Food and Drug Administration
U. S. Department of Agriculture
Centers for Disease Control and Prevention
May 27, 1998

Speakers

Moderator Rosario Quintanilla Vior
Richard Baldwin
DeAndra Beck
Terry Troxell
Michael Villaneva
Jeffrey Farrar
Michael Clegg
Frank Evaro
Mary Ayling
Ricardo Gomez
Don Bunin
Joyce Saltsman
Abraham Tenzer
Pat Paswater
Donna Garren
Lee Frankel
Juan Muniz
Lorena Santana
Jasper Hempel

P R O C E E D I N G S

(10:00 a.m.)

MODERATOR VIOR: May I have your attention? Hello. Is this on? Great.

Good morning, everybody, and welcome to today's public meeting on the microbial safety of fresh produce. My name is Rosario Quintanilla Vior, and I am the Public Affairs Specialist for the FDA at the Los Angeles District Office.

What I'd like to do today is welcome you, give you some background, go over the agenda, and some points that you may consider for today's meeting.

In October of 1997, President Clinton announced the Initiative to Assure the Safety of Imported Domestic Fruits and Vegetables, and as part of this initiative, the President directed the Secretary of Health and Human Services, in partnership with the Secretary of Agriculture, and in close cooperation with the agricultural community, to issue guidance on good agricultural practices, GAPs, and good manufacturing practices, GMPs, for fruits and vegetables.

The FDA and the USDA have developed a proposed guide that addresses the microbial food safety hazards and good management practices. The draft guidance is intended to assist growers and handlers in examining their operations for potential microbial hazards and in identifying management practice options that may be adopted to minimize the risk of microbial contamination from flesh produce.

Last December, we sponsored a series of workshops at grassroots meetings around the country to introduce a working draft of the guide. We will review comments today from those meetings, but today's meeting is intended to continue the process of seeking input on that guidance document.

We have the guide in Spanish. For those that would like that copy, it's available at the registration table. This meeting today is being transcribed. We have a transcriber at our left here. I would ask that any of you who ask a question, particularly at the end, when we're taking the public section, would you please introduce yourself so the transcribe can make note of that. And we will have slides in English and in Spanish on both sides of the podium here.

Today's meeting is structured to maximize the opportunity for you to ask questions and give us input as to the document. We ask that you please ask your questions clearly, and for those of you that prefer to write those in, there is going to be an address noted as to where you can submit those questions or comments, and you can submit them to the Dockets Management Branch.

A couple of housekeeping points. The restrooms and phones are out these back doors on my left, and you just keep veering to your left and you will find them. We will be taking a couple of breaks, and the speakers mostly will be available for those of you that would like to ask questions at that time, as well.

While this may seem a bit formal up here, we'd like to tell you that we want to keep this as informal as possible, so that we maximize the opportunity that you have to dialogue with the folks here.

Information packets were provided to you at the registration table. If you have not signed in, please do so. There is a packet available along with today's agenda.

Now, going back to that agenda, there is one change that I will make note for you, and that is that at the 11:15 discussion panel, the last speaker, on foreign technical cooperation, was to have been Mr. Lloyd Harbert. He will not be with us today, but DeAndra Beck will present that portion.

Without adding any more time to this, I would like to introduce this morning's panel and have them address you with some general comments. First, I'd like to introduce to you my boss, my boss' boss, Richard Baldwin, who is our Regional Food and Drug Director for the Pacific Region.

MR. BALDWIN: You've heard of synchronized swimming, so what we're doing is synchronized standing and walking. This morning I would like to welcome you on behalf of the Food and Drug Administration, in particular the Pacific Region.

When I got here earlier, I took the time to walk around and look at some of the photos, and one in particular caught my attention. It's Fason Lowe (phonetic), who is a producer and a director. He's over there. The quote there was "Always complete what you start," and I think that's appropriate for what we're doing today.

As Rosario mentioned, we had a number of public meetings back in December, and I remember doing something very similar in Geneva, New York, making a welcoming statement and moderating some of the sessions.

This is a work in progress. The good agricultural practices were shared back then, and we received a number of comments, and this is another effort to enlist from you your feedback, so that we make this a viable guideline that will be helpful in what I consider the government's business of consumer protection, at least the Food and Drug Administration.

If someone were to ask me what our bottom line is, I would say that we want to facilitate getting good products into commerce, and getting unsafe or bad products from consumer channels. That's what we're all about today.

The revised draft was made available April the 14th. The open period for comment is until June the 29th. I encourage you, through this meeting and formally, in writing, if you choose, to give us your feedback, so that we can speak frankly and candidly about the guidelines, and try and make them as viable as possible for all of us.

The guidelines are a partnership with the Food and Drug Administration, USDA, sister agencies at the federal and state level, and with the industry. We are partners with the industry. You're stakeholders with what we do, and vice versa.

FDA has a daunting task, I think. Twenty-five cents of every consumer dollar that's spent are on products that we're responsible for regulating. When I think of what we're doing today as far as the good agricultural practices, I kind of think of a network. For those of you that are familiar with e-mail, this is part of the network. If we don't have good guidelines, we're not going to be able to get food products from the farm to the table safely. So that's my analogy of what we're all ab

President Clinton, back in October, charged FDA to take the lead. We're working with our counterparts in doing that. I encourage you, as Rosario said, to use this as an opportunity. We'll be here most of the day. Some of us have to catch airplanes, but take the opportunity to have a good dialogue, to give us your feedback, to help us make this a viable partnership in the best possible guides we can put out for you. Thank you.

MODERATOR VIOR: Thank you, Richard. Next, I would like to introduce you to Terry Troxell, who is the Director of Division of Programs and Enforcement Policy -- excuse me -- DeAndra Beck, forgive me -- from the Foreign Agricultural Service, U.S. Department of Agriculture.

MS. BECK: Good morning. I'd certainly like to thank you and my colleagues at FDA for giving me the opportunity to speak here today on behalf of the U.S. Department of Agriculture. We certainly appreciate your interest, and also your participation in this process, in the initiative to ensure that we have fresh fruits and vegetables that are safe for our consumers.

The U.S. Department of Agriculture and the Food and Drug Administration have been and will remain partners in assuring the continued safety of our food. Moreover, USDA is committed to the continued expansion of world trade in food products, and also expanding freer markets worldwide. If we all maximize our comparative economic advantages, we're all going to benefit, including the consumers worldwide who, in fact, want safe food.

Of course, it's essential that all of our food safety regulations and guidance, including those being developed for fruit and vegetables, are based on scientific principles, and they're consistent with our international obligations under the World Trade Organization.

We intend to continue the dialogue established at earlier briefings and public meetings since the President's initiative came out in October 1997. Today's meeting is another occasion to ensure that we solicit the input of our trading partners into the guidance on good agricultural and manufacturing practices for both domestic and imported food.

We look forward to hearing your comments, in particular, on the good agricultural practices guidance document, either today or within the open comment period. We believe that, in continuing our cooperative educational and technical initiatives, we'll be better able to ensure that safety of domestic and imported food. Again, we really appreciate your participation, and we look forward to hearing your comments. Thank you.

MODERATOR VIOR: And now with us is Terry Troxell, Director of the Division of Programs and Enforcement Policy for Center for Food Safety and Applied Nutrition, Project Coordinator for the Produce Initiative, Food Safety Initiative of FDA.

MR. TROXELL: Thank you.

For the folks back in Washington at FDA's headquarters, in the Center of Food Safety and Applied Nutrition, I also want to thank you for coming. We recognize how valuable your time is. We really appreciate your coming to share your insights with us. For us, the most important part of the meeting is what you tell us either today or in written comment.

The program is also designed to brief you on the content of the produce guide in the broader context of the Food Safety Initiative of which it is a part. Mary Ayling, later this morning, will give us a brief overview of the comprehensive Food Safety Initiative which has been designed to tackle the problem at multiple points in the farm-to-table food production continuum.

What is the problem? People ask, why are we picking on produce? In my view, the problem, and what we are picking on, is emerging pathogens. Emerging pathogens are new pathogenic variants of bacteria like E. coli 0157:H7 which can cause horrible illness in young children. They are pathogens like Salmonella enteritidis, which has developed the capability of infecting the ovaries of laying hens, so that Salmonella are sometimes deposited inside the egg during its formation.

Emerging pathogens are also known pathogens like Cyclospora which suddenly cause outbreaks in foods or regions where it previously occurred infrequently. Cryptospiridium is another pathogen that has recently been recognized, mostly with drinking water. Globalization of markets, changing production technologies, mass distribution, and vulnerability of an aging and more susceptible U.S. population all contribute to the spread and/or impact of emerging pathogens. The Food Safety Initiative is

There are at least two themes that have been developing in food safety to redesign our system for the new millennium, to win the battle of the emergent pathogens. One them is cooperation and partnerships. The Fight Bac Consumer Education Initiative is a product of the partnership for food safety education. The Fight Bac character is on the folder that you received today.

Check out the Internet site which is identified on the back there sometime. There is a tremendous amount of information, and it's a tremendous program that really has a possibility of making real connections with children and consumers and children to improve -- so that we can get them to do their part.

Recently, the Food Safety Training and Educational Alliance was formed for retail food service vending institutions and regulators to optimize resources to deliver retail food safety training. In another cooperative effort, we will be working on a survey of producer and packer practices with USDA's National Agricultural Statistical Service. This survey is intended to help us measure progress in improving practices.

These are just a few examples. There will be cooperation of all sorts between national governments, between national governments and state and local governments, between governments and producers, et cetera, all this being facilitated, of course, by the computer communications revolution.

The other them is prevention. While prevention was always encouraged, there is a major shift from lot-by-lot testing to designing prevention into the production process. This means producers can have higher confidence in meeting their responsibility to produce safe products, and consumers will have more confidence in these products.

FDA's Hazard Analysis and Critical Control Point Regulations, HACCP for short, went into effect in December. These regulations are seafood regulations. HACCP is a science-based prevention system tailored to each production facility. USDA began phasing in HACCP regulations in 1997 for meat and poultry. On April 24th this year, FDA proposed HACCP regulations for juice. On April 28th, FDA announced a pilot HACCP program for retail settings. On May 19th this year, USDA and FDA issued a joi

We are here today to discuss the broad-scope produce guide to assist producers, packers, and distributors to take affirmative, voluntary, practical measures to prevent pathogens from causing food-borne illness. As you can see, the prevention theme recurs in many product areas. Once again, thanks for your assistance in developing the guide.

MODERATOR VIOR: Next, we have Mr. Michael Villaneva, Program Specialist for the Production Food Safety of the California State Department of Agriculture.

MR. VILLANEVA: Thank you. Good morning to all. Glad you could all make it, and appreciate you participating in this process.

I'm going to give you just a little bit of CDFA's perspective on this meeting and some of the things that we've been involved with. I think it's good that you've turned out, because this is an open process, and I want to commend FDA for putting this document together. I think we all recognize that there's issues and problems out there, but, you know, I'm real proud of what our industry is doing.

In terms of an open process, this document has gone through a lot of revisions, and I want to, you know, commend, again, FDA for allowing, you know, public input. We had a chance to go back, CDFA, and participate in the first draft revisions, and, having been in government for a while, I'm pleased to set that the document has undergone some significant revisions. It reads better. It's much more user friendly. And so I'm here to tell you that, by reviewing, analyzing, looking, and getting

I think one of the criticisms when the document came out was that there were some areas that weren't science-based. They seemed to be focusing on specific commodities, and we recognized that, and a lot of that has dropped out.

The other industries' concerns, and I think CDFA's as well, was that there needed to be more understanding and knowledge of what's going on out in the industry, and I speak for some of the associations here in California that have been very progressive and proactive in implementing and designing quality assurance programs.

We stress the need for FDA to get out and see what's happening, and, again, they're out here, and over today and tomorrow the next week, they're going to be out doing farm tours, and I think that's very critical, because, as I understand it, this is a living, dynamic document. It's going to be updated, and the more FDA and staff gets out and recognizes and sees what's reality in the field, the process will work a lot better.

So, again, I encourage you to participate, take the opportunity to ask questions, and we're looking forward to a good meeting. Thank you.

MODERATOR VIOR: Next, we have Jeffrey Farrar, Food and Drug Scientist with the Food and Drug Branch of the California State Department of Health Services.

MR. FARRAR: Good morning, and welcome. On behalf of the California Department of Health Services, I'd like to welcome you to San Diego, and hope that you'll take the opportunity to provide input into this very important document. Regrets from my boss, Stu Richardson, who could not be here today, but very much wanted to express his sentiment that this is a very important document and a very important process.

California Department of Health Services views the Food Safety Initiative as a positive step, a set of guidelines to enhance the safety of our food supply. This initiative essentially builds upon efforts already underway in California for a period of about 18 months to two years in developing a set of voluntary guidelines for the fresh-cut produce industry. This, too, was a cooperative effort between the industry, state, federal, and local regulators.

