Monday, December 1, 1997
PRESENTERS:Evelyn DeNike, Public Affairs Specialist, FDA |
MS. DENIKE: Good morning.
MR. GARDINE: Good morning, Evelyn.
MS. DENIKE: Welcome to the first Town Hall meeting, co-sponsored by the United States Department of Agriculture and the Food and Drug Administration on the microbial safety of fresh produce.
I would like to begin by introducing you to the people here at the front of the room. Starting at my extreme left, Michelle Smith from the Food and Drug Administration; Les Borquin, the Extension Food Safety Specialist at Michigan State University; Dan Wyant, Director of the Michigan Department of Agriculture; Tom Gardine from the Food and Drug Administration. On my extreme right, Ray Mlecko, District Director of Chicago and Detroit Districts; and Bob Hollingworth from Michigan State University. I am Evelyn DeNike, Public Affairs Specialist at the Food and Drug Administration based in Detroit.
On October 2nd, President Clinton announced a plan entitled, "Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables." As a part of this initiative, he told the United States Department of Agriculture and the Health and Human Services that we were to work together to produce these Town Hall meetings and to develop a plan to ensure the safety of our fresh produce.
So we've begun working on draft papers, and the guide that you got handed today is a draft. It's a work in progress. And we're looking at all kinds of things: Microbial food safety hazards, good management practices associated with water quality, sanitation, hygiene, transportation, manure and municipal sewage sludge. You have to say that slowly.
So what we want to do is keep this very, very informal. We are here to solicit your input. Our folks are going to take you through the guide, and then there will be ample opportunity for everyone to comment for the record. When you do comment, we ask that you come to one of the two microphones in the center and please give your name first, so that our reporter can get all this information down. We will have formal proceedings.
The restrooms are located -- if you go directly out this back door and straight down that hall, they are off on the right. And Dr. Hollingworth said to make sure you wash your hands before you return to the room.
MR. MLECKO: With soap and water.
MS. DENIKE: With soap and water.
MR. GARDINE: Warm water.
MS. DENIKE: Warm water. Do we want double scrubs?
MR. GARDINE: And wear gloves before you come back.
MS. DENIKE: The address for submitting written comments is out on the registration table. And the time is short. I believe December 19th will be the final day for comments. It will be about a week after the last Town Hall meeting. So those of you that might want to take this information back to your organizations and develop written comments, you need to know that they need to get it to us quickly.
We will try and amend the agenda and break for lunch at 11:30, allowing us first access to the restaurants, most of which are on the main floor in this hotel. Hopefully, we can get this turned around in an hour and then continue. As I said, we are going to make this informal and try and get as many comments as is possible.
And it is my pleasure now to introduce to you Ray Mlecko, the District Director of Chicago and Detroit Districts. Ray?
MR. MLECKO: Good morning. And good morning, Evelyn. And everybody can tell by her remarks that I'm her boss, or else it wouldn't be a pleasure introducing me the way it is.
I've spent a lot of my time in Chicago, and it really fee ls good to be out in the real world, so to speak, and now I know how the people in D.C. feel when they leave the Beltway and come out into the real world. This is a beautiful city here with a beautiful hotel, and I am very happy to be here today.
On behalf of the Food and Drug Administration, I would like to welcome you all here. And as you'll find out a little later, this really is a historical meeting. It's one of the first. And hopefully it will be the foundation upon which the other meetings can be built and the program can be developed.
Now, as most of you know, under the Federal Food, Drug and Cosmetic Act, it is the responsibility of the Food and Drug Administration to make sure that our food supply is both safe and wholesome. Now, we share this with the USDA and the state agencies and local agencies, et cetera. Part of FDA's role is to try to prevent problems before they occur, before they develop, before they get out of hand.
Now, based upon our public health responsibilities, President Clinton charged FDA to take the lead in developing a guidance -- and I want to underline the word, "guidance," I want to emphasize the word, "guidance" -- to assist farmers in minimizing microbial problems.
Now, I would like to emphasize two points about the President's initiative. First of all, it's a collaborative mission, it's a collaborative venture. We are including or we have included the U.S. Department of Agriculture, the various state departments, like the Michigan State Department of Agriculture, local people, local health authorities, and you, the public, and you, the farmer, and you, the processor.
This is one of six meetings that will be given throughout the United States to try to get your input. We're here to listen to you. Everyone will have the right to speak, to say whatever they would like to, voice their concerns in an atmosphere of openness. In other words, whatever you say will have a value to the folks in Washington.
The second thing I would like to emphasize is that we are not here to develop regulations. I think everybody agrees that we've got enough regulations now. We have regulations on the books that have been on the books for fifty years, and we don't enforce. There are too many regulations. But what we are trying to do with this meeting, we are trying to start to develop a guidance document for use by the farmers.
As we sit here today, we have two jobs. Or there are two tasks. First, we plan to review some of the major features of the President's initiative on fresh produce, and Tom Gardine will give you the background and will discuss the various forces that have led up to this point.
And, secondly, and even more importantly, you have an opportunity to give your input into the draft guidelines which are contained in your packet. These guidelines represent our first stab at the issue. And also, it reflects the preliminary thinking of the FDA and USDA scientists. It also has incorporated the comments from the produce subcommittee of the National Advisory Committee on Microbial Criteria in Food, which is an advisory committee to the FDA. And as I said before, these comments have been incorporated in the information you have in your packet.
Now, your comments here today, along with the comments from the other five meetings, will be recorded. We have a court reporter here to record the comments. And these comments, then, will be considered and incorporated, as appropriate, into the final draft. The final draft document will be published in the Federal Register early in 1998, calendar year. And then after they are published, you will have another opportunity to submit written comments concerning your viewpoint of the guidance document. And then afterwards, all these comments will be considered and be incorporated, as appropriate, into the final guidance document which also will be published in the Federal Register.
Now, both the final draft and the final document will be posted and can be found on FDA's web site, and our address for the web site is contained in the information packet.
Now, I can't emphasize enough, folks, that this is your opportunity to have input in something that may affect the way you do business. If there is something here that you can't live with, something here that you disagree with, it may be to your best interest to make your comments, let your views be known. Because without your input, there is a possibility something might be published at a later date that might not be the best thing for you folks here. So we need your input, we're begging for your input, and we hope that we get your input.
And finally I would like to thank everyone for taking time from their busy lives to be here and to participate in the first of these six meetings throughout the country. Incidentally, there are six meetings within the continental United States, and there will be one foreign meeting. I don't know where the foreign meeting is going to be, but maybe Tom Gardine does now.
And if there is anything -- if anybody has any questions for me personally, anything about the district or whatever, I will be around all day, and feel free to contact me. Thank you.
MS. DENIKE: Thanks, Ray. Now it is my pleasure to introduce someone who is not my boss, Commissioner Dan Wyant of the Michigan Department of Agriculture.
MR. WYANT: Evelyn, thanks. I appreciate the opportunity to be here. And let me start out by just welcoming everyone here to Michigan. Those who have come in from outside the state, I welcome you here to fine Grand Rapids, particularly this spot. Look at your schedule, I hope you will take a chance to look around. No snow yet, so we've so far been lucky there. And I want to thank everyone also for attending and being part of this.
Ray, to you I want to first recognize the outstanding partnership--Evelyn, Ray, Camille, Dr. Gomez in the back of the room--that exists, in my opinion, between the Michigan Department of Agriculture and our federal partners, in addition to our state land grant university. I heard the term "partnership," and we have certainly put an emphasis and focus on maintaining strong partnerships. I believe we've done that with the FDA, USDA, Michigan Department of Agriculture.
I want to underline the fact that this is an important discussion, important for many reasons. First of all, it's recognized--and, again, our appreciation to you coming here to Michigan-- fruit and vegetable in particular, agriculture in general is very important to the state of Michigan. It's our state's second largest industry. It is a $37 billion industry. And certainly a major component of that is our fruit and vegetable industry right here today in Grand Rapids in the front end of our annual court show or trade show. It's a fairly big show here for us in the state. So, again, a very timely discussion.
Important for the second reason, and that is food safety is absolutely a priority for all of us in the food and agriculture industry, whether you are on the farm, in food processing, retailing or ultimately consuming the food that is produced, not only in this state and this country, but around the world. So we all know, as I look around the room, because we have a lot of our agriculture leadership here today, that food safety has been a front burner issue and a priority for us and it is important to the consumer.
It is also important to us to be involved in the food and agriculture industry because, again, without a high degree of consumer confidence, we are not able to market and sell what we grow and produce. So, again, I think there is a general recognition of that, and, again, underline the importance of that.
I appreciate and do want to say that -- I want to emphasize, too, the fact that FDA/USDA has come in and said that they are prepared to work with industry and work together in a partnership. They are giving assurances the President's initiative will be scientifically based. And, again, it is not intended to cause an economic burden on farmers in particular. And so, again, as we sit here today, we will be anxious to look at some of the discussion, because, again, with that as a focus, we can appreciate that direction and that directive. So we're anxious to do that.
We in Michigan, as I said, have been very conscious of the food safety concerns. We've had some very visible experiences with hepatitis A, most recently E. coli in apple cider. Again, I want to emphasize there's been an outstanding relationship with our federal partner and with the university to tackle these kinds of problems. So, again, that is our goal here today, so we keep that foremost in mind.
We have attempted here in this state again to provide some leadership on this issue--our food safety alliance, our food safety awareness campaign, in addition to our new initiative that we call Project SAFE, Special Action for Food Emergencies, that tries to coordinate on a state level interagency responsibilities, and one that we're moving the university into and certainly will involve our federal partners as we move forward. And I would be remiss not to recognize, again, the National Food Safety and Toxicology Center at Michigan State University.
We think that just adds a wonderful resource to this state. That will allow us in Michigan to continue to be leaders in addressing this very important issue of food safety. So let me stop there. And I appreciate you coming to Michigan, making this one of your stops. It is absolutely a critical issue. I don't think you will find this group hesitant to respond and give you input, and certainly what you don't get today, you are guaranteed to get an adequate amount of input from the state of Michigan as you move forward in this process. So again, thanks for coming.
MS. DENIKE: Now I am delighted to introduce to you Bob Hollingworth, who is the Director of our National Food Safety and Toxicology Center, brand new, at Michigan State University. Bob?
MR. HOLLINGWORTH: Thank you, Evelyn. And on behalf of Michigan State, let me welcome you to this meeting. And I appreciate the chance to say a few words on behalf of the Extension system, but also I was asked by the Director of Agriculture Experimental Station, Lynn Gray, to include him in this message, and so we will do so.
The Director of our Extension program, Arlen Leholm, sends his apologies for not being able to attend himself. He had other business that was pressing, but it seems reasonably appropriate to me to represent him in view of our brand new center that we've developed in the area of food safety, which is just -- this is just the kind of issue that this was established to help work and resolve.
Obviously, everybody's become aware over the last few years of the rising number of incidents of human pathogenic microorganisms getting into the human food supply and causing, in some cases, fairly serious human disease problems, and some of those have been quite close to home. We are very familiar, even in this area, with the hepatitis problem in strawberries. Dan Wyant alluded to
E. coli getting into cider. And we've also had a problem in this state with bean sprouts, Cyclospora raspberries, et cetera. These have become almost a weekly or sometimes daily headline in the paper over the last couple or three years. Some of these incidents arise overseas, as far as we can tell, but some of them arise closer to home. And those in the business and processing area for fruits and vegetables are working to try to ensure this doesn't happen.
Some involve new and more dangerous strains of all pathogens. Sometimes they involve things that are rather exotic and have not been familiar to us before originating outside the United States. Some of these incidents are isolated, but they do have serious health impacts, and they also have serious financial implications for the producer. So it's entirely timely and appropriate that this kind of initiative start to arise and to get some input from the people who do the production as to how we can minimize the problem.
So, clearly, Michigan State's very happy to work with MDA and FDA and USDA and probably any other DA that has an interest in this whole situation in developing and disseminating good agricultural practices to decrease this potential problem with microbial contamination. We particularly support the concept of using an educational rather than a regulatory approach to solving this particular problem.
And the only thing I would feel it important to point out is that you can only develop good agricultural practices if you have a pretty good sense of what the origins and potential solutions to the problems are. And I would just point out, we have a lot to learn yet about the scope of these microbial contamination problems-- production systems that are most at risk, where microbial contamination in produce comes from, how it survives, what conditions favor its spread and what are the best critical control points to work on to minimize the problem.
Probably to do this properly, we are going to have to develop ways of testing for contaminating organisms and also that allows you to test the effectiveness of control measures that you have taken to decrease the problem. So it would be wise to spend some time investigating these issues before we can develop really detailed and effective programs. I would say that we have a lot more ignorance than we have knowledge of this situation at the moment.
Anyway, I look forward to hearing the discussion that ensues out of this document. We have got some very good people in the audience who know the Michigan production systems for fruits and vegetables intimately, and they are going to have a chance to comment. And we look forward to that and also to the role that MSU can play in this partnership in terms of research, outreach and educational programs for developing a safer system. Thanks.
MS. DENIKE: Thank you, Bob. Well, without further ado, Tom, we are going to turn it over to you for the review of the President's Import Food Safety Initiative. We don't call this PIFSI, do we, with the acronym?
MR. GARDINE: I might, but that would just be sloppy language.
MR. GARDINE: Good morning, everyone. I hope you all can hear me with this mobile mike. First, I would like to respond to some of the things that have been said so far. Ray mentioned the international meeting. I would be very delighted if I had the opportunity to travel to some exotic place, but the international meeting is scheduled for Washington, D.C. next Monday, across the street from the building where I work, so I will miss that opportunity. But it is intended to focus basically on the concerns of the international community through their emphasis and any trade organizations in those countries that wish to travel to the United States. As I said, I recommended Acapulco, but no one was listening.
You heard Dan mention that we want this document to be pragmatic. To take -- to give guidance as to what the grower and processor of fresh produce can do to preserve safety of the product and the market acceptance of the product. A key point to remember is that the U.S. government is stressing to the American people to eat fresh produce. I believe the National Cancer Institute has a recommendation of five servings a day. Fresh produce is good for people. We want them to eat it, we want them to enjoy it, and we want it to be as safe as possible. So together, once again, this cooperative effort between the grower and the federal agencies and the states to develop guidance that might pragmatically be helpful in this area, but which must be doable for the grower, and that's the sort of advice we are trying to solicit today.
You have a document in front of you. I know if you are like me you had other things to do over your Thanksgiving weekend than to sit down and read it in depth. That's why we are going to try to cover it with some detail this morning to give you some ideas to respond to. But what we want from you are comments as to is this doable, will it be helpful, where we are totally aware that document, that guidance is totally off the mark, where perhaps you, as a grower and industry, want -- might value more detailed guidance when and if it can be developed. We want your input.
As a number of people have said, this is a guidance document. It is not a regulation. It does not have the force of law. It is not intended to. It is intended to give the grower concepts that the grower should consider in their operation to minimize microbial hazard with fresh produce. We at the FDA, the USDA and the states and you all realize that we do not live in a sterile world. The earth you plant your crop in, the sky around it is not a sterile environment. The best we are hoping to do is to minimize microbial hazard on fresh produce.
One other thing before we start the slide presentation. I have been somewhat sloppy lately and have in casual conversation been referring to this as a regulation. If I do that, my colleagues at the table promised to throw something at me, but I want to stress, if I do misspeak, it is simply misspeaking and does not reflect in any way a hidden agenda on the part of anybody to make this a mandatory regulation, and it is intended to just be guidance.
So if we could turn on the lights -- turn on the slide and hit the lights.
First of all, a little bit about the President's initiative, the initiative to ensure the safety of imported and domestic fruits and vegetables, but you have heard this referred to as PIFSI for short. On October 2, as you heard, the President announced the directive, and he mandated the USFDA and the USDA to develop guidance to industry -- not new regulations, not new requirements, but guidance for consideration of industry to minimize the risk from -- of microbial hazards in produce.
If you've had a chance to look at the regulation yet, you know it is really focusing strictly on microbial hazards. The elements of the President's initiative are basically two. There is a legislative component and an administrative component. The basic part of the administrative component is the guidance to industry, but there is also a budget request. We will get that out of the way very quickly. The budget request is likely to happen, if it happens, for the federal government's FY '99 budget, so there is nothing we could tell you about it yet. We do not know what increased resources, if anything, will come to either agency to implement this. We expect some, we do not know what they will be.
