Transcript Of Remarks By Agriculture Secretary Mike Johanns And Dr. Robert Brackett, Director Of The Food And Drug Administration's Center For Food Safety And Applied Nutrition - Washington D.C. - August 18, 2006 | USDA Newsroom
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Release No. 0308.06
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Transcript Of Remarks By Agriculture Secretary Mike Johanns and Dr. Robert Brackett, Director of the Food and Drug Administration's Center for Food Safety and Applied Nutrition - Washington D.C. - August 18, 2006

MODERATOR: Good afternoon from Washington. I'm Larry Quinn speaking to you from the Broadcast Center at the U.S. Department of Agriculture. Welcome to today's news conference with Secretary of Agriculture Mike Johanns. Today's topic is Genetically Engineered Rice.

Joining the Secretary in the studio is Dr. Robert Brackett, director of the Food and Drug Administration's Center for Food Safety and Applied Nutrition.

Just a reminder for reporters, please press *1 on your telephone touchpad to alert us that you have a question to ask.

Now it's my pleasure to introduce Secretary of Agriculture Mike Johanns.

SEC. MIKE JOHANNS: Good afternoon, and let me just start out and say thanks to everybody who is joining us on the line this afternoon. I also want to start by saying welcome to Dr. Robert Brackett from the U.S. Food and Drug Administration. I do appreciate his participation in this call.

I might also mention that we are joined in the studio with Deputy Administrator for Biotechnology Regulatory Services, Cindy Smith. And when we get to the point where we take questions, both of them will be available to answer questions.

I will share with you some information about genetically modified rice, and then I'll invite Dr. Brackett to offer some thoughts on behalf of the FDA. And then as I indicated, we'd be happy to take some questions.

The U.S. Department of Agriculture and the U.S. Food and Drug Administration have been notified by Bayer Crop Science that the company has detected trace amounts of regulated genetically engineered rice in samples taken from commercial long grain rice. Both agencies have reviewed the available scientific data, and based on that data have concluded that there are no human health, food safety or environmental concerns associated with this GE rice.

Bayer has developed many GE herbicide tolerant products with the protein called "liberty link," three of which are rice. The regulated line is called LL Rice-601, and Bayer reports finding only trace amounts of it during its testing. Two deregulated lines, LL Rice-62 and LL Rice-06, which again use the same protein, have been through thorough safety evaluations and have been deemed safe for use in food and safe in the environment, although these lines have not been commercialized.

USDA's Animal and Plant Health Inspection Service conducted a risk assessment based on available data and information, which indicates this regulated rice line, LL Rice-601, is safe in the environment. Bayer indicated it had no plans to market it, and therefore had not requested deregulation.

Field testing on LL Rice-601 occurred between 1998 and 2001. Based on reports that it is in the marketplace and a petition from Bayer, APHIS will conduct a deregulation process including an opportunity for public comment. Because the line of GE rice in question was regulated, I have directed APHIS to conduct an investigation to determine the circumstances surrounding the release and whether any violations of USDA regulations occurred.

It is important to note that the protein found in this regulated rice line, LL Rice-601, is approved for use in other products. It has been repeatedly and thoroughly scientifically reviewed, and used safely in food and feed, cultivation, import and breeding in the United States.

It is also approved for use in nearly a dozen other countries around the world. Since 1987, APHIS has deregulated more than 70 GE crop lines. In the last decade farmers have increasingly planted biotech varieties engineered mainly for herbicide tolerance, insect resistance, and enhanced quality traits.

USDA's National Agricultural Statistics Service estimates that in 2006 61 percent of the corn, 83 percent of the cotton, and 89 percent of the soybeans planted in the United States were biotech varieties.

With that, I would like to invite Dr. Brackett to offer a few thoughts, and then as I indicated we'd be happy to take your questions.

Doctor?

DR. ROBERT BRACKETT: Thank you, Secretary Johanns.