So, without prolonging the welcome, please take this opportunity to provide as much input as you can, and thanks once again.

MODERATOR VIOR: And I would like to call up Michael Clegg -- where did you go? -- there you are -- the Dean of the College of Natural and Agricultural Sciences, University of California at Riverside.

MR. CLEGG: Thank you. I appreciate the opportunity to say a few words here this morning. I'm actually here representing Vice-President Reg Gomez for the Division of Agriculture and Natural Resources at the University of California system.

I think you might ask, well, why is University of California even here? What role does it even have to play in this process? And to answer that question, I'll say a couple of words about the purposes of the university and its origin.

The University of California actually traces its origins to the Morrell Act in 1963, which created the land grant university system in the United States, and that system is a federal/state/local partnership. The notion of partnerships in creation of solutions to public problems goes back to the year of the Civil War. We've been, we believe, very successful in playing our important role in that partnership.

We have two purposes as an institution. The first is to create the best possible science-based information through our research activities, and the second is to transmit that information to those who need it to solve problems in agriculture, in the environment, and all of the other facets of public policy that the nation deals with.

University of California does that by teaching students, by training students in research laboratories, by hiring the best faculty in the world, and also by creating a technology transfer system that carries scientific results out to the end users, and this is done through the Cooperative Extension Service, which has farm advisors in every county in the state of California.

So we're a science-based organization which does research to create new knowledge, to solve public policy problems, and we then transmit that knowledge to the public. We do this through a partnership with state and federal agencies, and there's no area that exemplifies these kinds of problems better than food safety problems.

These demand the best kind of science-based solutions, and in a state like California, with more than 250 different agricultural commodities, it requires the best efforts from all of the resources that the state and the federal government have to bring to bear on this problem. So I'm pleased to be here to represent the University of California in this process.

MODERATOR VIOR: Thank you.

I think, with all the formal welcomes and presentations, the one thing you might have picked up from everybody here is that the importance here today is to address your questions, explain the guidance document, and get your feedback, get your comments, and involve you in the process. That is what's critical here, and it's the entire purpose of this meeting.

As you've also heard, this is a multifaceted approach in terms of the Food Safety Initiative, everything involving from farm to table, or fork, as some people have said. It's education, it's science, it's research, it's regulatory involvement, and it's involving all partners concerned, which is why you have all the representatives you have here today. Please take advantage of that, and ask your questions, and address the folks that you need to ask those questions of.

Having said that now, I'm going to return to the part of the program where we now will have the draft guide presentation, and its update on the development, by Terry Troxell.

MR. TROXELL: We know the slides are set, but we haven't worked them from up here, so we'll have to -- we have slides in both English and Spanish. I did. Is that number one for both, Joyce?

UNIDENTIFIED SPEAKER: I'm sorry. What did you say, Terry?

MR. TROXELL: Have we hit number one for both?

UNIDENTIFIED SPEAKER: Not yet.

MR. TROXELL: Sorry. Okay. We set?

UNIDENTIFIED SPEAKER: Yes.

MR. TROXELL: Okay. Thank you.

On April 13th, FDA released for public comment the guidance document entitled "Guide to Minimizing Microbial Food Safety Hazards from Fresh Fruit and Vegetables," which we, for short, refer to as "the guide." The guide covers general good agricultural and good manufacturing practices most likely to reduce the risk of microbial contamination of fresh produce in the field/packing facility environments.

A little later this morning, in our panel discussion, we will look at relevant aspects of the larger Food Safety Initiative, as I already mentioned, and how the pieces fit together. First, however, I would like to introduce the guidance document and discuss how it was developed to this point, what we expect the next steps to be. I think the guide has come a long way since we released a working draft for comment in November of '97. Later this afternoon, in our section-by-section discussion

On October 2nd of last year, the President announced the Produce Initiative. This initiative is part of the larger Food Safety Initiative. It's an enhancement, basically, of the Food Safety Initiative. As part of the Produce Initiative, the President directed the Secretary of Health and Human Services, namely, FDA, in that context, and the Secretary of Agriculture, in cooperation with the agricultural community, to develop voluntary guidance on good agricultural and good manufacturing prac

Why produce? Why now? Although low, the proportion of food-borne illness linked to fresh produce is increasing compared to other foods. This may be due, in part, to an increased consumption of fresh produce in the U.S. Public health agencies, as you know, are encouraging the increased consumption of produce, and consumers are getting the message. Changing distribution patterns in the global supply now make fresh produce widely available year-round. Consumer demands also drive developmen

In addition, we face challenges from new pathogens, increased surveillance of pathogens, and in vulnerable populations, as I have mentioned this morning. Also, in addition to, obviously, the aging populations, we have a growing population of persons with weakened immune systems, people who, for example, are on chemotherapy.

A few points about the guide itself. The proposed guide is a broad-scope document addressing general principles common to the growing, harvesting, and packing of most fresh produce in basically all regions of the U.S. and abroad. "Fresh produce" means raw, unprocessed, or minimally processed fruits and vegetables, including fresh-cut.

The guide is voluntary. It does not impose any new requirements for domestic or imported produce. The guide focuses on risk reduction, not elimination. The guide is intended to increase awareness of potential sources of microbial contamination in the field and packinghouse environments, and to provide suggestions for practices that are likely to minimize these hazards.

The guide represents generally accepted recommendations based on current scientific knowledge of FDA and USDA, with input from experts and other federal and state agencies. For example, we work closely with staff from EPA and OSHA. The guide will be most effective when growers and packers apply the principles in the guide to their individual operations.

The proposed guide contains a list of general principles common to successful food safety programs. Two of these principles are prevention of microbial contamination is preferred over corrective actions once contamination has occurred, and the importance of establishing a system of accountability at all levels of agricultural environment.

People have spent many hours designing processes very carefully only to have the whole system fall apart if the process is not delivered. That's why it's important to follow through and assure that your design is executed carefully.

One of the first things that became clear to us in drafting the guide, and in other phases of this initiative, is how much we do not know. For example, no one knows how much of the contamination of fresh produce occurs on the farm or in the packinghouse.

On the other hand, current sound science and knowledge of the pathways by which produce may become contaminated enabled us to set out broad-scope recommendations which, if followed, can help reduce the risk of microbial contamination of fresh produce. Potential hazards cited in the proposed guide are listed.

When we began to draft the guide in October of last year, one of the first things we did was to review existing guidance documents developed by industry associations, universities, and state departments of agriculture and public health. The Western Growers' guidance document was obviously one of those. It was well out there, and was a document developed in partnership with many different groups.

We relied heavily on those early efforts to develop science-based guidelines that could be applied uniformly across commodities and regions. The first draft guide was reviewed by a broad range of technical experts and a host of federal and state agencies. Subsequently, consistent with FDA's good guidance practices policy, we sought input at a series of public meetings around the country.

We, FDA and USDA, held our first public meeting to discuss the content of the draft guide in November '97. We also worked with the produce subcommittee of the National Advisory Committee for Microbiological Criteria for Food to develop a working draft guide.

One of the things that I think is interesting is that back in '95, FDA had asked the National Advisory Committee on Micro Criteria to Foods (sic.) to look into the issue of produce, to look in because of the increase in concerns of the outbreaks. So this was already a subject on FDA's mind. I'm not sure whether it was early in '95 or late in '95, but, clearly, this has been something that's been brewing for quite a while, and is not something that has suddenly come upon us as of October of

This working draft, dated November 25th, '97, was presented at a series of regional meetings around the country, and at an international meeting in Washington, D.C. The regional meetings were in Grand Rapids, Michigan, Geneva, New York, West Palm Beach, Florida, Heletos, Texas, Salinas, California, and Portland, Oregon.

Comments at these meetings from consumer representatives and the agricultural community were captured in hundreds of pages of transcripts. We also received 55 letters from growers, packers, industry associations, academia, and state agencies, containing comments on the work in draft.

Comments at the public meetings helped shape the next steps for developing the guide. For example, the agricultural community stressed the importance of their relationships with other federal, state, and local agencies, and the need for these groups to play a significant role in developing the guide.

Consequently, FDA invited a group of representatives from state departments of public health and agricultural and other federal agencies to assist in identifying major issues raised by comments and to help revise the guide. These folks gave very generously of their time and knowledge, and Mike Villaneva and Jeff Farrar were among the people that helped us take the next step and reshape this document, make the leap forward to a wonderful -- what we think is a good proposed draft that we experts.

What did the comments say? Most comments agreed with the goal of improving food safety and general concepts of the guide. Some comments expressed concern about specific good agricultural or manufacturing practices. I'll cover some of these concerns, and our response, in more detail in a few minutes.

Some comments offered specific suggestions for improving the guide, and we thank you for that. The guide can only be as good as comments received, and that is why we are again asking for your help to improve this document.

A number of comments addressed areas other than good agricultural and manufacturing practices covered in the guide, for example, the pace of the guidance document development process and the impact of the guidance on international trade. Because these are important concerns, we will address them in an addendum in the back of the proposed guide.

Changes to the guide. Because of the comments, and with the help of our review team, we've made a number of changes in the guide, including changes in tone and format, which we hope will make the guide more useful. We've increased the emphasis on the health benefits of increased consumption of fresh produce.

The guide recognizes the efforts of industry, states, and universities to promote food safety programs, and the leadership role these groups have played in reducing microbial hazards for fresh produce. With the help of technical experts, we've reviewed the recommendations in the guide to ensure they are based on generally accepted scientific knowledge.

As I mentioned, some comments expressed concern about specific ag and manufacturing practices. For example, a number of comments questioned the recommendation that growers perform microbial testing of agricultural water when there are currently no established action levels or corrective actions.

We revised the proposed guide to recognize the difficulties and limitations of microbial testing for agricultural water. We've shifted our focus to good agricultural practices for maintaining water quality. We also refer growers to local water quality experts for guidance and assistance more specific to their operation and region.

In the working draft, we noted that submerging some produce in colder water may result in the internalization of water in pathogens, if present. This finding has led to recommendations that, for some produce, such as produce with internal air spaces, wash water should be maintained 10 degrees warmer than the produce.

Many comments maintained that exposing produce to warmer water is inconsistent with the need to remove field heat. In the proposed guide, this recommendation has been narrowed to tomatoes, which are known to be susceptible to water uptake. Recent site visits have shown tomato packers are carefully monitoring wash water temperatures.

In the manure section, a number of comments questioned the recommendation for at least 60 to 120 days between manure application and harvest without additional research. Some comments noted that the growing season in many regions is less than 120 days.

The proposed guide recommends maximizing the time between manure application and harvest. It references the 60-day minimum cited by the National Organic Standards Board, and deletes references to 120 days. The guide acknowledges that no one knows how long pathogens may survive in manure or in the field. More specific recommendations may be available as research progresses.

Many comments on the working draft expressed concerns about the difficulties of wild animal control. A number of comments noted that control measures may conflict with federal, state, and local animal protection requirements. We've revised the guide to recognize the difficulty of controlling wild animal populations, and the need for growers to comply with other requirements.

Nonetheless, heavy concentrations of wild animals may be a source of microbial contamination. Early feedback on the proposed guide indicates that some growers still have concerns about our recommendations. This is the opportunity to help us make this section do what it needs to do, in a reasonable and practical way.

There are many other areas we could talk about, but I don't want to belabor the meeting with discussions of changes. So, basically, where are we heading now? We've provided 75 days for comment on the proposed guide. Comments will be gathered at a series of public meetings, which this is the last of the public meetings, and may be submitted in writing to the FDA.

During the comment period, FDA and USDA personnel are continuing to visit fields and packing operations to observe current practices and get additional feedback. We anticipate working again with other federal and state agencies to review comments and revise the guide, along with the produce subcommittee of the National Advisory Committee on Microbiological Criteria for Foods.

We expect the final guide by October, although it is really a living document. As additional information becomes available, we'll revisit and revise the gaps and gimps in the guide, and thank you for your attention.

MODERATOR VIOR: At this point, we would like to address any questions that you may have for Mr. Troxell. Again, these questions would be focusing on the process taken on to achieve this document. Any questions?

Yes, sir.

MR. EVARO: Will the site visits be strictly domestic, or international?

MODERATOR VIOR: Would you identify yourself -- excuse me -- for the transcriber?

MR. EVARO: My name is Frank Evaro, E-V-A-R-O.

MODERATOR VIOR: And can you use the mike? I'm sorry. Right here.

MR. EVARO: Frank Evaro, Medina Imports. We're sprout growers in Mexico. Will these site visits be domestic, or will they include international?

MR. TROXELL: At this point, the site visits are all domestic, although we'd love to visit some -- you know, tour some production in our neighboring countries. That's a matter, though, that we'd have to arrange through the governments.

MODERATOR VIOR: Any other questions or comment?

(No response.)