The legislative proposal, which has been submitted -- by the way, it was sent forward to the House and Senate by Secretary Shalala, I believe November 13th. It has a sponsor in the -- let me focus that a little better -- no, we can't. Camille, could you see if you could focus that. It has sponsors in the House. I do not yet know if it has a sponsor in the Senate. It gives FDA the authority to halt food imports from countries whose systems do not achieve the U.S. level of protection.
Well, what does that mean? Does that mean we're going to apply this guidance document to foreign countries when we do not apply it domestically? No, it does not. It is guidance for us. It is guidance for foreign countries. But this does give us the option. If there are risks associated, known risks associated with foreign produce, and we can show that it is truly associated somehow with the agricultural practices in those countries, it gives us an option to limit the access of that product to the U.S. market.
Would we do that first? Probably not. We will probably work with countries in an educational mode, as we will work with our domestic industry in an educational mode, as our first step. But if people's health is at risk, here is another tool for the Food and Drug Administration to use.
It says here the legislation would provide FDA authority similar to USDA regarding meat and poultry. This is a bit of an exaggeration. We have no intention of requiring registration and preapproval of shipments of food products into the United States. We are simply pointing out that USDA has the authority to stop food shipments when they are produced under a system that does not meet their -- the U.S. government's requirements.
They, of course, do require approval almost on a plant by plant basis. I believe we have absolutely no intention of doing that. And after consultation with the Office of the Trade Representative, we believe that this proposed statute is consistent with free trade principles. What the statute would look like if it is ever turned into law, we do not know. The legislative process is just beginning.
The administrative components. As you heard, FDA in cooperation with the USDA is to issue within one year, as a final document, guidance for good agricultural practices, GAP's, for the production of fresh produce, and guidance for good manufacturing practices for the processing of fresh produce; i.e., fresh cut produce as an example. And FDA and USDA are to work together to coordinate assistance and educational activities to domestic and foreign industry. Obviously, we are just beginning to go down that road. It's difficult to plan an education program for a document that is, as you heard, nothing but a working draft at this point.
We will repeat this many, many times during the presentation. It is guidance; not a regulation. It is intended to help firms, growers and producers identify appropriate practices to minimize microbial hazards, try and identify where pathogens can get on fresh produce, ask that the grower evaluate his practices -- his or her practices in these areas, and perhaps where science exists, give some concrete suggestions and advice as to what a grower could do, given the constraints of his or her operation.
What you have in front of you, the guide, is a broad-scope document. It is intended to be applicable for most produce operations. It is -- it consists of general areas where we believe microbial contamination can get onto produce and areas that are somewhat within a grower's control or where there are things that a grower can do to minimize the risk within the constraints of his or her operation.
It is going to be a very public process. We had a public meeting to kick off discussions on November 17 in Washington. As you've heard, this is the first of a series of grass roots meetings or Town Hall meetings that will occur around the country this week and next. We are trying to go to major agricultural areas. It is, of course, impossible to go to them all, but we think we have a very good schedule to allow us to get input from most of the major growing areas at these regional meetings.
There will be one international meeting in Washington, as you heard, intended to get input from our trading partners. Imported produce is very, very important to this industry and to the American public. The amount is growing, and in some cases approximately one-third of the fruits and vegetables that we might ingest in this country is being imported.
One other challenge facing us is a proposal to--after we get this broad scope document, which we believe has a great deal of universal applicability--to develop specific GAP's and GMP's for four fresh fruits or vegetables during FY '98. Those have not yet been determined as to what they will be. We intend to go out with the Federal Register document, both soliciting suggestions and asking for any guidance documents that have been prepared by industry or academia in these areas to assist us in considering candidates for specific good agricultural practices, specific to a certain crop. And then to perhaps identify further ones for specific documents in later years and somewhat down the road.
This shows that I was up late last night looking at my slides (upside down screen).
This is to show you that the major component--once the good agricultural practice document is, indeed, finalized--is for USDA and FDA to work together to assist the domestic grower through outreach and education programs.
Let's hope I didn't do this on all of them. (Right side up screen comes into view.) Thank God.
One other thing about the public process is the goal right now is sometime in late January or February to publish the draft working guidance that we received today in the Federal Register as a proposed guide--not a final document-- with a 45-day comment period. After we absorb the comments we receive at these grass roots meetings and which we receive in writing, we will evaluate them, as you heard, and incorporate them in this draft. There will be another opportunity at that time for people to comment on the draft guidance and for us to review these comments before any final document is published.
A little bit very quickly about how -- the challenges facing us on imported produce. During this fiscal year, in FY '98, we had hoped to select foreign countries and products to be evaluated. We have to determine what criteria we will apply in this area--volume, importance to the American consumer, association with illness, perhaps risk associated with certain agricultural practices in foreign countries. These all have to be studied and determined as to -- to help us determine which countries to evaluate.
We have to evaluate how to best use FDA and USDA resources. USDA's already overseas in the Extension Service and APHIS and have a lot of knowledge that we have to share and work together. FDA has a lot of knowledge from its experience in testing of produce as it comes into the country. We have to plan for sampling in FY '99. Depending on what resources we receive, prepare a protocol for foreign country evaluations and develop profiles of countries to work on country evaluations.
We plan to do -- just as we planned to work extensively domestically with U.S. industry on education and outreach, we have to do that with our foreign trading partners, and we will be working with international organizations and consultants to develop non-FDA training, because neither we nor USDA can possibly do it all.
And the President challenged us to find ways to better increase or improve our border surveillance. Increasing border surveillance doesn't necessarily mean collecting more samples. We want to look at this in terms of outreach to the foreign countries, although there will be a component of increased border sampling in terms of evaluating how successful we have been in outreach to our foreign trading partners.
Before I continue, are there any questions for clarification? As I said, we have a lot to cover. I have no intention of talking for two hours. I am going to be going very fast. Are there any questions of clarification about the President's initiative at this point?
MR. HOLLINGWORTH: If I could ask one question. I don't want to divert you from this too much, but will there be a reciprocal increase in monitoring of produce in the United States that matches the increase in monitoring of overseas produce? I mean, is that part of the trade equity situation?
MR. GARDINE: We can do things differently here in the United States, in that through the Extension Service and state agencies, we are in a position to work with the farmer closely and have alternate ways to evaluate improvement or to see if the good agricultural practice documents have effect.
Will there be market basket type surveillance activities as a measurement to see how serious the microbial problem with fresh produce is? We -- that decision has not yet been made. We may try to do it, but with that, we have the same problem as we do with sampling fresh imported produce for microbiological hazards. The microbes don't spread out, it is a very spotty contamination, and we do not know whether that is the most effective way.
As I said, for imports, increased surveillance -- one small component of it might be more samples at the border, but that is not our real goal. We are trying to find better ways to do that job. So it is a possibility not yet determined, but we don't expect that to be a major component of our effort.
Ray?
MR. MLECKO: How did you know I wanted to say something?
MR. GARDINE: Because you pulled the mike closer.
MR. MLECKO: Is there any expectation on FDA's part that foreign growers will follow the good agricultural practices?
MS. DENIKE: We cannot force foreign growers to do this. We believe it is to their benefit. We have had some contact with their agricultural attaches in Washington. They are, of course--as domestic industry is--somewhat concerned with the implications of this guidance document. But most of our major trading partners that have spoken to us appear willing to look at the guidance and consider it, which at this point is all we can ask. The answer is there is no answer at this point.
MR. MLECKO: Thank you.
MR. WYANT: Tom, this is what I've heard you say: These are sort of guiding principles, if you will, scientifically based, pragmatic, educationally focused, not regulatory, and consistent with free trade principles. And I think I've heard you say also utilizing the states' existing networks and partnerships.
MS. DENIKE: Correct.
MR. WYANT: Whether that be Extension Service, whether it would be utilizing the partnership between the USDA, FDA and the state departments of agriculture or whatever the local regulatory arm would be. Am I correct in that to this point?
MS. DENIKE: So far, yes.
MR. WYANT: Anything else you would like to add to that list to ensure that?
MS. DENIKE: No, I think, Dan, you very much covered it. We do not want to recreate or create a new bureaucracy. There are things through Extension, through the state agencies that are working well. We want to work within that structure. We do not want to create a new structure.
I would just ask you to introduce yourself for the transcriber, please.
MR. GOLDY: My name is Ron Goldy. A couple questions. One is, once you develop the GAP's and the GMP's, will there then be an effort to implement a certified grower-type program?
MS. DENIKE: That is under consideration, but at the moment there are no firm plans to do that. It is one of the things being considered to encourage adoption of good agricultural practices, but at the moment it is merely a concept being considered. So the answer to that is we are much too early in the process to give you an answer to that.
MR. GOLDY: Again, once those are developed, will there be any additional record keeping on the grower's side that will need to be done?
MS. DENIKE: I think as you read the good agricultural practice document, it does not suggest any increased record keeping requirements whatsoever. I think there might be just one -- one area where it is suggested that if you are a packaging house, you may want to consider a pest control log is about the only thing that comes to mind. And you probably should be doing that right now under the good manufacturing practices as they currently exist.
Michelle Smith, who is one of our drafters -- Michelle, can you think of any other record keeping requirements being suggested under the guide?
MS. SMITH: I think the pest control log is a good example of where there might be places where it would be useful to keep track of what you are doing, whether it's to keep track of the pest control or to have records of employee training in areas of sanitation and hygiene. There is not a specific record keeping requirement, but it may be to your benefit to keep track of what you are doing to make your own process run more smoothly and efficiently. Does that answer the question?
MR. GOLDY: And then, finally, what about any kind of spo t inspections such as OSHA and other government agencies do? Will there be any of that?
MS. DENIKE: At the moment, there are no plans for spot inspection, but I am not going to stand up here and mislead anyone. While we do not anticipate anything like that, we do want to find ways to evaluate the impact of this guidance, so it is a possibility, but not anything that we are at the moment contemplating. But I do not want to mislead you and say under no circumstances will we not. In an attempt to measure the impact of these guidelines, that there is no possibility that that would be something that is done. Not necessarily by FDA, it can be done through other -- you know, through various mechanisms.
Stacey? And then we will move on.
MS. ZAWEL: My name is Stacey Zawel. I am with the United Fresh Fruit and Vegetable Association as their Director of Scientific Regulatory Affairs.
Tom, I just have a couple questions and a couple statements. One of those is that when you said 'sampling,' and we talked a little bit more about it earlier in this question period, I have a great concern that -- of trying to do that, although I also recognize the need to measure the effectiveness of interventions. And the industry has developed this industry-wide guidance, and we're trying to evaluate how, in fact, can we measure the effectiveness of that. So while I recognize that is a difficulty, sampling, as we both know, and many in the room, is a very ineffective way to do so, especially when we know there are some issues out there, and we can't test appropriately, Cyclospora being a very good example.
The second question is is there not -- you didn't state t his specifically, so I want to clarify. Is there not an opportunity to provide written comments to the document right now up hrough December 19?
MS. DENIKE: Yes, this is correct. Since Evelyn mentioned it, I did not, but I believe the Federal Register notice for these Town Hall meetings did mention that written comments -- and I believe, Evelyn, you said the address to send written comments is out on the welcoming table -- will be accepted through December 19th.
MS. ZAWEL: Right, thank you.
MS. DENIKE: And, you know, Stacey makes a very good point, and I think it is just reiterating what I said. We do recognize that end product testing is not the most effective means to evaluate any impact that this guidance document would have, but it is something we are considering among other things to measure the impact.
MS. ZAWEL: Okay. The other comment that I wanted to make is one that the industry finds to be very important, and, Tom, you've certainly heard this before, and I direct the comment basically to Mr. Wyant and Dr. Hollingworth in that it's very important, when we talk about foodborne disease outbreaks associated with certain products, that we identify specifically the vehicle that was involved. And strawberries and hepatitis are a perfect example where the hepatitis A caused people to get ill because of consumption of frozen strawberries.
And while we cannot determine whether the contamination occurred in a processing environment or whether it occurred in the field to the strawberries, it is very important, especially in light of meetings like that that are public and have opportunities for media to be involved, that very high profile people like yourselves convey that very important information.
MS. DENIKE: And let me convey that. At the public meeting, I had a slide talking about illnesses associated with fresh produce, and one of them was hepatitis A in strawberries. And Stacey and her colleagues very rightly pointed out that it wasn't hepatitis A in strawberries; it was hepatitis A in frozen strawberries. I was using that as an example of things that have come to the American public's attention. But we have to admit that in this case certainly and in some others we really don't know where the contaminant entered the food.
MR. WYANT: Can I comment real quickly?
MS. DENIKE: Last comment, Dan.
MR. WYANT: I need to respond to this. I couldn't agree with you more. Ann Veneman from California and I have had detailed discussions about this because, again, we do need to, as much as possible, when possible, like a laser beam, identify the product, because we put the entire industry at risk. Strawberries is a perfect example of that, because the broad base media implicates all strawberries; when, if we can identify not only frozen strawberries, but in addition to that, that we know the frozen strawberries that are at risk are quarantined and in certain locations, then we've got to be able to convince people that -- and as we get more sophisticated in our approaches, hopefully we can even do a better job, so we don't put the entire industry at risk.
MS. DENIKE: And, Dan, to save me a few minutes because that was pretty much my closing remark, but I may use -- I may use it anyway.
Now a little bit about the guide that you have in front of you today. A little bit about the general concepts. As you've heard, recent outbreaks have raised concerns about the safety of foods, including fresh vegetables and fruits that are not processed to eliminate pathogens. That slide is up there to remind us all of the risks associated with fresh produce. They are not processed in a plant, they are not cooked in the consumer's home; they are eaten as is when purchased by the consumer. And we -- and you as processors do have a certain responsibility to take prudent and doable steps to minimize the risk of microbial contaminants on fresh produce.
Not subject to steps to eliminate microbial pathogens, and, therefore, you have to be careful in controlling them.
The potential vehicles for pathogenic contamination that we talk about in the guide are water, manure and municipal sewage sludge, worker, field and facility sanitation and hygiene, and transportation. As you look at your guide, you will see there is a section on each of these. This is basically the design of the guidance document.
The guide is intended as guidance only, should you not have gathered that already. Growers are urged to take a proactive role in minimizing food safety risks. And at this point, we at FDA and USDA want to tip our hats and thank industry groups such as United Fresh Fruits and Growers, Western Growers, and a number of others who began working on industry good agricultural practices. Certainly we at FDA did, and whose thoughts and documents we have certainly borrowed from heavily in the documents you have in front of you. And what you are reading in that guidance is the best advice of FDA and USDA in consultation with industry and consumer groups, and that consultation is growing and will be increasing in the future.
Now that we have a document to talk about, we are having these Town Hall meetings, and we will be having further consultations with industry, academia, and consumer groups about the guidance.
The document, as I stated, is broad scoped. It focuses on what we believe are common elements in growing, production and distribution that should be common to most fresh fruits and vegetables. And it is intended -- the guidance in it is intended to reduce the risk of microbial contaminations. There are certainly other things you could talk about in good agricultural practices. This is a very narrowly-focused guide on microbial contamination.
We recognize, as you've heard from some of the speakers this morning, that there are many gaps in the science that leads to uncertainties in the degree of risk associated with certain farming practices. That is why in our guidance we talk about minimizing risk. Whenever we have identified these gaps, we try to identify them in the guidance as clearly a suggestion, but areas where further research is needed, and one of the components of the President's initiative is to fund further research to close these gaps.
We want the advice to be practical. It has to be something that's doable. That is why we are here today. You must look at it, read it and say it makes sense, it can be done, or, "My God, people, what world do you live in?" This is what we want to hear from you. And as I stated, research will be accelerated under the President's initiative.
In some areas, the guidance points out that under no circumstances does the guidance document obviate or eliminate the need to comply with existing state, federal or local laws and regulations. Some of these are on the books. The guidance document does not eliminate the need to comply with the law as it is written now. For example, we must point out that packing houses frequently, as an example, fall under FDA's good manufacturing practice regulation document, which is located in 21 CFR 100, I believe.