I'd just like to emphasize what the secretary just said, and that is on the basis of everything we know at this point, we're aware of no safety concerns here. We have a robust system for insuring the safety of foods in this country including those foods produced using bioengineering methods in which developers and marketers on one hand and the government on the other hand both have responsibilities. We're working closely with USDA and with the industry in this situation.

As is always the case, food that is marketed in this country must be safe and lawful. We fully expect that companies marketing food will be vigilant in this task as well as FDA and USDA. In the present case of bioengineered rice, as with all foods under FDA purview, if we become aware of any new information that suggests that food or feed may be unsafe, we can and will take appropriate action to ensure continued protection for consumers.

However, we have no suggestion that there's any food safety concerns at all with any rice on the market today, including any rice that may possibly contain LL Rice-601.

SEC. JOHANNS: Larry, with that I think we're ready to take some questions.

MODERATOR: Just before we begin, I would remind reporters to please press *1 to indicate if you do have a question.

Today our first question comes from Chris Clayton from DTN. Chris, go ahead, please.

REPORTER: Thanks for taking questions, Mr. Secretary. What was -- I'm sorry I didn't catch it necessarily -- what was the genetic enhancement or whatever that this rice line has? And what is the estimation in the amount of I guess spreading or contamination that may have occurred?

SEC. JOHANNS: Let me ask Cindy to take the first question, and then in terms of any estimation of spreading I'll offer a thought on that. But Cindy, go ahead.

MS. CINDY SMITH: Okay. The line that we are talking about that there's some preliminary information on is a rice line that conveys herbicide tolerance. And so what that means is that the plant is protected through the way that it's been genetically engineered against the Liberty Link Herbicide.

SEC. JOHANNS: In reference to your question about spreading, Chris, I would hesitate to even offer an opinion about that today. What I can tell you is that on July 31 the FDA and the USDA were notified that testing conducted had identified this genetically engineered rice in the sample that they had taken. But today it would be way premature for me to go beyond what we've been given by this company Bayer and try to surmise what percentage might be out there.

MODERATOR: Next question will come from Jackie Fatka of Farm Progress followed by Stewart Doan. Jackie, go ahead, please.

REPORTER: Good afternoon. Thank you for taking my question. You started off by saying that Bayer had reported trace amounts. What was it exactly that they found the trace amounts in? Was it other field testing they were doing?

And also, you had just mentioned that July 31 was when you were notified. Have you been doing investigations since then during the month of August, or what has been going on since July 31?

SEC. JOHANNS: I'll again ask Cindy to answer the first part of your question, and then let me talk about some of the things that we've been able to put in place in this short period of time in preparation for today. Cindy?

MS. SMITH: Yes. Thank you. Bayer tested a couple of market samples that were made up of long grain rice. That's what they tested and then found tested positive for the 601 Liberty Link.

SEC. JOHANNS: A couple of things that I would offer in terms of what we've been doing to prepare for today, we wanted to have a couple of tests validated or in the process of validation because we anticipate that producers out there will want to test rice or shippers will want to test rice. Customers may want rice tested.

So that actually is in the process, and we actually have a test available where you can identify the protein. More information will be available on that yet today.

The second issue was that we wanted to be able to offer based upon the information that was provided to us by Bayer, an indication as to food safety, public health, environmental. And so they provided us documents, which our experts have been reviewing to be able to say the things that we have offered today.

And again I emphasize that based upon the materials that have been provided, we have reached a determination based upon those materials that there isn't any environmental fear; there isn't a food safety fear.

Now as the doctor indicated, if there were additional information that would cause concern about that we of course would get that information out immediately and make that available to the public.

And then the other thing I would mention is that we just wanted to make sure that we knew what the genesis was, just gather as much information as we could about the rice and its testing and its background and that sort of thing. And so we've also been engaged in that process.

MODERATOR: Next question comes from Stewart Doan of Clear Channel Ag Networks. And Stuart will be followed by Jerry Hagstrom. Stuart?