MODERATOR VIOR: Everybody is ready for a break. I think we're due one. We can start our break a little earlier. I would ask -- we're scheduled for a 15-minute break -- that everybody would return at 11:05.

UNIDENTIFIED SPEAKER: Yes. Because of -- the second -- is longer.

MODERATOR VIOR: Okay. Let's move that up to 11:00 o'clock, if I may ask you to. Return here -- again, feel free to talk to the folks up here or anybody else that you think might be able to address some of your questions.

If anybody would prefer to address us in Spanish, Mr. Ricardo Gomez back there -- Ricardo, would you raise your hand?  We are available to help you out. Thank you.

(Whereupon, a brief recess was taken.)

MR. BALDWIN: Is Michael here, Michael Villaneva? Here he comes.

What we'd like to do next is to begin a panel discussion, and the purpose is to try and put in context good agricultural practices in a global sense. The panelists include Mary Ayling, who's the Director of Imports in the Los Angeles District in Food and Drug, Jeffrey Farrar, who's a Food and Drug scientists -- you had heard from him earlier -- with the Food and Drug branch in California Department of Health Services, and also Michael Villaneva, who is also with the state of Califo Food Safety and Technical Service Division.

Let me try and frame what we're trying to accomplish now, is to try and give you, in a sense, a broad oversight of how the pieces fit together with the good agricultural practices. It's to examine the importance of the good agricultural practices guides in meeting the board public health goal of improving food safety and reducing food-borne illness.

Also, it's to explore the examples of international cooperation and collaboration to reduce food-borne illness, because we are a global society, and to discuss models for information dissemination, technical assistance, and education on the good agricultural practices guides.

We're going to start with Mary, to give you an overview of the Food Safety Initiative.

MS. AYLING: Thank you. At least we're not swimming, here.

I'm here to give you the broad overview, to bring us back into perspective of times long ago, about a year-and-a-half ago, when the President initiated the Food Safety Initiative, and I think all of you have a copy of "From Farm to Table," which is the theme. It's also the copy of my notes today for the presentation, so I'll be flashing at you as much as possible to get this down.

The Food Safety Initiative has a very simple goal, and that's reduce, to the greatest extent possible, the incidence of food-borne illness.

There are several components of the Food Safety Initiative. One is surveillance, coordination, inspection, risk assessment, research, education, and the guidance, and the guidance is what we'll be discussing most of the rest of the day.

Surveillance. What we want to do with surveillance is expand our current surveillance. Most of this is done through CDC, with state and local health departments, and we want to enhance detection of food-borne illnesses. I think we mentioned earlier that we've seen greater incidences of outbreaks. One of the reasons is that we're doing greater surveillance and better surveillance.

I think one of the most exciting parts of the enhanced surveillance is the DNA fingerprinting, which we can use to identify a source of the infectious agents. If two people in two very different parts of the country come down with the same illness, that can be DNA fingerprinted to associate those two people with the same product, and then it can be traced right to the product.

This is great, because then we can identify the source better, we can hope to figure out what the problem was, and we can also not identify or fingerpoint at an entire industry, when it's maybe just one processor.

Enhanced coordination. We want enhanced coordination between federal, state, and local agencies so that we can improve the containment of outbreaks, and that we can also speak with one voice. To do that, we have developed the FORCE -G-, which is the Food-borne Outbreak Response Coordination Group. This way, we can speak with one voice, so we don't have different agencies talking about different parts of the food-borne outbreak, to give, sometimes, the wrong impression of what we know and w

Other coordination that we're doing is what you're seeing here today, and that's coordination between FDA and USDA to develop the good agricultural practices, to develop assistance in education for both the foreign and domestic food industries.

Next section is inspection, and some of our targets with inspection -- primarily, one of the greatest ones is to enhance food safety in retail establishments. I think most people realize that food-borne outbreaks commonly are traced to retail establishments, and often to consumers, so we're hoping to increase our inspections by using the Food Code across the country, so that we're all looking at the same thing in the same way.

Also, we want to increase the use of HACCP. Terry mentioned this already. One of our next uses of HACCP is with the proposed regulations for fruit and vegetable juices, which also contains regulations concerning warning labels on these products.

Risk assessment. Risk assessment will help us identify where to focus our resources so that we can minimize microbial risks to human health, and so that we aren't wasting resources where they don't need to be used, so that we can concentrate our resources, industry resources, educational resources where they're best used.

Research. There are many things, and many things, going on in research, which of course we can't get into too deeply today, but some of the areas where we're looking at increasing research is improving detection methods, both with foods, on the foods itself, and at the farm level. There are many illnesses that we've encountered where we may not be able to detect that organism in the food itself, where you can, of course, find it in a person.

The next one is we're looking at research to look at the resistance to traditional preservation methods. The foods have changed, the bugs have changed, and we're finding that some preservation methods just aren't working as well as they used to.

Antibiotic resistance, same thing with the bugs changing. I think we call them emerging pathogens because they are changing in their habits, I guess, and they are more resistant to antibiotics.

I think some of the more interesting things are involved in the intervention strategies, doing research into irradiation, ozone -- well, see, I can't even say that word, so they probably don't want me to talk about this part, but other intervention strategies that we're looking at that will protect foods or prevent further contamination of foods.

Last but not least is our education efforts, and we have plans with USDA and other agencies, industry, local and state agencies to develop training plans for the transportation industry. We have an alliance with industry, consumers' trade associations, and academia to share different kinds of education efforts that we have. We're promoting and incorporating food safety education in the school systems, and we're developing multilingual food programs for food workers.

Someday I'm going to get a color slide of this little guy, because this is our Fight Bac campaign, and it is central to our education campaign. I've noticed, I was in Mexico last week, and there is a very similar type of organism that's being used for education.

Now to bring us back to the reality of today is the guidance development that we're working on together to minimize the risk of food-borne illness and produce of both domestic and foreign origin.

We are also going to be talking about imported produce safety with technical assistance to foreign countries, some training modules, and coordination of some non-FDA training networks.

For the Food Safety Initiative to be effective, we have to enhance the coordination, we have to work in partnership with other government agencies, and we have to develop public and private partnerships.

The last is, again, a sales talk on our web site. It's very easy to get to our web site. We have tons of information, not only on the Food Safety Initiative, but on some of the legislation that's been proposed. There are hyperlinks to other web sites, and also to USDA's web site.

Thank you, and we'll answer questions at the close of the panel.

MR. BALDWIN: Thank you, Mary. We have a tag team for your entertainment this morning. Jeff and Michael will give you some insights into how cooperative programs can be used to enhance food safety.

MR. FARRAR: Thank you. These new challenges that you're hearing about, the terms "emerging pathogens," "public health crisis," "enhanced food safety," all these are new challenges that require innovative new approaches to solve these very complex issues.

One of the terms you've heard frequently bandied about, and you will continue to hear it, is a very much overused term, but still one that's very necessary for us here in California, and one we believe in very strongly, and that's the word partnership. We have a very strong history here in California of working together with federal, state, and local agencies to develop solutions to problems that arise.

The balance that we find with this term "partnership" includes the word "enforcement," partnerships and enforcement. There is a necessity for enforcement. When we see conditions that violate, clearly violate, state or federal regulations, enforcement actions must be taken. However, this does not lessen the desire or the necessity to continue working with the industry to develop mutual solutions to these problems.

A couple examples of some efforts here in California that we have underway, partnership efforts. We recently completed a statewide inspection, identification, education, and inspection of all alfalfa sprout growers in California. This was due to several documented, well-documented outbreaks of illness associated with alfalfa sprouts.

With the help from the county health departments, and together with the USFDA and our state field investigators, we inspected and collected baseline information from approximately 50 sprout growers throughout the state. Legal actions are being initiated against a couple of these sprout growers, and follow-up reinspections have been scheduled for several others.

Additionally, a statewide inspection of small- and medium-sized spring mix lettuce processors is currently in progress. We are about halfway through that statewide effort, and again a cooperative effort between the USFDA, states, and the county agencies. We'll see that to completion within the next 60 to 90 days.

The state has been fortunate to receive a small amount of funding to provide educational efforts for food safety. We are meeting cooperatively with our sister agencies, with the California League of Food Processors, and other industries to develop plans for how best to allocate those resources.

We're aggressively pushing legislation, pending legislation, to require food safety certification for managers in retail food facilities in California.

We're working closely with the industry, the fresh-cut industry and the California Grocers Association, to improve our ability to trace back products implicated in food-borne outbreaks.

These and other activities which are too numerous to mention are going on daily here in California. I just wanted to give you a taste for what we are doing. These efforts will continue, and we think the Food Safety Initiative will enhance the efforts we have underway. Thank you.

MR. VILLANEVA: Got these slides that -- kind of work from the hip, but -- talk about today -- spend some time talking about -- plants, particularly -- that's the key to moving ahead on food safety -- So there's a lot of exciting things happening, and, you know, the CDFA is not a regulatory agency in this arena, certainly in the fresh produce arena, but we want to complement what Food and Drug is doing, so we're finding opportunities to partnership, to encour

So what I've been doing -- and a lot of involvement working with the industry in trying to encourage them to adopt quality assurance plans, and so we've cut it to kind of a program that we put into place, and I just want to share some of those things with you.

When we look at the issues impacting ag, certainly food safety is right at the top, but it's kind of a -- it's a very dynamic process, and a lot of things that are going on impact food safety, either directly or indirectly. These are just some of the issues that come to bear. Certainly international trade -- we'll hear some more on that, but that's a looming problem.

In California, we have problems with the dairy wastes, and environmental problems, water quality, and of course most of you are familiar that we've had that suspected -- implicated back to dairy operations, and very much concerned about risk assessment. Science-based facts are needed, rather than unreliable assumptions, and we're all worried about urban legislatures, certainly here in California, and water use. There's just a whole raft of things.

When we approach the industry, food safety concerns are real. We've had deaths, E. coli in apple juice, and outbreaks in spring mix lettuce. So that's the real problem, and you're seeing a shift from concern about pesticide residues to pathogens, and the public is becoming aware of that. They're driving this agenda. So we can't disregard that. Legislation and regulation is very concerned that this be a voluntary program. Let's let the industry step up and do what they're doing, and they

Next slide.

We certainly have to look at the pathogens that are out there. They're real. One of the points I wanted to make here was that the consumer demand is driving the agenda. One thing I think we're concerned about is this whole decision-making process. These things are made high up, and they're public-driven. Oftentimes, it's not scientists making those decisions, it's administrators. We have a lot of policies out there, federal. There's overlap, USDA, FDA. That tends to complicate the pro product. It doesn't really matter what you did or didn't do. You're going to have to be held responsible."

Next slide.

Certainly public health has concerns here. We've got to work hand in hand as -- you know, shoulder to shoulder to solve the problem. They're very much concerned about the emerging pathogens. One thing that's interesting, and that's why we're so excited, and encouraging the industry and the regulators to come out to the field, is to see firsthand how things have shifted.

The food production and processing is really on the farm now, and that's created a whole new set of problems. They don't have the resources to effectively regulate legislation and regulation. So the onus is going to fall back on the industry, and I think we all acknowledge that the public today is not very up to speed on food safety, that it contributes to the problem.

When we look at -- we approach growers. We say, "You've got to look at the scope of the food chain. It's not just harvest, pack, and ship anymore. You have to look at it all the way through, particularly when you get into the wholesale preparation and consumption. That's where the consumer is ultimately getting your product, and you're going to be held responsible for it. So you've got to think about things like positive lawn identification and other things that are going to protect

A point I want to make here is -- and we heard "HACCP." That's a term that certainly has application in food processing plants, but from CDFA's perspective, we're concerned that that becomes the operative term for food safety. I'm pleased to hear that we're talking about gaps in GMPs, and we told the industry that a good quality assurance plan is not a HACCP plan. It's just identification and implementation of good ag practices. So we're constantly stressing that point.

When we're trying to sell quality assurance, there are several things that we view as opportunities for success, and certainly timing is everything. If you haven't got a plan in place and something happens, you've missed the mark, and you've got problems. Certainly, when we look at a voluntary program, that's the key. We think it has to be a ground-up approach, where the industry buys into it, and I want to commend Western Growers, the Strawberry Commission, and the other trade association

One of the keys here, too, is that they've got to be easily implemented. I think, when we first got started with this process, there were some unknowns, but I think we all know that a grower has to be able to understand and put those to work.

Certainly, when you look at some of the cost advantages, I think growers and the ag industry have to see a return on the dollar. It's going to take additional funding and expenditure of dollars to make these things work, but we think, in the long run, there's going to be opportunities for marketing advantages, just to use one example of that.

Just a little bit about what's going on in California. We're focused on fresh produce here today, but there are several different industries in this state that have gotten QAPs up and running. I just want to make a quick note that our egg industry -- about 90-percent of all the eggs produced in California are covered by a quality assurance plan, and that's been very effective in dealing with outbreaks. So that's the kind of advantages I see as the industry moves forwards and adopts th

The industry has to identify some key issues, and it may have to address these. They need to understand the purpose. They've got to be willing to expend the dollars to put the programs into place. Western Growers is already involved in an education program to set up some basic curriculum so that workers in the arena can get trained, and that's part of the process. Setting standards comes about from that.