A little bit about the guide. We believe there are common potential vectors for pathogens--manure, water, worker sanitation, facility sanitation and transportation. Once again, that is how the good agricultural practice document is designed. But we do recognize that there is enormous ranges in farms and facilities available, the climate, the soil that you must deal with. The guidance document will frequently say, "where feasible, based on local conditions and operations," but we expect, if a grower is going to use this guide, he or she will have to tailor it to his operation. The guide is not a one-size-fits-all.
Once again, we recognize cultural practices differ. They do differ. And here is the -- here is what we have to answer today. How can we best provide practical concrete advice to growers that will move us towards safer produce without being unnecessarily costly to growers? Once again, as you review the document and consider making comments, that's the basic question USDA and FDA want you to help us answer.
Specifics in the guidance document. Once again, we recognize certainly at this first meeting people did not spend the Thanksgiving weekend researching this, or at least hopefully many of you did not. We will go through very quickly some of the specific statements in the guidance document to give you something to think about perhaps over lunch and come back and comment on.
Once again, first part of the document talks about water, water as a vector of microbial pathogens, and what you should be concerned about. We are concerned with water in two aspects. As an inherent source of contamination itself. If the water is contaminated with pathogens, it may place those pathogens onto produce. And, if you take clean water and use it inappropriately to wash contaminated produce, it might spread that localized produce, depending on where -- spread those localized pathogens, depending on how you use the water.
Here are some of the pathogens that have been and are referenced in the document associated with water.
Because of water's potential as a source of pathogenic microrganisms, growers should carefully analyze practices involving water. The first thing you have to do under the guide is find out where your water is coming from and are you using it appropriately, and then think about how you could limit the possibility for waterborne contamination on fruits and vegetables.
You must recognize the potential for water as a source to contain pathogens, and the water you use should be of sufficient quality for its intended use. "Sufficient quality," is not defined in the good agricultural practice document. And if anyone wants to give suggestions on how it can be defined, we would very much appreciate that.
Growers should identify the source of water used in different operations. The source of water will vary with the intended use. The quality that is necessary will vary with the intended use. And, once again, what a grower can do is limited, based on the water sources available to them. We don't expect the impossible. The water you have is the water you must work with, and if you can make certain aspects of it better, we ask you to consider it. But if you are working with river water, downstream from a cattle farm, that's what you have to work with, and that's what we want you to evaluate, consider, and see if there are things that you could do to control and limit the pathogens associated with water. And once again, the guidance does not preempt any applicable federal, state or local regulations about the quality of water.
Growers should identify and review the source of water used on the farm, step one. As the degree of water-to-produce contact increases, so does the need for good quality water. The more water which is a potential source of pathogens comes into contact with the produce, the more important it is to be cognizant of this danger, be aware of it, and see what can be done to limit any potential for hazards or any contamination, if they exist.
Review may include determining whether the source of water is from a well, open canal, reservoir, reused irrigation water, a municipality or other sources. Depending on where you get your water, you have different options as to what you can do to try and control its quality.
Controls may include many options such as delaying water use until water quality improves. But if you have to irrigate your crops, that's damn hard to do. Water treatment is an option. Alternative application methods that avoid water-to- produce contact, if that is possible for you, depending on the needs of the crop. Maintaining alternative water supplies, if that is a possibility. The feasibility of these or other controls will depend on the intended use of the water and the needs and resources of a particular operation. We do realize that the options available to many growers will be limited in this area.
Irrigation water. Many factors influence a grower's choice of irrigation system: The economics, the water availability, the characteristics and cultural requirements for particular crops. Depending on the crop, growers may need to consider using water delivery systems such as drip irrigation that minimize direct water- to-produce contact for certain produce. Rather, this is just a possibility, a suggestion, something for you to consider. But if water is judged to be a potential hazard for your operation, one thing you should consider is are there ways to limit the contact of the water to the produce. Certainly that should be considered the closer you get to harvest.
For crop protection sprays. Water used to mix and load pesticide sprays should be considered a potential source of pathogens. One of the things -- no one has yet solved, for example, the problem you've heard about this morning with Cyclospora in Guatemalan raspberries. But one of the things that is being considered as a potential source was that we noted some of the farmers, in order to protect their primary water supply, their well water that was of sufficient quality when they were mixing their crop protection sprays, would go down to the river and use that, and then spray that on their crop. Something that perhaps if they thought about it a bit more they may not have done, and this is something for you to consider. Be careful as you are mixing your crop protection sprays.
Wash water. Safe and sanitary water is recommended for use in washing produce in the field and the packing environment. Once again, water has a potential to add pathogens to the product. It also has a potential -- we think of wash water as something that eliminates problems for us, and, indeed, it is if used properly. But we must remember that washing improperly may take a localized contamination and spread it. So care and thought must be given to the use of wash water. Wash water even with sanitizers may reduce but not eliminate pathogens on the surface of produce. If pathogens are internalized, washing has even less effect.
If pathogens are not removed or inactivated, they can spread, so a significant proportion of the produce is contaminated instead of sporadic items. Once again, washing may compound your problem if not done properly instead of helping you solve it.
For wash water, you may want to consider chlorination. If done properly, and it's something possible to do with the crops you are working with, it can help you control microbial pathogens in water.
Cooling operations. Water and ice used in cooling should be considered a potential source of contamination. Water that comes in contact with the produce is a potential for contamination. Any source of water, any use of water must be evaluated. Growers should be aware of the water source used to make ice and follow practices to reduce the risk of contamination during cooling operations.
Water is a vehicle for spreading localized contamination. That's just -- backing that up, that is just a reminder. Water, you must remember, wash water, any kind of water, we think of it as something to help solve our problems, and, indeed, if used properly it is. But if used improperly, it might only compound our problems. Please consider its use very carefully.
Manure and sewer sludges. Health officials and scientists agree that animal manure and human fecal matter represent a significant source of human pathogens. Bottom line, and no one I think will disagree.
The use of manure or municipal sewage sludge in the production of produce must be closely managed to limit the potential for pathogen contamination of produce. Growers must also be alert to the presence of human or animal fecal matter that may be unwittingly introduced into the produce growing and handling environment.
Properly treated manure and sewage sludge is necessary for your operations in many cases. Improperly treated manure or sewer sludge may contain pathogens that can contaminate the product, and as you heard, ruin potentially your marketing potential for a year when people start getting sick. We do recognize that municipal sewage sludge is not widely used on fields growing fresh produce; however, in addition to the potential for untreated sludge to serve as a source of contamination, properly treated municipal sewage sludge has been shown to have beneficial agricultural uses. We realize it's not used a great deal, but it's something that we wanted to talk about in our guidance document.
Sources of fecal contamination include the use of untreated or improperly treated manure; nearby composting or treatment operations that are not properly controlled; nearby livestock or poultry operations; nearby municipal wastewater storage or disposal areas; high concentrations of wildlife in growth areas. These are all things which in the guidance document we ask you to consider and evaluate their impact on your operations.
Growers may need to develop and follow good agricultural practices for handling manure to reduce the potential for introducing microbial hazards to produce. Practices may include processes such as composting to reduce the possible levels of pathogens in manure. Minimizing, to the extent feasible, direct or indirect manure-product contact, especially close to harvest. The closer the product gets to the consumer, the more care you should exercise. Assessing adjacent or nearby land uses to determine risks from animals that may shed pathogens that can cause contamination.
This is just to show that we realize and discuss in the document various treatments to reduce pathogens in manure before use, but we talk mostly about composting. Composting refers to the managed process in which organic materials are digested aerobically or anaerobically by microbial action. Properly composted manure can be an effective and safe fertilizer and/or soil amendment. But it is a controlled process; one that as a grower you should evaluate and make sure it is being done properly.
While the agencies USDA and FDA may not have sufficient data to make specific type and temperature recommendations--and we do not in the guidance document--that would apply to all composting or other manure treatment operations, good agricultural practices in this area may reduce the risk of microbial cross contamination from manure to fresh produce.
For untreated -- use of untreated manure, growers may reduce the risk of contamination from untreated manure by maximizing the time between application and harvest. Once again, you must increase your concern the closer you get to the consumer. Recommended minimums generally range from 40 to 60 days before harvest, and some recommendations are 120 days or longer for the use of untreated manure on fields.
The treated product -- treated manure/natural fertilizers, such as composted manure, may need to be produced in a manner to reduce the likelihood of introducing microbial hazards.
Care should be taken to avoid cross contamination of fresh produce from manure that is in the process of being composted or otherwise treated. It should be a controlled process. Likewise, improperly treated or incompletely treated manure may also be a source of contamination. If you are going to treat it, you should try working through Extension to treat it properly and learn what must be done.
Composting and other treatments may reduce but they may not eliminate pathogens in manure. Furthermore, it is unknown to what extent pathogens that survive treatment may regrow in composted manure. But for that reason, to the extent feasible, you may want to use the same recommendations that we have in the guidance document for untreated manure, essentially maximizing the time between application and harvest. Simply because it's been composted does not mean it is free of pathogens. More research is needed in this area.
During composting you should secure the manure or compost to prevent cross contamination of your fields by runoff, leaching or wind spread.
MS. DENIKE: Tom, it's almost 10:30. Why don't we take a 15-minute break here and give you a rest and then resume.
MR. GARDINE: Okay. Thank you.
MS. DENIKE: We will come back at quarter of.
(Break was taken from 10:30 to 10:46 a.m.)
MS. DENIKE: Thank you all for coming back after putting up with me for over an hour. We're close to the end, and I've asked Evelyn to stop me no matter where I am at a quarter after 11:00 so we could have questions of clarification on the guidance document before we go into our lunch break, which may help generate some questions and comments for the afternoon.
The next part of the guidance document deals with sanitation and hygiene. Worker health and hygiene play a critical role in the controls to minimize microbial contamination of produce. The bottom line is the fecal-oral diseases and the fecal-oral route is one of the primary concerns with pathogens getting onto produce and spreading disease.
Among the control of potential hazards is personal health of the agricultural worker. Good hygienic practices by all workers are essential in the controls of microbial hazards. Infectious disease, ill health with diarrhea, open lesions, et cetera, are a source of microbial contamination and can be transmitted to produce. This is the sort of thing that the manager, the grower, supervisor should be looking for in agricultural workers, whether in the packing house or in the field.
Among the comments or suggestions and advice in the guidance document is that an employee should report to a person in charge any information about their health or activities as they relate to diseases transmissible through food. The person in charge should be aware and monitor the health of employees. And individuals with diarrheal disease should not work with fresh produce. We know that's a hard thing to say, and it's a very hard thing for a grower/packing house operator to discern, but basically it's the bottom line of any food handling operation.
All employees who are involved in the harvesting, packing and distribution of fresh produce should be trained in good hygienic practices. Let's remember this product is going directly to the consumer. There is no cooking step that's going to be there to protect the product. You are a food -- you are producing a food, and some of the concerns that are more traditional in a retail or manufacturing operation should be considered and are applicable in the farm environment. You might want to consider establishing some form of training program or perhaps signing on to local or state training programs that might be available to your worker. And the program might include a system to monitor and evaluate -- "compliance" is a bad word here, but to monitor and evaluate the success of any training program.
The importance of hand washing. Once again, think of yourself, the growing operation, as a food producer. Washing hands after each absence from the work station--using the bathroom, eating and before coming to work--is very important. Dirty hands -- anything that could contain pathogens, be it water, manure, dirty hands, have the potential to gather and spread germs to the surfaces they contact. Washing hands with soap and warm water helps stop the spread of germs.
Employees should be taught proper hand washing techniques. You can't assume they know it.
Use of sanitation facilities. Facilities such as on-site latrines and avoiding the elimination of waste outside of these facilities should be encouraged. I think for the second part of that sentence, we probably should say, "should be required in the operation."
Some concerns with field sanitation. Toilet facilities in the field. The proximity and accessibility of facilities to harvest crews in all sectors of fresh produce production is important. Workers should have the opportunity to use the facilities when needed. This will help reduce the incidence of workers relieving themselves elsewhere.
Assure that the locations of facilities is not near a water source used in irrigation. There can be accidents, there can be leaks. Or in a location that would subject it to potential runoff in the event of heavy rains. Facilities should be provided for all workers.
Provide adequate hand washing stations with water, including warm water if possible, that is suitable for hand washing or drinking. Toilet facilities should be well supplied with the usual and maintained in a sanitary condition and in good repair at all times.
Examples of good practices to consider are the following: Clean or service portable toilets away from the field, if possible. And as you read this guidance document, you will see a lot of if-possibles and where-feasibles. Dispose of wastes through a subsurface septic draining system. Drain wastewater away from the field or collect it in a drainage tank to be correctly disposed of at a remote site. Once again, anything that could place something that could carry disease near the crop, near the produce, should be evaluated, considered, and if it can be controlled better, you should find a way to do so.
Septic trucks servicing the portable toilets should have direct access to the toilets. Locate toilets, where possible, in areas to minimize the likelihood of produce contamination. If you have an accident, if you have a break, things don't work properly, you don't want it uphill from your produce. Consider procedures for containment and treatment of any effluent from a toilet in the event of a leakage or spill.
The harvesting precautions. Remove as much dirt and mud as possible from the produce while in the field. Let's not bring it into the packing house where it could be a mechanism to spread localized contamination around the plant. Damaged or muddy cartons should be repaired, cleaned or discarded in an effort to reduce microbial contamination of fresh produce. You do not want to do anything that will add to an anticipated microbial load on the product. Let's remember, we're talking about minimizing risk here. You can't eliminate it, but there are things that are -- that obviously can be done, visible to the naked eye, that you should be doing. You should consider doing.
Care is needed to ensure that -- to ensure that produce that is packaged in the field is not contaminated in the process. And in the field or in the packing house, the guidance recommends that inspectors, buyers, visitors, wash their hands and/or wear clean disposable gloves before inspecting produce.
Equipment maintenance. A person should be in charge of maintaining equipment sanitation. Keep equipment as clean as possible. Items such as lunches, fuel, tools, et cetera should not be carried on harvesting equipment. Remove contaminants--mud, diesel, grease, et cetera--from equipment daily. While we know you don't expect harvesting equipment to be sanitized on a daily basis, but the same piece of equipment that is hauling manure one minute should not be used to move the crops. And the equipment you do use, certain care should be taken to keep it reasonably clean under the environment that you are working. And personal responsibility is something that you should consider. Someone should be put in charge of this, if possible.
In the facility, in the packing house, anything in the process from harvest to processing that makes contact with produce has the potential to contaminate it. We can't repeat that enough, and I'm sure many of you think we have already repeated that enough. But I don't think we can. Poor sanitation in the packing house can increase the risk of contamination of produce and water supplies used with produce. Become familiar with laws and regulations--local, federal, state--describing facility sanitation practices, such as 21 CFR 110 may be a good resource to use.
Equipment in the packing house, equipment such as knives, saws, blades and so forth should be inspected for defects on a regular basis and replaced as needed. Nothing more than is standard for a food processing facility.
Personnel should not use equipment that has contact with produce for carrying other materials. And you should keep the packing house and cooling facilities clean and sanitary.
Pest control. We mentioned this a little earlier. Obviously, in the packing house, all animals are a potential source of contamination. In enclosed facilities -- and look at the word, "enclosed" -- the pest control program is recommended. Packing house, processing facilities, and grounds around them should be in good condition to protect from pest contamination inside.
The final section in the regulation that deals with an area that may contaminate the produce is transportation. You could do the best possible job in growing, harvesting and packing your product, and if the truck that comes to pick it up is contaminated, if it is a mixed load with other product that may be contaminated, much of your -- some of your effort can go for naught.
Contamination of produce may occur due to improper practices during handling, loading, unloading, and transportation operations. Wherever produce is transported, the sanitation conditions should be evaluated, especially links between the distribution chain. You should inspect the truck before you put the produce on it, as one example.
Cross contamination from other foods and non-food sources and contaminated surfaces may occur during transport. What did the truck haul before it got to your product? Segregate fresh produce from other food and non-food sources of pathogens in order to prevent contamination of the produce where possible. Try to assure that trucks or other carrier sanitation requirements are met before loading produce. Put the product into a clean truck. Keep open communication along the transportation route regarding food safety risks and the need for adequate safety steps.
