work on those. We get the report, do what's necessary to get the report done at the short -- MR. MEDLEY, I mean, it's kind of like the commercial they have for the investment firm which says, you know, I kind of give my customer more than they asked for. And I guess all I'm saying is as we go through this, I think it's very critical that we be able to finish and push the report on if recommendations will be a barrier and inhibit our action of the group, then I think it's not what was asked. That's all I'm saying. I'm just trying to give us the best way of completing the task. MS. DILLEY: You're placing the emphasis on expeditiousness of expediting the report as opposed to making recommendations? MR. MEDLEY: Right. And being responsive to the initial request. MS. DILLEY: Charge. MR. MEDLEY: The charge from the department. MS. SULTON: Leon. MR. CORZINE: I was just wondering, Terry to address that concern rather than delete it, whether it was reworded, rather than a recommendation as this is an area of concern. And I don't think we would want to delete that one in particular. MR. MEDLEY: As I said I -- MR. CORZINE: You'd be alright with that. MS. DILLEY: I think, I mean, I think what's been proposed is to get the report completed as soon as possible. We don't to presuppose before we review it. However, just my experience and going through a 27-page document with recommendations is a tall order for a single meeting, so I think what Terry is suggesting is let's see what we got. If it's going to hang up expeditiously moving the report forward, let's delete it because the emphasis here is on getting the report completed. MR. SCHECHTMAN: But if everyone agrees to that sentence, then there's no problem. MS. SULTON: If we could return just to reaction to the overall report before we get to the implications section, to the general structure and the rewriting in accordance with what was said at the last meeting. Is everyone -- Mardi, do you have a comment? MS. MELLON: I just have one observation and maybe it's too late to respond to it, but it does seem to me that, you know, that this is written from the perspective of the U.S. as an exporter in the grain market, and that one of the things I see coming in the future is that we might become importers or become folks, you know, where we would be getting the genes that have been put into grain by the Chinese, by other folks, so it seems to me that it, and at this point I don't think we want to go back and try to analyze what those issues might be, but it might be good to just, you know, provide some sort of placeholder that we're not always going to be on the exporting end of the stick. We might be either on the importing end or the, in the position of discovering genes that are in our, you know, in food coming to us that are the result of adventitious presence in other countries. MS. SULTON: Carol Tucker Foreman and then Carole Cramer, then Terry. MS. FOREMAN: The chapter says in its first paragraph that itÕs written to talk about impact on the agricultural food and feed supply chain. There is nothing here about the impact of labeling and traceability requirements on the consumer and I think we have to acknowledge that in fact it does have an impact on the retail consumer. Consumers in other countries get information that American consumers don't get. And we don't have to say that it's good or bad that some countries have it and other countries don't have it, but I think we have to have some language that acknowledges the differences and that there is an impact of these differences on consumers. That there is some value to consumers for labels. There is, and because again the product, the labeling has an impact on the product that the consumer gets. In Europe consumers get products without genetically modified ingredients. In the United States you don't unless you want to buy USDA organic or something makes a claim. So we just, I think that there just has to be a few paragraphs that say that this is the reality and we don't need to get into good or bad or structures of what other countries do, just a discussion of the fact that this is the case. MS. DILLEY: So is that part of, just for clarification, is that part of explaining what the committee did and did not address in the bigger picture and you would want it to talk about, or those paragraphs to maybe talk about the fact that it's not talking about the perspective from the importer issues as well as some of the consumer issues? MS. FOREMAN: I think -- MS. DILLEY: To separate those out? MS. FOREMAN: I think, and I'd have to think about the exact wording there, but I think it'd just be saying that the statement of fact that labeling does have an impact on consumers, and a little explanation of what that impact is. MS. SULTON: Would you be willing to draft the language in that regard so we could take a look and consider it. MS. FOREMAN: I would and I'm, my problem is whether in the light of trying to finish this today and tomorrow I can do that. MS. SULTON: I know others had their card up. Duane, did you ant to respond specifically to what Carol said? MR. GRANT: Yeah, just specifically to that point, Carol. It's kind of in there on page 6, paragraph (c), it talks about a little toward frameworks for agricultural biotechnology that require mandatory biotechnology specific labeling and it talks about in the text that these requirements are based often on a right-to-know policy. I think that that might be a place where the emphasis on the consumer's right to know in specific markets might be drawn out perhaps a little bit more and I'd suggest that as a place to add some modification directly acknowledging the role that consumers play in those markets. MS. SULTON: I'm going to take a priority here and stay on this same point, Greg, please. MR. JAFFE: I guess I would have a, I think Carol's raised a very good point. I think this chapter is, and I've been on the working group, the one thing is missing is sort of the last part of the chain which is the impact on consumers, and I think it probably does deserve several paragraphs, three or four paragraphs to sort of talk about that. I guess I would put it somewhere different, Duane. I wouldn't put it there because that's just sort of an explanation of different regulatory frameworks, but I think in our section two, commercial impacts realities, it would be logical after markets, you know, as one of those seven bullets, seven different headings to have a heading here that said impact on consumers. We have impact on new market segmentation and we have a whole bunch of different things there, and we would just have an eight section there that would be impact on consumers and it would be three or four paragraphs or something like that. If it's not to be written in the next day and a half, I'd be happy to help Carol write it, but if it's something to be done the next day and a half, I don't have the time for that at this point. MS. SULTON: Okay, Ron. MR. OLSON: I'll just add to what Greg has said. It's also on page 26 in the food system, we talk about right to know and how, if we haven't expanded it uses the word consumer, but we've talked about the marketing and stuff like that, and I don't have a problem expanding that somewhat. Whether you use the word consumer or whatever, I mean, we can add some language in there to expand, but I think the reports hit at it, and then what Mardi said earlier too, there is a section about, you know, it's also talked about events approved elsewhere but not in the U.S., but we just didn't expand on it because the idea was to describe what's happening today more so than what's going to happen in the future in this particular report. The big report is what's going to happen five to 10 years from now and this one was more what's going on today, and today we really don't have a scenario, we talked about it but only briefly and the work group debated that quite a bit, that's why that piece is small. It's there, but small because it doesn't exist today. But we did put it in there just to alert the Secretary that this could be an issue that comes up in the future. MS. SULTON: So we have a proposed suggestion on this point. Is there anybody else on this particular point? MR. MEDLEY: Yes. I have a comment on this point. MS. SULTON: Okay. Terry. MR. MEDLEY: I think that having it under the section that Greg talked about in terms of commercial impact or realities is fine. I think the extent to what Carol has raised and the types of comments, but it seems to me that so far what I've heard is incomplete. I mean, if you're going to talk about, I would say commercial impacts and realities, you would not only talk about the reason why consumers wanted labeling, you would also have to get into cost that might be associated with specific labeling, and that, you know, that's another impact and that is a reality. And so I'm not exactly sure of what are the components per se would be in this section, but I think clearly when you talk about traceability labeling on the commercial impacts and realities, that is an area that needs to be addressed. MS. FOREMAN: Can you provide information about what the additional cost is in Europe now to non-source? The labeling itself. Once you've got all of these things that everybody's getting, the identity preservation, mechanisms for controlling adventitious presence, you've already spent that money. So the money that would be in addition for labeling I think is just the cost of changing labels. In Europe right now you're already sourcing to get non-GM products. The only thing that would be added there would be the cost of the label and there's a lot of data about the impact of nutrition labeling, the cost of nutrition labeling, the initial cost was fairly substantial. I'll defer to Ron, but I think now the continuing cost is really not significant. MR. MEDLEY: Then Carol, I think in that context then I would go back to what Duane said in terms of under right to know than in why wouldn't you put that in that concept? MS. FOREMAN: Because I think that what it needs is something that says that there is, a subhead that says consumer impact, different affects on consumer information. I'm not sure what we'd call it, but it needs to have a little subhead. MR. MEDLEY: Okay. MS. FOREMAN: And it is touched on in these areas. It's really touched on in terms of what the impact will be on the industry without a discussion of what the impact is on the people who eat the food. MS. SULTON: If we don't have time to draft it, is it possible we could get just a delineation of the major points that you want to make under that? MS. FOREMAN: That I think is a more realistic assignment during the period of the meeting. MS. SULTON: All right. Carole Cramer. MS. CRAMER: So initially I was just responding to Mardi which is, I think our job here is in this report is to do the now so that the import I think is more of a topic for the next report, but one of the things that I did sort of look at and not see, and mostly it's just a question, but right now we actually have a couple of small market crops that are biotech crops on the market, and I was just sort of to the committee, I guess the working group, the report has a lot of bias toward commodity crops which I think was where the issue really is, but we might just want to consider whether or not we've covered things like, you know, the papaya issue and exported papaya and see that those things that we've addressed cover sort of small market minor crops as well and whether or not there's a little bit of added language where we should see whether traceability is an issue for these crops and whether it's been integrated in the same way or is anticipated. MS. SULTON: Randy. MR. GIROUX: I believe that I agree that we should have some additional information on the consumer. I think that's appropriate, but at least from my perspective, the supply chain serves the consumer and strives to produce those things that the consumer wants. So to say that the consumer is not part of, you know, that the industry is doing this but this is what the consumers are doing, it seems like, it just seems like a disconnect to me. I mean, from my perspective, the development of all these non-GMO programs are a direct response to what the consumers want, and so those, the commercial impacts of the needs of the consumer in countries that don't want biotech develop non-GMO programs and the industry responds to their consumer need, desire and develops those programs, so I, to have a separate section about the consumer, suggesting that the consumer is not part of the supply chain, that the role of the food company is not to serve the needs of the consumer. That makes me feel a little uncomfortable, so I don't know how we figure that out. MR. CORZINE: I'm like Randy, I'm a little confused by that because I think at the end of the day I've been to a number of things, we talk about consumers and the economics are the driver and the consumer pays with, they vote, I guess you would say with the food basket, what they put in their food basket and how much they pay for different things that are labeled is determined by, we have a lot of those niche markets here. I also wanted to mention, you know, I think there's a misconception. If you want to make the statement, Carol, that there's very little cost to labeling and traceability in Europe, because it's just absolutely not true. Greg and I were both at a conference not very long ago where we were talking about that and they don't know yet how they're going to implement their labeling and traceability, and the longest presentation was on a fellow with a company that was trying to figure that out and had a system that turns out basically to be a witch hunt that is only accurate one out of three or two out of three, one out of three is going to be inaccurate. And Greg, if you remember, they wouldn't even talk about the cost. It was probably going to be in the billions of dollars for them to get this implemented across Europe so, I guess a comment is just there's, don't, let's not have an impression that there's no cost in Europe to what they are trying to do out there and they certainly are not there yet. MS. SULTON: Carol. MS. FOREMAN: Responding backwards. I did acknowledge that the initial costs are substantial after that, or at least they were on nutrition labeling. Right now because the companies are taking steps to have non-GMO sourced products in the EU there is no cost. Consumers are getting a different product there than they're getting in the United States. I don't want to put any value judgments on that, that's a reality and I want it stated as a reality. Randy, by definition the retail consumer is not part of the supply chain. The supply chain ends either one it leaves the hands of the food processor I would say or the food retailer and then the consumption of the product begins. We're not part of the supply chain. We're supposed to drive it. But in the case of this technology it was, I think, acknowledged in this document in several places that so far itÕs been a supply-push rather than a demand-pull technology. So, in fact, right now it is not a reflection of a consumer demand. MR. CORZINE: Just one other thing, Cindy. For the record I strongly disagree that Europe is not paying a cost and they're continuing to pay a huge cost if you really take a hard look at what's available to them and what they're paying. There definitely is a big cost. MS. FOREMAN: You think that there's a cost to consumers? MR. CORZINE: Definitely. No doubt. MS. LAYTON: To be more specific, are you saying that, for example, I hate to be naive, but I want to really get clear on this. That, for example, they're paying more for grain in order to source it, non-GMO and therefore it's, the price of bread, not bread because it's not wheat, but the price of Tostitos might be higher, not to use a brand name. The price of corn chips might be higher because of sourcing it in non-GMO? MR. CORZINE: I think there are a lot of examples. The consumers paying more at the store. They are paying, and I think that's the ultimate cost. I think, I know there are also examples, now they're getting some GM-labeled products that they are able to sell at a lesser cost than they are selling in Denmark, in Germany, in other places. It's not large yet, but so there is a price differentiation that people are paying so there are a lot of examples. The consumer is paying the higher cost in Europe. MS. FOREMAN: You know, somebody is going to have to show me the data on that because, in fact, I think what you're seeing is that the competition within the market is bringing the price down, but my argument is that all the way through this chapter is the discussion of all the steps that are being taken to implement steps to get products separate. Those expenses have already been absorbed or are already being absorbed. I just want to talk about the fact that the consumer is getting something different in Europe than they're getting in the United States, and either that or they're getting information we're not getting in the United States. We don't have to make a judgment about whether that's good or bad, I just want to -- MR. CORZINE: I agree, but just don't put out the misconception that they're not paying a price because they are. MS. SULTON: Terry. MR. MEDLEY: I guess on the point. Maybe one path forward might be picking up Carol on your last statement. There are discussions throughout the document in terms of where because of the labeling requirements food manufacturers will source non-GM so to avoid the labeling. So maybe if we can then build upon that and have maybe just a few bullets of major points we wanted to raise about the consumer getting a different product, then we'd have an essence of the kind of what we want to add so we don't get into the others, and then maybe we could move forward. We do make that statement in here that they are sourcing non-GM to avoid labeling. MS. FOREMAN: But that is all, I agree with you, Terry, those things are all stated from a point of view of the supplier. I just want a couple of paragraphs about from the point of view of the people who eat. MR. MEDLEY: So that's what I'm saying. If we could what those key points are then I think, you know, we can kind of move forward on it. MS. SULTON: And Carol, you've agreed to give us those key -- MS. LAYTON: Well, could we have a little group get together at lunch, Carol and Greg also said he would help. Is there a possibility of getting together at lunch and sort of jotting those down so that we can work them into language? MS. FOREMAN: I have some commitment at lunch and unfortunately I can't stay late this evening. So I don't want to hold up the whole group while we negotiate the details of this. When we break for lunch let's get together and see what we can do that can handle this in a timely fashion. MS. LAYTON: Okay good. Is everybody comfortable with that? Randy? MR. GIROUX: Yeah, I just want to make sure that we give whoever the people are that leave at lunch a very clear work product to go and develop. It would be unfortunate for us to not clearly understand and agree as a committee what is the deliverable to come out of that lunch group so that we, and when they do bring it back potentially we could go through that list and we could get agreeing on committee at yes, nos, are the key bullet points and now somebody go develop some text around that. If we could come back after lunch and have that and talk about what those key points are, get consensus that those are points and they need to belong somewhere in this document and they need to be articulated in paragraph. I'd be comfortable if we could get to that point with this group, not just to send them off and say, you know, develop some key points. Why don't we take a few moments to make sure that whoever our subgroup is clearly understands what the committee would like to see when they come back, I'd feel a lot more comfortable. MS. SULTON: Would you like to make some suggestions in that area? Anyone else? About what that small group should approach. MS. FOREMAN: Obviously the key points that I think should be there are that there is a difference that consumers in some countries have access to information about whether products contain genetically modified ingredients, and that in some countries consumers are getting as a matter of course products that are free of genetically modified ingredients, that in the United States that information is not generally available and the products are generally as we know genetically modified. I think there probably needs to be a paragraph that talks about the value of labels for consumers. There are paragraphs all the way through this chapter that talk about the value to different parts of the food chain for specific things that apply on the other end, and I can read you some of those paragraphs if you want. And, those are the key points that I would see. MR. SCHECHTMAN: Could you expand on what you mean by the value of the label to consumers? MS. FOREMAN: Consumers are benefitted by having information. This gives them information that in this country an overwhelming majority of consumers say they would like to have. From the consumer end we believe that information helps you make an informed decision and therefore spend your money in a way that is most effective and efficient in getting you the product that you want. I don't know what more I can say about it then that. MS. SULTON: Juan and then Greg. MR. ENRIQUEZ-CABOT: I'm not a member of this group so if I say something that you've already discussed, excuse me. I think part of the problem that we're having is we're discussing three things that are completely different and three completely different objectives in the idea of tracing and labeling. The first issue is sometimes you want to have tracing and labeling because you want consumer education and you want consumer choice. Then there's a second objective which is you want food safety. And then there's a third objective of this which is you want environmental safety. And the break points on what you have to do in those systems and how much you're going to spend are completely different because there's a hierarchy of these things, and I think if you broke it out and you said okay, here's part of what this committee or this group came to. The following things should be traced and labeled immediately, and you know, basically if you're going to move this from here to here. All of us agree, let's go and do that. Then these things we think should have standards set soon because they're breaking commerce or they're making things more difficult, but it's not an issue of environmental or food safety. Particularly with things like Tommy Thompson's comments and other things, these are issues that are now being mixed with things that have nothing to do with food, they have to do with geopolitics and stuff. And I think tracing and labeling, you know, it's not the same doing tracing and labeling because you want educated consumers as because you want to ensure safety in the food system, which you're going to do in one system and another, and the cost you're going to put in one system or another, and who's going to bear the cost of one