One area that I'm very interested from CDFA's perspective is verification. We think, as these programs develop and take off, there's going to be a need to have verification. I'm not sure if that's going to be third party or private sector individuals, but it is going to come.

Finally, I think, a final selling point is a good program provides a range of benefits. Certainly it allows you to review and to audit your entire operation, and I think a very important part of that is it makes you aware of the potential risks that might come about in your production/ag practices.

I think a key here is taking credit. I think at least I speak for California. Our industry has done a lot of good things. I don't think they've gotten all the credit that they deserve and should be credited for. So a QAP allows you to that, and certainly a verification process that shows you're addressing problems and making the proper changes is going to protect you.

Finally, to conclude, if you've got a good program, you're going to be able to provide the documentation and evidence that your product was produced in a safe and wholesome manner, and that's really the key. So, to kind of tie back with what Jeff mentioned, this is what our partnershipping is all about. It's using Food and Drug to help identify the risks, help hand in hand, and we're real excited about what's happening here in California.

MR. BALDWIN: Ricardo is going to help us understand how we can take present infrastructures that we have available in the extension services and expand the capabilities there to get the information out to the people that need to know.

MR. GOMEZ: That's quite a chore you gave me. I don't know if I can do that, but let me first give you a feeling for what USDA is. USDA was reorganized a while back, a few years back, and what happened was that agencies with more or less the same type of mission were put together in one group. The agency that I belong to, the Cooperative State Research, Education, and Extension Service, CSREES, is part of a missionary -- the research, education, and economics -- and the Agricultu Service is involved, and Terry Troxell mentioned the National Agricultural Statistical Service. That is also part of the agency.

Originally, the Agricultural Research Service was to do high-risk ag research, and our group of -- our agency was to do the practical part. That's changed a little bit. We both do those things, but that's the way it went. My agency is the agency that is linked to the land grant system, and that is a system of over 120 institutions throughout the United States and territories that have the experiment stations and the extension service.

So we have a presence, basically in each and every county in the U.S. We have the know-how, the research capabilities to not only do federal work, that is, nationwide, but we also come down to the local level, and California is one of the better examples of research being done at the local level.

One of the things that we have taken very seriously, both at FDA and USDA, is the word "initiative." The word "initiative," to us, means you need to focus on the problem. We at the USDA and FDA have redirected and requested additional funds to work on food safety, and food safety of fresh produce. So we are going to do additional stuff to get along and hurry this process up a little bit, or quite a bit.

One example that I want to give you, and Doctor Troxell mentioned it also, is that we really don't know lot about -- and I'll put manure on the table -- a lot about manure. We do know a lot about manure and its relationship to the organic matter and fertility of the soil. We know a lot about it. But we do not know much about its microbiological problems with foods that we consume. We have redirected quite a bit of our resources to deal with this issue, and we have requested addi

One of the things that our agency does -- and our agency, the agency that I belong to, there's only about 300 to 400 of us in there, but we're the federal partner, and the whole system has about 20,000 professionals out in the field. So we do get to everybody.

We have several programs ongoing, expanded food and nutrition -- and we must acknowledge, and we have, all of us, that this food safety problem is not only with the producer. It's a problem that is a whole continuum from the farm to the table. But we have the expanded food and nutrition program, which deals with nutritional habits of individuals, to improve them. We can incorporate food safety materials into that. We don't need to reinvent the wheel. We don't need, necessarily, to c

Some of you may be familiar with the pesticide applicator training programs, with the integrated pest management programs that have been so very successful. We can definitely incorporate some of the food safety concerns, water quality, into those programs, and not spend additional time and efforts in creating other programs.

One of the things that we must do, and we are doing, and we will continue to do, is to work with industry. We realize and we know that if we do not work with industry groups, with producers, we're sunk. We're not getting anywhere. We need their help, and we need their help in several ways. One is to reach as many people as possible, and the other one is for them to tell us what kind of information is lacking, what we need to research in order to do a better job. We must work with industr

I am a member of a group at USDA and FDA that has been appointed to deal with outreach and educational efforts on the fresh produce issue. Industry is a participant in that, a very strong partner. One of the things that we must do is learn from industry what kind of programs they have at the field level, and there are many, so that we don't duplicate the effort that has already been done. We need to utilize our funds creatively, and with the industry help, we think we can.

I do want to leave you with a message, though, if nothing else, is that it is greater risk to our health as individuals not to eat produce, fresh fruits and vegetables, than it is the risk of contamination. So keep eating your fruits and veggies. We'll all be the better for it. And eat a lot of them. Thank you.

MR. BALDWIN: DeAndra is going to give us some insight into the international aspects of technical cooperation, and we might want to turn the air conditioning back on, because we might lose some folks, because I feel it's getting warm in here, and since we have the microphones, I think we can talk over the noise.

MS. BECK: Can you all hear? Is this all right? Okay. Great.

Well, I think that Rick did a good job of explaining that USDA is involved in this initiative on many different fronts. Many of our USDA agencies have been very active in this whole initiative, from every component, to the monitoring surveillance, to research, to outreach, and there is an important component of this initiative for which my agency is involved, and that is the international component.

What I'd like to do is start out telling you a little bit about the Foreign Agricultural Service, and then I'd like to talk to you about some of our programs that we work with international partners on, because, you know, I think we can all say that our agriculture knows no borders at this point.

We're very dependent, in the U.S., on our exports, and we're also very dependent, as consumers, on our imports, and so I think the partnerships, again, reach not only within our USDA agencies, within our U.S. government agencies, but they also extend to our foreign partners, our near neighbors and those who are not quite so near.

So what I'd like to describe first is that the Foreign Agricultural Service really has two missions. We work with the U.S. agricultural community to facilitate trade and export of U.S. products, but we also have a very large component of activities and commitment to working with foreign producers, processors, governments, et cetera, to improve global food production, and processing and distribution.

FAS is a principal liaison, if you will, for the international partnerships that USDA agencies are involved in, including food safety, and we really span the spectrum of USDA's responsibilities in terms of these links. We work closely with our regulatory agencies, such as the Food Safety and Inspection Service. We also work with our marketing agencies, such as Ag Marketing Service, and we work with our technical agencies, such as the Agricultural Research Service, and we ensure that our tec

A little bit about FAS. We have staff in Washington, and we also have staff overseas, in embassies and consulates. There are 63 posts overseas that have FAS staff, and, in addition, we have 12 agricultural trade offices around the world. The posts overseas are staffed both by U.S. and by foreign service nationals, who, in fact, represent a lot of the Department of Agriculture's interests overseas.

Now, AFS is the acronym for Foreign Ag Service, and if I slip into Washington acronyms, forgive me. It's a little more efficient, however. FAS does have partnerships with many of the agricultural private sector groups across the world, and, for example, since the 1980s, FAS has worked closely with produce industries in the U.S. and Latin America, Caribbean countries, and Asia to promote concepts of quality grade and standards, and to develop and to implement post-harvest treatment technolog of cooperative efforts are going to be invaluable in working with both domestic and foreign industry to address these food safety issues.

Now, if I could have the next slide, please. Put the -- up. There you go. Okay.

Now, what I'd like to do is to explain the types of programs that FAS, the Foreign Ag Service, is involved in, and, again to reemphasize, many of the speakers up here have made note of that. We cannot do what we do without having the partnerships that we have with the land grant universities, with other U.S. agencies, U.S. government agencies, as well as USDA agencies, and industry has been a strong supporter of what we're trying to do overseas.

We implement international food safety-related programs really under four general areas of cooperation that are listed here. Our training and technical assistance efforts overseas -- I think a good example that some of you might be aware of is our Cochran Fellowship Program. Many folks have been very gracious hosts to the foreign visitors that we bring, to really have an idea of what our agricultural system is here in the United States. Over the past three years, the Cochran Fellowshi

The Foreign Ag Service also works very closely with a partner such as the U.S. Agency for International Development, AID, and also the multilateral development banks, such as the World Bank, the Inter-American Development Bank, and the Asian Development Bank, to provide USDA technical expertise, training, and consultation on various initiatives related to food safety worldwide.

The second area that we've been very involved in recently is in the data management side, and with the number of foreign visitors that we have coming to the U.S., we would like very much to know what their interests are, and be able to provide them with the kind of training and exposure to our regulatory and technical and production systems that we can. So we've been very involved in working other agencies such as the Animal, Plant, and Health Inspection Service, APHIS, to put together train

The third area that we're very involved in is our international cooperation and research. Now, we administer numerous programs in this area, particularly regarding food safety, both USDA-funded and externally funded programs. We have programs in over 20 countries worldwide, and these research initiatives address food safety topics, and this has a very high priority in the criteria for development of the proposals for cooperative research. We really feel like there's a lot of technical expe understanding of food safety issues.

I'd also like to mention the cooperation that we have with international organizations. I mentioned earlier that APHIS and FSIS and other agencies are very active in harmonizing sanitary and phytosanitary standards by working with many of the official multilateral standard-setting bodies. Examples are the Codex Elementarius, the Office of International Epizootics, and the International Plant Protection Convention of the United Nations Food and Agricultural Organization. Again, the harmoniz

These initiatives are helping us to ensure that imported products are safe for U.S. consumers and that our international trading partners understand the U.S. regulatory and policy framework relating to food safety. Moreover, it helps our U.S. scientists and technical expertise (sic.) gain access to the most current technologies, as I mentioned before. Some of these programs are funded by USDA. Others that are very heavy into technical assistance and cooperation we rely on funding from our

Now, the next slide, please.

I'd like to just highlight some of the issues that are being discussed in terms of priorities for technical cooperation on an international basis. I am part of a working group, as is Ricardo. It's an international working group related to the Food Safety Initiative, where we are working to meet the needs of our trading partners, as well as our own needs, in conveying this information worldwide.

A couple of the ideas that we have been striving with are targeting some of our efforts. What we'd like to do is increase awareness of how the Food Net system works, which is the state-of-the-art system for identifying and tracking sources of food-borne illness outbreaks, and I think one of the speakers this afternoon may go into more detail. We look forward to sharing the experiences that we've had with developing and implementing Food Net.

The second area that we'd like to focus on is improving our risk assessment methods for microbial contaminants. We found that our knowledge base is growing quite rapidly with respect to the food safety risk issues, particularly for seafood, meat, and poultry. Nonetheless, methods of assessing the risk of microbial contamination on produce continue to evolve, and really do need further evaluation.

The third area that we'd like to concentrate in is improved risk communication. A recent study by Doctor Tom Hoban at North Carolina State University was conducted on looking at consumer attitudes toward biotechnology, and, interestingly, as a part of the study, Doctor Hoban listed other sources of potential concerns to consumers.

The first series of studies was done 1995 through 1997, here in the U.S.

In fact, could I have the next slide, please.

I think the results of these are quite interesting. As you can see, given the issues of concern over pesticides, biotechnology, microbial contamination, by far, consumers in the U.S. were concerned about microbial contamination of their products. This same survey was done in 1995, and is now being updated in Europe.

If I could have the next slide, please.

Again, with a list of variables to choose from, microbial contamination from pathogens was number one concern in Europe.

What we'd like to do is to find out the best means by which government can raise public awareness on emerging issues of public health concern without unnecessarily eroding the confidence in the overall safety of our food supply, which, as Ricardo said, and I'll second, I think that we have very strong reason to believe that we have a very, very safe food supply here in the United States.

It is certain, as our detection and surveillance systems improve, that we're going to find more incidences of microbial contamination, so it's imperative for us to continue to communicate to our domestic and international consumers the levels of comparative risk.

The fourth area --

If you could go back to overheads, to the one prior to that.

The fourth area that we're interested in is to facilitate the development of international guidelines, recommendations, and standards. We are confident that a harmonized transparent set of international guidelines, recommendations, and standards will achieve a proper balance between public health objectives and the desire to facilitate international trade of food products.

The fifth area that we'd like to focus efforts on, or continuing, as Mary mentioned, there are a lot of issues of cooperative research, that we'd like to work with our international partners on to resolve concerns about food safety, and we feel pretty confident that the scientific community, working in cooperation with foreign partners, will continue to define the scientific basis upon which we base our food safety standards.

So I guess, in summary, the success of our international effort is going to, on a large part, be determined by the commitment of consumers, industry, and the academic community to work together in support of this initiative. Thank you.

MR. BALDWIN: What we'd like to do now is to give you the opportunity, if you'd like, to ask some questions or get some clarifications, to do that to the panel members before we break for lunch. Are there any questions, clarifications?

Could you tell us your name, and use the microphone, please.

MR. BUNIN: Name, rank, and serial number.

MR. BALDWIN: Yes, sir.