We realize, by the way, that the farmer, the grower is not the only -- to make this work, the farmer or the grower is not the only link in the chain that we have to speak to. And as an aside, I want to stress as part of this initiative, there is an initiative for consumer training and for retail training, and there is a regulation, I believe, by the Department of Commerce for transportation.
MS. SMITH: There is at least a guidance document that would be useful.
MS. DENIKE: Guidance document. That we need to work with the transportation industry to disseminate and educate them about.
One last thing that is -- has been sort of grafted onto this guidance document is a statement on trace backs, and I believe the current term of art is -- Michelle?
MS. SMITH: Positive lot identification.
MR. GARDINE: -- positive lot identification. Basically, what steps can you take if something does go wrong to limit it as much as possible? This is to your benefit, our benefit, and the consumer's benefit, if we can better identify contaminated product. So we asked growers to consider, where feasible for their operation, their crop, the way it's packaged. Once again, we have been talking about minimizing risk. Fresh produce will never be free of all contaminants. We realize that.
Trace backs or positive lot identification won't prevent a hazard, but it can limit the potential scope of an outbreak. FDA, if people are getting sick, will not have to recall the entire crop of apples from Washington state. If we could identify the source of the problem, it will limit the populations at risk. It will lead -- it will help us trace back to the specific company, source or growing field of the problem so corrections can be made by the grower. It will lessen the economic burden on operators not responsible for the problem. And it will be more easily implemented. We realize it will be more easily implemented in some operations than others.
Trace back, from a government point of view, minimizes the unnecessary expenditure of public health resources. If there is a way to focus on where the problem occurred, it gets us the ability to protect the public a lot quicker. It will reduce consumer anxiety. It frees consumers to enjoy fruits and vegetables not implicated in the outbreak. And as I said, your government is encouraging this. So operators, we ask that you examine current company procedures to trace, to track from farm to receiver, and operators we recommend should develop procedures and technologies to improve trace back from receiver to the farm, which a lot of that is not totally in the grower's control, but something we are encouraging throughout the distribution chain.
An effective positive lot identification system should have as much detail as possible. The documentation of the source of the product, the date of harvest, farm identification, chain of custody, and a mechanism for identifying the product that can follow from the farm to the consumer. So once we identify the bad stuff, the consumer can look at their shelf at home or in the grocery shelf and say this is safe to eat. Okay.
We are done. Will you turn on the lights. One other -- I just want to reiterate one comment that Dan made, and it does reflect a lot of some of the concerns about industry that we all share. One of the reasons the President gave for his initiative, not only does he recognize that our produce in the United States is probably the safest in the world, and he wants to keep it that way, but the President's initiative realizes that there is a component of this to protect American agriculture.
And one quick story having to deal with the hepatitis in strawberry incident that we talked about a little bit earlier. Once again, it was not hepatitis in strawberries; it was hepatitis in processed frozen strawberries, harvested in Mexico, processed in the United States.
The week that happened, my office -- my normal office is the Division of Import Operations with FDA. We were not actively involved because no one knew where the problem occurred. Did it occur in the food service? Did it occur in the processing facility? Did it occur on the farm? All we did was put out an advisory to our field staff saying Grower So-and-so in Mexico may be associated with an incident, you may want to sample his product. Although what good that would have done us, since we cannot test for hepatitis A on strawberries effectively -- there is a methodology, but it is not the most effective in the world.
But we had the advisory out so we would be looking at the product. That week I had other issues on my plate dealing with I think raisins from Turkey and heavy metal contamination. And sometime during the week I get a call that I was supposed to respond to. And I got back to the individual very late in the day, and I gave an apology and said, "You know, it's been a very busy week, and right now I'm having a bad time. Please excuse me for getting back to you so late." There was quiet at the end of the phone, and the man said, "Tom, I'm one of the major importers of strawberries from Mexico, and you think you're having a bad week."
And what he points out is what we all have to realize. When there is an illness out- break, the American consumer doesn't hear, "processed strawberries," or processed this or processed that. They don't hear, "strawberries from one farmer on the West Coast of Mexico." They hear, "strawberries." They don't buy the product whether it's grown in Mexico, grown in New Zealand, grown in Florida, grown in California. It affects everyone's market share.
So by working together on this through applying good agricultural practices, through considering trace back methods or positive lot identification mechanisms, we can work together, not only to make a safer product for the American consumer, but to protect American agriculture.
And I think now, questions of clarification. And there were some people wanted to ask questions during the break, and if they are available, now is the time.
MR. CARTIER: Good morning. My name is Dennis Cartier. And I was wondering if you could elaborate a little bit on the specific selection criteria that you intend to use for selecting four produce categories that you are going to go after first.
MR. GARDINE: A couple of points. One, the four items are not selected. We are going to go out, I believe I mentioned, with a Federal Register document, asking industry, consumers, interested parties to suggest criteria, suggest products that may be considered, and to share with us, if available, any guidance documents that may already have been developed.
But what criteria are we currently bouncing around in our heads? One, it has to be something of significant dietary impact to the American public. You would not want to spend a great deal of time by our drafters, like Michelle, doing something like star fruit from Asia. It is not significant, it is not worth it, so you would want to look at something with significant dietary impact.
Probably another thing you would want to consider, is it likely to be cooked? You know, is there a potential? I mean, it's produce, but how it is normally eaten is another consideration. You would want to associate with it things like has it been associated with illness outbreaks and what is the risk potential associated with the product. Those are a number of the things we are considering, and I'm sure we will hear a number of more things to consider.
MS. DENIKE: Tom, I have a question.
MR. GARDINE: Please.
MS. DENIKE: It looks like with the combined talent that's in this room, that we have in federal and state agencies, the growers themselves, that if we work together, we might be able to develop something in the way of an educational program that will serve everybody's needs, that will possibly be low cost, whatever that might bring into it. What suggestions do you have? Where do you see this coming into play? How far down the road and do we need to be thinking of perhaps pulling together our partnerships right now?
MR. GARDINE: We certainly have to start thinking about it, but let's look at what some of the time frames that have been publicly discussed are for this broad-scope guidance document. We are going through a series of grass -- of Town hall meetings this week and next. At which time we will have to wait for the transcription services to get the transcript with any comments, thoughts, suggestions into us. We will certainly be waiting for any further written comments through December 19, I believe.
Our goal is to get this document prepared as a draft Federal Register document sometime in late January or February or sometime during February for comment to solicit further comments from industry. And we usually give a -- Michelle?
MS. SMITH: 45.
MR. GARDINE: -- 45-day comment period. We then have to get these comments, work through them, and see what changes are necessary to the draft guidance. So the earliest that a final document can be published in the Federal Register is probably sometime in mid to late summer, is my guess.
We are talking to USDA and the National Association of State Departments of Agriculture about how you consider what steps -- what is the most effective way, what are the most effective tools, who could do what in terms of an outreach program. But it is really tough, Evelyn, to get down to details without a guidance document to talk about. But we are -- we are very cognizant, we don't want to recreate the wheel, and we will be working within existing mechanisms.
MR. GOLDY: Ron Goldy again. The document that you gave today, on the bottom of Page 22, I think we need to say that there is going to be an extreme amount of difficulty for growers in monitoring the personal health of their workers. Okay. It makes growers personal health police, and I don't think that that is going to be something that many growers are going to be very open to.
And I think that the other thing that is going to happen is that some of these things fall under the guidelines of -- or the jurisdiction, perhaps, of right of privacy for the workers. And then if there is an invasion of privacy, the grower might open themselves up to a discrimination lawsuit because they are being discriminated against because that worker is going to come and he can't work that day. And so because the grower says, "I think you've got something that's going to cause problems, I want you to go home." So I just think there's going to be some extreme difficulties in being able to monitor that, and I don't want this to go by without being able to say that.
MR. GARDINE: That is the sort of comment that we are here to listen to, and if anyone wants to expand on that right now or ask any other questions of clarification, please do so. That is -- that is exactly the sort of comment, by the way, that we are soliciting. What will work, what will not work.
MR. ROPER: Teryl Roper with the University of Wisconsin. I wanted to expand on that. Much of the harvest labor used for fresh produce tends to be at the lowest rung of the economic ladder. And if they come to work and say, "I have diarrhea" -- they are not going to tell you because they need the employment, they need the income.
On the other hand, if there were a means to compensate a grower -- or a harvester who is ill so that they could stay away, then I think you would have a lot of illness. Potential 'flu.
MR. GARDINE: If you would stay up a moment. But those points are all well taken. And believe me, it is something that we have heard from other people who have been talking to us. But the flip side of the coin is to simply not say that people with diarrheal illness should not -- you know, should be allowed to come in contact with food. So while these points are well taken and must be considered, you must realize that not saying it implies something else.
MR. GOLDY: I would be in favor of a strong educational program for these folks. And I think it would be not only advantageous to the safety of the American food supply, but it's going to be advantageous for the long-term health of these people. And it's really to their advantage to let them understand, not only the risk to other people, but the risk to themselves if they continue with that kind of a practice.
MR. GARDINE: Okay. Thank you.
MR. NYE: Ken Nye, Michigan Farm Bureau. The specific guidelines that would be developed, how rapidly would those proceed?
MR. GARDINE: Michelle, would you want to talk on that as one of the drafters?
MS. SMITH: One of the things that we're trying to do right now is we're trying to get the general guidance document as far along as possible, and in the comment process to make sure that we're on the right track. To the extent that we're successful in doing that, then we will hit a point where it makes sense to start working on the more specific documents.
Exactly when all this happens is kind of like having a crystal ball, but our best guess at the moment is that when this working draft is revised to be a draft stage, and it is published in the Federal Register, and we have the 45-day comment period, somewhere around there we will also have published the Federal Register notice soliciting comment on ways to identify the individual items or groups of items for the more specific guidance documents. And based on input from that Federal Register notice, we should be able to start working on both kind of in tandem. So we'll have a Federal Register notice asking for input on the specific crops. The general guide will have been far enough along to give us an idea of what direction we should be applying to the individual items once they are selected. I expect that process to be starting early next year.
MR. NYE: Tom, I think perhaps it was you, it may have been someone else from the panel, there was a reference made to some kind of a certification process or program; it would be under consideration, anyway. Can you elaborate on that? What are you looking at?
MR. GARDINE: In all honesty, we cannot elaborate. I think the point I made, that it is something that is being discussed as a possibility, but I have no details and do not know whether that will be a route we choose to go down. It is simply something that is being discussed.
MR. NYE: All right. The document references an increase in food safety health problems with fresh fruits and vegetables. How much of that has been attributed to the production side as opposed to the handling and marketing and retail and final preparation? Has there been a way of separating what's happened at the farm level and what's happening within the rest of that food handling chain? Any comments on that?
MR. GARDINE: The only comment I could give is that, one, the answer to your question is no, we have not been able to tweeze it out, except in those instances where perhaps state or CDC actually identified perhaps a food processing worker as the source of the illness. But we do recognize that an increase to some extent is due to the fact that fresh produce is being handled somewhat differently with the expansion of salad bars and like that. We do recognize that, but we have not been able to clearly differentiate what percent of that increase is due to what. And I don't think anyone else can, either.
MR. NYE: If the guidelines are intended primarily for production agriculture, what then is in the process or in the works to address fruit and vegetable safety issues in terms of a handling side of this, retail and so on?
MR. GARDINE: That is going to be handled through the Retail Food Code and the requirements of the food code. And that is -- that was implemented in the President's initiative of last year, the first food safety initiative, and those programs are likely to hit the ground within the next six months in terms of improvements with our -- with -- in the retail sector.
And I will ask if anyone has anything they want to add to that.
MS. SMITH: The only thing I would add to that is that this guidance document is -- the way I would look at it is it is more of a new element to add to other elements that go from the farm to table. And as additional areas of concern are identified, if there is not something in place already, then we would look at what's in place rather than reinvent the wheel. Then we could try to determine what is needed.
MR. NYE: Thank you.
MR. HOLLINGWORTH: Tom, could I ask a question? I think I already know the answer to that, but I'll ask it anyway. I happen to be involved in a project of putting out a new volume on Food and Feed Crops of the United States, which this attempts to list all those things that are grown for human food in the United States. And the last time I looked, there were 380 different crops. You are starting on 4 of them. Do you have any idea how far down that chain of 380 you are going to go before you stop?
MR. GARDINE: No, but probably nowhere near 380. I think we will be looking at the big impact crops, and I really can't give a number, but not -- not over two digits and probably the low two digits. And it will take several, several years to get there.
MR. THELAN: Curt Thelan with the Michigan Department of Agriculture. I have a general comment that echos the point brought up by Evelyn about maybe better utilizing the expertise within the states and the federal level. I know Michigan, like a lot of states, has developed state-specific practices that deal with some of these issues--water quality and the area of well head protection, manure management, just to name a few. I think the document could be enriched by making a general reference to some of those specific practices that are out there at the state and the local level.
MR. GARDINE: As a clarification question, are you suggesting further detail or simply refer people to these other guidances? Because what you don't have -- I believe there is an extensive reference list attached to the document, and are you simply suggesting that we, under these discussions, refer documents such as this to the reference list and suggest that people refer to them?
MR. THELAN: I would think in a document of this sort, it has to be general in nature, so probably a reference would be a better way to go at it without overburdening it with too much detail in those areas. But I think a reference section would be helpful, at least in giving a producer somewhere to go if he wanted to get those more specific details.
MS. SMITH: One of the things we are considering is doing something like that so if there are appropriate state or local agencies that would serve as the contact points for growers looking for more specific information about their region and about state and local regulations, we would be very happy to have names and addresses to include as contacts.
MR. THELAN: We will be happy to provide them for you.
MR. WYANT: If I can follow up on Curt's point, and I will speak on behalf of Michigan. I notice we have other states here. We all recognize that other states operate differently, and so there is some variety between states in how they manage issues, and food safety being one of those. In Michigan, for example, to Curt's point, we have developed good management practices in this state. They have been approved by our State Division of Agriculture. I mean, we have these working documents that we are working with and then with local teams to implement. And so we have developed a model in this state whereby management practices are developed with the help of the university scientific institutions, but then applied locally through soil conservation districts, extension service, and, again, our local partners, farmers themselves, as peer groups that will sit around and get these practices implemented. So we have got a system in this state on the farm.
Now we take that to another level with respect to processing, grocery stores and restaurants. Again, we're a little unique in Michigan because we are one of the few states that have put our food sanitation, grocery inspection into one agency. Most states have public health, Department of Agriculture regulating food handling aspect. We in this state have put that under one umbrella. Again, we have done that to be protective for consistent uniformity and responsiveness. And we think it's gone a long way.
I only say that to underline the fact that, again, we have standards and we have programs in place specific. And so, again, we would ask that you look at those or consider those that are already there. Because we're addressing those issues.
And then we were talking, Ray, during the break, I don't know of any other states other than California and Michigan that's doing this, but we have added a consumer education component. Again, recognizing that Extension has been doing this for quite some time, but we will be coordinating what the Extension is doing with what private industry is doing, because we also recognize, whether it be Spartan Stores or Kroger or other major retailers, have consumer education efforts in place. We are simply trying to coordinate that in a food safety awareness campaign. So we're one of the few states I'm aware -- I know California is doing it and we in Michigan are doing it, but there may be others. So we again in Michigan try to recognize throughout the system that food safety could break down, and so we have established an initiative, a protocol, where we address those issues.
So rather than keep rambling, again, the message here again is please consider the states' ongoing efforts that are already in place that are addressing this issue.
MS. DENIKE: And to add to that, this might encourage states that aren't as developed in their process as Michigan is to adapt some of these practices, if states that are doing a good job are highlighted and their materials are made available for others. Because, like you said, Tom, we don't want to reinvent the wheel.
MS. ZAWEL: My name is Stacey Zawel with the United Fresh Fruit and Vegetable Association. I want to also emphasize that as we represent many states, and they continue through this entire process to say there is a lot of stuff going on, California has a lot of regulations, and Florida and many other states, including Michigan, and others where this has force of impacting some of the ideas that are presented in here. They impact what the grower can do, because of other agencies that are making some recommendations, and you are going to hear a lot about those different impacts from manure use, sludge use, water use within different states throughout this process, which I think will be very beneficial.