system or another are very different requirements depending on why you're asking for that tracing and labeling. And I think in the measure that you say here are the minimum standards for environmental safety. Here are the minimum standards for food safety. And here are the minimum standards for products that really are very different from what is sitting out there and here's why they're different. Then you can take a whole chunk of this thing and say, in the short term let's make these changes to the system and let's not take on the entire system and try and agree on absolutely every product, on absolutely everything here, and then let's agree to disagree on how soon the following things should be done, and then let's say, you know, these are things which are relatively minor changes. And I think part of what's going to happen in this group is if you try and take those three issues and everybody's arguing about live modified organisms moving from one place to another, and other people arguing about whether the small change in X corn seed really means that is it a different product or not. You're going to start butting heads on this thing because you've got three very different objectives in agendas going here, and by the way, you may have agendas that have nothing to do with agriculture or this department that are going to come in and impose a series of things regardless of what we decide if we don't take those into account. MS. SULTON: Juan, I think when the committee was deliberating they stayed away from why countries came up with particular frameworks but rather just described what is, and I understand perhaps that makes it more difficult to move into recommendations without having that, but that's not -- I don't think it's structured that -- but Greg, you were on the committee and you had another comment anyway. MR. JAFFE: I mean I agree with what they're saying, Cindy. I'm not sure that's what Juan was getting at, but I mean, I do, I strongly believe that we should not get into in this report explaining why we think different countries have identified, set up regulatory systems that have labeling in them. I think that's just a, I've been a strong believer that that becomes a "he said, she said," you know, somebody thinks it's a trade barrier, somebody else thinks it's an information access. There's a whole host of reasons and I don't want to get into saying why the EU has it, I think we should be value neutral and say this is what they have and so forth. But I don't think we have to get into that to discuss what Carol wants to say and what I agree with in terms of a separate section on consumer impacts or consumer realities. And I was trying to get at, what Michael questioned, that he asked of Carol, and a little bit of what I think would go in this section, I think all those points Abby made are correct and just trying to espouse a little more on the value of labels, and I think what would fit in to me in the few paragraphs that would be written in this section would be a lot of our other sections, and I think it would fit in very well with our other sections, we don't talk solely about biotech. We talk about market segmentation generally. We talk about identity preservation generally. We talk about ways that the system is beginning to differentiate products. I think labeling and consumer information and education is a similar activity that's happening these days. People want to know whether they have free-range beef and there are systems being put in place for that. Country of origin labeling, organic, the internet, people want more information, they want to differentiate it, be it for environmental reasons, they want to support a certain environmental method, they think one is more nutritious for them, whether or not it is, and I think what those points, the points that are up there are specific to biotech and I think those are good, but I think we'd also want a paragraph here saying generally that in today's internet information world knowing whether something's biotech fits in very much with the consumers who want to know information about a host of things, country of origin labeling, how their beef was made and so forth and so on. And I think that, and that there are market systems being put in place to address those currently where there's a demand and so forth, and I think that would very much fit this three or four paragraph section in with some of the other sections under the commercial realities where we talk not just about the biotech specifically, but we talk to a degree about how markets and things are dealing with setting up systems. MS. FOREMAN: Sounds like an introductory paragraph to me. MR. JAFFE: And I think that'll get to the value of labels, that consumers these days, it's not so much valuing labels, but consumers are much more valuing information about their foods for health reasons, for safety reasons, for whatever reasons they're doing it, they're placing a value on that and voicing that value in the marketplace for the kinds of products they pick, and the marketplace is responding by setting up different systems, and I think that could be a context for this. MS. SULTON: Michael did you? MR. SCHECHTMAN: Yeah, actually I wanted to just probe a little bit further for you and Carol on this issue because I know Carol spoke initially about the desire to link the two reports or to make specific note in this report of the other report and also there is very specifically an issue that I think, it's not before the committee today, but it's an issue I think that you, if I'm not mistaken, Greg, worked on consumers are looking for more information. That there's an increased demand for information, so I'm trying to think of how to, to what extent it needs to be repeated here or linked to the other and just what the correct interplay is between the two. MS. FOREMAN: I would suggest that we can handle it that way if we handle adventitious presence and all the other issues that are discussed in the issues chapter the same way. MR. SCHECHTMAN: Okay, I just wanted to see where the touchiness is. MS. SULTON: Okay. Terry. MR. MEDLEY: I'm just trying to get clarity on where we are at this point in time, and I'm hearing a couple different things but I like the point, Greg, that you raised last about trying to address this from a more generic perspective of what's happening in the market place as it relates to consumers and information about their food rather than the specific biotech response. And I think that that might provide a way to move forward because when I look at the initial list, I was starting to wonder how responsive it is to the charge which is really looking at this proliferation of different and varying traceability labeling requirements and then how does that impact, what's the impact it has and I think that in a more generic sense it then fits in when you start talking about food systems, there's one section on food systems you can actually get into that in a more general sense, so I'm much more comfortable with that type of general prospective than the more narrow specific biotech, but -- MS. SULTON: Greg, could you -- MR. JAFFE: Terry, I was suggesting both. Having that first and then the specific. And I do think the specific fits within the charge because one of them was, what is the impact, and I think what Carol wants to say is one of the impacts is that the products in Europe are different from the products in the U.S. The consumer gets a different product, one having biotech, one not having biotech. A second difference is they get information on a label that other consumers don't get. Now whether those are material, some consumers may think those are material or not material, but those are impacts. I do think our charge while it's not just to talk about, was to talk about some of the impacts. I think those do fit in. But I think they'll feel better in the context of the way consumers are wanting information these days about a host of things. MS. DILLEY: Procedurally yes where we are and I think the committee was trying to respond directly to Randy's suggestion which is if we're going to have people go off and write some language, what are we asking them to write. Where it goes in the report we'll need to figure that out when they come back with the language, but I think right now we're trying to get clarity on what are the particular points that people want to see in additionally drafted language. So if we can stick with that and see what other points, if there are other points that need to be made and then the group can go off and at least draft some initial bullets that can then be turned into text later. MS. SULTON: Are there any other points that one would like to give for the groups that's going off to come up with some bullets? Terry. MR. MEDLEY: I guess what I'm struggling with as we do this is not the first point in terms of the accessed information or the value of information, the value of label, I guess what I'm struggling with is this whole concept of transgenic-free. I mean I'm just struggling with that because if you don't have systems in place, just how accurate is the statement we're making? That's my only concern. MS. SULTON: I guess, the phrase "transgenic-free," where are you -- MS. DILLEY: I was trying to stay away from GMO- free. I think Carol made two points, which was there are products that have information, the label provides information to make choices and then also the result is the product and I don't know what the appropriate terminology is you want to call it, but there's obviously an effort that comes through in the report that people are sourcing to have products that are "transgenic-free," if you will. MR. MEDLEY: No, I understand, but it's just the commercial reality of even when we get into IP systems there are, you know "IP light." MS. FOREMAN: Terry, there are other areas of this chapter where it is stated, where it is assumed that the industry is successfully sourcing non-GM, so if you want to open the notion that they're not getting a non-GM product in Europe, we're going to have to go back and rewrite a lot of this chapter. MR. MEDLEY: No, I mean, this gets into the percentage, it was just the whole concept of we've talked about this whole concept of not achieving zero and not free throughout. I mean even in those systems, so just this concept of free was just so positive, that's all I was saying. MS. FOREMAN: I didn't, I tried to use the language that was already used in the chapter or the report with regard to the other sourcing. MR. MEDLEY: Yeah, that would be good, yeah. MS. SULTON: So rather than "transgenic-free," "not sourced from." MS. FOREMAN: This is a language problem and I don't have any objection. MS. MELLON: But the issue is sourcing. MR. MEDLEY: I'm much more comfortable with that. MS. SULTON: Ron. MR. OLSON: And I think the report, we tried to leave a lot of that in there, I mean there is sections that talk about, it depends on what the tolerance is. You know, if you go to Europe there is a defined tolerance which allows you then to operate under an environment and you choose whether you can manage that risk or not or whether you want to incur the expense of operating under that risk level. We also alluded that most of the players in the supply chain prior to the consumer probably go tighter than what their regulation is to make sure that they don't screw it up, so if somebody wants a nine-tenths percent, a lot of the originators are at a half percent or less, or one-tenth of a percent. They don't want any. But not having any is not the right option because you can't get there in most cases, whether it's Europe or anywhere, zero is impossible. so that's why we threw in that section about acceptable zero, but we also tried to allude that depending on where the market is, the cost varies so much depending whether it's five percent tolerance or nine-tenths. There's a major difference in cost. And so we tried to weave all that through the report. We just didn't pull it out and write it in a paragraph. But I think it's woven through there reasonably well to try to capture it. Now, I agree with Carol we didn't, you know, say this is the consumer's, you know, I mean the U.S. has voluntary labeling and you can label products non-GMO here, but that's a whole section then on adventitious presence because if you label it non-GMO in the U.S., what is the tolerance? MR. MEDLEY: No, the thing I was raising here is the point you just raised and that is when you talk about labeling, what I saw and again I didn't participate in this group, it is too much "EU-centric." Another major market for our products, of course, is Japan. Japan has a very different system for labeling requirements. It's a much higher level. You know if you look at South Korea, so that's why I was just saying, I just, that was one of the reasons for saying that the "free" part bothered me because those systems are all very different. I mean five percent, three percent. MS. SULTON: Okay. Michael. MR. DYKES: I just want to comment. As I look at the title, global traceability labeling requirements for agricultural derived biotech derived products impacts and implications for the U.S., I think one of the things that comes out if you look at all these different systems, consumers all over the world are going to be getting different kinds of things because we've got several different examples of all different kinds of systems that are being put in place, and I don't have a count of them in this document but they're all over the map in terms of systems. They're all over the map in terms of an exemption list, and they're all over the map in terms of decimals, .9, five percent, whatever, just the recent examples. So I think that's kind of, it's woven throughout this report that there are different things happening in different world areas. One of the comments I was going to make about this report is that I think that the latter half of this chapter we start citing countries where these things are happening. In the first part of that report we don't cite which countries we're talking about whenever you're talking about a particular system. Coming back to the comment about the work group and what are we going to do, I'm fine with, and I thought, I don't know who made the comment, I don't know if it was Carol, someone having, where we talk about the impacts on market segmentation impact, having a section in there on impact of consumers where we spell out some of those points I think that's fine, but I also agree with Randy, I think the work we're doing here to get this kind of clear so that we can get something to come back and look at so we don't keep kicking this can down the field about text and revising text and so forth, so. MS. SULTON: Okay. Do we feel like we have enough specificity for the group to go away with to come back and give us something else to which we might react? All right. Are there other issues or other responses to the overall report? Terry. MR. MEDLEY: I think that in the summary of our plenary meeting notes, on page four, the comment was raised back in September that we were talking about this term list that, and I'll read, it says that, at the beginning of the doc which you refer to commercial risk and then use consistently in that sense throughout the text. I think that you will find in our current version that there still are several places where risk is used in an undefined context, and that we need to follow this and have it consistent throughout the report in terms of we're talking about the type of commercial risk because otherwise it gets back to Juan's point of the different types, whether its health or environment. And I think it was in more of a commercial risk context and that was raised before in our September meeting. MS. SULTON: So you're just suggesting that we go back through the document and make sure we defined it. MR. MEDLEY: Make sure we do what we said what we were going to do back then is throughout the document use it consistently in terms of commercial risk. MS. SULTON: So a word search. MR. MEDLEY: Yeah. MS. SULTON: Anything else? Any other points about the document as a whole in general and how well we responded to the issues that were raised the last time? Michael. MR. DYKES: I do have one specific point to Terry's that I also wanted to raise as well on page 22. Testing- associated risk is one case in point of what Terry is talking about. MS. DILLEY: In terms of qualifying that as a commercial risk. MR. DYKES: Yeah, well I mean I don't think there's any real health and safety risk in testing. MS. DILLEY: Testing an associated commercial risk. MR. DYKES: Yes. Spell it out or just make it testing. I think testing and risk in the same sentence requires more. MS. CRAMER: If I could add something on that. I had listed on mine as well. Should we consider in the first place where we placed definitions of adventitious presence that we add risk in there from a point of view to delineate that we're not talking necessarily safety risk but a commercial risk and this is what we mean? MR. DYKES: I guess to Carole's point on definition, that was another point I had on page four, there are several definitions there. I wonder if those shouldn't be moved, now that we have a definition section, that those shouldn't be moved to definitions. MS. LAYTON: Definitions are in the next report, not in this report. MR. DYKES: Oh, okay. MS. LAYTON: This is the definitions for this report. MR. MEDLEY: That was a comment I had also, that if we are going to make it the definition section, why not make it clear because here it just flows into it in terms of multiple paragraphs. But it really is the definition section, we don't call it that. We kind of talk about, it's in the introduction we talk about general things, how the report is divided and then we list biotechnology, labeling, industry, et cetera. MS. LAYTON: So, one point, I mean if the introduction was 1.0 then 1.1 would be, if you can have a 1.1 without a 1.2, definitions. Or at least an italicized heading right above the term, while the broad term biotechnology refers to the use of, we would have a section that says definitions or key terms. MR. MEDLEY: Yeah, other words like what Carole just raised, they would fit and you would see it, and you would know it as you were going through the report. Here are key terms and how they're defined. MS. LAYTON: And so editorially suggesting putting a heading before that paragraph that starts off, while the broad term biotechnology. We could say something like key terms or key definitions. MS. SULTON: Greg. MR. JAFFE: I guess going to that, I think that one of the things that usually is put in a report of this nature in the introduction is some discussion about how we did this report, some of the procedures, and there is no discussion about that. I mean, I can't remember whether we had any presentations that were relevant to this report. That this really is a report just based on the collective knowledge of the members in the committee and the companies and organizations they represent. I don't think we did take a lot of outside testimony or information about this. MS. LAYTON: We did have at least one I know because we had the guy talking about the testing systems. MR. JAFFE: So I'm saying I think we need to put in a few paragraphs about we had a subgroup and we've met how many times and what we've done to sort of generate this report. I think that would be helpful, not just how it's divided. MS. LAYTON: So add a procedures paragraph to the introduction? MR. JAFFE: Yeah. A couple of paragraphs, whatever, saying -- MS. SULTON: A process. MR. JAFFE: Process, procedure, yeah. MS. SULTON: Michael. MR. DYKES: Another general comment in here is I think this report is talking about plant-based products, but I think it's also on select uses and I think there are other, there's a couple of places in here and if we're going to go through it section by section because I'm just thinking about this generally speaking, there are a couple of sections where I think we need to highlight that other biotech food applications, and when we talk about the sections on the EU that do not require labeling, food additives, food colorings, enzymes, those kinds of things. That's missing from this discussion. MS. LAYTON: Can I raise a point? MS. SULTON: Yes, Pat. MS. LAYTON: I wanted to ask is the title still appropriate. We really, we speak a lot about the feed and grain industry and so I was just wondering is it impacts and implications for the United States or impacts and implications for U.S. feed and grain at this rate? Or food and feed industry or supply chains? I'm just asking a question of us, is a little bit more succinct title more applicable on this report? And I didn't write it, and it's very naive and you can tell me no. MS. SULTON: Duane. MR. GRANT: I think it's a well taken point, Pat. I guess rather than change the title, what I would like to do is really to follow up on Michael's point, make sure that we adapt the text as we go through so that the text can accommodate all of the different products that are out there, and I've got a couple of notes on mine that I'll bring up as we hit each section. MS. LAYTON: Okay, excellent. MS. SULTON: Greg. MR. JAFFE: I mean, I guess from the committee's point of view I think we were pretty much limiting this to the feed and, the grain and grain products situation. MS. LAYTON: You say that in the document. MR. JAFFE: And we say that and maybe we need to say it more specifically up front in the introduction, but I mean, I would advocate to still limit it to that. There aren't animals out there yet and so to start speculating about how animals and things are going through that, and in terms of the regulatory things, the response to Michael's comment, I mean I think our view, the view is not, we went through for the whole first third of the report when we talked about different regulatory systems, went through, do we identify specific countries and their specific exemptions and we decided not to do that. We tried to make it a generic thing. We don't, not one size fits all. We don't talk about every different .9 versus .5 percent threshold. We don't talk about every specific product that they don't exempt or they do exempt and things like that, and so I think the committee's view we did talk about enzymes and things like that and we said not, we made an affirmative decision not to include those, not to put discussions about what exemptions different, specific countries have. We wanted to talk generically about the different labeling and traceability things in part because they're moving targets. I mean, I think we do identify several times in this report that they constantly change. These are regulations that are in flux, they are changing, and as we were writing this report something changed in Brazil, and nothing changed here in there and a new EU system came into place and so the goal was not to, we used them as examples in the second half of the report where they are appropriate, we identify a specific thing and there are always a couple that represents the EU because they have a traceability system that others don't have. But overall we didn't want to have to identify every particular