MR. BUNIN: Hi, everybody. I'm Don Bunin from Warwick International Limited. You can tell by the "Limited" it's an English company, English specialty chemical company. I, as an individual, and the company I represent are a brand-new -- industry, so the comments and questions I'm going to have, as somebody with a strong environmental background, who lived through the whole development of environmental regulations and so on that apply to the chemical manufacturing industry and the chemi did look like apple pie.

Okay. A couple questions for the panel. Again, as a newcomer, what is the difference between the FDA's responsibilities in this area and USDA's -- you know, frankly, just listening for the first time, it sounds like there's a lot of overlap -- and as that applies specifically to this area of fresh produce? Instead of overlap, it's truly what we've been talking about, is partnership. We're doing it together, and we're doing it together because, number one, we were charged to do i concerned about duplicate programs or overlapping, we're just working on it together. Because we both have different audiences, constituents that we work with, we're trying to cover a broader picture this way, and also EPA, OSHA, Department of Labor. There are other agencies that we're also working with, in addition to all of the states, the land grant universities. Does that make sense?

MR. GOMEZ: Let me add something to that before we get to your next question, if I may. We have an integrated research plan that is jointly developed by governmental agencies, FDA, USDA, EPA, and so on. So it's a joint plan that each has a particular piece to develop. There is some overlap. That's why we're talking to one another, so that there is the least amount, but we have joint programs that are integrated.

MR. BUNIN: Are you all -- does each agency come from a different area of expertise and responsibility as it applies to the industry, you know, before all these joint efforts were set up?

MR. BALDWIN: Yes. Congress has charged us with different roles and responsibilities. What we're doing is to try to coordinate that so that we put the network together in a way that facilitates the entire process, because Congress is our board of directors, and they've given us certain requirements, and a legislation they've asked us to implement, and that legislation is different in the sense of, you know, what our different roles are, but we still have to talk to each other, because we ca

MR. GOMEZ: Yes. We definitely have different mission areas, missions to -- but we are working together on that.

MR. BUNIN: I guess it's outside the scope of this meeting to carry that any further. As far as the international situation, what areas of the world and/or what countries are the recognized leaders in this field? There's a nice one for you.

MS. BECK: Well, if you're talking about specific to fruits and vegetables --

MR. BUNIN: Yes.

MS. BECK:  -- typically, we see a huge amount of expertise, of course, residing here in the United States, Western Europe, Australia, but then there are pockets of excellence worldwide that, in fact, that we're reaching out to tap into. We have cooperative programs in Latin America, Central America, Asia, with our Central European counterparts. We have some very interesting programs in Poland and Hungary. So sometimes it's scientist-driven. Other times, systematically, we see some ad

MR. BUNIN: Thank you.

MR. BALDWIN: Are there any other questions?

(No response.)

MR. BALDWIN: If there are not, what I'd like to do is to break in a minute or two for lunch. We have fliers on the registration table that will clue you to some restaurants in the area. What I'd like to do is to take an hour for lunch, and try and be back here promptly at 1:00 o'clock. Thank you.

MR. BALDWIN: We're going to get started again now, if you could take your seats. This afternoon's session is an in-depth discussion of the guidance document, and I thought I'd just take a minute to introduce Joyce, because I met Joyce in December, on the other side of the country, in Geneva, New York, and, as I mentioned this morning, as I was walking around looking at some of the photos and some of the exhibits, there is some real art work here in the exhibits, and Joyce is really an artis

So you're going to get an opportunity to talk to the artist who is crafting the work in progress. Again, take this as an opportunity to have a dialogue, when it's appropriate to ask Joyce what, exactly, is meant by some of the things that are in the guidance document. Joyce is a Consumer Safety Officer in the Center for Food Safety.

I'm not going to spend any more time up here. I'm just going to turn the podium over to Joyce.

MS. SALTSMAN: Good afternoon. I hope we can keep this discussion going so you all don't get too sleepy after having such a wonderful lunch. Let me see if I can -- okay. If we could turn the lights out.

Okay. All right. As you know, the source -- I'm going to divide my talk now into the sections that are covered in the guidance document, from water, to manure in biosolids, into worker health and safety, and then into field and facility sanitation, transportation, and then trace-back.

If you have -- when I finish the section, I'm going to stop and see if you have any comments you'd like to make. I would appreciate it if you would direct your comments to the topic of the guidance document, in terms of asking for clarification or making suggestions on how we can improve it, because we really want this to be a working session, and not just to present the guide and say, "Here it is." We want to get feedback from you, and we really appreciate you all coming for that purp

Now, we know that the source and quality of water will dictate its potential for being a carrier of pathogenic organisms, many of which are shown on this slide. Water may be a direct source of contamination, or it may be an indirect source of contamination when the water itself carries organisms that are spread, perhaps, to the field or packing facility.

Even small amounts of pathogens can cause illness. No one knows what proportion of contamination on fresh produce is due to water use in the field or packinghouse. Further, many neighbors have to share a watershed. Operators may have limited control over activities outside the boundaries of their own properties. However, the guidance document urges them to be proactive, to minimize in those areas over which they might have some control.

A general guideline to consider for agricultural water is that the water quality should be adequate for its intended purpose or for its intended use. The potential for contaminating produce depends on many interrelated factors, such as the degree of contact, time between use and harvest, and the physical characteristics of the crop.

Growers are encouraged to identify their water sources and assess the potential for contamination. Some of the many different water sources used by growers are shown here. In general, groundwater, such as deep wells and municipal supplies, is less likely to be exposed to high levels of pathogens, compared to surface waters.

These are some general guidelines to maintain water quality. Growers should be aware of current and historical land use, and potential sources of microbial contamination related to that use. On-farm sources of contamination may include runoff from leaking or overflowing manure storage lagoons or livestock access to surface waters or pump areas. Growers are encouraged to follow good agricultural practices to reduce or eliminate obvious sources of contamination. Soil conservation practices

Now, that section -- this slide ends the section on agricultural water. I'm going to be begin on processing water, but I will now like to have any comments you'd like to make on this section, on agricultural water.

(No response.)

MS. SALTSMAN: Okay. We'll move on. A general guideline mentioned with agricultural water also applies with processing water, and that is that the water quality should be compatible with its intended use. As the degree of water to produce contact increases, water quality also needs to increase. Treatments towards the end of processing, such as the final rinse, may require higher water quality compared to earlier operations such as water that is used in dump tanks.

In general, water that meets the microbial standard for drinking water would be considered safe and sanitary. Water needs to be safe and sanitary for its intended use not just at the beginning of a process, but throughout the process. If water is recycled, it should be countercurrent to the movement of the produce through the unit operations.

The main point here is that, although water quality needs may vary, water should never contribute to the food safety concerns.

Good manufacturing practices to help maintain water quality would include periodic microbial testing, monitoring PH and antimicrobial levels, if antimicrobials are used, and changing water or adding back water or overflow as necessary to the process.

Packers should routinely clean water contact surfaces and equipment to remove debris, plant material, as necessary. They should also routinely inspect and maintain water quality equipment, such as the filters, backflow devices, chlorinations, chlorinators -- chlorine injectors, excuse me -- and so forth.

Sanitizers or antimicrobials in processing water may be useful in some operations for reducing both the pathogens on the surface of produce and for reducing pathogens in processing water. Chlorine, as you know, is the most commonly used antimicrobial in the produce industry, but there are additional -- there are other antimicrobial chemicals that are under research at this time.

General guidelines for the use of the antimicrobials in processing water are shown here. First and foremost is to certainly follow any applicable FDA and EPA requirements. Secondly, follow manufacturer's directions. That would help ensure the safety and efficacy of the use of that antimicrobial. And then, after using one, follow up with a clean-water rinse.

It is important to remember that antimicrobial washes may reduce, but not eliminate, pathogens on the surface of produce and in water. Some typical reductions may be from 10 to one hundredfold. As organic material, such as plant material, dirt, and debris builds up in the water, the effectiveness of antimicrobial chemicals will decreased. GMPs will include a prewash to remove the bulk of the field soil, and adding overflow water or changing water is needed. Operators should also monitor c

Are there any questions or comments on processing water?

Yes. Could you go to the microphone, please.

MR. TENZER: Are you aware of any tests that we can use for Cyclospora?

MS. SALTSMAN: Excuse me. I didn't --

MR. TENZER: Cyclospora.

MS. SALTSMAN: Yes.

MR. TROXELL: Testing for Cyclospora.

MR. TENZER: I understand that they are still developing tests for Cyclospora, because the existing tests are not reliable.

MR. TROXELL: That's my understanding, that the analytical methods are under development, and it's very difficult --

MR. TENZER: I spoke with Michael, and that's where I got my information. So how could we try to eliminate Cyclospora if we couldn't test for it?

MS. SALTSMAN: Well, we already have said many times that we have a lot of gaps in our knowledge on this area of the agricultural -- and a lot of the research going on now is to answer and address those questions that you have. I mean, that's a very --

MR. BALDWIN: The methodology that exists is not perfect. What we're trying to do is to enhance the recovery. Right now, we're getting about a 30-percent recovery on the spores, and we can do some DNA testing, too. So the capability is there. It's just that we're not comfortable that we've gotten the kinds of recoveries that we ought to have.

MS. SALTSMAN: All right. Animal manure or biosolids can be a beneficial fertilizer and soil amendment, but they also represent a significant potential source of human pathogens. One in particular that you're heard about is Escherichia coli, or E. coli, 0157:H7. It originates primarily in the ruminants, such as cattle, sheep, and deer, which shed it through their feces.

Those who use biosolids are no doubt aware of EPA regulations that are already in place. Requirements for the use of biosolids on non-public land, including land for growing food crops, are set out in Title 40 of the Code of Federal Regulations, Part 503. Part 503 requires either elimination of the pathogens or significant reduction of pathogens, along with certain restrictions.

One restriction is for the minimum times between the application of biosolids and harvest of different foods or feed crops. The minimum time interval may be as much as 26 months. Many states have additional restrictions, such as limiting the type of crops that may be grown in fields and orchards to which biosolids have been applied. So operators need to be aware of their own states' requirements, in addition to federal requirements.

The use of manure in the production of fresh produce must be closely managed to limit the potential for pathogen contamination. Good agricultural practices for handling manure include treatments to reduce pathogen levels and maximizing the time between manure application to crop fields and harvest of those crops.

Growers should be alert to the presence of fecal matter that may be introduced into the product growing and handling environments. Potential sources of contamination include use of untreated or improperly treated manure, nearby manure storage or treatment areas, livestock, dairy, or poultry operations, and high concentrations of wildlife.

The guide highlights some treatments to reduce pathogens in manure. There are both passive and active treatments. Passive treatments rely on time and the environment, temperature and moisture fluctuations, and UV irradiation. For passive treatments, manure should be well aged and decomposed before being used. Active treatments include pasteurization, heat drying, anaerobic or aerobic digestion, alkali stabilization, or a combination of treatments.

Composting is a controlled and monitored process commonly used to reduce the microbial hazards of raw manure. The high temperature generated during composting can kill most pathogens in a number of days. Thus, the risk of microbial contamination from composted manure is reduced compared to untreated manure, but this is not a perfect world, and composting is not a perfect process.

Some pathogens have a higher thermal threshold than others, and may survive composting. The time and temperature required to eliminate or reduce microbial hazards in manure or other organic materials may vary depending on the regional climate and the specific management practices of an individual operation.

Some guidelines when handling or storing manure are shown here. Growers should review existing practices and conditions to identify situations where manure might contaminate produce. Manure storage or treatment sites close to fresh produce fields increase the risk of contaminating the produce, the fields, and possibly water sources.

Growers should follow good agricultural practices such as securing manure in storage areas or establishing runoff controls to minimize contamination of produce from manure in open fields, compost piles or storage areas onto nearby maturing crops. Rainfall onto manure piles may result in leachee containing pathogens. Growers may want to consider covering manure storage or treatment areas, such as under a roof or appropriate covering.

Obviously, untreated manure carries a higher risk of contamination compared to treated manure. Applying raw manure to produce fields during the growing season by, say, broadcasting or side-dressing, is not recommended.

Growers may reduce the risk of contamination from manure by maximizing the time between application of manure to a field and harvest. As mentioned this morning, the National Organic Standard board, formed under the Organic Food Production Act of 1990, recommends that raw manure not be applied within 60 days of harvest of organic crops intended for human consumption.

A problem or concern here is that no one knows for sure how long pathogens can survive in the field or on produce, or how pathogens' survival may be influenced by environmental conditions.

Finally, treated manure. Composting and other treatments may reduce, but might not eliminate, pathogens in manure. It is unknown to what extent the pathogens will survive treatment and may possibly regrow in treated manure that is stored after use or before use. Therefore, to the extent feasible, growers using treated manure may want to consider some of the recommendations made for untreated manure, such as maximizing the time between application and harvest.