I have one question, maybe Michelle can answer. I noticed from the last draft to this draft there was an inclusion that suggested -- actually, I don't have pages for you, but it's under
Section 2.2.1 on untreated manure, where there was an addition to the suggestion that NOSB, I believe, makes for organic food production that manure should not be applied within 60 days of harvest. And then this got added, where -- this in the past few days, "minimum recommended intervals for specific crops may be longer, for example 120 to 150 days, between application and harvest for stone fruit." I am wondering what reference that is that supports that statement.
MS. SMITH: That came from discussions within the Produce Subcommittee of MACMA. There is not a specific written reference yet. As this is a working document, I felt it was worth including that for discussion purposes. To the extent that we have more support for it or not will decide what happens with that particular statement.
MS. ZAWEL: Yeah, and that's actually what I thought, as I was involved in those discussions very closely. And I have a concern, based on the fact that that may come -- may have come from that discussion, that casual mention of something like that could make its way into a document such as this without stronger public health impact recommendations that, in fact, it's been shown that if you don't do this, it could impact public health; where, in fact, that is not at all how the discussion went. And so while it's perhaps a practice, it's going to be very important to support statements like this very solidly with more information.
MS. SMITH: We intend to have things appropriately qualified where they appear in this document. We're in the process now of reviewing some of the references that we have received based on comments to previous drafts. And that's an ongoing process.
MS. ZAWEL: Yeah, because I think that as you may find through this process in the next few days, that people may be implementing measures. They may not be doing so because it has a public health impact. They may be doing so for many other reasons. And to take that information and include it because it may be a microbiological food safety issue is perhaps of minimal help. And, in fact, when you consider that Organic Food Production recommends 60 days, this applies to many different products obviously, but especially applies to row crops. So if you are going to suggest a 60-day harvest interval for row crops but 150-day perhaps for orchard, tree fruit, there is something that doesn't jibe in terms of parallel risk, in my mind, and that is kind of what needs to go through the process of thinking about some of the inclusions.
MS. SMITH: The intent there, for example, with reference to the 60-day is to not say that that is our recommendation, but that is the recommendation of the California Organic Board, and to put it in that context, along with statements of what we do know at this point in time and what we do not know.
MS. ZAWEL: Yeah, I know that that's the intent. And the way that we review this document is that while it is a guidance, and I know it is a guidance from the FDA-USDA's standpoint, the content of this is going to be enforced by the industry -- who the industry supplies. So the buyers throughout this country are going to take this document and they are going to say how come your interval is different for stone fruit, why do you use this when this document says 120 days. So it's opportunities like that that could occur that will, in fact, have greater impact on the industry than you intend it to have.
MS. SMITH: Okay. I hear the point.
MS. DENIKE: I think it's 11:30 now. Let's break for lunch and try and be back at 12:30, and we will resume at that point. Thank you.
(Lunch break taken from 11:30 to 12:49 p.m.)
MS. DENIKE: Ladies and gentlemen, it's show time. Well, I had to get your attention one way or another.
Our next presenter is Dr. Rick Gomez, Cooperative State Research, Education and Extension Service. And Rick is the principal horticulturist. Did I say that right?
DR. GOMEZ: You bet'cha.
DR. GOMEZ: Thank you, Evelyn, and good afternoon. I have been asked to tell you what the role of USDA is in this microbial safety of fresh produce. The agency that I come out of is a brand new agency of a couple, three years ago. And it is -- it was created by joining the Extension Service and the Cooperative State Research Service. And, therefore, you got that big long title: Cooperative State Research, Education and Extension Service. But, I will leave that aside for a minute.
USDA has and will have a major role to play in this, and some of the agencies that are involved you've already heard about this morning. APHIS, the Animal Plant Health Inspection Service, which is the agency that safeguards American agriculture from foreign pests. They do inspect produce coming in from other nations.
Another big player in this role -- in this initiative would be the Natural Resources Conservation Service, which is the old Soil Conservation Service revisited, through the Water and Soil Conservation District. I think we've heard those mentioned, also. So USDA does have a role.
My agency, the Cooperative State Research and Extension -- Education and Extension Service, CSREES, is the one that -- the federal partner of the Extension and the experiment station systems through the land grant universities. So we have a mechanism in place to reach down to the county and in the case of Louisiana, parish, level. We do have that educational arm down to that level. We also have many experiment stations throughout the United States that are part of our partnership with the institutions.
So we can, in case that there are -- and there are gaps in our knowledge. One was alluded to by Tom on some of the manure and fresh manure and so on. We do have ways to address those gaps through research and then through the Extension Service in the educational programs. So USDA does have a role from the outreach and education point of view, and in some cases from the monitoring point of view, such as APHIS.
The Natural Resources Conservation Service is also one of the agencies that approves farm plans, farm management plans, and they can play a role in transferring some of this knowledge to the grower.
We are definitely working with FDA on this initiative. One of the issues that can come up or will come up is resources. Where are we going to get additional resources if we are going to add educational programs through the Extension system. That is something that we all will have to decide -- Tom, and we're looking, you said, FY '99. That may be pushing it on our budget cycle from the USDA. We are already into FY '99, so it may be down the road. But it needs to be addressed. It definitely needs to be addressed. But it can be hooked onto other current initiatives or thrusts that Extension has throughout the states.
Water quality initiative is one that comes to mind very, very quickly. We also have several other programs that can be adapted up to a point, such as some of the pesticide programs, pesticide applicator training, and we do those in conjunction with the state departments of agriculture, so we're linked throughout -- throughout this whole initiative process.
One of the things that I do want to clarify is that we have made statements here this morning and in previous days about CSREES, my agency, monitoring some of the things that are going to happen out in the state and at the producer level. My agency is not a monitoring agency. We do not do that. But we can evaluate the practices that are ongoing in the farm and come back, serve as a feedback mechanism to both FDA and USDA to let us know what is and is not working.
How do programs begin in my agency? There are two ways, as usual. From the top down and from the bottom up. We would like to think that most of our programs come from the bottom up, and they do in reality. They address needs of the local level. But once in a while, we have some federal government initiatives, such as this one, that comes from the top down. Those only tend to work when there are additional resources put into them; otherwise, the effort can be minimal if there are no additional resources.
But the important part is that the producers at the local level come to us, to the Extension and the experiment station system staff, and tell us what they need, tell us how things really work on the farm. That is our major strength in our agency and in the experiment station and Extension system throughout the United States. And it is a good system. We -- other countries try to emulate our system. So it does work.
I think producers, themselves, we need to remember that they eat stuff, also. And they want it as safe as can be. Don't think that they are irresponsible. I think they are the most responsible people that there are. So if we can help them in developing methods and avenues to safeguard our produce more than it is now, they would really appreciate it.
One of the things that really happens is that as we develop methods and approaches, programs, they become our partners in the process. And I guess these town meetings are part of that partnership-building process. We have had several commodity groups and we have the departments of ag represented, we have experiment station and Extension people, FDA people both at the federal and local levels and district levels. So we are all represented. And this is the type of partnership we need to encourage to come up with some of these programs to benefit the consumer and us.
I do want to leave you with one thought, though. And it has been emphasized, I think Tom mentioned that our produce here in the U.S. is probably the safest in the world. And -- but I want to add something. That it is probably -- I know it is, more risky not to eat fresh produce than it is from contamination. I want to leave you there. Thank you.
MS. DENIKE: Thank you, Rick. We do have some three by five cards if anyone would rather write down a question for a presenter, rather than ask it out loud. That is an option available to you. We are going to go into the questions for clarification now. Anyone with a question.
(No response.)
MS. DENIKE: No one out there is befuddled or confused about anything? Boy, did we do a good job. Oh, I knew we would get at least one. Thank you, John.
MR. TILDEN: I'm always befuddled, so it doesn't surprise anybody.
MS. DENIKE: Name?
MR. GARDINE: John Tilden with the Michigan Department of Agriculture. Just a question about the process that we are going through and the process that you are going to be using to develop these guidelines further. I guess state and local governments and commodity groups are used to working with managing risks from the chemical risk through the risk management process. There are established guidelines for how to do risk assessments that list mitigation steps. There's risk communication, and we have experience with that. How does that fit in with the process that you are beginning here?
MR. GARDINE: Let me start with attempting to answer your question. Of course, as with many things, many of the questions that have been raised, the answers are frequently unsatisfactory because of where we stand here. It is -- the risk assessment -- you notice that this is not, for example, a passive document. It is not a passive document because the science of risk assessment in this area--microbiological contamination on produce--is such that the risks cannot be totally quantified, nor can the control mechanisms.
Risk assessment I think is someplace we'd like to go to, but we have a lot of work before we can. So we're at the point of -- you know, minimizing risks where there is science available, but I do not want to pretend we're at a point where we could do satisfactory risk assessment, although that is something that people will be doing research and thinking about a great deal.
MR. TILDEN: I will make a pitch here. We are all used to dealing with uncertainties, and we make decisions every day based on limited knowledge. And in Michigan, we just had a phenomenon experience working collaboratively with industry groups and with Extension folks to try to come up with the best solutions we can with the imperfect knowledge that we've got. And one of the things that's been very important has been trying to identify what is known and what is not known. So that we have a shared understanding of where the data gaps are, so to speak.
My concern with a document like the one that we have is that there is an awful lot of good recommendations in it, but it doesn't show the uncertainty in there. I think if you had some feel for what we can say emphatically and what we cannot state emphatically, you would have a lot broader- based support for some of the specific recommendations that would come out.
We found that early on in our work with apple cider, for example, that we were making recommendations that when we started looking through the published peer review literature, there was precious little to support many of the common sense recommendations. We also found by talking with industry folks that they had a wealth of experience that may not be in the peer review literature, but expert opinion I think is a very valid form of getting information that can be used in risk assessment.
I think if we had a structured approach for how we gather this information and how we share this information, it would be a lot easier for all the different stake holders in this process to find a role where we could work together. Because what we found in Michigan is there is an awful lot of common values that we share on this in the area of food safety.
MR. KROPF: Roger Kropf, Kropf Fruit Company here near Grand Rapids, Michigan. We are a grower and shipper of fresh apples. Two questions: First one -- and possibly I missed this early on -- the dates that you gave for approximately the middle of February for a rough draft and 45 days later for final, is that a drop dead date?
MS. SMITH: Now, I think there is a little misunderstanding. Late January/mid February we're anticipating publishing the draft in the Federal Register with a 45-day comment period. Those comments would then need to be evaluated and taken into consideration before a final document would be available later in the year. So there's not going to be a final within 45 days of having published the draft.
The other thing about deadlines, when we request comments by a certain deadline, like we're requesting comments from these Town Hall meetings by December 19th, to ensure that your comments are fully considered, you need to make that deadline. But if at all possible, we can still consider untimely comments. We don't -- whenever we can, we try to take into consideration all the useful information we can gather, wherever it comes from.
MR. KROPF: Thank you for that. I may have been the only one that didn't understand that. Secondly, when this process of the town meetings finishes somewhere by the 17th or something of December, when this information is gathered, is there a -- is there a way that the participants will have feedback from the other groups that are going to be participating and how the information will flow? Is that going to be a possibility?
MR. GARDINE: Could you clarify the question, unless someone else understands.
MS. SMITH: I think I understand, and if I don't you can tell me. But all of the comments that we receive -- let me back up a little bit. Transcripts of all of these Town Hall meetings will be made available to anyone that wants a copy of the transcripts. There would be a per page charge, and I don't know all the details, but we could get that information to you.
The written comments that will be submitted to Documents from anyone who's interested in providing additional comments, when they have had a chance to take the document home and look at it some more. Those are submitted to Documents Management Branch and they become part of the public record. Documents has mechanisms in place to share those comments with people.
MR. KROPF: Thank you.
MR. ALMY: I am Al Almy. Tom, this morning you were kind of going over the -- in very broad general terms, the monitoring, if I can use that term, I guess, of practices that growers and the processing community and other nations importing food into the United States conduct. And there is a perception, and I am asking for clarification, I guess, if you are able to, there is a perception that this would mean the United States teams visiting the farms in foreign countries to determine if their production practices are meeting standards that would be acceptable here or equal here to prevent the importation of food that might in some way be contaminated. And that this, in turn, would result in foreign government teams coming to visit U.S. farms. And I think you can understand the apprehension, if there is any truth to this at all, that U.S. growers might have. Could you clarify, is there any specifics as to how the United States might be monitoring the foreign practices?
MR. GARDINE: Okay. Number one, I want to stress again this document is guidance, and what is guidance for our domestic industry is equal guidance and suggestions for our trading partners. Nonetheless, we do hope to find out what the agricultural practices are with some of our major trading partners that might contribute to microbiological hazards in produce imported to the U.S., as we are interested in evaluating and getting reports on conditions in the U.S. that might do the same to domestically-grown produce.
One of the things that we would consider doing is perhaps visiting and evaluating agricultural sectors with some of our trading partners, but that would have to be done in cooperation with the appropriate regulatory agencies in those countries. How exactly it will be done, how we will develop such a program, how we will coordinate it with the foreign governments, what role international organizations that do this already, such as the Foreign Agricultural Organization, FAO, at the UN, has not yet been determined.
But it is highly likely that we will be asking our trading partners for discussions that may include assessment visits in some portions of their agricultural community. Does that mean they will turn around and ask to do the same here? It means they can. Will they? I don't know.
MR. ALMY: Thank you.
MS. DENIKE: Other questions?
(No response.)
MS. DENIKE: Seeing none at this time, I would like to take us into the industry group presentations and call on Stacey Zawel of the United Fresh Fruit and Vegetable Association.
MS. ZAWEL: Thank you. I just want to make some relatively brief and general comments about the guidance and the process. United itself is a national trade organization that represents over 1,100 growers, shippers, wholesalers and brokers of produce. And I would first like to start by thanking the USFDA and the USDA, who are together developing the guidance for the grass roots meetings, for allowing us to contribute to the process. And we will continue to encourage you to do so, and hold additional meetings in other key produce situations in addition to the six that are being held over the next two weeks.
Extensive feedback into any guidance that is intended for the fresh fruit and vegetable industry must be developed with the knowledge of and consideration for what is practical and reasonable to do. And there are a number of areas within this draft guidance -- and I will emphasize "draft" -- that are absent of this practicality; for example, covering reservoirs to protect them and putting off irrigation until water quality improves.
And we encourage you through the next two-week period, to -- and certainly beyond, to listen to the industry to help shape the guidance towards more appropriate and effective recommendations, because, in fact, the industry itself wants to foster consumer confidence in our products, and we will certainly support efforts which will effectively do so.
And the produce industry has spent the past year developing voluntary, industry-wide guidance documents and is well aware of the challenges that are posed by such an endeavor. We have discerned that in many instances there is very little sound scientific knowledge as to the sources of potential microbial hazards in the production, packaging and transportation of produce. And while individual operators put prescriptive prevention -- interventions in place, federal guidance should not do so without sound scientific support; and issuing any guidance that suggests impractical recommendations which are not based on sound science or reasonable information would be counter- productive and ineffective.
And we certainly fear that the current rapid pace of this effort threatens to marginalize the produce industry participation. It will ignore the complexity of the industry, and it certainly disregards the scientific uncertainty behind micro- biological food safety issues for produce. But, in fact, if the guidance is developed to represent what's practical and what's reasonable and remains within the boundaries of science, and if the education and outreach programs are well thought out and implemented appropriately, then this initiative will be effective. And commodity-specific items will be unnecessary, leaving precious resources to focus efforts where the most benefit can be realized.
I want to just encourage that throughout discussions, throughout future documents, future drafts and any media participation that we are all involved in -- and Tom, you did a fantastic job this morning -- it's in the guidance that we encourage the consumption of fresh fruits and vegetables because we continue -- there is an increasing -- there is a rise in consumption of refined foods, along with a rise in chronic disease such as cancer and heart disease. And when an overwhelming -- also, an overwhelming number of scientific studies indicate that we must increase our consumption of fruits and vegetables from anywhere to five to ten servings per day, and not jeopardize the public health by forgetting to add those very important statements, but instead encourage increased consumption.