kind of exemption for each specific country and did it more generically and I think that's something that we did think about and talk about. MR. DYKES: If I could just respond. MS. SULTON: Yes, Mike. MR. DYKES: Yeah, I agree, Greg. I don't think we need to get into the whole pages of all the different exemptions or the different starches and all those different kinds of things. I just think where it's a matter of a difference in policy we should list that. Sometimes it's important to say, and again, I come back to the example, the EU, I just think, and when we go through specific section I can give you what my thoughts are about that because it's only two or three words. It's important to say what's not included because it's a bit contradictory on the policy. But to get through specific items that are exempted, and I totally agree with you on that. My other point about the countries was, I just think as you read it and you, and again, not that it's an exhaustive list because I agree with you, it's evolving. But as you read about a particular system, if you don't mention one or two countries or where it's being implemented or where it was just passed or something, you have no context as to, so where is that? Is anybody in the world requiring it or doing it or implementing it? That was my only point. Not that it would be the exhaustive deal end all, but at least you got some idea, okay, so that's the kind of thing they're talking about Australia, or wherever it may be. MS. SULTON: Okay, we'll get to that as we go through, when we get back to going through. Juan, did you have another bit issue? A broad issue? MR. ENRIQUEZ-CABOT: I think Pat's comment is exactly right on target because I think what you've got is a report on global trace and labeling requirements for food and feed derived from agricultural biotechnology products, commercial implications for the United States. Because what you don't, I mean, what worries me a little bit about this is that it seems to be a black and white issue. You label and you trace or you don't label and you trace. And if you're going to take on the whole of the systems as opposed to just the food or the feed system, you don't have a hierarchy of why you don't want to trace these things. Do they reproduce in a different country when they move across? Are you talking about an animal or a piece of grain? Are you talking a seed that can go into the ground and reproduce or are you talking about a seed that's been processed and won't reproduce? Those are entirely different issues as to how much and how accurate you want to be and what your standards are going to be. I think there should be a very different standard for a seed that if taken out of that packet can go in the ground and reproduce with the same GM application than from a seed that has gone into a food and has been processed and will not go into the ground and will not reproduce when it crosses a border. Maybe that's just me. MS. MELLON: But it is a different port to actually go back and develop. You don't discuss the policies underlying all these recommendations. MR. ENRIQUEZ-CABOT: That's why this idea of changing the title of it and being specific about what you're talking about in tracing and labeling it makes a lot of sense because otherwise we're going to make recommendations on things that can have very different effects when they have crossed borders. And I don't think that's a debate if you label or you don't label, right. I think it's very different when you take a piece of grain that can grow someplace else across a border and if you take a processed grain across a border, just conceptual. MS. DILLEY: Grits is different than corn. So the specific title change would be global traceability and labeling and commerce for plant agricultural biotechnology derived products impacts and implications for the U.S. food and feed supply chain? To get more specific about what is and is not and then a further elaboration along Michael Dykes' points and Greg's in terms of this report addresses current plant-based products only, that's the last line of the second paragraph, and then elaborate on what it does and does not cover? MS. SULTON: Greg. MR. JAFFE: I mean, I guess the question is, I'm not sure whether the food and feed does it for me as opposed to grain and grain products because food and feed is. MS. LAYTON: So get even more specific. MR. JAFFE: The papayas and things like that which we really don't discuss very much, if at all in the report. MS. DILLEY: So grain and grain products did you say? MR. JAFFE: Yeah. MS. SULTON: Randy. MR. GRANT: I guess I'm just getting more and more confused because if we say it's the feed food and feed supply chain, where does the consumer fit in that because I think Carol you just finished telling me that they're not part of the food and feed supply chain. And then if we talk about grain and grain products, so we need to be very careful here and we're trying, we had a very broad title which was all- encompassing but all the stakeholders have to be part of this document. If we're going to start narrowing the scope of this document down, you know we can qualify what we're going to talk about, but if we choose to title this the food and feed supply chain, Carol where does that put you? MS. FOREMAN: Yeah, I agree with you. I like it the way it is. MS. LAYTON: Okay, I just brought it up. Then keep the title broad like it is and then just elaborate and what you do and do not cover within the text of the introduction. Everybody comfortable with that? MS. FOREMAN: I think that should be okay. MS. LAYTON: Then as we go through, we're going to make sure we've got the right words there. Because we're not going to talk papaya, right? MS. SULTON: Daryl. MR. BUSS: I was just going to note that regardless of where that definition fits, it seems to me there is significant advantages to being consistent in using grain and grain products as opposed to food and feed because food is not necessarily limited to grain and grain products. MS. SULTON: It could be meat too. MR. BUSS: Right. MS. SULTON: So we need to do another word search and make sure we are consistent in the term throughout. MR. DYKES: And that ties in with the comment I was making about food colorings, additives and enzymes. MS. SULTON: Greg. MR. JAFFE: I mean it seems to me we need a rewritten introduction that is more detailed and sort of explains and I don't think it's just as Pat says, when we go through this just sort of I'll add a sentence or add a thing here. I think we need a group or some people to go back and actually separate out the definitions and have a definition section. I mean that was a good idea from Terry, and to write a page or a page and a half introduction that talks about what we want to accomplish, what we didn't want to accomplish, what's included, what's not included. We have two paragraphs there for it, but I think we need three or four other concepts that we've talked about here that need to be included in that introduction. MS. SULTON: All right. The other big bite that we wanted to take was on the implications section before we went - - I'm sorry, Randy, did you have something? MR. GIROUX: Did we come to some conclusions about what we were going to do? MS. SULTON: Oh. Are we agreeing that we need to rewrite the introduction section to include these items? MR. MEDLEY: I think that there were two things suggested. One was whether or not we're going to be very specific, and I would say if you're going to do it in the title in terms of grain and grain products, that was one thing was raised by Daryl. The other which was raised by Greg is, irrespective of what we have in the title, that there should be a few paragraphs very up front which lays out very specifically what we're doing and not doing. Those are the two things I heard. MS. SULTON: I also heard that we needed in the introductions a discussion of definitions as well as a discussion of process. MS. LAYTON: What I heard was the following. We are not going to change the title yet. We're not changing the title. We are going to be very specific on what we are going to cover and not going to cover in both one piece of the executive summary and some additional language in the introduction including the subset of the word definitions within the introduction, and that we were going to add some process paragraphs in the introduction. From Daryl's comment I heard go back, do a word search and make sure that you don't necessarily use the word feed, because we specifically state on one of these paragraphs that we were only going to do plant- based products for one thing and that the term that we were more specific to grain and grain products in here and so that whenever we start talking about products, that we might use the terms, you know, based on a word search as we go through, make sure it's grain and grain products that we're talking about and not food in general because we're really not doing food in general. Correct? MS. SULTON: That's what I heard too. Daryl. MR. BUSS: Actually, the second paragraph of the introduction on page three, the last sentence is quite explicit. It says this report addresses current plant-based products only. MS. LAYTON: Absolutely. MR. BUSS: I mean that distinction is, it's maybe hidden too much, but it's there. MS. LAYTON: But we were not going to talk, we aren't talking papaya or we are going to talk papaya. MS. SULTON: We're not. MS. LAYTON: So we're not. So it really is not all plant-based food products current. It's primarily grain and grain products. MS. SULTON: Carol. MS. CRAMER: I just have a general question though. These guys that are involved, are there labeling traceability implications with respect to, say, papaya which clearly is and how do they compare to grain. MR. GRANT: They're basically the same. I mean, there's a distinction between meat and grain, grain products or plant products if you will, but so we use grain, grain products as the example here, but we can clearly say that the implications for grain and grain products apply to other plant- based food products as well and leave it there. And that should cover it. MS. LAYTON: Okay, so plant-based -- MR. GRANT: Food products. MS. LAYTON: -- food products is the key word. I just want to make sure we get it right, it wouldn't be surprising, given the constitution of the committee. I mean it's reflective of the committee that you use most of your examples are commodity groups. MS. SULTON: Vincent. MR. VILKER: Could I just ask what a label on papaya might look like and that includes not just whether it's transgenic, but how you would identify nutritional value? I've not seen one, perhaps others have. MS. SULTON: Terry. MS. FOREMAN: There are, in fact, labels on fresh fruit. You know, if you go to the store right now you'll find any number of fruits are labeled. The lemons are labeled. The cantaloupes are labeled, country of origin among other things and there're claims. The nutrition labeling is specifically altered for the purposes of fresh fruits and vegetables. MR. VINCENT: The other thing about the papayas, I mean, when you're dealing with whole fruits or vegetables, it's much easier and different than we're talking about commodity grains, and especially with regard to the papaya, there was specific variety that was transformed and it's called the Rainbow, and it's very specific and they can label it and you know very clearly what you have. I mean it's real easy. MR. DYKES: But coming back to the EU system. If it's papaya juice and something else that comes from Rainbow, as to Duane's point, all the rules apply. So it doesn't make a distinction because it's grain. If it's kiwi juice, it would be the same thing. MS. LAYTON: And that's good. MR. DYKES: Whether it's detectable or not. MS. LAYTON: Thank you. MS. DILLEY: So again, just to acknowledge that the focus of this is on plant-based products, most of the examples are grain and grain products because that reflects the expertise or membership of the committee, but the assumption is that a lot of these apply to other kinds of commodities. MS. LAYTON: Okay, let me ask a clarifying point. It's plant-based food products or plant-based products period. I'm asking on the subject of cotton. That's what my personal example was. Food/feed products or is it all plant-derived products. MR. GRANT: It's, and correct me if I'm wrong on this, there are some experts in the field but, my understanding is it's plant-based food or feed products. Cotton, if it's used in a food product, would be subject to the regulation. Cotton lint used in the euro, for example, is not subject. MS. LAYTON: In the paper money, yeah. Is not subject. MR. DYKES: I guess the point I was going to make is, and it's going to depend on how broad we're going to be on it. If we're going to add the papayas and the other things. But if we're not, one fix to it would be address as current plant- based products only for selected uses, therefore, and the selected uses we pulled out here in this report are primarily grain and grain based products. That helps get around that issue. MR. JAFFE: And I think we primarily do it for food. I don't really have any recollection of where in this report we talk about feed labeling or feed traceability. MR. GRANT: It's in there, Greg in a couple of places. The requirements are much lower, but it is in there. And the reason I think it's important that we not narrow it too finely is because, feed, grain and products derived from grain are the vast bulk, and this is a real-time document, so it's real appropriate to use those as the example, but from my perspective, and some of my peers being producers of minor groups, the implications that emerge from this document are very applicable to those other crops, so it's important to include them, at least by implication. MS. LAYTON: So plant-based products for specific uses, and then we're going to define those specific uses. MR. GRANT: Food and feed. MS. SULTON: So wait a minute. We're hearing two different things. You added a new phrase and we were, I thought the argument was being made to keep what we have but make clear that we were talking about grain and grain products as an example. MR. GRANT: And in the phrase that I may have added I think it was included in the context of what we were talking about earlier is that the implications that are drawn from the examples of grain apply to other food and feed products as well. MR. MEDLEY: Or they could, so could we just maybe say that in that introductory paragraph rather than, because if we don't constrain it in that way then whenever you're having discussions throughout the document you're going to have to get into how does it apply to those. If we could do that and then I think it would address it. MR. GRANT: Again focusing on the fact that this is a real-time document, it's addressing issues that we're looking at this month. MR. MEDLEY: The papaya and squash, I mean the volumes are just so low. I mean other than, you know, the papayas, the major half of the market is the U.S., the other half was Japan and so they're dealing with that but it's very different. MR. CORZINE: My comment was going to not the title, but to that sentence in the second paragraph. MS. LAYTON: That's exactly where I was reading. MR. CORZINE: Okay. I just wanted to make sure I wasn't confusing. MS. LAYTON: No, no. So we need to work on that and I'm going to hope that even a little work group maybe can kind of look at this and then maybe even show it on an LCD projector. We don't have an LCD projector. MS. SULTON: We have one up there if we just connect to the document. MS. LAYTON: That maybe show some things before we get out of here. To make sure we're all comfortable with that. Or pass it around. Something that we can see and feel comfortable with. I think that, in other words, if we can come up with this sentence about grain and grain products could apply to other food crops or whatever that wording needs to be. So I'm sort of asking for us to have a couple of volunteers think about what that word or the sentence needs to be so we can pin this down. Because if not, we're going to be here in February or March doing this again. So we have to actually have language and it's language that incorporates the whole committee and not just this work group because I think, I'm sorry, I'm not sorry to say this, but I think you guys have done so much and you're so close to it now it may be hard for you to not just go hit your head against the wall instead of trying to create new language, and so I want to offer the rest of us who are looking at with fresh eyes to try to help out here. MS. SULTON: Duane and Terry can do it. MS. LAYTON: I want you to come back after lunch with two sentences. (Discussion off the record.) MR. JAFFE: I hate to be the one to bring up process stuff, but I guess I'm, with sort of like an agenda chapter to sort of figure out what our plan is the next day and I know Pat sort of said everything's off the table, but maybe she had some idea of what was on the table. I'd like to have an understanding. I mean we could spend the next day and a half just on the traceability and labeling report and if we want to do that as a committee, maybe we could get it done. I'm trying to understand what we're trying to do and maybe, I think maybe the most efficient thing might not be to send different people off at lunchtime to do a sentence here or a sentence there. If we're spending all our time on labeling and traceability, maybe we should take the 3:30 to 5 o'clock time period. We've never had more than one comment in our history yet, well maybe one or two, and they never take more than five or 10 minutes, and maybe break up into small groups and one group might write the introductory chapter and one group might rewrite the introductory section, one group might rewrite the consumer section and things like that. That if we're deciding that, I guess, in my mind I don't understand what was the goal of this group in terms of a traceability and labeling chapter. Is it to send the committee, the subcommittee back to make these changes or so forth. I know I can't work this evening. It is the Hanukkah holiday, I'm sure that other people have other things to do. I guess I'm trying to get a feel for what is our broad plan for the next day-and-a-half. I know it's not set in stone, but get a feel for what we're trying to do both in terms of the next day-and-a-half, and also trying to get a feel for what do we mean by our goal which was at the beginning of the agenda which was to finalize the traceability and labeling report. What does that mean? MS. DILLEY: You've raised two process questions and one is a suggestion that I think people are interested in entertaining because I saw people's eyeballs go up which means they're interested in entertaining it. One is, what are we doing over the next two days, and two is, how can we best accomplish what we have in mind in terms of achieving what we want to come out of this meeting. We have to at least assess progress on both reports, but the emphasis for this morning's discussion is to push the traceability and labeling document as far as possible and closer to finalization with the caveat that the committee has committed to and fully intends to complete the full charge which is both reports. So that language you need to put in there. Your second question, so we need to at least a check of the other report and plan it. We need to set aside time to do some of that, just in terms of getting some marching orders coming out of this meeting and how to move that report forward. But the emphasis will be on the traceability and labeling report. I think your other idea of breaking into small groups and actually just getting down and doing some writing is an excellent one from my perspective. I don't know how the rest of the committee feels. We obviously need to make sure that we do diligence on public comment, but once that's completed and we know how many public comments we're going to have, we can certainly take, insist on seizing the opportunity to get as much work done as possible and maybe breaking into small groups to draft is the best way to do that. MS. SULTON: What's the pleasure of the committee? Michael. MR. DYKES: I like the idea of taking the time we need to get the traceability and labeling done because I'm with Greg, if we don't, we'll be here next December still rehashing this thing. We might even feel fortunate if we could get it done. But I like Greg's suggestion of breaking up in groups and maybe one of the things we should do, and this is a further refinement to that, at some point in time we should go beyond the general and try to break this up as we have in the individual work groups to okay, either do it by pages or do it by sections and we go through and we identify what some of these other topics may be. We've got two thus far that need a break-out, I would use the term break-out group on it. As we go through this we may decide we've got five that need a break- out group, for example, then we can divide up who wants to go with whatever break-up group and we can break up at some point and time during this two day process, come back to the full committee and here's the results of the break-out group, we kind of try to close in on those and we bring this thing down to some kind of closure. Because we're going to have to come with what the concerns are, develop some fairly specific text around those concerns and then have that text brought back here so people can review it. And if we don't condense that into something that will occur during this two days, we're going to be, the horse is going to be out of the barn. MS. SULTON: Well, my thought was it would be in two areas, the broad points that you've brought up about the document as a whole and also in the implication section where you would possibly need this work done and that the things that we come up with if we went section by section would probably would be clarification and not necessarily require that kind of a massive, you know, a break-out group. MR. DYKES: I would probably make the same assumption, but I don't know that that's accurate because as we get through this stuff we may find other points that people will have that will result in, yeah, that's right, we need to blow that up or we need to add it back to the, that too needs to be covered in the introduction or that too needs to be covered someplace. MS. SULTON: Well, it's clear that the implication section is not complete. The Committee didn't feel that they had completed and was looking for some amplification from -- MR. DYKES: Maybe that's another break out. MS. LAYTON: Okay, let me suggest this. It's five minutes to 12:00, we have a break coming up at 12:30 although we could probably take it any point in time, but at 12:30 we're scheduled for a break for lunch and then coming back at 1:30 for from lunch. I like the idea and it's probably more worthwhile, frankly, to do any writing during that afternoon session instead of public comments than it is to try and do it over lunch. Because trying to do it over lunch is awful and you never have any of what you need, and the other suggestion I have is I see at least one, two, Carol has her laptop somewhere, but I