REPORTER: Thank you, Larry. Good afternoon, Mr. Secretary. Where was the -- the sampling question, where did it come from-- a commercial warehouse in what state, what part of the country?

Secondly, impact, potential impact on exports, what is USDA doing? Are you communicating with major buyers of U.S. rice? Is APHIS or FAS doing that, sir?

SEC. JOHANNS: I can't offer anything on the first part, but I can, Stewart, offer a couple of thoughts on our sales overseas. Of course we do have a very solid market in terms of rice overseas. We will be working with those trading partners. In fact that has already begun this afternoon where we have indicated we'll get information in their hands.

But the thing that I've emphasized in the discussions I've had, and I suspect they will continue in the weeks ahead, is that not only the USDA but the FDA has been involved in this, that based upon the materials provided there isn't a food safety concern, there isn't an environmental concern.

I gave them some verbal information but I also indicated to them that our scientists were at their disposal. I also indicated to them that any paperwork that we could provide we wanted to provide, and that our experts would work with them.

I also wanted to be able to tell them and was able to tell them today the status of the validation of the testing to ascertain the existence of this protein.

So all of that information was shared, and we're going to continue to do that in the days and weeks ahead.

SEC. JOHANNS: I'm just not going to get that far down the trail because one of the things I learned long ago is you should try to do everything you can to avoid interfering with an investigation, needless to say. So my direction to APHIS has been, you do whatever you feel you need to do to make sure that this investigation is thorough and complete. And you're not going to get any interference whatsoever in that effort. In fact, we want to make sure that they have all the cooperation in the world to make sure that when the investigation is done that they've looked at all aspects of the issue.

REPORTER: Thank you, sir.

MODERATOR: Jerry Hagstrom of Congress Daily is next, followed by Brian Hartman. Jerry?

REPORTER: Yes. Mr. Secretary, a rice lobbyist has just e-mailed me a message saying that there is some, that there is a bit of confusion out here about whether the rice that has been contaminated was part of the 2005 rice crop or whether it is part of the 2006 crop that is now in the field. Can you clarify that?

Secondly, there are rumors out there that this positive sample came from rice that was grown in Louisiana, and it's held by Riceland Foods. Can you comment on that?

And third, I would ask you, do we know if this contamination has occurred in the various rice-growing regions of the country? Or if it is just in one area rather than, let's say, both Louisiana and California?

SEC. JOHANNS: It was the 2005 crop, I can tell you that. I won't verify rumors. And your third question about region, we are working off of samples that the company has provided, and so I'll turn to Cindy on that. I don't believe I have ever heard, Cindy, of what region this was from. But --

MS. SMITH: I think what we know is that it's long grained rice that's in question. I think that's as much as we know.

SEC. JOHANNS: Okay, great.

REPORTER: And is -- excuse me -- is long grain grown in one part of the country?

MODERATOR: -- of ABC News. And standing by should be Scott Kilman. Brian?

REPORTER: Sure. First off, back to the July 31 thing, why didn't we hear about this on August 1? And second of all, when you say long grain rice we're talking about there was a package on a grocery store shelf that had this rice in there somewhere?

SEC. JOHANNS: Brian, the reason why you didn't hear about it on August 1 or even July 31st is because we didn't have all the information that we felt was necessary to even get this story out today at that point in time.

We were supplied with significant amount of information. We definitely wanted to make sure that FDA's experts had an opportunity to look at that. And we wanted to make sure that our experts had an opportunity to look at that.

The other thing was that we knew that the day that this was talked about that producers out there, justifiably so, or people who might be sold rice would want to know what tests are available. And that is a very, very justified request. And so we've been working on validating tests so we would be able to answer that question today.

I can tell you that we wanted to make sure that we were doing everything we could to try to get a handle, based upon the information we had, relative to environmental safety and food safety. And so we've really intensely been working on those issues so we could say what we did today.