To capitalize on this opportunity throughout the next two weeks, we have gathered a number of industry experts together that represent numerous commodities to convey a number of things, such as why certain practices are followed, demonstrate diversity and complexity of the industry, and also convey what is practical and reasonable and demonstrate that the industry does take this issue of food safety extremely seriously. And I think, Evelyn, you've got the list of the number of industry representatives that are now going to speak. Thank you.
MS. DENIKE: Are they going to go in this order?
MS. ZAWEL: Yes.
MS. DENIKE: Then we would like to call on Roger Kropf, is it? Is that correct?
MR. KROPF: That's correct. Again, Roger Kropf, Kropf Fruit Company, Kropf Orchards and Storage. We are growers and shippers of fresh apples here in Michigan. And Stacey is our scientist and our specialist in conversation, and we are just the lay people that come up here to talk to you from the grass roots of where we come from, and we make our living from the soil and growing fruit and selling the produce to the public.
And first and foremost in our minds is food safety. We always need to remember and understand that. I have five grandchildren, and I'm reminded every day by these little guys that, "Grandpa, did you wash that?" They are hearing this every day in school. And we push the five a day produce for health, and USDA has supported that dramatically, and the Cancer Society has supported it.
We've got a tremendous movement going in this country. And we least not forget that we have the safest food supply in the world now. But there's always room to better ourselves, and we know that, and we can see that, and we're always, constantly working towards that.
I guess what I would like to do is share some of my concerns in how we go about accomplishing this. And part of this is that we -- we as the lay people need direction in what some measure of guidance for -- do we get an A, B or C for the kind of results that we create for you. Do we -- are we making our food safer? How do we always know that? And that we have to rely on the scientific industry and scientific people and research people to tell us that. We need the scientists. We need the MSU -- all the universities. We need the USDA's running the tabulations of all this so we understand where we stand in this project.
And I have a concern that we have many, many levels of different types of food safety for different food products. We have food that's grown in the soil, from the soil, over the soil. We have food that's transported in many different ways, and this is not an easy solution. The reason for my question was there a drop dead date, there is no such thing as a drop dead date when it comes to the food in our industry, and we and our children and grandchildren live on forever. So we hope that the resolution to what we're trying to solve here will be an ongoing process and not something that is set in the next four months, six months, or twelve months. They are going to say, okay, that stuff's going to make us all better for a hundred years. That is not going to happen. We know that.
So we have in Michigan some of the finest research and development programs going on here, and safety, of any place in the world--maybe next to California--that has proven that there is a lot of good things happening in agriculture. And if we can utilize already in place the people, the budgets, the money's already allocated, and the expertise that we have to work with, and somehow have that information flow back to us at grass roots, because only that is going to work. It has to be information that we can practically put in place and allow it to happen.
And there are things that many of us can do. For example, we do some things in our business. We have gone into quite a major ozonating process, and we ozonate all of our storage rooms where we store all of our apples, and we have found that we are killing everything in that room, so to speak. We don't see molds, we don't see mildews, we don't see any of the bacterial actions. We have nearly stopped the rot processes, because just ozonating the room kills all this bacteria and fungi. And I suspect it will strongly affect some of these microbiological organisms that we're talking about.
From there we move on to ozonating the submersion tanks that our fruit goes into when it comes out of storage before it goes down the packing line. But then again, there lies my concern. Because as soon as that fruit leaves our plant, we no longer have control. So there is many levels of control and many levels of restriction areas that can cause problems.
I mean, you know, I will talk about my own product so I don't step on anybody else's toes, okay. We have large bulk apple displays in our supermarkets today. And how many times do you pick up an apple that someone else picked up 12 times before you decided that was yours? And that's our life today. That's what we do. But we want to find how we can make it safer.
And I want to encourage -- encourage the committee to take all the information and bring their information together from the sources that have the correct abilities to bring us the proper information for us to put into practicality. We can do that for the people. We can do that for the consumers. It's not difficult. But we need to have some guidelines to give us what you want to reach. Do we want 100 percent perfection? Do we want 99.999 percent? Do we want 99? We don't know. Whatever that is, we'll do.
But it needs to have practical sense and it needs not to take our pocketbooks to the point of no return. At the same time, we don't need to drain budgets that we're going to pay for, also. Because we're double paying this, folks. We're grass roots. We put the monies into the taxes to pay -- to fund the programs, create the programs, process the programs, then regulate the programs. And then we still have to pay the money to make the process work before it ever gets to the consumer.
So please consider that in the next few weeks while you're putting this together and please help us to understand where we really need to go with a good final reading that we can all put in practical use. Thank you very much.
MS. DENIKE: Thank you, Roger.
MR. GRAHAM: Thank you. Good afternoon, my name is Tom Graham. I serve as the Director of Operations for the Michigan Blueberry Growers Association, also known as MBG Marketing. We are headquartered here in Grand Junction, Michigan. MBG is a producer-owned blueberry marketing, sales and processing cooperative, and have been in operation since 1936. We currently have more than 450 member owners in Michigan, Indiana, Florida and Georgia. Including our marketing contracts, our cooperative represents over 750 blueberry producers in seven states.
I'd like to begin by stating our disappointment with the organization of today's meeting. It seems nearly futile to have been invited to comment on the draft version of the good agricultural practices guide when we are seeing it for the first time today. Perhaps it was our misfortune to be included in the first of these Town Hall meetings. Attendees would have been better prepared to constructively participate had we had the chance to review the draft guide before today.
We strongly support the grass roots effort being exhibited here and do believe government, industry and the American public can work together to reach reasonable and practical solutions to issues such as food safety. Let's give all parties the same opportunity for input. We applaud the initiative to establish a comprehensive guide to help insure the safety of fresh fruits and vegetables and certainly prefer this approach to prescriptive regulation. We hope the final version of the guide will contain sufficient flexibility to recognize the tremendous diversity in food production systems and enough common sense to avoid paralyzing economic constraints.
At MBG Marketing, our producers have been committed to good food safety practices since 1936. We clearly recognize our products are consumed by people of all ages, and they rely on us to provide healthy, unadulterated fruit. We view our customers' comfort and safety with the same conviction as our own families'. Consumers provide for our economic wellbeing; the least we must do is provide for the safe stewardship of our food supply. Thank you.
MS. DENIKE: Thank you. Bob DeBruyn? Did I pronounce that correctly, Bob?
MR. DEBRUYN: It's pronounced a lot of ways, and that's probably better than many. I'm Bob DeBruyn with DeBruyn Produce Company. We've been growers and shippers of onions and carrots for 30 or so years, and I have got a lot of experience not only in Michigan but in most of the states that produce those items and some foreign production. I would like to out of that experience give you a few things -- a few ideas of the things that we do and things we do differently in Michigan and things I hope get considered.
I, too, have not read the guidelines, and I will try to answer some of the areas that I think you were looking at. First of all, I will try to run parallel, but there are some differences between onions and carrots that start out right away. Onions are dry. They are not particularly temperature sensitive. I think Texas has kept onions at 85 degrees for three months with moving air with no problem. Most onions are eaten peeled. I have never found anyone who likes onion skins very much. And at some point they have been thought to have medicinal benefit; they even rubbed them into wounds in the Middle Ages, as I understand it. Kind of a tearful experience.
But, at any rate, carrots meanwhile need to be kept damp, cool, and are quite often eaten in their raw state, which has some bearing on what you can do with them.
Michigan grows both onions and carrots on peat or muck type soil. There has been some development of carrot growth on sandy or mineral type soils, but primary production has been on muck soils. And they tend to rotate between carrots and onions, sometimes celery, those kinds of things. This means that the growers tend to use as much of the same equipment as they can--the same irrigation systems, the same spraying systems, all of those kinds of things.
Now, obviously, the needs of the crop diverge. You were interested in manure application. As far as I know, somewhere back during the Depression when fertilizer was unaffordable, people tried it and found out that manure was unaffordable because you got no crop quality. And I don't know in my lifetime that I can remember people using manure applications on muck at all. I suppose those deer, when they go out and eat the carrots, leave a little. We try to keep them out. And, obviously, deer don't like onions.
As far as irrigation, use of irrigation, at least on the muck crops--clearly the sandy crops or mineral soil have to be sprinkled--has been declining substantially. This is partly I think because we've been hard put to see the benefits, partly because both the Michigan onion and carrot industries are in very precarious economic condition. Another year or two like we've had, and I suspect you will see acreage drop extremely rapidly. We have had two or three years where virtually everybody has been working at well below the cost of production.
Anyway, the major way on the muck of irrigating is, of course, to subirrigate by holding the ditches up or pumping water into the ditches and bringing it up through the tile system. We have got to realize that no matter how you irrigate, the crops we are talking about are going to come in contact with the water because they sit on the ground. I don't think you can furrow irrigate if you wanted to on muck, it would all sink before it got to the next microphone, no matter how much you poured at it practically. And drip tape, given the fact that you don't irrigate consistently, then it becomes extremely uneconomic in the situation that we're looking at. That's why people use muck, is because the soil holds the moisture and continues to feed the crop moisture. That's why it's good for celery as well, as Duane and will probably tell you a little later. So we're not given a lot of choice, I don't think, about methods of irrigation.
Occasionally irrigation is used for wind control. Once in a great while for cooling. If you are planting carrots, for example, late in the season, and you get some extremely hot days, quite often it's used to try to cool the temperature down to help the emergence, but it has just been declining in its usage.
As far as water sources, wells, ditches, perhaps some ponds, there are areas in Michigan where there is no deep well water available. Ditches are practically at that point the only point. I know one farmer who drilled a water well 600 feet, found it filled with salt water, and decided there wasn't water available except through the ditches. We have tested for pH and chemicals. Normally we have relied on governmental sources to test for coliforms and so on, and in my recollection it's not done particularly often, but has been done quite a lot more in recent years. It so happens that we have not had -- or I have not seen bad tests on places we were irrigating, so that's kind of where that would rest, I guess.
We don't reclaim water except -- unless you consider that as you irrigate on muck, it goes down, and it comes through the subsystem, and you might pick it up again in the ditch. But I think that may give you some little idea at least on the irrigation and cooling.
As far as sprays, Michigan probably has to spray more than many areas because, given the humidity and the fact that we have an awful lot of nice friendly naturally grown weeds, we use more fungicides and herbicides than people that I know do in the west. Naturally, these sprays take water. It's normally from wells, in my experience, because you want water that's pretty clean for a lot of -- so it works in the sprayer and so on.
Most of the guys now have gone from backflow protectors to separate tanks to make sure they don't feed back into the system. Backflow protectors were the big thing years ago, but this other is newer at this point. I think that will give you some idea on the spraying, anyway.
As far as both of these crops are not hand harvested. They are machine harvested, mostly chemically weeded, if you will, or use herbicides, so there are very few people in the field. Michigan had a real fight over a Michigan porta-potty law that was somewhat more stringent than OSHA's, and I think most of the growers here are aware of what's needed and do use those kinds of things if they do have weeding crews and so on, but it is a very minimal kind of activity.
When it comes to cooling, onions of course are, if they are cooled at all, cooled pretty much by natural air. And, in fact, I talked to a grower this morning; he's a little nervous that el nino will take away some of the Lord's benefits this winter. Most of the rest of us would probably like that.
Carrots. Depending on the grower, carrots can be air cooled; in other words, cold storage room with fans, vacuum sealed. The bigger productions often hydrocool, which then does put the carrots in contact with water. The water is chlorinated. I don't know everybody's regimen for changing the water. Usually there's some continuous flow of water and a continuous flow of chlorine or some other disinfectant.
As far as handling, onions are of course not washed, they are brushed. I know of no good way to wash an onion and get -- and have any shelf life left. I think that comes back to normally onions are peeled. Carrots, of course, are washed. They are normally harvested in dump trailers and either with conveyor bottoms or washed out of trucks into carrot pits, and then in either situation they then go into a washing set-up that as far as I know is chlorinated.
We're probably a little imprecise on just what level we have maintained over the years, not being sure what level really is accurate other than to judge by the quality of the product.
Going back to a point Roger made, most of us probably eat the stuff right out of the wash water, so we're not eager to get sick, but that's hardly a really good guideline, I guess. As far as the pits that carrots are washed out of trucks, we have chlorinated at relatively high levels, simply because one of the real problems with chlorination is that the organic matter absorbs the chlorine and you can throw an awful lot at it and not stay effective too long. There was a time years ago when Michigan State told us we couldn't put enough in to be effective, but we noticed the difference in the quality of the product, and, therefore, have continued to chlorinate in that situation.
After the carrots are washed in our own plant, we then have a chlorine dioxide spray after they went on down the line, after they were previously washed, because we were looking for a somewhat longer-lasting benefit other than just the quick chlorine shock.
As far as plant clean-up and so on, I think it's probably not uncommon to scrub plants down or hose them down on a daily basis. We usually then at least once a week get a more heavy-duty wash down using disinfectants at some point, but probably not as wildly as you would in a food processing operation, which we had one of those at one point.
Training employees. Now I guess it always seemed to me kind of senseless to train employees to wash their hands after they went to the bathroom. We wouldn't have to do that, but our training films did include that type of thing usually along with HACCP training and sometimes the migrant housing training, some of those kinds of things. Because I know I've read the surveys that more people don't than do usually. And in dealing with food, that's fairly important.
Monitoring the health of the employees. Certainly no plant doctors or anything. If somebody really looks sick, you tend to send them home. We have been notified a few times about people that had TB, which is -- since I also helped write the state OSHA health regs, I'm finding is on the increase in the country. And normally we try to move those people to a position where the doctor would advise us that that was not a -- that it was not a hazard. And fortunately the medical profession is pretty good about notifying us.
Transporting. When you -- when the stuff is harvested in the field, as I've said -- I've kind of covered that. Transported normally in farm vehicles or dedicated vehicles that haul primarily that product. In the case of carrots, if you wash them out of the truck, the truck gets washed every time, albeit with kind of muddy water. In a lot of the other cases, it rains a lot in Michigan, I suspect that's the most frequent other cause. Because this stuff is used just on the farm.
Onions are transported in bins, wooden bins, dry, on open top trucks or perhaps in bulk trucks. Those again normally tend to only be washed by nature, because you really aren't trying to get the product wet; you are trying to keep it dry and you try to keep those containers dry. They obviously carry some dirt, although muck, when it is dry, is very powdery and goes everywhere you don't want it to go, frankly. So after a while there aren't usually big gobs of mud or something hanging on the thing.
As far as outbound trucks, our people on the dock are always instructed if a truck didn't smell right or really looked bad to come get us and we would decide what the carrier had previously hauled, whether there was a reason. Our guys didn't like banana gas and we didn't figure that was really a good reason not to load a truck. On the other hand, we've had some that were -- had been hauling something else, and we would send them to be washed out or rejected. Kind of one of those things that's hard to keep track of, but we have not had a major problem with trucks coming in looking terrible. I think the reason is that, again, Michigan is a great return state to places like Florida where the trucks haul vegetables up, they haul vegetables back, you don't get into the back haul situation. That would most likely happen if trucks were going in some other directions.
Identification. We have used a pallet tag system that does real well until the stuff gets on the truck. We can tell which growers and sometimes track it back through the grower to which field the merchandise came from. But when it gets on the truck, you tend to pull the tags because you want the records for your accounting records, and so it doesn't normally go on to the other end, and it's quite possible that we would get loads of two or three growers' produce or something like that.
I think that gives you kind of a few of the ideas in the areas that you've talked about, some things that are different in Michigan. I think we have probably, from all I'm hearing, have a lot to learn in the microbiological area. We have gone through a lot of this same process in field sanitation with chemicals. As growers we have done things that we said hell no, we never could do. At the same time, I think government's found that, yes, there were things that hell no, we couldn't do. And only by working together can we find some common ground that solves both problems, and that's the thought I guess I would leave you with. Thank you.
MS. DENIKE: Thank you. Duane Frens?
MR. FRENS: I am Duane Frens with the Michigan Celery Promotion Co-op in Hudsonville, Michigan. I didn't exactly plan on speaking today, but basically the celery industry in Michigan is all on muck soil, as is the carrot and onion industry. Our growers apply pesticides on a regular basis, using an IBM monitoring program for the most part to minimize the amount of applications and risk and residue. Irrigation is very common in muck with -- on celery, using mostly overhead irrigation from ditches, ponds and well water. I don't know which would be the most common. All three of them are used. Usually with the rain, they get about an inch a week during the main growing season.