can go back and get mine, you have another one, I have the document electronically and can use the strikethrough kinds of things if we want to be very specific, so we know what we're doing. So, I'd be willing to type for people. I'm not necessarily going to give you constructive words, but I can type. So I was just thinking that might be, you know, we bring, I can get some laptops or make sure we've got four five laptops here and we'll go from there if we've got the documents on it. So, what I would suggest is that before we break for lunch, I think you said you wanted to do implications, I think that's a work group, so I'm not sure I want to discuss that right now, but I thought we might could do is we've certainly got an introduction piece. Should we then look at sort of on a page-by-page basis, is there something then big enough in a particular page that we think needs substantial work and identify those. And then come back from lunch if we cannot finish that, identify what those are and try to, you know, pin down what it is that needs to be done so that we could just work on it. MR. DYKES: I'd ask the question, they may not require considerable work, but how are we going to manage two and three word edits-- insert the word "the export of." How are we going to take care of those kinds of things? MS. SULTON: Well, we were suggesting that you could send those to us in email. MR. DYKES: If we were going to send those to you -- MS. SULTON: I really can't agree to the -- MR. DYKES: No, I don't think that works. We need to go through and do them. MS. SULTON: Michael. MR. SCHECHTMAN: I think we're going to have to get to those and those may be, you know, when we know that we have the big pieces done, you know, we will see how much time we have for those, but I think it might be important to just make sure about the large things, and I'm a little reluctant to send implications off to a work group before, since those are really very big picture things, I'd be reluctant to send those off without having the group as a whole, you know, take the temperature on each of those. I mean some of them have recommendations in them as Terry mentioned, and we want to see if those things are controversies or apple pie. MS. LAYTON: Okay, let me ask this. Is it possible for us to take, it's a page and a half, to sort of do a gut check on each of those one by one right now and then come back after lunch and do sort of this needs work or this doesn't need work, looking at an afternoon time writing session? MS. SULTON: Greg. MR. JAFFE: Two things. I mean, I agree with Michael, the Implications section, I think really we need an hour or more discussion as a group about before we then decide that there are some of them we might have a working group rewrite numbers one and two and somebody else rewrite number 6, 7 and 10 or something like that. But I think that, I mean, I think that that is something that even as a subcommittee we haven't spent a lot of time discussing, but clearly as a large committee we haven't spent time discussing and I don't want that to be short-shrifted. MS. LAYTON: So that's better after lunch. MR. JAFFE: Right. Clearly. It seems to me we should put a running, a list of things that we want, that we need to accomplish in the report over the next two days. I'm putting my own little list together, but one is rewrite the intro. One is write a consumer implication section. I think Terry raised the point about the risk and making sure we've defined that correctly. I don't think that's just a word search problem. I think that is something that maybe one could do, might do in the afternoon. Look through and find all the spots and do the editing that would need to be done in those different aspects. Fourth, I think Carole Cramer raised a good point about the minor crops and this issue, I think, to respond to that will require some changes and some language in different parts of the report and somebody will need to go through and do that. So I think if we start putting it together, a list of these things on a piece of paper as we move thing, we'll figure out some of these may require just one person to work on their own from 3:30 to 5:00. Some may require a group of two or three people to get together and then we could then come back the next day with all those proposals to work through, but those are the four I had. Somebody else may have other things we've captured. To rewrite the intro has a number of different steps and is Carol Tucker Foreman's comment about just one being of many reports, it clearly has what the scope and what is in and what isn't in this, it also has the discussion about our process, so there are three or four things that fit within that rewrite. MS. DILLEY: When you say the intro, you're talking about the executive summary and the intro? MR. JAFFE: No, I'm not talking about the executive summary at all. MS. DILLEY: Just the introduction, okay. I just want to be clear about that. MR. JAFFE: Anyway, that's sort of my, I don't want to lose sight of those, those are the things I think we've discussed to date so far. MS. LAYTON: Yeah, I think that's very good. Thank you, Greg. Do we want to break now or do we want to try to tackle a few pieces before we break for lunch, because we can take an early lunch. We can do our lunch break earlier and not violate the Federal Register notice. MR. MEDLEY: The only difference and Greg and I were just talking about is it depends upon if you want to be able to get into a restaurant and out. The earlier in this area, I think the better. That's just one factor. MS. LAYTON: Yeah, I used to work here so I agree with Terry, that the closer to 12:00 you get to the restaurant, the better off of getting out of it at a decent hour, yeah. Okay, so we're going to do a lunch, 1:15 we're going to be back here ready to go. (Whereupon, a luncheon recess was taken.) MS. LAYTON: Ladies and Gentlemen, it's now 1:20 and we need to get started, please. (Discussion off the record.) MS. LAYTON: Okay, let's get going. I'm going to remind everybody since I just turned my phone on to turn their phones off. (Discussion off the record.) MS. LAYTON: Can we get started? Now, I had a question during lunch of what was the charge of the committee, and so I asked my sources here and they said as close as they could get to a written charge is the first paragraph of the executive summary. So that's the answer back. Page 26. MS. SULTON: The way I would suggest, we have here, the work group has outlined for you 12 issues, polices, and what we're wondering is if we could kind of focus on the ones about which we have the most concern. MR. MEDLEY: Before we do that, since I wasn't in this particular group, when I see policies and issues raised and then you see the 12 whatever, what was the thinking of the group in terms of what were they putting in this section? MS. SULTON: I'll ask the group to correct me if I'm wrong, but after having written what was basically a descriptive explanatory report, there was discussion about whether or not they would make recommendations and instead what they decided to do is to outline the major issues that emanated from the descriptive report they had written. Is that Randy? MR. GIROUX; Right, Cindy, that's very close. We looked at this, this document is a very descriptive document. Within a lot of the nuances or impacts or issues that this text raised, may or may not be clearly evident, so we wanted to call those things out of the report. We wanted to say, you know, these are the issues that what's described in these pages creates for industry. Just to call them out and then, and really was kind of a brainstorming, we just kind of, what are all the issues that if we look at what the implications of what's written in these pages are, and these are the kind of issues that are raised for us and we threw them out. MR. MEDLEY: So just to make it very clear, this would be the policy concerns or issues raised by the characterization on the current state of traceability and labeling globally as it relates to food and, whatever we want to call it. MR. GIROUX: Right. That's correct. MS. LAYTON: And were they industry policies or are they -- MR. GIROUX: They are all the issues that the group threw out, so that included Greg who was on the group, so, I can't speak for Greg, he's not in the room. MR. DYKES: So, are we going with a clarification, Terry, just, because I had a similar question. This section is going to be called policy concerns and issues raised by, what did you say, Terry? MR. MEDLEY: Well, it was raised by, you know, how we characterized the current state of global traceability and mandatory labeling requirements. MR. DYKES: That's correct. By the current state -- MR. MEDLEY: Because I think what's important, though, to me is that way as we're going through these, we can -- it's not something that someone is just raising, but in fact, it does emanate from the document and what's been said here. Because otherwise you don't, you're just way out there. MS. LAYTON: Can we reiterate that then what I think I just heard a title being suggested. MS. SULTON: It's the policies and issues raised by the analysis of the current state of labeling and traceability requirements throughout the world. MR. MEDLEY: And I guess what I'm suggesting is that you simply say, the heading would be, policy concerns and issues raised. Then you would have a narrative sentence right below that which would explain what this is in terms of these are the policy concerns and issues that emanate from the previous characterization of the global traceability and labeling requirements as they impact whatever we've said before. And we just repeat that. MS. LAYTON: Period. MS. SULTON: A paragraph just explaining that. MR. MEDLEY: Yeah. And that way people -- MR. GIROUX It's clear what you're reading then. MR. MEDLEY: Exactly. MS. SULTON: Okay, so with that as background. Well, what we wanted to do, because some of them kind of fit together, what I was going to suggest, some of them not, they're related. Perhaps if we went through and we could begin to cluster the ones about which people have ideas or concerns. And Daryl, do you? MR. BUSS: Well, along that line, it seemed that number 1 and number 3 were really addressing substantially the same issue. It can either be combined or -- MS. LAYTON: Together. MR. BUSS: Yeah, it didn't seem obvious why there'd be two separate issues. MS. SULTON: You almost, you're suggesting perhaps that you deduce 1 from 3? MR. BUSS: Well, it seems that number 3 to me was already implicit in number 1. MR. JAFFE: I mean that was my, I had the same sort of question. I mean, number 1 talks about variability and number 3 talks about complexity, and are those different concepts? They both talk about them sort of relating to inefficiencies and costs. So the question is, are they really two concepts or not? MR. GRANT: I would say they're related. I mean they are variable and they are complex. They're both. MR. OLSON: Number 1 talks just about commodity trading, so we'd have to pick up the concept of the supply chain in number 3 and get that into number 1. MS. LAYTON: You could actually then, couldn't you just take that sentence at the end? Could you add the sentence number 3 at the end of point number 1? MS. SULTON: Terry. MR. MEDLEY: I think it's, the concern that I have is that the way in which these are phrased, it isn't clear to me what we're saying as the concern of the issues, and I'll just give an example. If I look at 1 and 2, basically an issue that's raised is that one, these regulations vary from country to country. Two, that they are complex, and the policy issue which seems to be raised here is there's a lack of international harmonization as it relates to such requirements. To me that's what I read in those two. I think the symptoms that, you know, variability imposes inefficiencies and costs are not necessarily enhancing safety is in fact someone's judgment about the system. Now if you were to change it and say, you know, a variability that isn't conclusive but tries to raise that, you know, an issue of whether costs are associated with this, but it seems to me that the clear statements of the issues are the regulations vary, they're complex and the policy issue is that there's a lack of international standards. MS. LAYTON: So it's variable and it's complex, therefore we should think about harmonization. MR. MEDLEY: Well, there's a lack of it. And I mean, what we want to do, I don't, you know. That's going to be a judgment call. But to me that's what this raises. MS. SULTON: So basically what you really are talking about is just rephrasing this to make it clearer. MR. MEDLEY: And not putting in subjective. MR. JAFFE: I mean, I agree with Terry completely, but I wouldn't say he's just rephrasing it to make it clearer. MS. SULTON: Then tell me. MR. JAFFE: He's eliminating a lot of what are subjective statements that flow from these more factual statements that Terry's going for. MS. SULTON: Randy. MR. GIROUX: That said, I like the approach of looking at each one of these individually because we didn't create a distinct format as we laid these out, but sort of to lay out what are the factual statements here that we agree to as a committee, and then if there is a policy recommendation statement that we put that as the last sentence. So we don't, we try to tear them apart. The factual statements, and make them, put them in logical order and try not to tear apart the intermingling of the facts with the policy. That might help as a committee on what we agree on, what we don't agree on and how to fix it. MS. SULTON: With that in mind, Terry has rephrased number 1, does that seem to make sense to the committee? There are two basic facts and we'll subtract out that value judgment. Randy. MR. GIROUX: I'd like to make another recommendation and that is, that instead of us as a whole committee trying to wordsmith each one of these individually, we can do that, that's fine, but another option might be for us to look at them just quickly and, you know, are they okay as they stand, do they need major revisions, do they need minor revisions and then create some buckets. And then, because the ones that need major revision, then it might be useful for us to send those at 3:30 or after the public comment to one of the committees to rework them or some, just trying to make most, efficient use of our time here. MS. SULTON: So, with that in mind, does number one fall into minor revisions? Greg. MR. JAFFE: I don't know what minor versus major means. I would consider this one a major revision. What Terry said was a major revision. MS. SULTON: By that meaning whether we need to go to committee, we need to have a work group to rewrite it. MR. JAFFE: I would say yes, number one needs a work group to rewrite it. I would say that's a major. Easily rewritten, but needs to be done. MS. SULTON: Okay. Easily rewritten but needs to be done is a bucket. MR. DYKES: I mean because we basically got the tenets there, just needs the words put around it. MS. SULTON: Okay, and Angela got part of those down, I think. Number 2 then. Sorry, Greg. MR. JAFFE: And I have another question sort of related to number 1, 2 and 3 just so it's clear in my mind. Number 1 uses the word country. Number 2 and 3 used the word markets. I always think of labeling requirements as a country- specific thing not a market thing. So I don't know if there was a reason when people drafted these. So number 1 talks about differences in labeling varying from country to country, and number two talks about different labeling regulations in different markets. Number 3 talks about different markets, I would suggest using country unless there was a specific reason why we were using markets. MS. SULTON: I think it was just probably, your point's well taken. As countries, it takes a government to put together regulations, not the market. Anything else on number 1 or number 2? MR. DYKES: On number 2 the requirements are often uncertain and I would replace "or" with "and." I don't think it's an either-or situation. MS. SULTON: Uncertain and rapidly involving? MR. DYKES: Yes. Daryl. MR. BUSS: Since we're talking about 1 and 2 and to the extent 3, I guess I'm wondering if at least a portion of number 6 doesn't belong clustered with that group as well. Because all allude in varying ways to harmonization or differences. MR. DYKES: My sense is I'd take number 6 to be more along the lines of sampling and testing than I would be, while it's got the word harmonization in the sentence, I think it's going more to the points about testing and sampling. I'd see it as different, but -- MS. SULTON: I think so. Seeing heads shake in agreement with Mike on that. Maybe it would logically follow in order. Terry. Keeping the harmonization of regulations and then of testing protocols. Terry. MR. MEDLEY: I guess I have just a question for the drafting committee, and my question is, in the second part of 2, we say that these uncertainties plus parallel ones associated with international treatises create difficulties. And difficult to me is not, I mean it's not very descriptive. So is there some way we could, I mean what was meant there? Is it additional delay, it's additional requirements, is it, I mean, I'm just trying to get a sense around the word difficulties. MS. SULTON: Greg. MR. JAFFE: I also was going to have the same thing with the word uncertain. And these requirements are often uncertain. It seems to me that's, I'm not sure I understand what that means. If there's a way we can sort of clarify better what we mean by the uncertain. They're not clearly spelled, are they, and they're not transparent, they're not defined enough. I mean I don't know what is meant by they're uncertain. MR. DYKES: I wasn't on the work group, Greg, but as I read that uncertain and thinking back to the text, I think so much of this is a broad outline they can put forward, but the actual implementation on how it's going to work is still uncertain. Many of the details, especially in the European system, some of these grandfathering provisions are still uncertain. So I didn't have any problems with the uncertainty because that's the point of view from which I read it. Again, I'm not on the work group, so others in the work group may have had a different take. MR. MEDLEY: I mean I understand that, I mean, because it seems to me then what you're saying is, since the requirements are constantly evolving, enforcement, compliance, you know, it's made more difficult because you don't know exactly what the requirements are. MR. DYKES: Absolutely. MS. SULTON: So we'll put this one in that needs to be rewritten but fairly easily can be done. MR. DYKES: Well, I think the only question we're down to is what do we mean by the word difficulties -- MR. OLSON: If you captured what Michael said that solves the uncertain issue, defines it cleaner, and then it's just a matter of picking up with what do we mean by difficulties. I don't think we need to send it on. I think it's being solved. MS. SULTON: It's a procedural burden, is that what you mean? MS. DILLEY: It's the challenge of complying with a moving target. MS. SULTON: Greg. MR. JAFFE: I mean I take what Michael said. I think, I guess what was troubling me in part was the first sentence, which I'm not sure even needs to be in there. Followed by the sentence because not all of them are necessarily uncertain and the fact that they're different isn't what's leading to the uncertainty here, it's the fact that they're not defined or clear or how they act in practice, so that's what was confusing to me was the whether we use different twice in the sentence before and then we get to uncertain, so I think we need to get rid of either the first sentence or say for some of these regulatory systems -- MR. OLSON: That's right. I think we cross out the first sentence and start the second sentence one with some instead of these. MS. SULTON: Some labeling and traceability requirements are uncertain and are -- MR. OLSON: It's whatever term Michael used for uncertain. MR. SCHECHTMAN: Does unclear, is unclear better than uncertain? Does that, or do you want the longer explanation. MR. JAFFE: No, because it's, the impression I got from Michael and others is it's not the fact that they are unclear, it's that in practice they may not, it's how they're carried out in practice. I mean there's a law in the EU, I mean, so, some people would argue that's not unclear or not uncertain, they do say you've got to label this, you've got to do that, but what I understand here is, when one goes to take those and put them into practice there are a lot of uncertain - - a lot of questions that's going to arise, so whether we say some labeling and traceability requirements when implemented raise many questions or raise a lot of uncertainties or something, but just to say they're uncertain I think will be criticized and said no, there's a regulation there it's quite clear on its face what you're supposed to do. MR. DYKES: Maybe Greg as -- one suggestion is we take what Ron said is, some T and L requirements are often uncertain and are rapidly evolving. Then you say, maybe the next sentence is the implementation of these raises additional uncertainties or something to get to your point for that second sentence. MR. JAFFE: Why make that uncertain or rapidly evolving because one doesn't know how they're going to be implemented or the implementation of them is, you know, something. MS. SULTON: Duane, did you want to make another point? MR. GRANT: I think they've, no, I think they've got it. MS. LAYTON: Okay, what about the difficulties word? MS. SULTON: Create difficulties for production marketing and trade. Is it difficulties or obstacles? UNIDENTIFIED SPEAKER: Do you like the word challenges better? MS. LAYTON: I like challenges but, or is it commercial risk? MR. GIROUX: Could be unclear signals. MS. SULTON: What, I think, you're getting to impacts now aren't you? MR. GIROUX: I think Pat's suggestion of commercial risk is probably the operable word there, that is what the difficulties are around. MR. DYKES: Challenges is fairly broad that may encompass all of those different things. MR. MEDLEY: So are we finding a word for difficulty? MS. SULTON: Yeah, are we just getting a synonym for difficulty? MR. DYKES: A synonym for difficulties. By definition your point, Terry. MR. MEDLEY: It is. It's not just a word change question. MS. SULTON: We want it explained. MR. MEDLEY: It's a more substantive of what are, what are the impacts that we're saying this is having. MS. SULTON: So example. MR. MEDLEY: Does it make compliance more difficult? Does it make movements more difficult? I mean, just specify. MS. SULTON: Greg. MR. JAFFE: I guess I'm, I don't love the phrase plus the parallel ones associated with international treaties, I'm not sure what, what is the parallel there? What are the parallel ones? What are we talking about? That's such a broad statement, international treaties, parallel what? Are we trying -- MS. LAYTON: You just said what it was, it was the implementation of the, how you do international treaties of what the parallel would be the first statement we make. MR. JAFFE: What international treaties? Are we talking about Biotech Protocol? Are