In terms of your question about was this off a shelf, or something like that, let me again point something out here. It's very, very important because I don't want to read too much into your question, but it implies to me something that quite honestly I find concerning in your question.

The genetically engineered products in the United States are very, very common, have been for many, many years. We estimate that about 70 percent of the processed food in the United States would have some genetic engineering component, some background to it. In other words, it's just not an unusual phenomena here. In fact it is a very, very common phenomena.

The protein that was used in this rice was a protein that is identical to two other lines of rice that would have gone through our entire process, could be commercialized here, absolutely have met the requirements that are out there and satisfied those requirements.

REPORTER: But if it's not unusual, why are we having --

SEC. JOHANNS: I guess what I would say to you is this. I'm not exactly certain where the sample came from, but I didn't want anything about your question to imply to people that there's a safety concern here because based upon all the information we see -- and we took the time to look at it -- we don't see that.

Now again, as the doctor indicated, if we got any indication to the contrary we would get that information out there just as quickly as we possibly could.

REPORTER: But you haven't answered the question --

MODERATOR: Next question will come from Scott Kilman of Wall Street Journal, and Scott will be followed by Jack Caske (sp). Scott, go ahead, please.

REPORTER: I'll reask the question and I'll ask another one, two questions. One is, what happens to rice that contains this unapproved strain, the 601? Does it have to be recalled or be destroyed? That's my first question.

And number two, Mr. Secretary, are you saying that the USDA knows where this unapproved variety of genetically modified rice was found, but you're not going to tell the public?

SEC. JOHANNS: The first question, whether we would recall it or destroy it, there's nothing that we have seen that would justify that action, nothing whatsoever. Again, I point out to you that the FDA and the USDA have been both involved in this.

And I'll ask Dr. Brackett to offer a thought on that too, but there would be nothing that would justify that action.

And I can tell you in terms of the location of this sample and the information I've provided I can tell you very candidly, I didn't ask where this sample came from. I know it's long grain rice. I can't tell you if that came from this state or that state. The information that was provided to me was sufficient for purposes of ascertaining the safety of this, and I wanted to know where the process was at, and had it been through the process, and a whole list of things. (Note to readers: Secretary Johanns did not request information about the specific states from which the samples were collected because he was advised that the samples came from grain bins that contained rice from several states, making it impossible to determine where the sampled rice was actually grown.)

But whether it came from this state or that state, quite honestly, is an issue that I just, it never came up, and it's an issue that hadn't been addressed in the conversations I'd had.

DR. BRACKETT: I agree completely. The mere fact that this rice has some genetically engineered components in it doesn't in and of itself make the food unsafe. In fact, we have looked at all the data that's been provided and arrived at the conclusion that this does not pose any food or feed safety concerns to us.

And so consequently FDA does not plan to take any regulatory action based on the presence of this bioengineered rice variety in food or feed.

MODERATOR: Next question is from Jack Caske (sp) of Bloomberg News. And Jack will be followed by Sally Schuff. Jack, go ahead, please.

REPORTER: Good afternoon. What percentage of U.S. long grain rice is exported? And what are you doing to protect those imports? How is it affecting those imports?

SEC. JOHANNS: What are we doing to protect the exports probably is your question.

REPORTER: Yeah, exports. What percentage --

SEC. JOHANNS: About 50 percent of the rice crop is sent into the export market. About 80 percent of that would be long grain rice if I remember my statistics. So 50 percent of the rice crop thereabouts goes into the export market and about 80 percent of that would be long grain rice.

The best way to deal with trade issues is to deal very, very directly with your trading partners, and we are doing that. We are engaging them. We are providing information to my colleagues. I'm talking to them. In addition I have indicated to them that we will provide whatever information they need, we'll put our experts together with their experts.

I also indicated during our phone conversation today that the determination has been made based upon the information we were supplied that there is not an environmental risk, there's not a food safety risk. And I've also indicated to them that as we continue to go through whatever process we have that we'll continue to stay in touch and provide them with information.