Celery in Michigan is all machine harvested in the field. We do not have field workers. This is different than what it is in Florida, Texas or California. The celery then that's harvested in the field is hauled to the packing sheds, and is trimmed and washed with a high-volume, low-pressure wash, and then is given a final rinse of fresh water, sometimes with chlorine, sometimes without chlorine in it.
The cooling is done normally at the shipper, and it's usually just cold air storage, cooling or vacuum cooling. And the product is basically identified on the carton by grower, but not on the product itself at the consumer level. That's the practices that we have in Michigan for harvesting and packing of celery.
MS. DENIKE: Thank you, Duane. Our next industry presenter is Jim Miller from the Board of Directors of the Michigan Farm Bureau.
MR. MILLER: Thank you very much. Good afternoon, ladies and gentlemen. I certainly appreciate the opportunity to address you today. I am a grower in southwestern Michigan, fruit, primarily peaches and apples, and as you mentioned, I am on the Board of Directors of Michigan Farm Bureau. Again, I want to thank the FDA and the USDA for allowing us this opportunity to address your proposed guidelines, and we certainly thank you for coming to Michigan for your meeting and allowing us this opportunity.
In fact, we would thank you basically for looking at this whole food safety issue in the perspective that it appears you have taken, and that is allowing the ag community, the grower in particular, giving him the credit for being able to work through a self-help guideline type program that you have offered. We would again look forward to the final draft of these guidelines, and probably at this point, my comments will be quite brief until we really see what we are going to be looking at in that final draft.
But growers certainly do recognize the stake that they have in maintaining the consumer confidence in a safe food supply, and certainly look forward to being able to utilize your guidelines in evaluating their own operations and making those improvements where they can.
I would simply say, though, and say it quite strongly, I think Farm Bureau certainly expects these guidelines to stay as guidelines, as you have indicated many times here, and certainly not become regulations, as you have stated.
I am going to just touch on two real quick issues, and then my colleague, Dan Hill, is going to address a couple of specifics that you have listed in your guidelines. Mr. Almy asked a question earlier about the inspection proposal of going into the other countries to look at their operations, farms and processing plants, et cetera. And Farm Bureau would certainly have some concerns about any type of activity like that in, you know, visiting another sovereign state and -- any type of activity in that regard that would allow and invite the opportunity for a retaliatory-type response for them to come into our country, we would be opposed to at this point.
Plant inspections at the border of our country we feel are very important and would certainly encourage adequate funding to maintain those inspections, increase those inspections, and we feel that inspection at the border is a very viable alternative to moving into other countries and inspecting their operations.
Also, being that these are voluntary guidelines, you know, a good working relationship really is going to be extremely important. We feel that the USDA has that working relationship with the agricultural community now. Food and Drug, as I understand, is the lead agency on this. We would think that USDA might be considered as becoming the lead agency on this, particularly if you have, as I understand, indicated there are going to be two or three separate guides farther up the food chain into the retail level. And then there is going to be quite an extensive education, consumer education, a consumer type program, that these guidelines and this initiative here might fall under the lead of the USDA. We feel their relationship with the grower community is very good, and the possibility of a little better implementation through USDA might be possible.
Thank you again for allowing me to make these few comments. We would look forward to seeing the final draft. Dan, I am going to ask him if he --with your permission--could address a couple of those specific issues.
MR. HILL: Dan Hill. I hope am not speaking out of turn at the moment.
MS. DENIKE: No, you're fine, Dan.
MR. HILL: I am a grower. I am a farm marketer from the eastern side of the state, a small farm market. We sell direct to consumers. We sell retail, wholesale, pick your own. We cover all the marketing ends. And I think that's one thing I haven't seen really addressed in your recommendations right here. I realize there's several crops you can look at. There's lots of different ways to market, also.
We are a third generation family farm. I am chairman of commodities -- Food and Vegetable Advisory Board for Farm Bureau. I am also on the Vegetable Council for the State of Michigan. And I think one thing you've got to get through to the agricultural community is FDA, as we know, is a regulatory agency, not a recommendatory agency. Every time we see something in writing from you folks, we think it's just a regulation waiting to happen.
We appreciate the input and the chance to speak on this. And I recognize quite a few of these recommendations -- I went to the Farm Assist program this year, through the Natural Resources Conservation -- get the new name, NCRS. And I recognize a few things from the worker protection standards and a few more from the field sanitation. I think FDA has done a good job of taking the lead and putting these things together, because I opened my eyes a little bit when I went through the Farm Assist program with the water management, and I think it's very valuable for any grower to go through this.
And I think at this time it would behoove the FDA to pass those regulations on to USDA and then to MDA, who has done a superb job in this state unifying a lot of those regulations and compliance procedures and inspections into one area. I have had the opportunity to work with MDA, Department of Health and different places with different people coming out to inspect my property. It is much easier to work with my inspector--not that it's easier to buy them off or anything--but they know who you are and where you are. They don't have to call you for directions from the wrong farm. It is so much easier to get to know these people, and they can communicate with the agricultural community on a one-to-one basis.
I had a chance to speak with several FDA inspectors this year who came out to see my cider mill. Nicest folks you ever met. But they ask me, do you sell more than one variety of apple? I realize we have a bit of a learning curve to give to FDA; whereas, if USDA and the MDA inspector had come out together, we wouldn't see something that looks like an interagency rivalry. We certainly don't want to have that happen.
We have had a good working rapport with MDA, who works well with USDA. And as it is on most farms, we get inspected by MDA, USDA, we have a chance for Department of Labor to come out, but we have a lot of opportunities for different folks to come out. We would like to see that unified, if possible. I think then the message would get through to the agricultural community that these are good recommendations to work with, to work towards.
My farm grows a dozen crops or more. I know of several growers that grow more than that. I think when you get into specific recommendations, it's going to end up looking like some of the insurance deals to the government. It takes a long time, and there is a lot of variables, by sending markets different ways they sell fruits and vegetables. You may be stepping into a mess bigger than you can actually finish in a lifetime. I know the insurance people at the federal government have kind of seen that. I know they are working towards something new. But I think the general recommendations as they are are very nice. I think they are very valuable. And I would like to see us work towards staying on a recommendation level on those things, working through the USDA and MDA. Thank you.
MS. DENIKE: Thank you very much, Dan. Are there other comments for the record at this time? From anyone? Please identify yourself and your group.
MR. DUDEK: Thomas Dudek, Michigan State University Extension, Grand Haven, Michigan. Just a couple of comments or observations.
When we talk about the trace-back aspect of it, I think Duane alluded to it in that celery at the consumer level is sold by the stalk, many times it's not in a sleeve, a pepper, a cucumber, tomato, an apple, as Roger had mentioned sold individually. You know, if the end consumer needs to find out if there was a problem with that particular piece of fruit or vegetable, it's not on the sticker. If you are going to go to a -- they are not stickering.
And if you go to a sticker, that just jacks up the cost. We've seen that already with squash. For instance, many growers now market hard squash with recipe labels on it, and it adds to the cost of production. It wasn't something they maybe chose to do, but they were forced to do because of marketing competitors doing it. So in order to stay in business, you do it. Here again, you will have to look at that one and see where that end use trace-back comes to the consumer.
The other thing was mentioned, I am one of the USDA people from Extension that's going to probably end up carrying out some of this locally, right here in the 5-county area around Grand Rapids. Resources are a concern. I know we don't want to extend more dollars into a program, but if we're going to redirect dollars from something to something else, then, you know, where do we go with that.
But resources are very helpful. When we started the pesticide education programs and helped growers do a better job of making sure that they were certified to spray materials, USDA's federal partners came in and gave dollars down to the State to produce the resources and the materials. And that's real helpful. We are going to need those things to do the job, whatever job is going to be done. Whether they are written resources, videos, slides, et cetera, et cetera. There need to be those resources. It helps us to do that. Michigan has been a very good state in putting packages like this together, but they have gotten the resources.
The other thing is, since we're dealing in many cases with bilingual people that we will look at targeting these programs towards, we are going to have to have bilingual resources if we're going to be effective. Thank you.
MS. DENIKE: Thank you. Somebody else was getting up?
MR. FOGG: My name is Ralph Fogg. I am with the Michigan Vegetable Council, and our group and I would just like to tell you a little bit about it. We have about 2,500 vegetable growers that are a member of the organization, all voluntary, and our main purpose is to conduct educational meetings, which we will be doing in January, to try to inform the growers of new practices. And included on the program this year is a food safety session.
We have worked with MDA. We have worked with Michigan State University very closely. We have somebody from MDA and Michigan State on our executive board and appreciate the guidance they give us and we've -- I would like to reiterate what Dan Hill said, that we've had a very good relationship between Michigan agricultural producers, the MDA, and Michigan State University, and also USDA. I think these are all people that are familiar with agriculture.
When we hear, 'FDA,' I guess I get a little concerned all of a sudden because this is a regulatory agency. I think a couple of things I would like to see you keep in mind is that when you make a guideline, and a suggested guideline, it might often be interpreted as the correct way to do things. And then if there is a problem with a food product, they are going to look up and down the chain and see is everybody following the guidelines, whether they apply to our farm or not. We may be looked at as a person contributing to that problem, and have some liability there.
If that's the case, which it very well could be, I think growers are going to look at it and say these are guidelines but they are also interpreted as regulations. We have to comply. And in the process of complying and hiring people -- like our farm is a one-horse show. If you want to know who fills out the I-9's, you are looking at the person. And who does the jobs that the workers refuse to do? Well, you are looking at the person.
So when a regulation comes along, I have to comply with that. And it gets difficult right now, on our operation, to do all the things that are necessary from a regulatory standpoint. If you come along with more regulations, even though they are guidelines, I am going to have to comply with them. And I think what you are going to see is less people my size and more people of larger operations. And I am not sure this is the direction we want to push things. But this is what regulations do.
The idea of tracking is of concern to me because we raise zucchini, and to put a sticker on every zucchini is difficult. And a big buyer in this area is the Meijer store, who buy from us, and they buy from at least three other growers at the same time. So my product is going to be mixed with their product on the shelf. It is going to be difficult to keep it separate. Although I can see why knowing where something came from is going to be a desirable thing.
Workers' health. This last year was probably the worst year we've had for working with labor. The labor supply was adequate, but there just seemed to be more indifference towards attendance especially. Diarrhea was the number one reason given for why a worker missed. And I guess I find it a little bit difficult to ask that question of my workers every morning before we go out to work as far as what their health is like, particularly that issue.
The water supply we use for irrigation comes from some rivers adjacent to our farm. Upstream from the river is a city called Flint, Michigan. And I don't know what's in that water. Sometimes maybe I think I don't want to know, but I suppose we should want to know. We have never had a problem, but is it my responsibility to know what they are putting in the water on a continuous basis? I should -- I think I should be able to feel that that supply of water is not contaminated by municipalities upstream. And if it is, it shouldn't be my responsibility to monitor that continuously.
I guess the other question as we talk about all these different things, I hope somebody someplace says this is what it is going to cost and this is how many people's lives we expect to save. Because if we can't answer that question, then I think we're spinning our wheels, and maybe that should be addressed early on. In my operation I have to do that. I have to have a cost analysis of everything; sometimes it's not too formal, sometimes it's quite formal. And I hope your organization will someplace along the line look at that and say if we implement all these things, here's how many lives we expect to save. And also take into consideration that many of the problems from a health standpoint are deliberate violations of present regulations, that it's not going to be affected by this. Thank you.
MS. DENIKE: Thank you. Somebody else?
MR. ROPER: Teryl Roper from the University of Wisconsin. I wanted to reiterate the need for funding for outreach activities to the states. While I think the state Extension service is a very warranted program in this area and is willing to work with growers and their employees on these kinds of agricultural practices, we do need resources to do that.
Secondly, I am wondering if there are opportunities for cooperation of wildlife management agencies to reduce deer and other wildlife populations in and around fruit and vegetable plants. I think that is a big problem in Wisconsin as well as Michigan. Unfortunately, many of the wildlife management agencies' primary clientele are hunters, recreational use, and they turn a deaf ear to the impact of particularly deer on agriculture. And we may be able to view this as more of a microbial contamination issue than a crop reduction kind of issue. I think there are real opportunities for discussion with the wildlife management agencies on that regard.
Perhaps I am in a minority view here. Growers could perhaps view these suggestions or guidelines as protection. If they are doing a good job of following the guidelines once they are established and have been -- the procedure has been gone through to establish them, and if there were a problem, and if they are following those guidelines, they can say I did the very best job I could and there was a problem. While they can't absolve themselves of responsibility for it, they can at least say I did the best job that I could.
One of the crops I work with in Wisconsin is the cranberry industry, and that is an unusual industry, and admittedly a small industry related to the overall food chain in the United States. Cranberries are irrigated, and they are largely irrigated from surface waters; in fact, exclusively irrigated from surface waters. For the fresh product in Wisconsin, the fruit are water harvested. Lots of water. Water tends to be shifted from one bed to another as harvest proceeds, because of the large quantities of water that are required.
Once the berries are harvested, they are dried, and they are kept dried thereafter until they are consumed. They are perishable to some extent, like strawberries or raspberries, in that if they were moistened again or washed again, once they had been dried, there would be a great opportunity for rot. And, frankly, if you have seen many fresh cranberries in the grocery stores this year, you know about the opportunity for rot.
It is really impossible to protect those surface waters that are used for irrigation and harvest. Acres and acres of open reservoir. In fact, one of the reasons that -- one of the advantages of the cranberry industry is that it provides abundant habitat for water fowl, which creates another problem there, because we know what water fowl leave behind. So we need to make these guidelines broad enough to account for very minor crops in the fresh fruit and vegetable area, as well. And those are my comments.
MS. DENIKE: Thank you. Would anyone else care to comment? Yes.
MS. DECHOW: Mary Dechow from Spartan Stores. Spartan Stores is a grocery wholesaler. We are based here in Grand Rapids, so we didn't have to drive very far, but we do welcome all of you that came from a long distance at the end of this holiday weekend.
We supply groceries to better than 500 supermarkets in Michigan, Indiana and Ohio. We're the ninth largest grocery wholesaler in the United States.
I wanted to offer just a couple comments really on the positive lot identification issue that is dealt with at the end of the document that we received. And coming from a wholesaler standpoint, we can see some real problems with tracking and positive lot identification.
And I would welcome any of you to stop in and visit us sometime and see what we do. At any one given time, we could have as many as 400 different fruits and vegetable items coming through our warehouse. And, of course, the blueberries that I buy from New Zealand today may tomorrow be coming from Grand Junction. And ultimately from our warehouse they are loaded into loads for various stores and then shipped on to those retail supermarkets where, again, not only are they comingled in my warehouse, but then they end up comingled back at the supermarket level where the consumer buys it and/or she may buy blueberries today and may buy some more next week, so they also end up comingled at home as they are trying to mix the fruit salad.
Positive identification all the way through the food chain is truly, truly impossible. Can we identify it from the time that it arrives in our facility? Most certainly can. Because we know who we've bought that from and generally the shipping crates are identified, at least to the packer that packed those. Now, quite often they may not be identified as to the actual grower that grew those, but to the packer that received everything.
We do have tracking systems in place and are working on new tracking systems to even better keep control of that and know exactly where things come from. But if I get a call from, for instance, a media person that might say, "We've got an outbreak of something that happened at XYZ Supermarket that we suspect may have had it, and can you tell me where this came from," believe me, Gail Drew, who is with me today, and is our food tech person, can spend hours on end trying to figure out where something came from. And ultimately maybe have a 50-percent guess that we hopefully will know where it's from.
So I caution you, as we look at this whole positive identification, to keep in mind the logistics of the whole food distribution system. Recently in the supermarket you have seen more product look-up codes on fresh fruits and vegetables. And we've gotten into that because it's much easier for us to make sure that prices are correct at the front end of the store. The interesting thing that it's prompted is a lot of consumer complaints, because they don't like those little stickers on their green peppers or whatever else they may appear on. And so it becomes -- it becomes a problem.
And, obviously, identifying each and every fruit and vegetable as it comes through, because of size, because of quantity and all the other factors is going to be impossible. So I caution you, as you look at that, to make sure you are working with the wholesale industry to see what is feasible and, of course, the growing industry, as well.