Now, this concludes the section on manure. If you have any questions, I would be glad to take them now.

Yes.

MR. PASWATER: I'm Pat Paswater with the Integrated Waste Management Board, and I was curious on your one statement here relative to composting that may vary according to different regions as far as pathogenic kill and whatnot. What do you predicate that on, if the temperature is constant in pile, in North Dakota versus California? Is it variance by region of what is considered an optimum time-temperature kill in a different region?

MS. SALTSMAN: Well, the whole issue has been the time-temperature variations throughout, and they don't have enough data on it to really come out with specific guidelines.

MR. PASWATER: Yes. There's the inference, though, that the local climate influences the time-temperature in the pile, if, like in the 503 regulations, the stipulation is for a minimum time-temperature relationship of a certain degree over a period of time, and your statement here infers that that might not be a valid approach.

MR. TROXELL: The issue is the time-temperature. The question -- I mean, how many farmers are putting temperature probes in the piles? And, you know, if you're up in North Dakota, and the pile is frozen on the surface, versus Florida, where it's still 75 degrees, there's quite a difference in the time-temperature curve. That would be the main issue.

MR. PASWATER: I would suggest a little clarification of that point in the guidelines.

MR. TROXELL: Thank you. That's a good point.

MS. SALTSMAN: Yes. Thank you for that comment.

There is no slide up, so this is now the sanitation and hygiene section, and I just want to preface this by saying that we must recognize that we have a very diverse agricultural work force in this country that is made up of individuals with different backgrounds and cultures. It cannot be assumed that this work force knows about or practices good hygienic practices while working with fresh produce. The guide, therefore, recommends that all operators establish good hygienic practices that s

Perhaps the first step in establishing a good hygiene program begins with growers and packers being aware of existing state and federal regulations regarding standards for worker hygiene. For example, the Occupational Safety and Health Act has standards for protecting worker health in both the field and packing facilities. Now, OSHA standards aim to protect workers. Coming from the viewpoint of protecting the produce, we must remember that infected employees will increase the risk of trans

What can employers do? We recommend that they establish a training program to teach good hygienic practices. Each program should be geared towards the level of understanding of the workers. A formalized program, along with periodic reevaluation and follow-up training, has been proven to be effective in other segments of the food industry. Operators or the person in charge of employees should also become familiar with typical signs and symptoms of infectious diseases.

Now, we had comments to our last version of the guide saying that you can't expect operators to become physicians, and we aren't asking for that. We are just saying the Food Code, the FDA's Food Code, gives typical signs and symptoms of infectious diseases that are used throughout the food industry. By being aware of these signs and symptoms, you might be able to question a worker whether or not they might be ill, and that's just simply taking a precaution that's a wise one.

We do recommend that workers with diarrheal disease or other signs of infectious diseases not work with fresh produce or produce-handling equipment. Lesions that contain pus that are located on parts of the body that might have contact with fresh produce can contaminate it, so operators should provide some kind of protection for those employees who might have a lesion. If a lesion cannot be adequately covered to prevent it from making contact with produce, the worker should not be working w

The guide also mentions the use of gloves, and we received a number of comments questioning the recommendation to use gloves as an alternate hygienic practice. However, we had many comments that indicated that gloves are a common practice among certain agricultural practices. Therefore, we only recommend that gloves, if they are used as an alternative practice, that they be used in combination with good hand-washing practices, and it's very important to ensure that glove use is not --

As already mentioned, we encourage a training program. This simply highlights some things we mentioned in the guidance document about what to teach. We would encourage that everyone be taught the importance of good hygiene and what can happen in its absence. Teach them the importance of good hand washing and hand-washing techniques. Don't assume that everyone knows how to wash and dry their hands. This simply task is an important one, and it ought to be done correctly.

At our last group of public meetings back in January or December, we had a comment from an employer who said, "I've never thought about that, that my employees may not wash their hands correctly," and he mentioned that he may have to -- that maybe he needs to reevaluate that.

With respect to toilet facilities, the guide recommends that workers be encouraged to use available facilities to reduce the potential for cross-contaminating fields, produce, other workers, and water supplies. Be sure that workers are given the opportunity to use toilet facilities when needed, and not simply when they are given the time for a break.

Provision of toilet facilities for workers is required by law. We don't repeat the law in the guidance document, but we make reference to it. OSHA has two separate laws under -- 29 Code of Federal Regulations 1928 applies to field sanitary practices, and for facility sanitary practices, 29 Code of Federal Regulations 1910 applies to packinghouses or packing facilities. So those we just want you to be aware of.

Some general practices to apply to sanitary facilities, including toilets and hand-washing facilities, are that they be accessible. They should be properly located so as not to be near a water source used in irrigation or in an area subject to potential runoff in the event of heavy rains. Likewise, they should be well supplied with paper, a water basin, water, soap, sanitary hand-drying devices, and a waste container. All facilities should be kept clean and sanitary, and containers used to

When handling sewage disposal, operators should also consider following all applicable EPA regulations. Under 40 CFR Part 503, we've mention of this already today. They indicate proper disposal of sewage. Tank trucks should have direct access to toilets when servicing them. For all toilets, it's important to have a plan for containment of effluent in the even of a spill or leakage.

We have seen one operation where toilet facilities were moved in the field on a tractor bed as the workers were harvesting the crops. This situation certainly maximized the accessibility of the toilet facilities to the workers, but care must be taken to ensure that the facilities do not contaminate the field and produce. In this particular instance, they did not, because they were following along in parts of the field that were already harvested.

Now, before continuing on with field sanitation, I would welcome your questions or comments on the worker health section.

(No response.)

MS. SALTSMAN: Some good manufacturing practices that are recommended when working in the field are shown here. Most of these are pretty much just good common sense and good practice. One, just cleaning harvest storage facilities prior to use, repair or discarding damaged cartons. When you can't clean a carton properly, it's going to -- there's a tremendous potential for it to hang on to pathogens that may be in the mud and dirt that they come in contact with. Then clean muddy contai ensure produce that is packaged in the field is not contaminated in the process.

It is also important that field equipment be used appropriately, where it is during planting, growing, or harvesting season. Field equipment includes a wide variety of things, not just the large machinery that you commonly see, but it includes cartons, baskets, tables, cutting materials, packaging, buckets, aprons, anything.

For the large equipment, if any equipment has been used to haul garbage or manure or other such material, it should not be used with fresh produce, unless that piece of equipment has been cleaned and disinfected first. The guide recommends that operators assign someone to be in charge of equipment and be responsible for ensuring that it is maintained, working properly, and as clean as practicable.

For all packing facilities or packinghouses and the grounds around them, a general recommendation is that they be maintained in good condition so as to reduce the potential for microbial contamination of fresh produce. This would focus on keeping grasses cut, debris, trash, old equipment hauled away. Anything that could harbor or fester pests should be cleaned up and kept away from the packing facility.

Similar guidelines here as to the field is to remove as much dirt and mud as practicable from produce outside the packing facility or packing areas. Repair or discard damaged cartons, and then clean muddy pallets, containers, and so forth before using to transport fresh produce.

In one our site visits, we saw a carrot packing facility where trucks seemed to be unloading as much dirt as they were carrots. This extra field soil certainly placed a tremendous burden on the cleaning operations in that facility.

Packing and packaging equipment, like field equipment, needs to be kept in good working condition, as clean as practicable, and used appropriately to prevent microbial contamination of fresh produce. All packing areas should be cleaned at the end of each day of use, or more frequently as needed.

Packing facilities that are not enclosed certainly come with their own sets of concerns with respect to contamination, and blowing air can easily carry contaminants onto the produce. So that requires much more caution, when you're going to be packing out in the field.

Operators should ensure that cooling systems are maintained in proper working order and be kept clean. It is also important to clean all product storage areas on a regular basis, removing dirt, debris, and produce waste.

Finally, for all packing facilities, we are recommending that you establish a pest control system. The guide recommends that operators establish a pest control system, maintain the grounds in good condition, monitor and maintain facilities regularly, try to block access of pests into the enclosed facilities, and to use a pest control log which could be used to monitor or to register when treatments have been used, were they successful, follow-up inspections, and so forth.

Now, before going to the last section of the guide, I'd like to hear any comments you might have on field and facility sanitation.

(No response.)

MS. SALTSMAN: A new section that appears in this guide that did not appear in the last one was put in in response to comments. Operators who permit customers to pick their own produce or who sell produce directly to customers should use the opportunity to teach customers about good handling practices for fresh produce and to promote good hygienic practices.

Customers should follow established hygienic practices, just as you would require employees to do. The guide recommends that all customers who pick produce be provided with properly equipped hand-washing stations in the field, and that there be clean, well equipped, and convenient restrooms for their use. Finally, we encourage operators to educate consumers about washing produce before eating produce raw.

Transportation, another important area. Again, throughout the whole guidance document, we have maintained a general statement that anything that comes in contact with fresh produce has the potential of contaminating it, whether it's water, manure, workers, and certainly the transportation segment is no exception.

Produce may become contaminated during loading, unloading, storage, or transport operations. Workers involved in the transportation field should follow the same kind of good hygienic practices that are required for field and facility workers.

The guide recommends that operators ensure that someone is responsible for inspecting trucks and transport cartons before loading produce. Inspect for cleanliness, odor, and any signs of contamination. Find out what prior loads were carried in the vehicle before loading the vehicle. It may be prudent to clean and disinfect it before loading fresh produce.

We had one comment from an operator who automatically makes it his business to clean transport -- clean trucks and any cartons before loading his produce, just because he doesn't want to have to try to guess what the transport carton was used for.

So it's important to keep transportation vehicles clean in order to reduce microbial contamination or cross-contamination of fresh produce. The bottom line, again, is to try to focus on prevention of problems instead of trying to put out the fires once they begin.

During transportation, it is recommended that proper storage temperatures be maintained to ensure both the quality and the safety of fresh produce. Load trucks or transport cartons in a manner in which you minimize damage to fresh produce.

Trace-back. You've heard that mentioned earlier today. Trace-back is the ability to track food items from the consumer to the source of the products. Effective trace-back programs can serve as an important complement to good agricultural and manufacturing practices intended to prevent the occurrence of food safety problems.

This just gives an overview of a trace-back process that we present in the guidance document. It begins with identifying the suspected food item and the point of service, where the food that caused the outbreak was served or sold. Next, pertinent product information is gathered, such as identifying product type, packaging, labeling, lot numbers, expected shelf life, and so forth.

Identifications and documentation of the source of the suspect shipments of the produce can be obtained up to the point of service in one of two ways, one, by tracing lot numbers, or by reviewing delivery records for information about the time period when the product was saleable and useable, combined with employee interviews at all points in the distribution chain.

Now, this option requires a lot of time and effort, and the information gained may be less than perfect. There is absolutely nothing easy about trace-back when you're dealing with produce, and it's very difficult, and there are no clear answers on the best way for it to be done at this point, but the guidance document just recommends that operators do what they can to cover their own responsibility in the process.

Some of the challenges for the fresh produce are shown here. Applying a trace-back system does have many challenges, and one of which is that fresh produce has a short shelf life, and is often gone by the time an outbreak is reported. Current practices in fresh produce marketing and distribution systems makes a direct identification of the source difficult.

Two such practices are the use of recycled shipping crates and commingling of produce during distribution or at retail. Further, if an implicated location such as a field or packing facility is identified, the source of contamination may no longer be present when investigators arrive at the scene.

In spite of the challenges, an effective trace-back system offers several benefits. First of all, it may lead to a specific region or packinghouse or field, rather than to an entire commodity. It may limit the population at risk. It might help minimize unnecessary expenditure of already scarce public health resources.

Probably, from the operator's point of view, very important is to help reduce consumer anxiety about eating the produce. We are never trying to minimize the importance of eating fresh produce, and are certainly going to encourage that more fresh fruits and vegetables be consumed. Improved trace-back may also lead to information about the sources of contamination that might help refine future good agricultural and manufacturing practice recommendations for minimizing contamination.

Now, once good practices are in place, it's important to ensure that the process is working correctly. We encourage the regular monitoring of the operations to ensure that all practices are being followed. Without accountability, the best attempts to minimize risk of contaminating fresh produce are going to be subject to failure.

Now, this concludes my presentation on the guidance document. Are there any questions on any section that you would like to raise?

MS. GARREN: Donna Garren from Boskovich Farm. You made mention to the transportation industry. Being that we are growers and packers and processors, our missing link tends to be the transportation industry. When trucks come in, a lot of them are independent trucking agencies, and between retail and end, they're our only links, and if they're not clean, or if they don't have certain standards that they need to abide by, how are we going to monitor? I know you've mentioned something about

MR. TROXELL: Let me make a couple comments on that issue. It's been a while ago now, so I don't remember exactly when we put out a Federal Register advanced notice of proposed rule making dealing with transportation issues. We have not moved to do a proposal, but, in the meantime, the trucking industry has taken a great deal of interest in doing industry guidance, and they're actively pursuing developing industry guidance.