So our goal here is to just make sure that we're engaged with them, not only today but on any day that they want information or are seeking advice on what we're doing.

MODERATOR: Sally Schuff of Feed Stuffs Magazine is next, followed by Kevin Freking of Associated Press. Sally?

REPORTER: Yes. Hello, sir, and thank you for taking my call. And I apologize -- I came on the call a little bit late, so this question may have been asked. But how was this discovery made? Was it, was the testing that called this to your attention conducted by a consumer group or one of the regulatory agencies or perhaps the company?

SEC. JOHANNS: The company came to us voluntarily, and they indicated that they had performed tests and indicated that those tests had shown a very small presence of a GE product in the rice. So that's how it came to us through the company, through Bayer.

REPORTER: Thank you.

MODERATOR: Kevin Freking of Associated Press is next followed by Christopher Dohring. Kevin, go ahead, please.

REPORTER: Yes. I understand the safety message that you're stressing and you don't believe any regulatory action is required. But I'm still wondering, is this a product that is something on the shelves today? Are American consumers potentially buying this product?

SEC. JOHANNS: That's very, very hard to answer just simply because the information we have received and the information, the statements we are making is based upon the testing that we have seen. And I was asked the question earlier, what percentage of rice may be impacted by this, and I just hate to venture out there because there's just nothing I have that I could base that statement on.

Kevin, if I might just offer a thought, I think you indicated there was no need for further regulatory action. There's actually two things that are happening here that involved the regulatory aspect of this. The first thing is that as I indicated in my statement, we are going to do an investigation to see how this product, which has not been deregulated, is out there.

And APHIS will be conducting that. And again, my direction to them is to do a complete and thorough investigation.

The second thing I would tell you is that they, "they" being Bayer, will petition for the deregulation of this rice line. Keep in mind that two rice lines that have the same protein have been deregulated. They could be used. I can also tell you that this line, a pretty significant amount of work had been done on this line when Bayer decided it was not going to commercialize it and did not pursue it to a final result.

But I can tell you that the risk assessment that we have done to date indicates that this rice from the USDA standpoint is environmentally safe.

Now let me emphasize something very strongly. This process will involve public comment. We will invite the scientific community, the public, whoever, to offer their thoughts. And we will give them the opportunity to do that and that will be very, very carefully reviewed as we review all of that information in a regulatory process. And based upon all of that and the work that has been done and will be done by APHIS, a decision will be made as to whether this should continue to be regulated or whether it should be deregulated.

MODERATOR: And our final question today comes from Christopher Dohring of Reuters. Christopher, go ahead, please.

REPORTER: Yes. Thank you for taking my question. I'm just curious to know if anything -- I know you've had other instances in the past where crops have been contaminated between biotech and traditional crops. Is this the first time this has happened as far as rice is concerned?

SEC. JOHANNS: Let me ask -- I believe it is. But let me have somebody else answer that.

MS. SMITH: That's correct. This is the first issue that's come up with respect to rice because this was a crop that actually while it was approved previously to be marketed the company had not yet brought it to market. We've not had any other situations involving rice.

REPORTER: Thank you.

MODERATOR: Mr. Secretary, any final thoughts?

SEC. JOHANNS: Let me just wrap up my comments by expressing my appreciation to those who have so diligently worked on this and to those who are in the studio with me. If I were to wrap up with just a final message, this message would be that based upon the information we have seen, this product is safe. At the USDA we have already done a significant amount of work on this line. We invite people to comment as the deregulation process goes forward, and that will start immediately. That will be posted in the Federal Register as we always do.

The other thing that I would urge people to do is to stay in touch with our website. Any information that we have will be posted on our website, and it will be available for anyone to see.

With that, let me just finally say to all of those who have joined in the call today, we appreciate that immensely.

MODERATOR: Secretary of Agriculture Mike Johanns.

I'm Larry Quinn bidding you a good afternoon from Washington.