Thank you for the opportunity to comment and appreciate working with you in the future on it.
MS. DENIKE: Thank you, Mary. Additional comments, please? Yes, sir.
MR. HOSFIELD: My name is George Hosfield, and I am with the USDA Agriculture Research Service, and I would like to comment on something I don't think has been adequately addressed here.
Recently, Secretary of Agriculture Dan Glickman implemented a new activity for USDA called the Gleaning and Food Recovery Activities. Now, I picked this brochure up, I would just like to read something here. Connecticut.
"The Connecticut Agriculture Experiment Station, New Haven, provides excess produce from two research farms to soup kitchens and churches in the Hartford, New Haven and Waterbury areas."
Now, these are areas--because I'm from the East--of considerable populations. Now, this program that Secretary Glickman is asking I know USDA to implement, represents a non-traditional entry of food into the food consumer chain.
Now, under the federal purview, okay, the Agriculture Research Service would be involved in agriculture research as it deals with farm crops and horticultural crops.
Now, for example, I am a plant breeder, and I don't know very much about microbiology. And in my department I don't have a food safety program there. So I guess the thing that -- and I am suggesting is somehow that this activity--gleaning and food recovery--be worked into your documents somehow. Because here we are going to have food through a non-traditional mechanism getting into the food chain. So there has to be some precautions with regard to this type of food because there could be -- also could be contamination because it is in a food production system that operates the same way that any grower or whatever has on his own farm, and also with regard to the distribution of it.
MS. DENIKE: For point of clarification, are you suggesting, then, for experimental stations that may be donating it, that we apply the same yardstick that we do to a regular grower in the field? A regular grower?
MR. HOSFIELD: I think if we are going to protect the food safety of people in this country, we are going to have to.
MS. DENIKE: I just wanted to clarify. Thank you. Somebody else? The man in the striped shirt. If you all want to line up one behind the other, we can do it that way and save a little bit of time. I didn't think of it until just now.
MR. FALAK: Appreciate the opportunity to come here today. Chris Falak. I am involved in the produce industry, also a member of the Michigan Vegetable Council.
We have established here today that the United States has the -- probably the safest food in the world. Nobody--unless I missed it early in the day--has made the comment that it is also one of the most inexpensive producers of food in the world. And the public expects that when they buy it.
I guess this goes two different ways. While these guidelines and recommendations are made, we have said common sense plays into it. And that would also play into the fact that if they are common sense, they shouldn't cost nearly as much money on the grower side of things to make that possible.
I guess to take it a step further, for the information that is given to the consumer, if it would be possible, when it's passed on to them to indicate to them that somewhere down the road these prices are going to have to go up for us to continue to improve our food safety. Because at the present time, if I am not mistaken, the average consumer wants the safest food, but they don't want to pay any more for it. Thank you.
MS. DENIKE: Thank you. Next, please.
MR. KARNEMAAT: Kent Karnemaat from Fremont. I am a grower and a packer and a shipper of various fruits and vegetables. I want to thank you for the privilege to come and to listen and to share some concerns. And just a couple things that I think haven't been mentioned.
Ralph alluded to the fact that there are a lot of small family businesses that these guidelines will affect. And I think that's very true, and we need to remember that. We are not dealing with corporate America here. This is going to come right back to home.
And the second comment I would like to make, as far as the health of the hand labor and the workers who harvest these crops. We employ about 60 people in our harvesting season. These people aren't tractors or machinery. They are people. And to meet them in the morning and say, "Okay, Lupe, I think you look a little under the weather. You may have to stay home today," it's not going to happen. We don't work as a manager and as a worker; we work together, okay.
And they are going to decide for themselves whether they work that day or they don't, and I am not going to tell them you work or you don't work. And money is very important to these people, and they are not -- if they can walk, they will work. And we need to remember that when we come up with guidelines to try and determine whether they can work today or they can't. They have a family to feed, and I think that's very important.
And I would also, just as a question, I wonder how this meeting is publicized to people. I'm very concerned for the number of growers that I see here today, very few are here, and I think the reason being many don't know the meeting is even going on. I didn't know about the meeting until about 8:00 o'clock this morning, and I think it's definitely a concern of many growers, and I hope to speak for many of them. And, once again, I want to thank you for the chance to come and to talk to you. Thank you.
MS. DENIKE: Thank you. In terms of notification, we relied a lot on the people in this room to help get the word out. We were on a short time frame. I know the Michigan Department of Agriculture, Michigan Farm Bureau did excellent jobs getting this out. The Extension Service got this throughout the state. I think part of the problem is this comes on the tail end of a holiday weekend. And I think that probably more than any single thing affects attendance. Other comments for the record?
MR. WYANT: Evelyn, I would like to make a comment? Do I need to go --
MS. DENIKE: No, you've got your own mike.
MR. WYANT: I want to speak and I want to get in on this, also, on behalf of the Michigan Department of Agriculture and on behalf of the entire food and agriculture industry. A comment and observations. A comment. And that is I think -- I know that the food and agriculture industry in this state understands the importance of food safety. They absolutely realize that's the cornerstone of their future success. So I think we've got to give some recognition to that, that this industry has been providing leadership in the private sector, on farms, to ensure a safe food supply.
I also, though, want to comment to say that we have to continue to do better, because we are going to be asked to do better, whether we like it or not. Again, because the consumer, the marketplace, will dictate that to you. You--those who are involved economically in the industry. So it's again a fundamental fact that it will be, again, as I predict, a cornerstone to your future success.
Observations with respect to what I consider to be critical, guiding principles to make this a successful initiative. And again, on behalf of Michigan, I want to thank FDA, USDA and the President for recognizing food safety as an important issue. One, again, that all of us here in this room do recognize of the first and foremost. And it's been said here scientifically-based guidance; again, I can't overemphasize that enough, we've got to have guidance and principles based in sound science.
I absolutely think it's critical that it's educationally focused, and n only educationally focused, but that we use current infrastructure and that's state and local team building. Dan Hill said it best. We've got USDA, FDA, MDA, the local Public Health, State Public Health, Extension on your farm today, and so, again, I think our local partners are there to help carry this message out. And it's the most effective way when we use local leadership and local input and involvement.
So, again, I again suggest strongly that for this to work, it has to involve our local teams. It's important related to that that we don't duplicate bureaucracies. I see a real risk of that in this process. In other words, some very nice things were said about MDA, but, again, I think a lot of that comes from the fact that we utilize local Extension, we utilize our local team, and I would hope again that FDA understands that, and USDA would understand that. And, again, we don't need to create yet another set of bureaucracy to look at food safety.
Certainly we appreciate and need to continue to recognize a partnership as we move forward and work as partners, because FDA has a responsibility. The President has given them the charge. Whether we like it or not, you are going to be involved in that. I just again would ask that for this to work, it has to work in coordination with states and also our local partners.
I think that for this to work, I think Bob DeBruyn said this well, we have to be sophisticated enough not only to understand and recognize commodity differences, but also regional differences. I am absolutely convinced that we do things a little differently here than in Florida, California and in Washington with respect to chemical use, manure management, and, again, just our climate and our soils create differences. And we're sophisticated enough, I think in many instances, to recognize those differences, and I think it's important to realize.
And then finally one last point I want to make. This absolutely has to be consistent in my mind with free trade principles. Jim Miller and others have talked about this well. In other words, if we create a system where we're creating barriers to trade, I think agriculture's put at severe risk. And so, again, a foundation has to be that we recognize free market, free market principles. And I'm concerned about that, only because I have a bias, and that's where Michigan agriculture's future growth, a lot of it is going to exist, and that's in export trade. Anything that would diminish that export opportunity I think would be detrimental to the Michigan agriculture industry. So I wanted to go on record with those comments. Thank you.
MS. DENIKE: Other comments?
MR. DEBRUYN: If I may presume to say just a little more.
MS. DENIKE: Would you identify yourself.
MR. DEBRUYN: I'm sorry, Bob DeBruyn. My observation has been that in Michigan over the years there have been a lot of small producers, some middle producers, and then a few very large producers. The very large producers can do a lot of things that you ask one way or the other. The guys on the bottom, if the rules aren't practical--it comes from some experience with OSHA, field sanitation and some other things--if the rules aren't practical and reasonably well accepted, you will have a substantial group who will market to their own local markets and whatever. They simply don't want to know too much, I suppose, or maybe can't afford to know too much.
The really tragic part of that is if that happens, that it means that there's -- it makes it almost impossible for that guy to move up and become a responsible kind of middle group or move on up to the bigger, because the costs are so much higher, that he likes to just stay there, hide, and do what he wants. And I think that would be a really tragic result of regulating something that didn't work fairly practically.
MR. MCCREARY: My name is Kirk McCreary. I am with MBG Marketing, blueberries. I guess just one observation. You are going to be going around to several meetings in different regions of the country, and I want to compliment you for getting out into the field, so to speak. But if it's not on your agenda, I would certainly encourage you to take that one step farther and get out actually into the field.
Today you've heard from several groups, which obviously all have some sort of an agenda. And you had some growers which can describe in part or in full quite well how they are doing it. But until you get out and see how some of these growers have to operate, the kind of labor they have to deal with, the conditions they are working under, the types of water they are using. Going to a wholesale market for example in Chicago or Philadelphia would be an eye opener on how food is handled.
I really would like to encourage you or someone from the group that is making these decisions to get out -- stay away from the glossy people, the strawberry people, stay away from the blueberry people -- get out and talk to growers, people who are doing it, mid-size growers perhaps, people who are dealing with this day to day. Find out what their problems are, how they have to operate.
See how the food chain works on a practical basis. How does this stuff go on the truck, what happens to this truck when it's going down the road, what happens when it gets to Spartan Stores or to a wholesale distributor in Chicago. And get a firsthand feel for how this stuff is handled. And I think this will do as much to give you an idea, first of all, how it's done now, what's the practical way of impacting food safety, and that should be a very important part of your decision making process. Because, again, if this isn't a practical program that you put together that we can all work with, it's not going to happen. And I think that's a goal that we all have to do. So I again say get out and get dirty and see how it really happens. Thank you.
MS. DENIKE: It's time we got a little mud on our boots, huh? It's time we got some boots maybe.
Other comments?
(No response.)
MS. DENIKE: From the table? Michelle, any final thoughts?
MS. SMITH: One thing that jumped into my mind, a number of the commenters talked about the difficulties with lot identification. And we fully understand that there are a lot of things that make it very difficult, but -- and so you may not be able to use the laser beam that was mentioned this morning and really narrowing down, but if you make anything more narrow than the broad generalization of 'all strawberries,' you've helped the situation. If you can narrow down the source of produce to a region or even a handful of farms, that's certainly a step in the right direction.
And the other thing I would like to say is that I think the input has been very valuable here, and I appreciate the opportunity to have come and listened to it. What we do can only be as good as the material that you give us to work with. So I say thanks.
MS. DENIKE: Okay. Tom? Final comments?
MR. GARDINE: Well, I don't know if I will be final. I think you are reserving that for yourself, Evelyn.
MS. DENIKE: You put me in charge.
MR. GARDINE: First rule, a sincere thank you. I came here with a bit of concern. I know there was concern on your part that you didn't have sufficient time to review the document and the point raised by several of you was understood and taken, but we were under some -- we had to get started sometime, and it didn't help to wait till Christmas week, because then no one would come.
But I just want -- I was a bit concerned as to the comments we would get, and I was sitting here looking quickly at my notes, and I didn't write down all of the comments, because I was trying to get ready to respond to many of them. And I counted at least five suggestions and ideas that we are going to have to go back and either change or reevaluate in our mind whether what we put in there is appropriate and consider at further meetings.
I think any time you have a group like this, a gathering like this, and come away with this minimum of five suggestions and ideas that have to be looked at further -- and I know there were more because, as I said, there were a few I didn't write down as I was trying to get ready to respond. I am so pleased with the participation here, and I am grateful to all of you for coming to this meeting.
And, once again, this is intended to be a public meeting. This cannot work without the cooperation of industry. And we will try to keep this process as public as we possibly can. And once again, thank you.
MS. DENIKE: Dan, you made your comments already?
MR. WYANT: (Nodding head in the affirmative.)
MS. DENIKE: Les, do you have anything you would care to say?
MR. BORQUIN: Just a couple things since Bob has left. I just wanted to chime in and agree with a lot of things that Dan talked about. MSU has benefited greatly from partnering with FDA, FDA over in the Detroit district, and cooperating on some of the issues that have come up recently.
I wanted also to chime in on what John Tilden told us earlier, that we really need to make sure that the recommendations that come out in this document, that we apply some measure of risk assessments to this. Because a lot of these recommendations look to make good sense, but in many cases I think we don't necessarily have a good idea of just to what extent these changes really will have with regard to safety of the final product. That's an area that really does need some additional research in the future, and we would certainly hope that some resources would be assigned to that area in addition to additional support for education that may come out of this process.
MS. DENIKE: Ray?
MR. MLECKO: I am a government bureaucrat, and I have had extensive, wide experience in the area of drugs and devices. I've spent most of my life in those areas. I don't have that much experience with fresh produce. But I can tell you from my experiences with drugs and devices that if we, all of us, don't make this work, some other country will, and there will go our market. We all have to work together to make this work.
Folks, I've seen it happen with devices and with drugs. A lot of people are predicting that in another 20 years, all of our medical devices will be manufactured overseas. And as a consumer, all I have to do is pick up a can of canned mushrooms and it may have -- it may have a U.S. brand on it, but if you look on the other side, you can see where it's coming from, and it's not manufactured in this country.
And I predict that unless we can come up with a safe and wholesome product, fresh produce, if we can't do it, some other country will, and they will reap the economic benefits of the product.
The other point I would like to make is that the gentleman that talked about the FDA, I agree with him, that we have a reputation of being strong regulators. In the old days, we used to feel that we wore the white hats, industry wore the black hats, and all we could do was seize and cite and prosecute, et cetera, et cetera. That was thirty, forty years ago. The FDA has changed. We now have a number of cooperative programs with industry, and we're great believers today in voluntary compliance. So some of the impressions that people may have of the FDA, that may have been the old FDA, and we are trying to change.
And as a matter of fact, President Clinton gave us this very important initiative, and I kind of predict it's going to be made on a non-confrontational basis with industry and with the USDA and with the various state departments. And the only way this country is going to survive, believe me, is if we all cooperate, we all work together. If we can't do that, we are going to be in deep economic trouble as some of our other commodity areas have been in the past. Thank you.
MS. DENIKE: Thank you. I am very proud of us here, collectively, in the room. People of goodwill have not forgotten the person at the end of the road: The American consumer. And our responsibility collectively to the consumer to provide the best, most wholesome, most economic food that is possible to produce. And American agriculture is second to none, worldwide, in being able to do this. We need to crank it up a notch and see what we can do collectively.
I am proud of the fact that this was guidance, as opposed to regulations. This is an area, like Ray said, that's a little newer to us, and we are embracing it, and that is our intention, to work with you collectively, so that the consumer can benefit. So that we don't have the scare of the month.
And thank you very much for coming. Please, please get your comments in to us. You will have ample opportunity to read this guidance document over the next couple weeks. Get your comments in to us. It's very, very important that your voice be heard.
Camille, anything? Any final wrap-up.
CAMILLE: No, thank you so much.
MS. DENIKE: Thank you very much for coming. The meeting is adjourned.
(Meeting concluded at 2:28 p.m.)
END OF RECORD
CERTIFICATE (STATE OF MICHIGAN COUNTY OF KENT)
I, DARLENE D. FULLER, Certified Shorthand Reporter and Notary Public, do hereby certify that the foregoing meeting was held in my presence at the time and place hereinbefore set forth;
I FURTHER CERTIFY that this meeting was recorded in shorthand, and thereafter transcribed by me personally with the assistance of computer-aided transcription, and that it is a true and accurate transcription of my original shorthand notes.
IN WITNESS WHEREOF, I have hereunto set my hand this 3rd sav of December, 1997, in Reed City, Michigan.
Darlene D. Fuller, CSR-0929 Notary Public in and for the County of Osceola, acting in the County of Kent, State of Michigan
My commission expires 9-16-99.