What's interesting is that the trucking industry seems to have pieces of guidance. You know, one group has some, another group has some, but this effort now which we're doing in partnership with Food Safety Inspection Service of USDA is going to bring all the groups together, and they can, you know, build on each other's work already done. So they're well aware of our concerns, and we're pursuing those.

MS. SALTSMAN: Yes, sir.

MR. TENZER: Abe Tenzer, Bonagra. I would like to comment about two or three points. The first point is that, in the sanitation section, mention was made that organic matter may affect the efficacy of chlorine in leaving enough chlorine to sanitize the fruits and the vegetables, and your recommendation is to add more chlorine, and I would like to address the subject later from a scientific point of view.

Having chlorine doesn't necessarily mean that you will get better sanitation. There is a certain compound that you need which, is hydrochloric acid, to kill the microorganisms, and if you don't monitor the HOCL, you don't know what's going on in your sanitation wash to begin with.

Second thing is, you could not rely on people coming in every half-an-hour or 20 minutes or 15 minutes and adding chlorine, because you don't know what the temperature conditions were, and the conditions for the formation of hydrochloric acid are very, very limited, both in PH and temperature range, so that, if you don't have an automatic system that monitors and injects, and ascertains that the HOCL level is steady, you don't have a steady sanitation. To this effect, our company and some ot

Coming back to the comments about the practices, the field practices, one of the biggest problems that we found out with our growers both in America and in Mexico is that they are using the same things. They started by using wooden bins, which are, A, a big no-no in this industry and shouldn't be used at all. They switched to plastic, big bins that are coming in from the fields loaded with the tomatoes, the peppers, and things like that.

Those bins have to be sanitized before they go back to the fields, because, if there is any contamination in any of the bins, it will cross-contaminate the new produce that is going to be shipped the second time around, or the third time around, or the fourth time around, and I don't believe that the guidelines have specifically addressed this issue.

Another thing which I would like to add is in the area of transportation. You mentioned that one of your comments indicated that he sanitizes every truck that comes in, and I think that that should become mandatory. We know only of one or two large trucking companies that are forcing their drivers to sanitize by using sanitation chemicals and high-pressure hoses, with water and desanitizer, the trucks. Our company has developed a sanitation product for trucks, and so do other companies. T

That's basically what I would like to comment in the various sections, and I hope I didn't take too much of your time, but I know that each one of the comments has proven to be very critical to us.

MR. TROXELL: Thank you.

MS. SALTSMAN: Thank you for your comments.

MR. FRANKEL: My name is Lee Frankel. I'm with the Fresh Produce Association of the Americas, and I have just some specific comments, more on how certain items are presented in the guidance document, and wanted to give a little feedback.

I guess one question that would help maybe clarify from the nontechnical user's point of view, there's a definition of "sanitized" being a five-log reduction in the microbial count, and I guess just a general question is, well, what's the starting point? Is this like a dirty vehicle, contaminated implement that we're hosing off, or is this something that we generally keep clean that we need to make practically sterile, and maybe just a little bit more explanation there would be helpful.

I guess another comment was on section two, on the water. I guess that's subsection 2.1. It talks about a general consideration for water used in a series of processes, and it makes a statement that maybe the water in the first dump tank doesn't need to be as clean as the last water.

I was thinking maybe we should take that statement or implication out, if, you know, we're talking about something like tomatoes, later on, that says, you know, if there's a difference in the pulp temperature compared to the first wash water temperature, that there will be infiltration of water in that first stage, and maybe that's the area where it's the most critical to have the cleanest water.

I guess in the same section on water, I guess 2.2, in the wash water, specifically, it says, "Use appropriate wash methods," and then it sort of mentions maybe using hot water surfactants, and I guess we're making the recommendation just to go ahead and have, right there, a little bit more explanation as to why that's useful from a producer's point of view.

I guess one of the other bullet points was consider the use of sanitizers, and it talks about monitoring chlorine levels. Maybe we could make it sanitizer-neutral, and talk about sanitizing agent levels instead of chlorine levels.

Let's see. Then I guess it talks about considering the wash water temperature, and I understand you got complaints from certain people that pre-cool product, and you switched back to emphasizing on tomatoes again, and I guess my understanding is it's not so much maybe tomatoes in particular, but anything that has a stem-end scar or a harvest scar. That's where the opportunity -- where you're getting this pressure differentials, and maybe if we can avoid being so specific on tomatoes, a

Let's see. I guess, on section four, sanitation hygiene, there's references to damaged cartons. I guess "cartons" sort of has a specific connotation of kind of a final carton that the product is shipped in to the market, as opposed to how much if you're looking -- maybe the word "container" would be better if we're talking about harvest containers as well as shipping cartons, or just all the different areas, and maybe "containers" has less industry connotation and would be all-encompas

Let's see. I guess those were -- well, I guess one other one was --

UNIDENTIFIED SPEAKER: Excuse me, Mr. Frankel. Would you speak up? We can't hear you in the back.

MR. FRANKEL: Okay. I'll speak closer to the mike, and I'm just about finished, anyway, so I apologize.

The other one was talking about removing dirt, and in the guidance document itself it focuses solely on the fact that dirt may contain fecal contamination, but I guess some scientists are talking about the high-level microbial activity in just any soil, anywhere, and I don't know if that's a threat to human health that we need to be worried about, or maybe just clearing up one way or the other, I guess, might be helpful as well. Thanks.

MS. SALTSMAN: Thank you for those comments.

We will be getting copies from the transcripts here, so your comments will be considered. I'm not writing them down. That's why I don't have to. Somebody else is doing that.

MR. TROXELL: Other questions?

(No response.)

MR. TROXELL: If not, I have a question. There has been -- obviously, one of the hot spots in this has been wild game, wild animals, and there's been concern about how the wording has been cast about the balance between protecting, you know, the wildlife, versus the potential for contamination. So what I would like from the audience, either now or in writing, is, you know, wording for dancing through that that will help us cast it in a way that is more appropriate. I mean, we really n

MODERATOR VIOR: Are there any other questions specific to what was presented just now in regards to the presentation? Step up.

MR. TENZER: Are there any other sanitizers approved to this moment in time? It's directed to you, Ted. Any other sanitation systems, methods, chemicals approved to this point in time to replace the conventional sodium hydrochloride or chlorine dioxide, such as UV or ozone? What's the status on that? That's question number one.

Question number two, what are we going to do about determining the maximum allowed microbial contamination on the various commodities, in numbers of colonies per gram or any other description? What are we doing about that, and, particularly, are we going to abide or be guided by guidelines that have been developed in Canada, in the United Kingdom, and in Australia, in Israel, in general practice, about this minimum requirement? Because it's very, very difficult to work without having a 

MR. TROXELL: On the second question, let me say, if you have some information to shed some light on that, along with the scientific basis to support the numbers, we would be glad to consider it. We're focused on pathogens, and any other endpoints we would look at would be used as surrogate markers, in lieu of being able to detect the pathogens, but we'd have to be able to -- we'd want to, presumably, be able to link that surrogate to the likelihood of a pathogen being present.

I cannot, unfortunately, provide, you know, song and verse on each of the disinfectants. I know ozone is used in some drinking water systems as a disinfectant, sometimes in combinations with chlorine or in lieu of chlorine. So, you know, we just need to use these in accordance with the federal regulations. It's either food additive regulations or EPA's regulations on disinfectants for use on raw agricultural products.

We realize there's a great need to clear more of these, to provide flexibility in doing these various sanitizing operations, and that's something that both agencies need to work on, but, in the meantime, there is a basic set of disinfectants available for use in your operations.

MODERATOR VIOR: Anything else? We were scheduled, if you look at your agenda, for a break, and then go into the specific public comment period. Given the fact that we're ahead, and people's schedules, if you would indulge me, I think we can do away with the break and move into the public comment, so that all of you can move on with your day as well as ourselves.

There were a number of folks who had indicated they would like to make public comment and address their issue. I have some names here. Juan Muniz, Lee Frankel, Lorena Santana, and Abraham Tenzer, if you would step up, if that is still your interest and preference to do so.

It's Juan Muniz.

Just one housekeeping rule. There is a limit of three minutes. Not that we're running -- but, please, in order to give everybody an opportunity.

MR. MUNIZ: Juan Muniz with Ramos Laboratories, and my concern right now is how we are addressing the packing facilities, for example, that we are trying to define and we are going to use their good manufacturing practices, again, HACCP program, because we are using mainly packing facilities that kill reduction of microbial contamination, like chlorinations systems that we are talking about, but in processing facilities, the -- of the fresh vegetables, we are doing HACCP programs for tha

So my concern is where we are going to get exactly what we are going to use in packing facilities. It will be good manufacturing practices only, or we are introducing the HACCP programs for that particular areas? Because there's still a big debate there.

MR. TROXELL: If you would like me to comment on that, I can take a minute. I mean, basically, HACCP programs have basic sanitation operating, basic SOP, sanitation SOPs, along with that program. So, if you're able to accomplish a HACCP program or HACCP-type program, whatever it meets, which incorporates sanitation SOPs, then basically you will have achieved what we're trying to achieve here, and probably more. So that's great.

MR. MUNIZ: Yes. I'm going with the HACCP program, but it's still a big debate out there. People want to use -- with a good manufacturing practices, in kind of a quality control manner, instead of trying to set up a critical control point there in the packing facility, when the operation is similar, where we have in processing facilities, in terms of using a chlorination system to reduce the allowed of (sic.) bacteria. So that was only my --

MS. SALTSMAN: Thank you.

Mr. Frankel.

MR. FRANKEL: Good afternoon, again. My name is Lee Frankel, and I'm speaking on behalf of the Fresh Produce Association, which is a -- the core members are importers who import approximately 4,000,000,000 pounds of fresh produce from Mexico each year, and I guess, given that I've already made some specific document comments, I'm going to have make some general Food Safety Initiative comments.

The first request is that the FDA, and USDA in particular, should try to help more clearly outline the goals of risk reduction that we're hoping to achieve, beyond just a general statement of safer food. I think virtually all within the industry and consumer groups alike support safer foods, but without, maybe, some specific goals in mind, it makes the task to try to motivate the millions of people around the world involved in the production processes properly motivated (sic.).

Then I also wanted to kind of call your attention to, I guess, a 1998 article from the Columbia Journalism Review that sort of went back and tried to find out where does this 9,000 deaths annually number come from, and I guess they -- you know, it wasn't USDA or it wasn't CDC, but it was back to the original papers done by a couple professors for their mathematical models, and how it's not necessarily a real kind of peer review type of number.

That's sort of just like as an example, that if we can, you know, also encourage kind of a devotion of resources to establishing some types of more accurate risk analysis that growers and producers and shippers can use to help guide them prioritize what should be the first things that we're attacking, or what's the most important things that we can be doing in order to achieve a safer food supply.

The second general request is that the guidance document should maybe more clearly reference the entire farm-to-table pathway, given the kind of big title from the guide, "Guide To Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables." You know, I guess, again, you know, maybe an area just to show or make the industry feel like you're not picking on us, you're taking care of the whole subject, is maybe reference some of the work you've already done with the 1997 Food Code a

I guess, in addition, I'll forward this on to you, but there is a 1998 survey by Audits International which surveyed -- 99-percent of the U.S. household kitchens that they surveyed were "unacceptable," sort of based on some of these Food Code recommendations and guidelines, and sort of in short, just as, you know, our association recommends that we kind of reemphasize the need for strong educational efforts, and maybe even guidelines, maybe even in this document itself, that the home con

One of the other points is just a request, again, that the administration effort for food safety continue to respect the concept of national treatment on this issue. We believe that food should be held to the same level of safety regardless of the country of origin.

I guess recently I spoke with the staff member for one of the congresswomen that introduced some of the FDA expansion, or encouraging them to do more foreign inspections, and giving them the authority, and changing the definition of "adulterated food," and the comment from that staffer was, "Well, we don't care. Imports have to be 10 times safer than what we require of U.S. producers. You know, we're just interested in safe foods."

I think, you know, if we kind of even lose that veneer, that this is about a public health issue instead of a trade issue, that -- you know, I guess more work needs to be done on that, and I guess one request is -- I know both the FDA and the USDA have legislative affairs offices, and maybe if there can be some increased activity to try and educate the people that will be passing the laws and the regulations, I guess that would be greatly appreciated.

I guess one of the other points along that front, as I looked back and looked at the sort of food-borne illnesses associated with produce reported since 1990, and saw that the incidences were roughly proportional with the market penetration of imports and domestic foods -- I guess, again, if that could maybe be reemphasized to some of the policy makers, that just if we ban all imports and replace that with domestic production, that the food-borne illness incidence will probably not be ch

I guess I would like to give a brief summary of some of the major programs some of the different growing regions in Mexico have undertaken on this effort. I guess you'll be hearing somebody from the state of Sinaloa, and their growers' association has developed guidance document for their growers. They've done a baseline survey of their hundred largest produce farms, and they have a dedicated staff members to work individually with the growers to correct some of the things they found during

The growers in the San Guetin region of Baja California likewise have a dedicated staff, just on just field sanitation, a hygiene education program, I guess some GAPs and good manufacturing practices for their main commodities, and the state of Sonora has authorized funding for 40 full-time staff members to go throughout the entire state and conduct that type of work.

