U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
July 21, 2000


Public Meeting on Use of the Term "Fresh"
on Foods Processed with Alternative Technologies

Chicago, Illinois, July 21, 2000

PANEL:
CHRISTINE LEWIS
GERALDINE JUNE
CHARLES SIZER
BRENDA DERBY
CLARK NARDINELLI
RAYMOND MLECKO

INDEX OF SPEAKERS

WELCOME - RAY MLECKO, DISTRICT DIRECTOR

OPENING REMARKS - CHRISTINE LEWIS

THE "FRESH" REGULATION - GERALDINE JUNE

CONSUMER UNDERSTANDING OF THE TERM "FRESH" - BRENDA DERBY

ECONOMIC IMPACT OF USE OF THE TERM "FRESH": THE ROLE OF ECONOMIC ANALYSIS - CLARK NARDINELLI

SPECIAL INVITED PRESENTATION: OVERVIEW OF THE ALTERNATIVE TECHNOLOGIES - CHARLES SIZER

PRESENTATION BY PARTICIPANTS

CLOSING REMARKS - CHRISTINE J. LEWIS AND RAYMOND MLECKO



PROCEEDINGS

(8:30 A.M.)

MR. MLECKO: Good morning. I don't know whether I need the microphone. I'm Ray Mlecko and I am the District Director and the local representative and I cover the States of Illinois, Michigan, and Indiana.

And I'd like on behalf of the local office of FDA, I'd like to welcome all you industry and you consumer and you organizational or association folks here and also our colleagues from Washington, D.C.

It's always nice to have our colleagues from headquarters here to enable us to get the latest information, what's going on at headquarters.

And we also are always pleased to have these kinds of public meetings in our area because it gives the agency an opportunity to hear from the people, "the people".

Once you get out of the beltway, I understand that life is a little different. And our perceptions of the world are a little different.

So it's very important to us as a government employee and also as a consumer, for you to get your input into the policy-making decisions at headquarters.

And so it's very, very important because without that, we wouldn't have the progress that we're making and the continued progress that we're hoping to achieve.

Now, the topic today is the word "fresh". And when I first heard that, fresh, I kind of snickered and said, you mean to tell me we're going to spend the whole day on the word "fresh"? Sure enough we are.

But I had an opportunity recently to talk to my minister. And I told my minister that I was going to spend the whole day at a meeting on the word "fresh". And he said, well, that shouldn't take that long, because that topic was discussed in Heaven. And it was successfully resolved in Heaven. And so my minister told me a little story about the word "fresh" in Heaven.

It appeared that a number of years ago, in the fine City of Chicago in one of our food warehouses, there was a nest of little mice. Newly born mice.

And if you've ever seen a newly born mouse, you realize the pink little ears and the pink little feet and pink little tail, they're really cute. They're so fresh-looking.

And as it happened, one day there was a tragic accident in the warehouse and a lift truck went over the nest and killed the poor, beautiful, fresh-looking mice.

And as it should be, the mice went directly to Heaven, because they were good mice. So they were in Heaven and they were having a good old time in Heaven, frolicking and everything else.

And one day they ran across Saint Peter. And Saint Peter looked at these beautiful little, fresh-looking mice and said, how are you mice enjoying Heaven?

And they said, Saint Peter, this place is wonderful. It meets all of our expectations. It's wonderful. Except, there's so much to see, so much to do, that with our little legs, we can't get around quick enough.

Saint Peter said, don't worry. He said I'll get you, I'll fit you out with roller skates. And you'll be able to skate around Heaven and be able to see everything and do everything. And he did it.

Then about that time, Tom, the wicked old alley cat from the Chicago area, died. And through a bureaucratic mistake or a bookkeeping mistake, he went directly to Heaven, too.

And he was there for awhile in Heaven. I guess he couldn't believe he was in Heaven, but here he was in Heaven. One day he ran across Saint Peter.

And Saint Peter looked at Tom, the grizzly old tomcat, and he said, Tom, how do you like it here?

Tom looked at Saint Peter and said, Saint Peter, this place is marvelous. Everybody treats me with respect. Nobody shoos me away. And the food. The food is so good in Heaven it's hard to believe. And it's not only good, but it's fresh. And what I like the most, are those meals on wheels.

(Laughter.)

So, Heaven has attacked the problem and perhaps maybe we can get some good insights from you today to enable our colleagues from headquarters to be better informed on the problem.

Again, I'd like to welcome everybody here. And I've got a number of FDA folks here and we'll, we're just waiting to hear what you have to say. Thank you.

MS. LEWIS: Thank you, Ray, and good morning. He's a very hard act to follow, but I will try. I want to also welcome you today to the meeting on "fresh".