we talking to -- I mean, there are lots of international treaties. MS. LAYTON: The ones that were described in here. MR. JAFFE: Well, now Codex is not an international treaty, that's described in here. The IPPC is described in here but I'm not sure we're talking about that one. So, I mean -- MS. DILLEY: Who were you talking about then? MR. JAFFE: I didn't write this. I thought they were talking about the Protocol. It would be nice to have a factual statement here about -- not just say parallel ones in terms of treaties, but say what is the, I mean, -- MS. DILLEY: What's the requirements associated with X, whatever -- MR. JAFFE: I mean it would be, let's say the fact that the Protocol hasn't been implemented yet by countries or something, but say, I mean what's causing the uncertainty here? Is it just the Protocol? Is it the Protocol itself the uncertainty or is it the fact that the countries haven't, is it the fact that the Protocol's uncertain or is it the fact that the countries haven't implemented the Protocol? It's how they're doing it, what's leading to the uncertainty. MR. MEDLEY: It's both of the above. I mean the ProtocolÕs still have provisions and if not, then explain or clarify it. It's clear. There are things that are still quote "in brackets." MR. DYKES: Maybe it's as simple as saying what's the parallel ones associated with the Biosafety Protocol, however it's referred to in here. Maybe just define international treaties in this text here. Maybe just put in Biosafety Protocol. MR. MEDLEY: Because that's too broad. The international treaties is too broad. This context you talk about, the Biosafety Protocol and there are provisions in the Protocol that have not been established or -- MR. JAFFE: I'd rather say something along the lines of that -- I guess I'm more concerned with the, well the parallel ones and the international treaties, so we just defined it by Protocol, that's better. Instead of saying parallel, but saying something to the fact of that the Protocol has not yet well defined the labeling. MS. LAYTON: Okay, what I wrote down as I was scribbling notes was, plus the requirements associated with the BSP and its implementation. MR. JAFFE: Well, it's not just, it's not the BSP, it's specifically the labeling. MS. LAYTON: So plus the requirements associated with the BSP -- plus the labeling requirements associated with the Biosafety Protocol. MS. SLUTSKY: I think you need to say documentation requirements. There are no labeling requirements. MS. LAYTON: Plus the documentation requirements associated with the Biosafety Protocol and their implementation? MR. DYKES: I don't know if you need and implementation. I just think once you know what the requirements are, the others will follow, I would think. Maybe not, Greg, maybe it doesn't suit you, I don't know. MR. JAFFE: I'm sorry, I wasn't -- MR. DYKES: The question is, is do you need to say, once you say the documentation requirements associated with the Biosafety Protocol and the implementation of Biosafety Protocol or is it sufficient to end it at Biosafety Protocol? MR. JAFFE: You can identify it -- MR. DYKES: To me it's almost inherent once you kind of know what the documentation is, you're going to be closer toward what that is. MS. LAYTON: Okay, create commercial risk for the production marketing and trade of grain and grain products. Create -- MR. DYKES: Again, back to the comment Terry made this morning on risk, number 3 there as well, because you've got risk listed there. I would say commercial challenges and not use the work risk. MR. JAFFE: I think that's good. MS. SULTON: Daryl. MR. BUSS: I think this is really a minor point, but I'm wondering about the advantages of substituting increase for create. Create implies there would be zero otherwise, which didn't seem to be realistic. MS. SULTON: So the increased commercial challenges. Do we have to explain challenges here? All right, is that it for number 2? Number 3 we've already done. Did we decide that we wanted to put it with number 1 and rewrite it or did we want to look at it separately as Randy suggested, I think. Do we want to look at it separately or we can combine it? MR. GRANT: I didn't suggest that. MS. SULTON: Okay. I misunderstood you. MR. DYKES: I'm fine with combine it. I would like to delete the word "and risk" following cost. Again, to be consistent because I think we use that, I don't think it detracts from the meaning of the sentence. MS. SULTON: Any objections? All right. Then we can move to number 4? Industry grappling with the impacts of complying with biotechnology-specific regulations governing product characteristics that cannot be detected. MS. LAYTON: Are we talking product characteristics or are we talking about genes? MS. CRAMER: Characteristic, well. MS. SULTON: I couldn't hear you, Carole. MS. CRAMER: You have a corn oil that is from a BT corn, if you take that oil and try to test and detect it, you don't see it. MR. DYKES: I think itÕs characteristics. MS. SULTON: Greg. MR. JAFFE: In that first sentence I would change the word regulations to labeling, because that's really what we're talking about here. MS. SULTON: So labeling requirements complying with labeling, biotechnology specifically labeling. MR. JAFFE: Labeling. MS. SULTON: You should comply with labeling requirements? MR. OLSON: No, just labeling. MS. SULTON: Just labels, okay. MS. CRAMER: Isn't it all, well. MS. SULTON: Yes, Carole. MS. CRAMER: Isn't it also an issue with respect to traceability which is if you've got a testing system that is supposed to somehow measure the transgene product and you now have oil that doesn't measure it, but you're still required to meet certain traceability requirements, that does remain an issue, so it's not just a labeling. MR. DYKES: I'd agree with Carole. I almost think we'd be better just to leave it as it is rather than, because if we do that then we have to do the word traceability and labeling biotech-specific, which is what the chapter is about. I'm fine with doing that, but I almost think -- MS. SULTON: Greg, go ahead. MR. JAFFE: I guess by biotechnology-specific regulations to me means safety and a whole bunch of other things, and I don't see industry having trouble with doing those and so, I mean. MR. DYKES: Well, like I say, if you want to put complying with traceability and labeling biotechnology specific regulations. Because that's what the chapter is about. MR. JAFFE: That's fine. MS. LAYTON: Okay, so traceability and labeling biotechnology specific regulations governing product characteristics that cannot be detected. MS. MELLON: I think that biotechnology specific should go first. MS. LAYTON: So biotechnology specific tracing and labeling regulations governing product characteristics that cannot be detected. MS. SULTON: Terry. MR. MEDLEY: It just seems that then this should be one sentence. I mean the issue basically is that the new challenges, the new challenges for the marketplace caused by what you just said. I mean, isn't that what we're saying the issue is? I'm trying to say why do we have two sentences? I mean what is the issue? The issue is that there are challenges that are created for, as we're calling, the marketplace because of these requirements which require certification on characteristics that cannot be detected. And that's what the issue is, right or not. MR. JAFFE: That's my question also because when you look at the second sentence, I'm not sure the word new is really needed. That goes as challenges, I'm not sure they're new challenges, but I guess for me the question here is, is it the fact that they're government-imposed, that's the concern here, because we have process certifications. I mean, radiation and a lot of other things have process certifications that organic is process certification and things like that. I mean, is the concern here that it's, I guess, is the emphasis is because it's government-imposed or is it the emphasis here because you can't detect it, you can't detect organic, you can't detect irradiation, things like that. So what is, I'm grappling with what is the sort of the issue here, what's the pressure point? MR. MEDLEY: Well, I think that, and again, not being on the group but taking your examples, with organic if there are, there are certain things that you can detect such as pesticide residues, et cetera. I mean there is, physically you can do it. With radiation it does change the structure somewhat, but here they're saying, you know, processed oil. Currently now we do, with no detectable DNA, what are you supposed to do? I mean, I thought that was really the issue. It's imposing a requirement where there's not a technology to comply with it. MS. MELLON: No, but there are, I mean there detection technologies that are associated with radiation, people don't go around detecting whether products were irradiated. I think the response is that because you can't detect it you put in place of a certification system. One needs those certification systems the way, you know, rather than by testing products, by getting assurances, you know, through the chain that the product was treated in a certain way. The question is are those uniquely challenging. MR. MEDLEY: But I think there was a new requirement, you currently right now can look at basically what's going on even though it's not perfect, you have places by which detection occurs and you're able to certify or not certify. The situation here, with these highly processed products and what's being required that lack the DNA, even if you wanted to, so what you're forced to do is to go to a goal system of IP which is a totally contained, which is a challenge. I mean it definitely is. MS. MELLON: It is a challenge in this context. I mean you would never say organic, you know, IP kind of goal standard IP as a challenge in the context of organic. That's the whole point of organic. So here, are we saying that it's difficult on top of other requirements? It's difficult because it, why is it difficult here? MR. MEDLEY: Okay, I can, I mean, I spent a lot of time on this issue. First of all, you have to go back, the perfect system would start with the grower, there would be certain training, there would be certain, you would track the seed, I mean it is a very different type of system if you want to comply with this particular standard. It's a very different system. MS. MELLON: No, I know it's difficult, I just don't know why it's, what the issue is that it is. MS. SULTON: Randy. MS. MELLON: More difficult than an alternative. Difficult, it adds costs that aren't justified. MR. MEDLEY: Well, I think it's going to require new and different IP systems. MS. SULTON: Randy, do you want to respond? MR. GIROUX: Just a few comments. So what Terry is saying is correct, and I think it provides new challenges particularly in the areas of oils or products that are nondetected and produced in commodity systems. When we have products that are nondetectable, how do we develop identity preservations that pass the red face test around, that you actually did it. You can get a piece of paper, but how do you verify, how does a country that its legal requirements have no rights outside of Europe, how do they verify that the oil that was sent to them was sourced from non-GM, through identify preservation programs, and how do they verify that in their domestic country? And so the challenge then becomes an enforcement and compliance question or something, but then also, what are the requirements in documentation and this is a new challenge. It's clearly a new challenge because there are things that are not clarified. There are things that have not been interpreted in those regulations and so, it is, it is unclear and because of the nature of the products that this impacts, they do create new challenges. Although detectability or not detectability. MS. SULTON: Mardi. MS. MELLON: I mean, I think I understand, you know half of, we might say well, the lack of detectability ought to make things easier. People can't say whether they're there or not, and therefore, that uncertainty in some ways should, you know, in some ways sort of facilitates the commerce. But what I'm hearing is that somehow you need to go, it's because of the commercial acceptability standards at the end of the chain that people won't, you know need to have something more than apparently what's even required in order for them to be assured that the products meet these standards. Is that it or is it? I mean, are the third party certification systems in place? MS. DILLEY: Sounds like the whole system integrity issue and how do you establish it. MR. MEDLEY: There's some of them that have third party certification, but one of the questions that that raises is whether or not X country will accept a commercial independent third party, as opposed to a government certification which you don't have. I mean, there are just a lot of issues that are raised when you don't have the capability to say this is how we've complied with this new requirement. And your suggestion is right. If that's the way it would work at the end that well, no, you have to prove that it is, unfortunately the standard is you have to prove that it's not. MS. SULTON: Ron. MR. OLSON: I would agree with what Terry's saying. I mean, if we buy a product, if we're making a product from an oil that we can't detect and we are declaring that that product is GMO-free, we are going to require the person selling us the oil to provide us total documentation how they derived that oil because we're not going to take the risk of some, a third party group going back and saying ah ha, General Mills, we've discovered you're using oil that really was derived and so therefore your products are out of compliance. We will not take that risk. So we will require, and I can use Randy as an example, we'll require Cargill to give us all the test results on the corn that they derived that oil from and all their processes and how they ensure that it was non-GMO. Because we can't test and detect it. MS. MELLON: Right. But that's what I was trying to kind of -- I'm trying to grapple with is that the problem is that you're, is that you're going to, it's not those requirements have been imposed on you to actually do that third party certification, it's that there is some more general requirement, whether it's commercial or legal for you to show that the stuff is GM-free and that you feel that the only you can do that is by kind of constructing this new third party certification system. MR. OLSON: And I think part of it is how the Europe, is going to define traceability. They said they want trace back, but they don't say from where to where. Do you want to trace it all the way back to the farm or just want to trace it, that this came from the United States period. Is that good enough or do you have to trace it, which railcars, which trucks, which elevators, which farmers. How far back do you have to go to prove that the system exists? So that's unclear when you sell in Europe. They say trace it, but trace back to what? Where to where? MS. MELLON: Those were real uncertainties. MS. SULTON: David, did you have a comment? MR. HOISINGTON: Well, I was just going to say that it seems like this is, I mean this issue and the one on harmonization of testing and there's a few others that I see that relate to this whole issue of how do you test through the whole supply chain, is what you're talking about. If you start out with well how do you actually test a sample of grain for the presence of a transgene or an event, but now we're all the way going to the end of the food chain and saying how do you test where you don't even have that transgene in the product. So it's all just a matter of, testing a plant in the field is pretty straightforward, although we know there are a lot of issues around that. Testing grain that's been shipped around the world is another set of issues, and you got the final one which is you've got to test your product where that gene doesn't exist, or even the product of that gene. So it seems like maybe we need to wrap these together because it's just, really it's more a matter of how you detect. MS. SULTON: How do you detect or how do you certify? MR. HOISINGTON: How do you detect and then how do you prove it? MS. DILLEY: Part of it is how do you prove a negative. MR. HOISINGTON: Yes. Which you can't do usually. MS. SULTON: So that may be, is that the sum of it is how do you prove a negative and then explain from there? MS. MELLON: It seems to me that in some commercial context that the standard that's being demanded is basically the absence of something and you have to figure out a way in a commercial, it's really more in a commercial, but maybe in a, because you had commercial legal setting for proving that something doesn't exist and that in many cases that's the driving, the food chain to develop its own kind of certification systems because you can't, you know, because there's no available technology, detection technology that would enable you to assure someone that something doesn't exist. MR. DYKES: I think that's well said. MS. SULTON: Randy. MR. GIROUX: Right. I would just second Mardi, you are correct. This is a commercial issue because legally it's when it's placed on the market. And the first time that it's placed on the market is in Europe, if we talk about European labeling and traceability. And my obligations on sending something to Europe is to label it or not to label it, or to label it product X derived from genetically modified X and if there's not in part any legal requirement on me to provide documentation back to the farm. I guess that's my interpretation of the law. MS. SULTON: It sounds like this is one that would go into the bucket of taking, requiring some significant work to rewrite. MR. GRANT: I don't' think so. MS. SULTON: Duane. MR. GRANT: I actually think this one is pretty clear. From everything I heard, the industry is grappling with how to address the issue and we've heard a lot of different interpretations of how that might be done, different ideas kicked around about, even different systems that are being evolved to address that, but frankly, we don't know the right direction because nobody's going to know when we're in compliance and when we're not. MS. SULTON: Well, if we left it as it was with the changes that were suggested, it would be industry's grappling with the impacts of complying with biotechnology specific tracing and labeling regulations governing product characteristics that cannot be detected and government imposed process certification requirements pose challenges, not new challenges for the market place. MR. GRANT: And I would just leave it just like that and then deal with number 6 when we get to it because that is a little bit different issue. MS. SULTON: Are we having all nodding heads here, okay. Number 5. It's one about acceptable zero versus absolute zero. MR. OLSON: I would say number 5, it's approved and unapproved, but that's both. MS. SULTON: Approved and unapproved? MR. OLSON: Because you're going to market a product non-GMO it might be an approved event but you still want to market label it non-GMO, you're dealing with how do you have an adventitious presence or tolerance or something on that product. MR. GRANT: Ron, I would just, we get into that a little bit in number 7. I wonder if they are two different issues. MS. SULTON: 5 and 7. MR. GRANT: Yeah. In 7 you get into the effect of zero tolerance to avoid exceeding guidelines. You want to make zero claim. MS. LAYTON: Okay, so is the real issue in number 5 that there is no way to define that absolute zero can exist? I'm just asking because I don't know. MS. SULTON: As I recall -- MR. GRANT: From my perspective, the issue in number 5 is that absolute zero is, and frankly doesn't exist, and if you have an unapproved event, that event is illegal in any market. Whereas in number 7 you can have an event that doesn't, that can't meet the absolute zero claim and can be marketed in certain markets. MS. SULTON: Greg. MR. JAFFE: I agree. I mean I was going to raise the same thing Ron raised which is the way at least 5 is written, I think you need to include unapproved events if you're getting rid of the second sentence which I think is what Terry had recommended earlier today, then you could have a different -- 5 could just address unapproved events and 7 could address approved events, but when you put, link that second sentence of having this presence policy, from my perspective that includes both of those scenarios and so, then it looked like the first sentence was missing something. The other thing I just would get rid of such issues as, I mean, if 5 is going to talk about unapproved events, we don't need that qualifier. MS. MELLON: I think we should, I mean, I think a statement like industry's grappling with how to deal with acceptable zero versus an absolute zero doesn't, you know, kind of have much context. We really need what Duane just said, you know, unapproved biotech events are illegal in all markets, and it's in that context that, I mean then I think it makes sense to say industry's grappling with how to address, you know, the differences between an acceptable zero and an absolute zero in this context. MR. OLSON: I'm going to add that, using StarLink as an example, the milling industry is saying how much longer do we have to keep testing corn for StarLink. Because Canada has announced we're not going to test anymore. But in the U.S. we don't have that option. We have to test every load of corn yet for StarLink, and the question is, do we ever reach a point, I don't think we'll ever reach a point that StarLink is gone. So the question is, is there an acceptable level of StarLink that is allowed in the food chain before it's illegal or whatever the right term is. That's what I would call acceptable zero. MS. MELLON: It is a perfect example and I mean, all I'm trying to say is that that kind of general notion of what's an acceptable zero has to have a context and you know, the StarLink example is a perfect context, the kind of general notion of dealing with unapproved products that are unapproved in all markets, everywhere, that becomes an issue when you know it's very hard to reduce these things to absolute zero, but I just know all I want is some statement of context and both of those are perfect. MS. SULTON: Okay. Greg. MR. JAFFE: I agree with Mardi and Duane and everybody about rewriting this a little more of context, I would just say, Mardi just raised one thing that I think is not correct which is that, there are countries that do allow certain levels of unapproved events. Europe did things, there were things that went through their food safety, but they had a, clearance was assigned to a committee but didn't get approval, so I just want to be careful that we accurately portray what, if we're talking about multiple markets or are we just talking about the U.S. that's one thing, but if we're going to make a statement, and it's unclear whether this one is, I thought this was only talking about what's happening in the U.S., but we should make clear whether this is only, because other countries do have different policies about what might be, what would happen with an unapproved event. MS. LAYTON: Okay. So let me get