I guess the reason I bring those programs out is to show that, you know, there is a need for a concept of regionalization like the USDA and FDA do with phytosanitary issues and chemical residue inspections. You know, the U.S. government recognizes that particular regions may be cleaner than others, as well as individual growers, and I guess our feeling is, if those growers or regions meet or exceed all U.S. regulations, rather than relying solely on what a foreign country's national policy i

So I would just like to reiterate that we support, you know, the goals of the administration on this project, and I wanted to say thank you for the changes that you did make from the first draft to the draft you have now, and, hopefully, with the upcoming memorandum of understanding between the U.S. and Mexico, that not only will that sort of help pave the way for us in foreign field visits, but also closer coordination of the policy between the two countries. Thanks again.

MS. SALTSMAN: Thank you.

Lorena. Ricardo, I think we might need your assistance.

MS. SANTANA: Good afternoon. My name is Lorena Santana, and I represent CADIS, from Culiacan, Sinaloa, and I will start to speak Spanish, and answer, and I'm sorry because I can't do it in English.

I would like to comment on what my group has been doing with the voluntary guidelines. We started by doing a -- or diagnosing our hygiene and our cleanliness. It is a sanitation --

MR. GOMEZ: Well, yes.

MS. SALTSMAN: Regarding -- sanitation practices?

MR. GOMEZ: Yes, yes.

MS. SANTANA: Okay. We visited some packinghouses and fields, and we had some interesting results and observations, which led us to make some conclusions, and they started working on those.

During this evaluation, we found three things that were very important that we consider, and they were involvement, investment, and training of people. We were then able to catalogue or classify the producers and packers into three categories, and we found that some producers were very much involved and very much up to date, and wanted to be involved in following good practices, but we still have a long way to go with some of the others that are not as up to speed as these were.

We have a quality program, or program on quality, and we have three different aspects of it, qualities of physical qualities, chemical qualities, and microbial quality, and the third one, of course, is the good agricultural practices and good GMPs.

We found out that the most needed part was education, and we have then developed a video for training, and it refers to the good ag practices and good GMPs for the workers both at the field and packinghouse.

We've also started to develop a program based on standard operating procedures following the guide, and in these SOPs, we're considering management, disposal, potable water for the employees, and very many others. The list is very long.

We are working very hard. I don't know whether we've done a little or a lot, but we are working hard at it. Thank you.

MS. SALTSMAN: Thank you, and thank you, Ricardo.

We have one more person, Mr. Tenzer.

MR. TENZER: For some reason, the overhead transparency equipment was given back or is not here anymore.

MS. SALTSMAN: No.

MR. TENZER: And if you remember, I mentioned that I would maybe provide presentation. I don't know why this happened. But since we don't have it, there's very little I can do about it, so I'll have to talk instead of showing you what we have done, and I would like to say a few things.

UNIDENTIFIED SPEAKER: Well, clearly, please submit the entire -- all the materials, you know, in a comment later. We'll include it in the record.

MR. TENZER: Fine. That's very kind of you. I appreciate it.

First of all, there's a question of the five-log production that I believe Lee Frankel mentioned, and the juice people have gotten -- the 11th Commandment, and the question that I'm asked by the juice people, as we are involved in the sanitation and microbial testing, is "What's the minimum number that we can afford?" Because log five of 100,000,000 colonies is a different number than a log five of 100,000 colonies. What's the meaning of the FDA requirements of five-log reduction, for

Secondly, what's the contact time? Because sanitation, as you all know, doesn't depend only on the antimicrobial agent that we have. It depends on the amount of time that we are really using the antimicrobial agent on the fruits and the vegetables.

So I would like to call your attention to this point. You have to be more specific. You couldn't just state the general idea of five-log reduction, which is not possible with chlorine unless you go to 1,000, 2,000, or 3,000 ppm, and even in alfalfa sprouts, doesn't -- kill the Salmonella that you have in there.

So we are really in a limbo here, and by not being specific, we are aggravating the situation, and I'm sure it's -- bearing in mind that we have -- in the FDA and the USDA, and in the industry in America, we can come up with some more meaningful information. That's number one.

Now, the other thing is, there is only one specification, to the best of my knowledge, that is applicable to the sanitation to the fruits and vegetables, and that's CFR 21 173.315. Am I right in that or wrong on that? CFR 21 173.315 is the only specification that specifies the antimicrobial agents that we are allowed to use in washing and cleaning fruits and vegetables.

MR. TROXELL: There may be a few other references. Some of those may already be listed on the graphs list or something. So we'd have to --

MR. TENZER: Yes. Well, if something is listed on graphs, you can just use it without making reference to this particular specification?

MR. TROXELL: I'd have to get back to you on that.

MR. TENZER: Okay.

MR. TROXELL: I'm not exactly sure.

MR. TENZER: Okay. Right. And our company, Bonagra, has developed a chlorine potentiator. It took us about eight years and two-and-a-half million dollars to develop it, and what we have done is we have applied components that are specified in CFR 21 173.315, which is the same specification that allows us to use chlorine, so that it's considered to be a processing aid, and that technology has been available in the United States for the past eight years.

As you mentioned before, Ted, we need compliance with the FDA or the -- you know -- specification. This, our CP, the chlorine potentiator, is in full compliance with CFR 21, and was tested for simplicity by Gibraltar Testing Labs way back in 1990, and was found to be nontoxic in '98, and based on EPA -- so this technology is available, and it's an American technology, developed in America, being used by American companies, and we would like very, very much to recommend that yo

Number two, the chlorine potentiator technology allows us to work in packaging houses -- up to a range of 100 degrees Fahrenheit, which you could not work with regular chlorine, because, as you know, chlorine starts evaporating at 55 degrees Fahrenheit, and conditions in most of the packinghouses, both in America and Mexico and other countries, are far from being 55 degrees. Only the processing plants which are contained in buildings could maintain this temperature range. So I would li if you can.

The third point is that the PH range that we are usually working to obtain the hydrochloric acid, HOCL, is usually between 6.5 to 7.5. In our particular testing, for the past six, seven years, we found out that we can extend the range of the HOCL formation up to between a PH of six to a PH of 10.

The sum total of the system is, is that we have a system which is much more effective in utilizing chlorine. We can cut down on the amount of chlorine that we use, which everybody would like to do, by 30 to 50-percent, and get a much better -- by utilizing our technology with the chlorine, and the result is that you get a cleaner produce that has much less count of plant pathogens and human pathogens in it.

We have demonstrated by studies that we ran with Dairy Food Laboratories that this technology could eliminate E. coli 0157:87 to the extent of five, six logs, under certain conditions. This is why I asked the first question to begin with, because, again, we are working against an unknown requirement by the FDA, and we would like to clear this up. Thank you very much.

MR. HEMPEL: I didn't sign in, but hopefully I can --

MS. SALTSMAN: No problem. Good morning.

MR. HEMPEL: Thank you very much. I'm Jasper Hempel. I represent the Western Growers Association, and on behalf of Western Growers Association, I want to compliment you for making the changes. This is truly -- one time in our earlier grassroots hearing you heard us. You accommodated most of the changes. I won't belabor the issue of wild animals. That's an issue that we are going to be commenting to you specifically on in our written comments, and we'll try to provide some guidance

Having said that, I don't want to be redundant, but I do want to reiterate a couple of points that Lee Frankel and others have made, and the question is, with all due respect, it's not the question of "Why produce, why now," but why are we focusing on the grower side of the equation, harvest to transportation, as opposed to focusing on where the real problem is, which is post-purchase food handling practices?

I was delighted to hear that you are looking at educating consumers, and we applaud that, and suggest that you take the bulk of the resources that are available to you and make that your primary focus, especially if your own statistics and CDC's statistics confirm that over 70-percent of food-borne outbreaks occur by post-purchase food handling practices by unknowing consumers.

Having said that, again, though, we developed our food safety guidelines because we believe that it's the right thing to do, not only for our members but for consumers, and for anybody that eats fresh fruits and vegetables. They need to have assurance that we in the farm community are doing everything we can to minimize microbial contamination. Your guidance document furthers our goals, as well.

So I wanted to share with you some of the things that we'll be doing in the near future. You've already heard of some of them, but what we would like to do at our next iteration of our voluntary food safety guidelines is to incorporate some of the concepts which you have presented in your guidance document that we don't have in our guidance document.

At the same time, we are working in cooperation with the state of California and our friends in the grocer community, California Grocers Association, to try to develop a comprehensive trace-back system. Right now, we have various forms of trace-back from the field to the first point of distribution, whether that's supermarket, retail -- excuse me -- distribution, retailers, and food service.

We need to get beyond that point because now, if a consumer gets sick, you can probably get it back as far as the supermarket, but you can't, in many cases, get it back to the field, and we agree with everything that has been said so far of the damage to the industry as a whole if we don't have a very specific trace-back system. So we are working aggressively on that.

We're also working aggressively to develop an educational program, and as many of you from government know, Western Growers, along with United and other organizations, have been involved with your educational outreach efforts. Again, I say this with a certain amount of respect. That is, we don't think you're going quickly enough on education, and so we feel compelled to move a little faster than you are.

To that end, we are going to build on the work that the California Strawberry Commission has put together, an outstanding quality assurance plan, and they have allowed us to use that as a template for a textbook around which we'll build a food safety curriculum, using university scientists as well as public health and public food and ag officials, and we plan to have our first educational guinea pig seminar right around the first of September. What we intend to do is to give some evidence of

Again, we appreciate all your efforts. I guess in some ways it's giving us impetus to move quicker than you. We want to stay ahead of you, if we can. But thank you for coming to California. Thank you for sharing your views today. Thank you.

MS. SALTSMAN: Thank you.

MR. TROXELL: Thank you, and we'll certainly use as much of your work as we can in our efforts nationally.

MS. GARREN: I'm Donna Garren from Boskovich Farms. This is kind of a statement to statements that might have been made here. I can't say I represent the whole produce industry, per se, being from Boskovich Farms, but some of the comments that were made, such as developing minimum bacterial counts for produce, I have a problem with, just based on the fact that maybe other countries do have minimums for their bacteria. One, we don't know what those minimums are based on, based on scientific problem with that. It may be that, meeting those certain minimum requirements for certain produce commodities, we may be getting rid of a lot of natural background microflora that's present there to spoil, you know, the produce, per se, before pathogens, such as opportunistic pathogens, take place and grow and proliferate. So I think more science-based should be not just because other countries are doing it, that we should do it. This is a statement made, basically, on minimum standards for m

Also, putting references of certain technologies that we have or should be available to us, such as chlorine alternatives to us, I don't think should be put in a guidance document. I don't mind have a section where you say that there's references that you can go to to obtain alternatives to chlorine, or something to that effect, but actually putting certain technologies into the guidance document -- these people are going to use this guidance document to help them develop programs in th

To actually have technologies, specific technologies, placed in a guidance document I think may lead people astray, but having a source of information other than the guidance document available to them of the list of possible technologies available to them may be better suited, as opposed to putting it into this document, per se. Thank you.

MODERATOR VIOR: Anyone else?

(No response.)

MODERATOR VIOR: Anything from the table?

MR. BALDWIN: No.

MODERATOR VIOR: Okay. Well, I guess it's my job to wrap this up, and first and foremost, I think, is to thank you. You are the principal players in designing this meeting, in trying to get your feedback, your comments. As we heard, I think we listened and made some changes before, and there will be changes, I'm sure, for the following document.

So please take at heart that we do listen to your comments, and we will be addressing them in the guidance document. Transcripts will be made available of this meeting, and so we have the transcription service today. I'd like to thank you all for taking the time to be with us today and giving us your comments. They're very important to us.

On a separate note, I want to thank the staff that made this meeting possible, all our staff from headquarters, all the partners and agencies involved in developing this document. I personally would like to thank the staff at this library who made the meeting room available to us at a short notice, and our Los Angeles FDA staff, Robert Rast, and, most heartfully, David Sevilla of my office, who is the best support, and got a lot of the things we needed done here today done.

So I'd like to thank those persons, and, again, I would encourage you, if you did not speak today, if you have an afterthought, as we all do sometimes, please make your comments known in written format. In your packet, there is the Federal Register notice that indicates the Management Branch Office address where you can make those -- where you can submit those. So I would encourage you to do so. Also, check our web site. Things are happening all the time. Thank you once again.

Draft Guidance: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (Español) April 13, 1998

Final Guidance: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables October 26, 1998