My name is Christine Lewis. I'm the new Director of the Center for Food Safety and Applied Nutritions, newest office.

It's actually a melding together of the old Office of Food Labeling and the Office of Special Nutritionals. And we have the name of the Office of Nutritional Product Labelling and Dietary Supplements.

And "fresh" being, at least for today at least, a labelling term. That's why most of us from D.C. are here.

I wanted to thank especially Ray and his staff for hosting this meeting. They've done a wonderful job and have been extremely cooperative. And also to thank you folks for taking the time and giving us the chance to listen to your comments and your concerns.

I thought I would spend just a few minutes going over some background and setting some context. We have some other FDA speakers here, as well as a couple of special presentations.

And then of course the floor will be turned over to you folks to give us various concepts, concerns and issues that you'd like raised as we go through this rather interesting area of the word "fresh".

I was saying to several people, I left a vacation with my family to attend today this meeting on "fresh".

And as I explained to them as I was getting on the plane to go to a meeting on "fresh", my rather well and educated and well informed family as a group turned to me and said, huh?

So while I think it's very important for us, there's some context outside the beltway that we're all very much aware of.

Why we're here today is of course the word "fresh". And as you probably know, FDA has dealt with both the use and the misuse of this term "fresh" for many years.

In 1993, as some of you may know, we did promulgate a regulation on the use of the term "fresh".

And at that point we defined the word "fresh" when used in a manner that implies that the food is unprocessed to mean that the food is not frozen and has not been thermally treated or otherwise preserved.

Now, recently manufacturers have begun to develop and use new, what we'll call non-thermal technologies to process food in a manner to control pathogens while keeping some of the fresh characteristics.

So we're entering more or less a new area, in terms of what is happening and what is appropriate for the use of "fresh".

These manufacturers, people interested in these non-thermal approaches, have asked FDA whether they can label their products "fresh". In a nutshell, that's why we're here.

The purpose of today's meeting is two-fold. It's to gather input on whether the use of the term "fresh" is truthful and not misleading on products processed with the alternative non-thermal technologies.

The second purpose is to gather input on what type of criteria FDA should use when considering use of the term with future technologies.

Now, to move just a little bit of the focus of today's meeting, I would like to emphasize that we'll address only the use of the term with foods processed with alternative non-thermal technologies. We won't address other aspects of the regulation of the term "fresh".

I also want to set the focus in terms of FDA being in a listening mode. We're gathering information, and have not yet formulated our own ideas on this. That's the purpose of a public meeting, for us to hear your input.

Now, as probably most of you are aware, we identified the questions for today's meeting in the federal register, and I'll just go through them quickly so we're all reading from the same page.

In terms of the questions that we're specifically inviting comment on, one is do consumers associate the term "fresh" with organic characteristics, nutritional characteristics, or some other characteristic?

Second, do consumers want a way to identify foods that taste and look fresh, but have been processed to control pathogens?

Next, is the term "fresh", when applied to foods processed with these new technologies, misleading to consumers?

And fourth, what does the food industry believe the term "fresh" means?

We also have some what I consider technologically oriented questions. Do the new technologies preserve the food? Are the new technologies truly non-thermal?

Are there four quantifiable parameters, for example, level of nutrients, vitamins and what not, are they such characteristics that could be measured to determine if the food is fresh? Is there a way to quantify it?

And then back to basics again, is there a term other than "fresh" that can be used for foods processed with new technologies?

Would consumers understand the new term? What is the economic impact of allowing the use of the term "fresh" for foods processed with new technology?

And then last, would allowing the term fresh on foods processed with the new technologies place small firms, unable to use these technologies, at an economic disadvantage?

Those are really the crux issues for today. And I think at various points in time, we're hoping that all of these questions will be addressed in some way.

Having begun the morning with a little bit of context, I do want to introduce the panelists who will be setting the stage for a little bit more this morning. And then we'll turn it over to you folks.

Ms. Geraldine June, who is in our new office of Nutritional Product Labelling and Dietary Supplements, is within our division of standards and labelling regulations. And she's worked most closely here with the Chicago staff on this meeting.

We also have Dr. Brenda Derby with us, who is with FDA's Centers Consumer Studies Group.

As well as Clark Nardinelli, who is with the Economics Group of the same center. Office of Support and Analysis.

We also have on our podium today a special invited speaker, Dr. Charles Sizer, who will give some context on the technologies themselves.

In terms of the agenda, I hope you all have a copy of the agenda in front of you. We will stick strictly to the agenda, at least as much as possible.