to the bottom on here, we still need to rewrite. MR. JAFFE: Yes. MS. LAYTON: Okay. Can we move on? MS. SULTON: Are we rewriting it alone or in combination with 7? MR. JAFFE: We haven't got to 7 yet. MS. SULTON: Haven't gotten to 7 yet. Number 6. Greg. MR. JAFFE: I'll start. I guess the only thing that struck me in this one was the words "downstream parties," like I said I would like those to be defined. I'm not sure what they mean by members of the food and feed chain here, are they talking about governments, because we are talking about harmonization and testing results. I wasn't sure, I wouldn't consider government a "downstream party," but I didn't know if we were talking about governments here or who we're talking about when we say "downstream parties." It would help with that being clarified. MR. OLSON: I would say downstream parties because you check at the farm, you check at the, I mean, you've checked about six or seven different times throughout the chain. MR. JAFFE: Can we say "downstream members of the food and feed chain?" MR. OLSON: Sure. You could define it that way, but the problem you run into and I think it can be tested, you know, complying, complying, complying, complying then when the boat arrives or the unit arrives or the truck arrives it's not in compliance and we reject it. Because our test shows that it doesn't comply. MR. JAFFE: I understand the concept, I'm just, the word "parties" to me, we haven't used that anywhere else and we always talk about members of the food and feed chain. MR. OLSON: The various members of or the various levels of or something. MR. JAFFE: I didn't know here whether we're also talking about governments, because if you want to talk about governments, I wouldn't consider them a downstream party necessarily. MR. OLSON: Then we need to say or governments, or and/or governments. MR. GRANT: So I would be fine with the food and feed supply chain but I do think it's important that we also include compliance and enforcement testing because that really is the last place where these things can and may be tested for compliance. So maybe we have to include food and feed chain and enforcement and compliance activities. That something that'll work for you, Greg? Because that is a significant risk. MS. SULTON: So members of the food chain and enforcement of compliance agencies officials. Anything else on number 6? Randy, is your card still up? MR. GIROUX: I'm not sure where we are on 6. MS. SULTON: Well, we've spent a lot of time, we talked about downstream, we added the concept of enforcement and compliance which gets to government. MS. LAYTON: And is it predictability or accuracy on the second sentence? Industry is facing difficulties because the predictability of testing along the supply chain is poor or the accuracy of testing is? MR. GIROUX: The correct word is predictability. MS. LAYTON: It is predictability. MS. SULTON: Is this where it varies from, one place you get one result and you test the next place you get another? MR. OLSON: That's correct, because a lot of times you destroy the sample when you test it, so you can't test the same sample. MR. GIROUX: Clearly the issue is that if I tested here I want predictability that if they tested there and they will get the same answer. Whether or not that's an accurate answer can be important, but it's from an industry perspective the issue is more can I predict this number here will mean that number there. MS. SULTON: Isn't that in sampling theory, would that be like reliability? MS. MELLON: I think it's more like reliability. You want reliable tests so that every time you do them you get the same answers. MS. LAYTON: It's accuracy and precision. MR. OLSON: If it's right it's predictability. MS. MELLON: Well, then I think it's important just to say that, you need methods that used one place will achieve some other results used elsewhere or further down the supply chain. MS. SULTON: Okay. Carole and then -- MR. BUSS: I think there are two different issues, one of which is reproducibility of the method of the test and what I was thinking from Ron is that's probably less the issue than the fact that you're testing different samples. And so it's more a sampling issue probably than is aspect GC reproducible it is. That you're doing the different sample at any point in time. MR. GIROUX: I would agree that the total predictability, the total variability in the methods is going to be your analytical method of variability plus your sampling variability, plus other variabilities. If those are all added up and all, when you put them all together in a bucket and you shake them up, it's based on how much variability is there, can I predict that this number here will give you this number. And that's the essence of the need is testing grain or testing corn chips at the end of the chain, they may not be the same number. But at least I can predict what the number will be. I may have to modify what I do here to make sure I can do this, but I can predict this number is going to give me this number. MS. SULTON: Terry then Carole. MR. MEDLEY: I'm struggling just a little bit because I'm hearing a lot of different things. When I read number 6, and I tried to see what I thought were the issues, I saw two very distinct things. One was the fact that even if you had a validated sampling and testing protocols that those difference, so there should be some harmonization on, you know, kind on a more global basis of what those are. That's very different than what you talk about in number 8. The second thing I saw in terms of number 6 was a question that, you know, which results take precedence and there I think it's going back to where it happens in the chain. I mean, ideally what you would like is testing at origination and so you would say it's been tested, that one controls, however, that's not what's happening in a lot of places. It's like, well, you test fine here, you get there they do another sample or someone throws something in and now test is positive, so I mean, I see, those are very different issues and to me, I don't think we have just carved out just what are the specific issues that are raised here. So one is lack of harmonization and two is the whole issue concerning, you know, which test takes precedence, origination, destination or whatever. And we should probably kind of say those. MS. MELLON: You mean the test at which point in the food chain, because I thought you meant whether it would be a DNA test. MR. MEDLEY: No, no. I saw that that was when we get down to 8. You're right, I first I thought what they were talking about is it genetic based or -- MS. MELLON: Right. MR. MEDLEY: But then I read and I realized no, it's point in the chain of testing. MS. SULTON: Carole, did you want to make a point? MS. CRAMER: No, that's okay. MS. SULTON: Randy. MR. GIROUX: No. MS. SULTON: So we need to rewrite this to focus more on the point in the food chain or testing at different points in the food chain. Predictability with all the variables is an issue when you test at various points in the food chain. MR. MEDLEY: This is not particular or unique to biotechnology. If you look in agriculture, there are a number of countries that pay significantly for the U.S. to have inspectors in their country and do certification at origination simply so you don't have these issues upon arrival. MS. SULTON: Greg, are you? MR. JAFFE: It's not about this one. Before we move on to the next one, I just want to make one general comment that's on my mind before I forget it. MS. SULTON: All right. MR. JAFFE: In carrying on the discussion, I mean, I think we said it before, but I think it's only, and I want to make sure it's captured in the introduction when the group goes to write that. Which is that this report is for a current snapshot in time and so, I think we do need to put somewhere in the introduction that this an evolving area and this report is really a snapshot in time and is talking about the current state of these testings and things like that. Things may change tremendously as we move forward. And so, just a concept that I think needs to be captured in the intro to set the stage for all of this so we don't say it in each one of these recommendations, but they are what is the current situation now in December of 2004 or January 2005 whenever this comes out. MS. SULTON: So another note for the intro? MR. JAFFE: Yes. MS. SULTON: Carole, your card is up and then Lisa. MS. CRAMER: This is sort of still on 6. The word I was thinking of before is validation from the point of view of testing protocols which is a pretty extensive concept say in pharmaceuticals, but would we capture some of sort of the issues if we just say harmonization and validation of sampling and testing because part of it is that you would like there to be a standard that's acceptable. That if you get this test done at this place and that carries through the chain. MS. MELLON: I think that's number 8. MR. GIROUX: That's what I thought. Cindy, I'd like to make a recommendation. MS. SULTON: Yes, Randy. MR. GIROUX: We park this one and take this one and do a rewrite on it. I understand and I have some thoughts on how we can make it very clear that addresses what Terry wants, what Carole wants, so why don't we park this one and we'll work out alternate language? MS. SULTON: Is everybody okay with that? All right. Then we'll go to 7. MR. JAFFE: I was just going to pick up on the word guidelines. I don't know what's being referred to there. I mean, I'm not sure that is the correct word we're talking about. MS. SULTON: Thresholds. MR. JAFFE: Are we talking about regulations? Are we talking about commercial expectations, I don't know what, but guidelines to me is always, is a government, usually in this kind of context and this kind of report one would think of guidelines as government guidelines or guidance or something like that, but I'm not sure that's what we're referring to here, so I don't know what we're referring to when we talk about guidelines. MS. SULTON: In the context could it be thresholds? MR. JAFFE: Are we talking about commercial tolerances? Are we talking about government-imposed tolerances? What are we talking about here? MS. LAYTON: I didn't understand the first sentence. I mean, I don't understand how the commercial market place is struggling with varying concepts of what constitutes genetically engineered versus non-engineered. MR. JAFFE: I'll let Ron answer that. MR. OLSON: I didn't write this one, so -- I'm not sure what that answer is. MS. SULTON: Duane, did you want to say -- MR. GRANT: Add to the confusion I think. And I didn't write it either, so -- actually I wasn't on this work group so -- in my mind we're really talking about two different issues in number 7. I think that first sentence is a separate issue, what constitutes genetically engineered or non- engineered, and I'm not really sure what was meant either, so I guess I'll, I'm sure open to clarification. It could be are we talking about true transgenics versus mutagenesis? I mean, that's been an issue in the industry. Is that what we're talking about? Are we talking about GM products for which all of the protein has been removed and there's actually debate within the industry, whether they actually are GM or not. So we need some clarification there. Then I think a second issue, which is the author took a stab in the second sentence, is really the issue of the imposition of market tolerances superimposed over regulatory tolerances. MS. SULTON: Did you want to say something? MS. SLUTSKY: No, all I was going to say is, I'm presuming that this means, they're referring to tolerances, I mean if you're, the product is considered, like if a buyer wants to buy a non-biotech product, what does that mean. Does that mean, you know, you can have 3 percent, 1 percent tolerance for, you know biotech and put it in that product. When I read that, that's what I thought about. MS. ZANNONI: Yeah, and I think we talked about this in the committee one time, I didn't write it either, but, I think, it should have been, what's genetically modified and what's not genetically modified because of the tolerance. Because he can have, if it's over .1 percent, if it's less than .1 percent in Europe, then it's not genetically modified, you don't have a genetically modified product because it's not labeled under the detection. MR. MEDLEY: Well, I mean, obviously I'm not in the work group so I didn't write it. When I read this and I too struggled with the first sentence. I thought that there were two issues that were being raised by 7. The first issue had to do with, you know, where tolerances are set such that something in essence if it's below that it's considered non-genetically engineered, and then the second question was even if you do that, the issue we're facing is that others in the supply chain to protect themselves are raising the level higher such that in essence what ends up happening is you added zero either way you go whether it's imposed by a competent authority or imposed under contract, and then how do you deal with that. But, I mean, that's just one interpretation. MS. MELLON: Well, I do think there's a, I mean, it seems to me that overarching and really important part of this whole chapter, the overall arching kind of point is that in today's world commercial realities coexist with and interact with legal realities in a way that really is unlike a lot of other U.S., you know ag trade issues, and so it's not just a matter of meeting bewildering trade requirements or regulatory requirements because the answer to that is harmonize the requirements. You know the, I think the message to the Department is that just harmonizing the requirements probably isn't going to, you know, solve the problem from the point of view of the views of trade and this is, you know, there are lots of kind of, or several, not lots, there are several examples of that point here and this, you know, is a good one. But I think, you know, I think the second half of 7 is more, you know, seems to be easier to grasp than the first. Unless some more context is out there, you know, is the definition of genetically engineered a quantitative one or does it determine, does it hang in some way on the methodology for the production of the crop? MS. SULTON: Leon. MR. CORZINE: Keeping up the record of deniability, I didn't write it either. But when I read this, I thought this addressed the issue that the Europeans have as they try to differentiate, like if you heard them try to define what they mean by "derived from" rather than "derived with." I mean that's a serious thing and that's all clear outside of tolerances and thresholds, fits the definition. And it's a real one where they try to differentiate their products derived with, derived from. I think it's back to the labeling, you're supposed to clarify for consumers which adds confusion to the whole labeling process, but that is what they are trying to do. So that's what this really addresses because in a commercial world, which this says, how in the heck do you address that? MR. MEDLEY: Yeah, but you're talking about the process aids issue, the enzymes or -- MR. CORZINE: That's what they get to so that, and the whole key is, so that in the marketplace they think they have to derive things from overseas and not from within the EU, but that is what the point that they use. And that's what I thought this was trying to address was more a definition than the whole threshold thing. MS. SULTON: Greg. MR. JAFFE: I mean I don't think it is trying to address that. That issue is not addressed at all in the chapter, so I don't think, if we don't address it in the chapter I don't think we would discuss that issue in the policy issues. I don't think that that was what was meant here. MR. CORZINE: But it sure looks like it could. MS. SULTON: If we dealt with process aids which we didn't in the chapter. Are we going to rewrite this one? MS. LAYTON: And nobody wants to defend it so maybe it, we could even just -- MS. SULTON: Carole. MS. CRAMER: Actually, I didn't speak up but I didn't write it either. Is part of the concept here that only, we have a situation where a single product would be labeled as biotech in one country and not biotech in another, is that just the simple reality of it? MR. CORZINE: One part, yes. MS. CRAMER: So it's the same product, so the commercial uncertainties around the fact that you can have the exact same product prepared in the exact same way and in one country it's labeled biotech and in another country it's non- biotech. MR. GRANT: It depends which is the EU, I think is a good example of that. MS. CRAMER: I mean does that capture the concept any simpler? MR. JAFFE: I thought the concept wasn't so much differences but the fact that, I mean, one might have a 3 percent tolerance and one might have a 1 percent tolerance and so one would be your label differently, but I thought this was, I mean getting back to what we talked about in number 5, number 5 dealt with adventitious presence when you're dealing with unapproved events, I thought number 7 here was dealing with really adventitious presence with approved events, which is how much of an approved event can you have in something and still call it, somebody who wants to call it non-biotech be able to call it non-biotech. And so, and the fact, so I thought that's what this one. I thought this was the companion to number 5 that completed sort of the adventitious presence which we spend time about in the chapter. MS. SULTON: Michael. MR. SCHECHTMAN: Let me just add to that. And I think that I also heard that the issue was that in addition to the differing requirements, on top of that was the concern that the marketplace, notwithstanding what the definition is because of the concerns in the marketplace, companies in responding to what they perceive as commercial demands are feeling compelled to go beyond what that definition is to, whether it's protect their brands or to comply with what they perceive as what's really being required of them by other forces. Is that correct in? MR. GIROUX: I think that's in there as well. If I can speak, Cindy. I think that's in there as well. I really think there's three issues in here, and it needs to be rewritten to accommodate those three or we may want to, as some wanted to earlier, move the AP issue up and combine it with the earlier, I'm going to back away from that actually. I don't think we want to muddle the earlier one. So we do have those three issues though. MS. SULTON: Yes, Michael. MR. DYKES: As I read this one, I thought this one was all to do with a confidence interval. I thought that was just no more -- UNIDENTIFIED SPEAKER: The what? MR. DYKES: The confidence interval. In other words, if you got a .3 percent tolerance, where are you going to operate at relative to .3? I mean you can't operate at .3 all the time because of all of the complexities we just talked about here later. So, as you try to get lower and lower to make sure that you're going to be in compliance, that's what I took number 7 to be addressing. Am I being confusing? MR. MEDLEY: No, no, you're not, we were just commenting that, you know as we've read this, we've had several different people say this is how I interpreted it, and if we're interpreting that way then clearly this has to be rewritten because there's so many different interpretations on what it says. MS. SULTON: We're going back to number 8 since we know this one needs to be rewritten. Significant methodological issues with commercial and regulatory requirements for testing grain to low tolerance levels for genetically engineered content. MR. MEDLEY: I thought this was Carole's validation issue, that's what I thought they were trying to do here. MR. DYKES: This is reproducibility, validation, accuracy, all that kind of stuff. This is if you test 10 different times do we have validated testing methods, predictability such that you get the same answer 10 different times. MS. LAYTON: So is this just a restatement of the one we had last? MS. MELLON: This is a fairly technical issue. There aren't techniques available that are truly precise, but are reproducible and that does lead to you know something the USDA could do something about. MS. SULTON: Randy. MR. GIROUX: I would suggest we park this one and rewrite it. Unless everybody agrees, but I don't want to go through this again. MS. SULTON: Number 8 then, precision and reproducibility where 6 is predictability, those are the distinctions, Randy? MR. GIROUX: This one addresses specifically that the lower you go, the greater the variability. So as you have tolerances at high levels, the same test that could work on a five percent sample can't work on a sample at .1 percent. The lower you go the increased variability, so this ties directly between establishing tolerances that can be predictably enforced and complied against, this is all around predictability of testing and ties it directly to what is the threshold for enforcement. So I can rewrite it to make it more clear, or we'll just leave it the way it is. MS. LAYTON: Yeah, is it clear to everyone? Are we comfortable with this one? I see a lot of nods. MR. BUSS: I was having problems with the second sentence because when I reconstruct it seems to say at high precision and testing makes it difficult to practically and reproducibly determine. And I'm struggling with why would high precision -- MS. LAYTON: It's the absence of high precision. MS. MELLON: Because there are no standard methodologies and the available methodologies are not highly precise. MR. BUSS: I read it differently. I read the two as two separate, in other words absence of standards plus high precision as opposed to -- MS. LAYTON: Absence of standards and of, the second of. Vincent has a question. MR. VILKER: This is again, reminding people I work at NIST. One element that hasn't been captured yet here and it does involve testing, is not only does there, would harmonization of regulations and bottom line levels be important worldwide, but the testing methodology needs to be harmonized. I agree, testing protocols is explicitly mentioned. Sorry. MS. SULTON: But it does seem that, was it 8, there are several that relate to this. MS. LAYTON: So we can leave 8, yes and go to 9. MR. GIROUX: Just there are two words to clarify that, okay, so in the second sentence that's beginning with absence, the absence of standards and high precision at low levels makes it difficult to practically and reproducibly determine. MR. SCHECHTMAN: I don't think you need the "of." MR. GIROUX: You don't need high precision, just precision at low levels. MS. LAYTON: It doesn't need to be the absence of precision at low levels. So do you need the word "of" after the word "and." MR. GIROUX: Yes. The absence of standards and precision at low levels in testing makes it difficult to practically and reproducibly determine if grain and grain products are above or below. MR. DYKES: So you don't have absence of high precision or you don't have absence of precision. You have precision. MS. LAYTON: Okay. We don't have precision. Okay, so the absence of standards and precision at low levels of testing and testing makes, okay, got it. MS. MELLON: Daryl, maybe it's the absence of standard and highly precise methods at low level. I mean what you want are standard methodologies where everybody uses the same methodology for testing for the presence of DNA. There are no standard methodologies that say here's the way you do it. Here are the 14 steps in the standard methodology. So we don't have a standard methodology and the methodologies we do have are not precise. You do them -- MR. BUSS: At low levels. MS. MELLON: Well, at high levels. They're not that precise, but certainly, you know especially at low levels. MS. LAYTON: The absence of standards and highly precise -- MS. MELLON: I would say standard methods. MS. LAYTON: Standard methods. MS. CRAMER: I think we actually really talking standards. MR. HOISINGTON: Mostly standards. That's what makes the method precise. MS. CRAMER: Which is that you validate based on the fact that your test detects this in a test sample and then test this in your, in a control sample and this in a test sample was part of the validation, so it actually is acceptable standards that your system can detect it in this one and then it can detect so it's a validation system that creates, you know, standards, controls like we do in science. MS. MELLON: Those are control standards. MR. BUSS: Just all depending on the wording. When it talks about, if we use precision at low levels implies to me then that the precision is dependent on the level of the unknown. So the precision of the test is less if the content is low and the precision is higher if the content is high. That's what I want to make sure we were saying what we meant. MS. SULTON: Vince. MR. VILKER: To reinforce the point Carole made, control, there are no controls. The lack of controls will inhibit the issue of accuracy at low levels and the standard protocols are required to be validated against controls, and you don't have either at this point. You don't have the standardized protocols nor do you have the controls to establish if those protocols are truly worth anything. MS. SULTON: All right, I think we know how to fix number 9. Number 10. I'm sorry, that was 8. Yes, one more on 8. MR. MEDLEY: As we are rewriting that and that is, clearly there's a major difference if we're talking about grain and then material from a highly processed medium. I mean it gets even more difficult when you start talking about the, you know, let's say the product that contains this as an ingredient and it's a highly processed food product, it's even more difficult. MS. SULTON: Grits. MR. MEDLEY: Yeah. (Discussion off the record.) MS. SULTON: Michael. MR. SCHECHTMAN: Yeah, I just want to check where we are on this one. I heard a number of different comments, but I'm not quite sure whether we say this needs to be rewritten or whether just the changes that we have to the second sentence, something like the absence of standards, I think it was, rather than standard methods, and precision at low tolerance levels. MS. LAYTON: No. It's low actual presence of the gene products. MR. SCHECHTMAN: End testing makes it, et cetera. Does that leave everyone at the point that says that we don't need to rewrite this one? MS. LAYTON: Yes. MS. SULTON: So we don't need to say anything about the validation standards. Okay. MR. GRANT: How about Terry's last comment that this issue is amplified in processed products. Does that need to be, I mean, I think it's a good point, but does that need to be in this? MS. LAYTON: I think you say that in 6. MR. HOISINGTON: But you took out the word standard methods, and I think that's the key to it. That's part of the combination, you have to have standards and you have to have standardized methods to have an accurate protocol. And neither one of those exist. We have methods to detect in almost everything we want to detect, but they're not standardized at all, and we have no standard references to judge by. MR. SCHECHTMAN: So you're saying standards and standard methods. MR. HOISINGTON: Then it doesn't matter which product you're talking about. If you don't have a method for detecting it in oil, you can't -- MS. LAYTON: Standards and standardized -- MS. CRAMER: Actually, I would suggest one more word which is the way I'd written it is, the absence of validated standards and protocols. Because then it gets the process that, I mean, the concept that you've got oversight of that. MS. LAYTON: Validated standards and protocols. MS. SULTON: Okay everybody? Number 9. Ron. MR. OLSON: I don't know who wrote it specifically, but that basically is just a summary of the market implication section. It's a lot of assumptions. I mean the issue, that's really not the issue itself. The issue is the impacts of traceability are unknown as far as whoÕs going to bear the liability and is it going to segregate farmers as price transfers are going to disappear. Nobody knows. The issue is we don't know what the impacts are, and this one is kind of written like we say what the impacts are going to be. We don't know for sure, that's our assumption that that could lead to do. I don't know if that whole thing, it needs a major rewrite if we were going to keep it. MS. SULTON: The minimum we need a lead-in saying that impacts are unknown in the areas where they have the potential for impact are. MR. OLSON: I guess the question I put in, all this is covered in the implications section of the report, so I don't even know if it needs to be listed here. MS. LAYTON: Okay, so you would suggest deleting it. MR. OLSON: I would suggest deleting it. MS. SULTON: Mardi and Michael Dykes agree. Daryl? MR. BUSS: I agree. MS. SULTON: Nobody arguing for it, we move to number 10. Terry. MR. MEDLEY: I just would like for whoever drafted number 10 to tell me whether the issue we're addressing. MS. SULTON: You'd like us to tell you if -- MR. MEDLEY: I would like for whoever drafted number 10 just to state for me what the issue is we're addressing. MR. SCHECHTMAN: I can't do that, but I can actually tell you who did draft it, since I can safely do this and this was Dick Crowder. MR. MEDLEY: Okay. Because we've stated quite frequently in the document the fact that, you know, we're going to see food manufacturers source the ingredients from non-GM. I was just wondering what was the issue. Is the issue how the product spectrum will evolve for these markets uncertain? MR. OLSON: That's the only issue I see. MR. DYKES: That's the only issue and I think that's akin to the one Ron just talked about. It's throughout the document. MS. LAYTON: Suggest we delete it? MR. DYKES: Yeah, I'd delete it. MS. LAYTON: Any nodding heads around the table? MS. SULTON: Number 11. Liability insurance frameworks. Number 11. MS. MELLON: What's an insurance framework? MS. SULTON: Ron: MR. OLSON: I don't think this is worded properly. Everybody's laughing a little bit, so it's probably not. Insurance framework, there are insurance agencies now that are putting out because the liability is unclear who bears it and especially at the grain handling level, insurance companies are now writing biotech exclusion policies in the insurance agency in case a recall drives it back. If you have traceability, and you can trace it back further, you can say you caused my problem, the insurance company's not going to cover that. So a lot of the insurance companies, especially for contra elevators are writing insurance exclusions in their insurance policies for country elevators. That's a big issue. MR. MEDLEY: What does the exclusion say? I mean, I know -- MR. OLSON: They will not pay any claims related to biotechnology. MR. MEDLEY: So maybe that would be the certain issue that -- MR. OLSON: That's the issue. It's a question of how we word that. MR. MEDLEY: Yeah, that would be, yeah. MR. OLSON: Another liability issue is totally undefined at this point is where does liability land because in today's world without biotech, liability transfers with the testing at the contract level and biotech may allow that contract level to be violated. That's a big concern in the grain industry. MS. LAYTON: So what are we saying here? MS. SULTON: Mike. MR. DYKES: Just the liability and the insurance protection issues are yet to be resolved in this area. MR. MEDLEY: That's true, but I thought, why aren't we saying something different, and that is, we know right now, I mean, Swiss Re and others they have put phrases which talk about, you know, really there's language which is talking we will not pay for, and so that is today. And that does raise an issue when you look at the marketplace. So if there's a way we could just phrase that, I think -- MS. MELLON: We could just state that. MS. LAYTON: Is that not in page 21? MR. MEDLEY: No, I read it in the text of the document. I don't know if it was 21 or -- MS. LAYTON: Twenty-one and 22 are contracting and liability. MR. MEDLEY: No, there was, I remember reading it. There was actually a parens in here that there was going to be specific language. Yeah, it was the bottom of page 20. There some insurance exclusions and the work group suggests that we find the literal text from one of the exclusions and insert here. MR. OLSON: Now whether that's Swiss Re or any of those, we can just insert that. MR. MEDLEY: And you can just take from that very specifically, it's this type of exclusion issue raises, whatever. It'll be very specific and it's current state. MR. DYKES: Well, maybe then what we need to do is to add the text that's suggested here for the text of the document and then how do we fix the text of the document we pick it up over in the other one. MR. MEDLEY: That's what I was suggesting. MS. LAYTON: Does anyone have text of the insurance policy with them today? MR. OLSON: No, I mean, the national random sheet has a whole paper on it, and Leon, I think your group has done a lot of work on it too. MR. CORZINE: Yes. MR. OLSON: So I mean, there's groups that are working on this right here in Washington have it. MS. LAYTON: So maybe we could get a fax of some language. MR. OLSON: Leon, does your group have the specific clauses? MR. CORZINE: We were more producer oriented, but it also flowed over into the grain handlers. MR. SCHECHTMAN: Can I ask whether we actually need, whether you really think what you need to get that specific language as opposed to just referring to the two points that Ron mentioned for the issues, for this one issue raised, uncertainties as to liability transfer and, you know, current insurance exclusions for biotechnology products. Does that just capture all that you need to capture here? MR. MEDLEY: No. MR. SCHECHTMAN: No? MR. MEDLEY: I mean, I think you have to, the second point if you phrase it in terms of an issue might be appropriate over on the policies and issues that we're talking about. But I think that in the text of what's here -- MR. SCHECHTMAN: Yes, yes. No. In the text put that, but I'm talking about whether for this number 11, whether we can just take number 11 with those two things and then be sure we come back and get the exact language for the text. MR. MEDLEY: Well, if we don't get it, but if we can get it, it would be better. MS. LAYTON: Okay, so reiterate what you thought we could use as number 11. MR. SCHECHTMAN: Uncertainties as to liability transfer and insurance exclusions for biotechnology. MR. OLSON: Certain pieces of the marketing chain or supply chain, whatever we're calling it, are getting, can't get insurance to cover the risk anymore. That's why the liability issue is becoming more important because you can pass it to somebody, but they'll file bankruptcy because they don't have the ability to pay for it and they don't have the insurance to pay for it. MS. LAYTON: Okay. So uncertainty as to liability transfer and exclusions for biotech products. MR. OLSON: Insurance companies are writing exclusions for biotech related claims at certain levels in the supply chain for various handlers, and that starts all the way with the farmer. The farmer and the country elevator are the primary levels where that's occurring, so it's basically at the farmer and the country elevator level. MS. SULTON: Randy. MR. GIROUX: I'd just like to make sure we qualify that a little bit, that some insurance companies are -- MR. CORZINE: Primarily one. MR. OLSON: A large one. MR. MEDLEY: In fact, it will be interesting when that's placed in there and I understand the Department also does business with that, so it'll be curious to see how it evolves. MS. MELLON: So who ends up bearing -- who's going to end up bearing the risk? MR. OLSON: Ask can I hold the hot potato. MS. MELLON: Yeah, who holds the hot potato if you've got -- MR. OLSON: If General Mills has a recall and we bought it from Cargill we probably can claim it from Cargill. If Cargill bought it from Jerry, and Jerry's insurance says I won't pay, he can file bankruptcy and Cargill bears the brunt. So it's whoever in the chain can't get insurance, it's the first big guy in the chain pays. Because the little guys in the chain are not going to be able to buy the insurance. MS. LAYTON: Big guys pay, little guys go bankrupt. MR. MEDLEY: And you're not concerned if it was based upon risk. MS. LAYTON: Okay, now we're not putting that in. MS. MELLON: But it never goes back to the tech company? (Discussion off the record) MS. SULTON: Now, we're making real progress. You all are lighting up. Number 12. The role for international organizations in addressing some of the impacts and implications. MS. LAYTON: Are we talking about international standard organizations? MR. JAFFE: I have no idea what we're talking about. That was my question. What are we talking about, international organization? I mean, they're trade associations, I mean, Crop Life International is an international organization, what are we talking about here? MR. GRANT: It says it's unclear, Greg. MS. SULTON: It must have come from a treaty. MR. OLSON: I think this got into the section on the Biosafety Protocol. Codex was working on some things and then the U.S., Canada, Mexico, you know, bilateral treaties, stuff like this. I mean, there's just different groups and different cities that are evolving to try to move forward. I mean, I think that's what was intended to be captured here, but it may be too broad to write. MR. DYKES: I don't know. I wonder if this one isn't, I agree with you. This may be one of those that we've got covered sufficiently in the document. I don't know if there's an issue there in that one. So maybe it could be deleted as well. I don't see an issue. I think it's a summary statement of what points been made in this doc. MR. OLSON: I think so too. MS. MELLON: I don't know though. I don't know enough about this issue, but, I think it's interesting to, you know, to ask the question whether the only international venue within which to address these issues is the kind of multilateral negotiations or international organizations. I mean, it seems to me that, you know, if, and I'm not clear at all on whether this is the case, but that if it's possible to address issues on a bilateral basis, that that's something that we might want to say. It isn't obvious to me. MR. MEDLEY: No, but that's what's happening. You have a national, bilateral and you have regionals. MS. MELLON: Well I know that a lot of trade things are being done that way, but I just didn't know that these kinds of issues were being addressed on a bilateral basis. So you say to Mexico we won't test your stuff if you won't test ours? MR. OLSON: Well, they also established a 5 percent tolerance. MS. MELLON: All right, so then you say -- MR. OLSON: I mean, Mexico and Canada, you have to establish a 5 percent tolerance before you have to call it GMO. MS. MELLON: And that is discussed in the text. MR. OLSON: Right, as an example. MS. MELLON: As an example. So basically those two, those two countries to whom the U.S. exports are saying to you all, to all of you in the chain, if it doesn't hit about 5 percent you're not going to hear from us. MR. OLSON: It's non-GMO. MS. MELLON: And the governments are saying that and I guess there are not private entities that are saying otherwise. MR. OLSON: I don't know. Private entities have commented on the disagreement that I've seen. MS. SLUTSKY: I mean, it might be helpful to clarify a bit. It's not a formal government-to-government agreement. It's an arrangement and it was done, it's an arrangement that's implemented by the industry, but it was an arrangement that the governments discussed together, you know, in conjunction with the industry, but it's implemented by, contractually by the industry. So it hasn't been put into, for example, U.S. regulations, government regulations. MS. MELLON: To me that's an important thing to say is that industry to industry, governments negotiated in, I don't know, you know, with government participation or something like that, have led to informal agreements that have accomplished, whatever you would like to say has been accomplished. MR. MEDLEY: But that's in the text, I thought. MS. MELLON: All right, okay. Well then, I mean, is there, so there is no issue -- MR. MEDLEY: Right. MS. MELLON: -- that these should be, you know, the availability of these might be pursued or maybe it's just obvious because it's there. MS. SULTON: Duane. MR. GRANT: So, is the issue here that there's kind of competition between different entities as far as which entity will emerge as the predominant setter of standards, if you will, that's a poor way to describe it, but is there a competition between, you know, bilateral, multilateral agreements or going to Codex or, you know, is that what the issue is? It's unclear where these issues will be resolved at? MS. SULTON: Randy. MR. GIROUX: So, if I look at the, a lot of the text says that we don't have consistency, we don't have agreements between countries, we have different interpretations of the regulations, all of that outcome being that we want some level of harmonization, standard setting between individual countries, between regions, it doesn't matter. How do we accomplish that goal? That, and I believe that this statement says there is a role for international organizations to address these issues and help us solve these problems. That's what I see the essence is here. The essence is calling it out clearly in this, and perhaps it's worded incorrectly, but there is a role for these organizations to help lead us there. MR. SCHECHTMAN: I think if I can try to paraphrase what I remembered from the discussions with Dick on this particular issue. I think the point was that there are, you know, lots of different organizations and they're all starting to get involved and talking about this, some fora may be more productive than others for the U.S., some of these things may best be done in multilateral contexts, some may best be done on bilateral contexts, and the point, the implication that was raised was that the U.S. needs to think creatively about how best to solve each of the particular problems. Whether that is enough of a policy issue raised, you know, I think that was the general intent of the item. MS. MELLON: But maybe it's that in being creative and pursuing bilateral agreements, that the agency does need to consider a kind of impending collision between standards and agreements arrived in multilateral context and those arrived at in bilateral context. I mean, that seems to be an issue that a whole bunch of side agreements could just be a whole other layer of unharmonized standards and requirements. And that they could be superseded, or that they could tie the U.S.' hands when two years from now somebody actually gets around in an international context to setting standards, the U.S. is already committed to all these agreements. It just seems to me to be, that the potential conflicts and inconsistencies between the provisions of agreements set in these different ways is an issue that the USDA might want to address or be prepared to address. MS. SULTON: Terry, do you want to add to that and then Greg. MR. MEDLEY: No, Greg was first. MS. SULTON: Greg and then Terry. MR. JAFFE: I would just say two things. I mean, I guess one is this reads like a recommendation to me, and we've been eliminating recommendations from the other ones and I guess we still haven't come to the question are we trying, I mean, I know Terry had a view about recommendations, Michael had a view about recommendations, but this reads to me as a recommendation, and so the question, and still open in my mind is are we making recommendations. The second part of this one is it's just way too broad for me. I mean, international organizations I still haven't qualified what that is, and we just have issues generally, I mean, all traceability and labeling issues, what are we trying to deal with here? It's just, it's very broad, very all-encompassing. Before I would feel comfortable with it, I would need a lot more definition about which organizations, what kind of organizations, what kinds of issues we're trying to talk about here be it bilateral or multilateral. I don't disagree with those concepts, but they're just too broad at this point. MS. SULTON: Terry, since you brought the issue of recommendations. MR. MEDLEY: No, I was just going to, my comment on this one was that I think we should just either phrase an issue or delete it. MS. SULTON: Pat. MS. LAYTON: I could see where, for example, yeah, I could see for example where if this statement followed something about standard methodologies that international organizations could step up to the table and define testing standards or methodologies or protocols, that it might be less obtrusive to you, so I want, and so that made me start thinking about as we look at this, you know, we talked about a couple of these, maybe are more linked, and so what I wanted to think about was is there an organizational aspect to this to where, I think somebody said 1 and 3 were linked, so therefore, as the groups go out, should them kind of come back and say, these are linked to this area and then there were several that I think had to do with standards and testing, the one about predictability and then the one about absence of validated standards and protocols. Should we sort of look at a grouping of regulations and then sampling and testing, and then something else, and I don't know what that something else is, the insurance is one maybe all by itself, so, I was just thinking about organizationally is there a way to group some of these to where they flow together and make more sense. MS. SULTON: Daryl. MR. BUSS: I guess I was thinking about taking it one step further back. We had suggested that we were going to add an introductory sentence at the beginning of this section under policy issues raised. Could this not be part of that sentence that would lead into these various issues? In other words, as a follow on whatever the introductory sentence is, could we then just say there may be a role for international organizations in addressing some of the impacts and implications raised below or something to that effect? MS. SULTON: Terry. MS. MEDLEY: I mean, just picking on something Greg said, it's just so broad, I mean. I mean, what's the issue? Is this supposed to be -- or what's the policy concern? I mean, just give it to me very directly. MS. LAYTON: Okay, so drop number 12, okay. Drop number 12 for now unless somebody comes up with a way to put it into something about some specific thing into one of these. Drop number 12? It's gone. MS. SULTON: Yes, Leon. MR. CORZINE: I just wanted to respond to one thing that Mardi said that I think we've got to be careful of here, that offering an opinion of pros or cons, of bilateral or multilateral agreements on trade, which are necessary for trade to continue, with the concern that a standard that may never come, it'll be unlikely if it does, I don't think we want to go there and offer that as any kind of recommendation or thought. MS. MELLON: I couldn't agree with you more. I don't think we want to offer a recommendation. I was just trying to surface that there's an issue here of potential inconsistency that I don't even think that's a big issue and it would be more than comfortable just letting it go as something we haven't discussed. It may be obvious from reading the report. But it means that there's really only one other recommendation left, right, and that's the adventitious presence policy recommendation, and so, I think we could -- it's in number 5? But it seems to me that we could just decide to take that out and not have recommendations. We would just have surfaced some issues. MS. LAYTON: I had deleted that. MS. MELLON: All right, then that issue is now moot. MS. LAYTON: I think we were going to still say something about grappling with issues of absolute zero versus, I thought we dealt with the first sentence in that section and deleted the second one, so that was my notes there. MS. MELLON: Right, that's just stating an issue but -- but that's the only recommendation that I think -- MS. LAYTON: And we had deleted it. MS. SULTON: Greg and then Leon. MR. JAFFE: We've deleted a bunch of things which I have no problem with. I think when we introduce this section, I think it's important to state that, sometimes we deleted things because they're in the text somewhere else. And I guess, and I don't know if we've done a sort of comprehensive, I wasn't with, I'm in the subcommittee but I was not there when we brainstormed over this list to begin with, and I would hate to give the impression in this report that these now 7 or 8 things are the only policy issues or concerns to come out of this whole 25-page report. So I'd like to have something in the beginning of the section that sort of says that, you know, we've highlighted a few, these are some but not all. We decided to keep some of these key ones. Otherwise I think we need to go back and figure out if we've missed other key ones. MS. SULTON: Leon. MR. CORZINE: Well, I have a little concern with number 5 if we're going to drop that second sentence. We really should say something about adventitious presence. Now if we don't want, we want to reword it where it doesn't sound like a recommendation that's fine, but that is an issue that is there. MS. SULTON: It doesn't come up with the testing? MR. CORZINE: If it does, that's fine. It needs to be somewhere. It's a little bit like Greg said, a little comprehensive look to make sure that that's still there and maybe we don't drop it here until we make sure that it is somewhere. MR. MEDLEY: As I stated earlier when I made that suggestion, I mean, it's a vital, it's an important deliverable, and I just thought on pages 14 and 15 on top of 16, that's all on adventitious presence. We talk about OSTP policy, we talk about FDA, we also say that EPA and USDA should get there's in line, it's all there. I mean, that's why I felt comfortable because there's over two pages on just AP and that we need this. MS. SULTON: Ron. MR. OLSON: I kind of agree with Leon saying, what we could say on number 5, you could say industry is grappling, excuse me, industry is grappling with how to address adventitious presence to achieve an acceptable zero versus an absolute zero. That way you could get the words in there, because I think it is a big issue in the report, so I don't think it's wrong to re-highlight that as an issue because it is one of the primary issues that we've spent time on, not only in here, but in the next report it's a big issue as well. So, I think it's good to state it as an issue. Do it that way rather than a recommendation. MS. SULTON: Mardi. MS. MELLON: I mean, actually I would agree with it as a recommendation. I would just, if we were going to make it as a recommendation, I would want to be clear about what the term "adventitious presence" means. To me it's a catch-all for, you know, for a number of related, for a cluster of related issues and it's very, one of the reasons it never goes anywhere is we're never quite sure which of the cluster you're talking about when you're just talking about an AP policy, but I actually think it's one of the big, you know, issues ahead of us. It's dealing with that cluster of issues, but if that's true, then I think we do need to look very carefully at the discussion of the issue on 14 and 15 which, you know, I think hasn't been massaged as much as some of the rest of it. MS. LAYTON: And Mardi, if I can interrupt, I think that's an excellent idea, but it's 3:20. MS. MELLON: I just want to point out that we do have another nearly, I mean, it's another take on the issue that might be, you know, that we produced as whatever it is, but issues, and that it might be better, a solution to the problem might be to use that text for this. MS. SULTON: As relates to labeling and traceability? MS. MELLON: I mean, we can either rewrite this or we could read the two together. MS. LAYTON: Okay, but it's going out to a group, so let's, because we need to take a 10-minute break before we have public comment at 3:30. (Discussion off the record.) MR. DYKES: When we come back, are we going to, so we've gone through these and we've kind of got them, then find out which ones are rewrites and which ones are related. The only thing we got left to do here is to come back and clearly articulate what are we going to rewrite. MS. LAYTON: That's correct. And the introduction summary. Okay, so we'll come back and make assignments. Because as I understand it, if you are, if I can just say this, if there's anyone in the audience that intends to make public comment, please sign up with Diane now and make sure that we have a copy of your comments, and that as soon as we reconvene at 3:30, we will begin public comment period. (Whereupon, a brief recess was taken.) MS. LAYTON: Ladies and gentlemen, if you can take your seats, please. We need to begin again. Ladies and gentlemen, it is time for public comments. If there are any public comments, please come forward to make your comments, but we need to get your name and your comments. Going once. Going twice. We have no public comments at this time. We will check later on in the meeting just to make sure no public commenters have come into the meeting. Therefore, we have set up several tasks during the previous two hours, and I would ask Abby or Michael, and Cindy. We've made some tentative assignments. MS. SULTON: We're going to redo the introduction. We were going to write a section on the impact on consumers that Greg and Carol Tucker Foreman volunteered to help with. We were going to add a section on the charge that perhaps Michael and the facilitators could write. The scope of the report, what's in and what's not. We're wondering if maybe Carole Cramer and Duane might consider doing that. We can come back after we go all through and see how you feel about this. Then the process, how we went about putting the report together. Lisa and Leon maybe. Useful terms. Basically the commercial risk issue that we wanted to put in the introduction. And Terry, you raised it, and we were wondering if maybe you and Michael Dykes, I think we talked about you possibly doing that. Then as far as the issues are concerned, we've kind of grouped them. 1 and 3, thinking maybe Ron, Duane and Daryl might be a group that might be able to address that. And then we grouped 5, 6 and 7, and wondering if Mardi and perhaps Randy could address that. Now, we stand ready to get correction on anything we may have left out and whether someone else might be appropriate to do it. MS. LAYTON: I just want to clarify. Carol brought up a point about how to write up a sentence in there about that this is the first report of the committee and does not cover all of the issues that the committee feels are important and that these will be further covered in our next version, and I want to find out exactly who is writing that sentence so we know. MS. SULTON: If you could put that in with the scope. MS. LAYTON: I can do it, I can help that group, but I want to know where it goes in so it goes in the appropriate part of the introduction. MS. SULTON: In the introduction probably as regards to scope maybe. MS. FOREMAN: But, you know the most dismissive phrase in all the English language is "we know there are other important issues." MS. LAYTON: Yes, we'll be sensitive. MS. FOREMAN: We are going to have another report that covers the very, the -- you know what I mean. MS. SULTON: The specific issue. MS. FOREMAN: Too late in the afternoon. MS. LAYTON: I'll get the right words. MS. SULTON: Are these the things we talked about rewriting? Have I left anything out? Carole? MS. CRAMER: Consumer. MS. SULTON: Carol Tucker Foreman and Greg are going to write something on the consumer issue. MS. FOREMAN: We were going to at least make a proposal on that which we're going to do I assume when we go off to do our assignments. MS. SULTON: That was not part of the introduction either, was it. It was to be part of the substantive text. So I stand corrected on that. Section two. MR. MEDLEY: Why doesn't that be the language and then I think there were a couple of suggestions as to where it'd be most appropriately fit. MR. JAFFE: In the commercial realities, part 2 is one of the issues. MS. SULTON: Yes, commercial realities I think is where we talked about it being. So not here, but in commercial realities. Ron? MR. OLSON: I have a question, Cindy. Somebody, I don't know if anybody is taking notes, but you guys are writing a lot up there. Does somebody have the notes on these specific issues that were discussed that will be shared with the people? Thank you. MS. LAYTON: I did some. MS. SULTON: Yes, we all have notes and Angela's been taking notes, I've been taking notes. Yes. We'll float around to give you what we have in our notes. MR. OLSON: Okay. MS. SULTON: Okay. MR. SCHECHTMAN: Probably we all have a part of them, since the comments were going fast and furious. MS. SULTON: What we have is several laptops. Abby, you have yours, right. Angela has one and Pat has one. Carole, you have your own, is that correct? Randy, do you have yours? And if anybody needs the documents we can possibly copy it. So what I suggest that maybe we recess the session to go into these little work groups, right, and maybe just gather in various places where we can find a plug. MR. SCHECHTMAN: I would suggest that we plan on reconvening in an hour, quarter to five, so we can see where we are and give us a chance to check again if anyone has some in for public comment. MS. SULTON: We have Duane on two. Is there someone else that might join Carole Cramer to work on the scope? MS. LAYTON: I was named to do that. MS. SULTON: Pat. (Discussion off the record.) MS. SULTON: All right. So we need captains of these teams so they make sure everybody has a machine. Leon. Pat has a machine to work with Carole, and Lisa and Leon, you need a machine? MS. ZANNONI: Yes and Michael also. Michael Schechtman. MS. SULTON: You want a machine and Michael. (Discussion off the record.) MR. SCHECHTMAN: So we will take an adjournment of one hour and folks will be able to come back and report on, actually, let's see if we can make it 45 minutes. Let's do 45 minutes it'll give us a little more time to read over what we've got. So at 4:30 we'll return. (Whereupon, a brief recess was taken.) MS. SULTON: What we want to do is see where we are on the introduction and Angela tried to collect on her memory stick some of this and some of it's on Abby's computer as well. So if it's not on one of those two machines, please let us know. The scope that Carole Cramer and Duane worked on. MS. LAYTON: It's actually Carol and Pat. MS. SULTON: Carol and Pat. Do we have yours on one of the machines? MS. LAYTON: Yes. MS. SULTON: The process. Lisa and Leon and Michael. Do we have it on a machine? MS. ZANNONI: We got it. MS. SULTON: Useful terms. Terry? MR. MEDLEY: It's actually terms used and it's Michael, Dave and Terry. MS. SULTON: Okay. And we got it? MS. LAYTON: And they've got it. MS. SULTON: And then we had the people working on different issues. Number 1 and 3 and I think you addressed 2 as well, Ron, Duane and Daryl? MG. GRANT: Yes, and we also did 12. MS. SULTON: And 12. Now where is it? Does Angela have all of that? MR. GRANT: Yes. MR. OLSON: Three was combined into 1 and so there's no 3 and then 2 was just edited. Three was combined into 1, and 2 was just reworked a little bit. MS. SULTON: And what happened to 12? MR. OLSON: It was deleted when it got to us, but it was circling around about possible reinsertion and we ran out of time, but there is some issues there that I think. MS. SULTON: Then Randy and Mardi you worked on issues 5, 6 and 7? MS. MELLON: And 8. MS. SULTON: And 8? MS. MELLON: That's our freebie. MS. SULTON: And do we have that? MS. MELLON: Yes, you do. MS. SULTON: Well, then we are just as happy as we can be. So those were done and we thought they were done and now they are double done. Okay, what we propose to do now that we have all this is to consolidate the changes that we've made and figure out how we can get them reproduced to you in the morning and so we can go over that for the beginning of the morning and then go very, hopefully fairly quickly through the document. Yes, Michael. MR. DYKES: One suggestion. I'm assuming you're going to try and put that in one document and then print it off for us, and just as another thing if it's easy, as long as it's easy, you email to us so perhaps if we get a chance to print it tonight we might could read it before we -- (Discussion off the record.) MS. SULTON: If we can, we will. MR. DYKES: No, don't worry about it. MS. SULTON: So if we spend a couple of hours in the morning on that then hopefully we can then turn to the long- term document. And Michael, do we have any focus that we want them to take on that, anticipate on that? MR. SCHECHTMAN: I would think that realizing still that some parts are going to get short-shrifted, I think there are two really key things that we need to be able to move forward on that document even realizing that we're not going to do all the things we need to do. One of them is to see if this kind of formulation that we have for the issues, for the three issues that we presented, meets the test so that we can go home from this meeting and so for once, okay, this isn't all of them but you've got the approach right, which we haven't been able to say yet. And second, that we can go back and talk about what's going to happen in the scenarios chapter in terms of implications and has the work group been able to focus, you know, approach that topic in the right way. I think those are the key things we want to get out. We would like to get the definitions, we'd love to get back to the introduction. I think they're less likely that we're going to get to them. Are people okay with that? MR. DYKES: It sounds good to me. I think one thing too is we've got to be realistic about our time. We only have one more day left and we've only talked about the last three pages of this document and the introduction and scope, so the whole intervening 25 pages we've never proofed yet. MS. SULTON: We did start off this morning by asking generally what people's general reaction was to the whole document and that's how we got off on the discussion with consumer and decided to put it in that commercial reality section. MR. DYKES: Well, I'll tell you, I'm not talking about the big issue, I'm just talking as we go through it there's two and three words and -- MS. SULTON: Well, hopefully if we spend an hour on what you've written tomorrow because we know you've written it so well, it'll be great, and then we'll go back and do those sections. We'll go through it section by section. MR. SCHECHTMAN: Although we may very well not finish that tomorrow. But if those are mostly little word things, if we are going to have to come back and give it a final blessing, if it's little word things, those are things that could be done at the next meeting. MS. SULTON: What we could do is ask for significant points in each section and then we'll address those, and if we get to editing things we'll ask you to get them to us, subsequently. MR. SCHECHTMAN: Randy. MR. GIROUX: Just for my information five minutes or less. What is the process for finishing this document? How do we, when, you know, so we can edit this forever potentially. Little words, little words, how do we, what's the process for wrapping it up and really I just don't know. Does everybody on this committee agree that it, and sign off on it. I mean, I believe people here probably want to take it back, show the final version to somebody before they bless it. I just want to know what the process is. MR. SCHECHTMAN: Ideally what we would like to be able to do is at one of these meetings say are you, with whatever changes we have, you know, whatever small word changes we have agreed to at this meeting can you then give us a thumbs up for the document. Is everyone willing to do this? And I think that's what we need. MR. DYKES: To put a little finer point on that, just for expectation, that's tomorrow, sometime tomorrow are we planning to get to that point? MR. SCHECHTMAN: I don't think that's possible. MR. DYKES: Well, if that's the case then, we're not going to finish this by the end of the year because we're not going to have another meeting to do this. MS. SULTON: We've agreed that. MR. DYKES: Well, I didn't know we -- I thought we were still going down the track to try to get this traceability and labeling piece. I thought that's what we said at the outset of the discussions this morning, we wanted to try to get this piece completed and we were going to take the things off, we were going to put flexibility into the agenda so we could get this one done. That's what I thought the conversation was about this morning. What I'm hearing now is, this is an editing process, we're going to come back to another plenary, and we're going go, what, edit and comment and review and revise again? MS. DILLEY: I think the question is, even if we walk through and had all the edits done, don't some of you have to go back and show somebody at your respective organization at some point and have some time to do that or no? Do people not have that requirement? MR. DYKES: We may, we may not. I think that's different. I don't -- MS. DILLEY: Because part of it is just time to do whatever internal process you need to do. If there is any. If there isn't any, then I think a lot of it depends on where we are once we got the edited portions, we go through the other two sections that we haven't gone through and see where we are. MR. MEDLEY: I think it would better to see where we are rather than to predetermine that you can't. MR. DYKES: I'm fine with that, but what IÕm hearing is it's a foregone conclusion we're not going to make it. MS. LAYTON: Yeah, I mean I would say, I mean idealistically we could go through those sections, there may be some minor word edits, but at that point in time we could kind of say, substance is here, minor word edits may still have to be done but substance is here, I'm, you know, 50 percent comfortable or I'm 90 percent comfortable. MR. SCHECHTMAN: I'm completely fine with that. I was actually sort of reacting to the comment that I had gotten I thought from you and from Terry about there being a lot of little things, and those just take time. MR. DYKES: I guess that's what I'm thinking. I'm thinking, the one's I'm thinking about in my own text is they're just to clarify, again, the export of, or some of those kinds of things, but which we could give and you could send it out to us by email, we can get that tomorrow afternoon. I guess I just didn't want us to shut down the possibility that we can't complete T and L by the end of this year. MS. LAYTON: Substantively. MR. DYKES: Well even complete it. I would think if we could get a thumbs up tomorrow and if there's some more word edits, that could probably be done via email to all of us, and we could say we're in, we're out by 8, 10 days later. MR. SCHECHTMAN: Then you sort of get a provisional thumbs up, thumbs down. MR. MEDLEY: And if people are not in, then that's it, they're not in. MR. DYKES: Yeah, we need to know that though. Otherwise, we'll be back in March and another plenary and back to the same races. MR. SCHECHTMAN: I think that's fine if we can get there. MS. LAYTON: A question that came up in our group was, if the charter would be done by the end of the year. If we don't, if we're not having a meeting before February 13th, is there a committee that could still meet in March? Are the current members held until replaced or is it just going to be half a committee. That just was a question somebody asked me and I didn't know the answer, and I thought I'd better ask. MR. SCHECHTMAN: Yeah, I think the answer to that is we can't hold a half meeting. MembersÕ terms expire and we would hold the next meeting when we have a full committee. MR. MEDLEY: See, and I think that's why we need to, as this committee, do whatever we can possibly do to try to complete the task. If you can't, you can't. I don't think we should just automatically say you can't. MR. SCHECHTMAN: Okay. I mean, I think if there's a way to do it that incorporates the little changes that come in from folks and have it done via email once we're convinced that the big things are done, you know, that's okay if everyone is okay with it and it gives everyone ample opportunity to do what they need. MR. MEDLEY: We haven't set any dates but, what we do know is that the terms of charter for this particular committee were to expire, I guess is it February 13th? MR. SCHECHTMAN: Eleven, 12, 13. MR. MEDLEY: Something like that. I mean, that's, so we do know that particular day. We can look at where we are, we can make some assessments, but I think our objective should be that as a committee, you know, we want to try to complete one of the two projects. MR. JAFFE: After we've taken off the option of also coming back for a one day meeting before February 13. MR. SCHECHTMAN: I'm not taking it off the table. Let's see where we are tomorrow and then see if we need it. MR. CORZINE: Good, Michael, that's what I'd ask. Let's see if the objective is tomorrow to be ready to sign off because we have this whole issue if we don't, we may have several new members around the table too, which will delay us even more. MS. LAYTON: Adjourned for today. (Whereupon, at 5:13 p.m. the meeting was adjourned.) C E R T I F I C A T E DEPOSITION SERVICES, INC., hereby certifies that the attached pages represent an accurate transcript of the electronic sound recording of the USDA Committee Meeting. By: ____________________________________ Keena Lukacinsky, Transcriber 178 kel