I do want to point out that a transcript will be made of the proceedings, and will be available on FDA's web page, which surprisingly enough is QUICKSAND.FDA.GOV. [correct URL is http://vm.cfsan.fda.gov/ - ed.]

And then in addition to verbal comments, you would be able to read the transcript.

Comments can be made to Dockets Management Branch on this meeting in writing. The docket number, as it would say in the Federal Register Notice, if you have a copy of it, is 00N1351.

Information on the exact web address again is in the Federal Register Notice. So we're taking both written comments today, as well as verbal comments which will appear in the transcript.

As always in meetings, there are a few housekeeping tasks I'd like to make before we begin with our panelists.

The first is that the Chicago staff have provided a number of monitors for you. There are in fact four people circulating in the meeting hall that will be available for assistance if any of you need it.

As always, there are certain facilities, such as restrooms that people need to be aware of. And if you didn't notice them, they're to the left behind the registration podium.

And then there are also three restrooms here in the hotel for lunch, as well as several others in the area. And again, at the registration table there are brochures that would help you for lunch.

We did want to ask specifically that you turn off your cell phones for today's meetings.

And also prior to the presentations for those of you that are presenting, we have a couple of suggestions.

One is that I do want to reiterate that the meeting is being transcribed. So people who are presenting should speak clearly into the microphone.

Second, please remember to give your name and company name or affiliation.

And third, kindly remember that the presentations will be timed and limited to 10 minutes. So we'll try to give you a warning if you get very close to 10 minutes.

Fourth, there is a timing device down here on the table. It will start ticking off 10 minutes when you begin to speak. And apparently, Geraldine, change colors. Is that right?

MS JUNE: Yes.

MS. LEWIS: And then should of you have brought hand outs, you can leave them in the back table in the room.

We want to thank you very much for participating. I do want to remind you that we're in listening mode and we're very interested in the comments you have to say today.

I believe our first panelist is Ms. June with our new office. She will begin to set a little bit more specifics for the term "fresh".

Thank you.

MS. JUNE: Good morning. This morning I would like to give you an overview of the term "fresh". I have broken my presentation down into four parts.

First I would like to do a historical overview to tell you some of the policy statements we've made in the past and how we came to write a final regulation.

Next, I will go over the actual provisions in the final rule.

Then I will describe some of FDA's actions against misuse of the term "fresh".

And I will conclude with discussing the new issues we are dealing with regarding the term "fresh".

We have been dealing with this term for many, many years. As late as the 1940's, we were giving guidance on the term "fresh".

Back in the 1940's, we issued what was called trade correspondence. And in one such trade correspondence, we stated that the term "fresh tomato juice" was not appropriate for a canned product.

In another trade correspondence, we stated that we would object, I'm sorry, we would not object to the term "frozen fresh" on the package of frozen foods as long as they were fresh when they were actually frozen. For example, they were recently harvested, then frozen.

In the 1960's, we were still dealing with the term "fresh". And when we issued statements of identity for orange juice and orange juice products, we had several findings of fact.

In one such finding of fact regarding the term "fresh", we stated that "fresh orange juice" was not suitable for a commercially packaged product because consumers who have for years squeezed orange juice from oranges considered that a fresh orange juice product.

A second finding of fact was that we stated that the most frequently encountered problem in the U.S. at that time was the adulteration of orange juice with water.

But the second most frequently encountered problem was the misrepresentation of frozen, I'm sorry, reconstituted juice and pasteurized juice as fresh juice.

In the 1960's, we decided to issue a more formal policy in the form of a compliance policy guide. In 1969, we issued CPG7120.06. It has been reissued and is now in our CPG562.450.

This CPG states that the term "fresh" should not be used on products that have been heat or chemically processed. This CPG also states that we would not object to the term "fresh frozen" or "frozen fresh" if foods have been quickly frozen while they're still fresh.

In the late '80's and early '90's, we received a proliferation of complaints against the misuse of the term "fresh".

So, in 1991, FDA issued a Federal Register Notice asking industries not to use the term "fresh" until we could come up with a final rule defining the term.

At that time, we had received trade complaints, complaints from consumers, consumer groups, the media and members of Congress.

In the Federal Register Notice, we stated that we would make determinations or an enforcement action on a case-by-case basis. And until we could issue a final regulation, we asked that industries ceased to increase usage of the term "fresh".

So in 1993, January, 1993, along with many other regulations that implemented nutrition labelling and education act, we issued our final regulation on the term "fresh". Since it's also the one that currently exists. And 21CFR101.95.

We defined the term "fresh" when used in a manner to suggest or imply that a food is not processed to mean that the food is in its raw state and has not been frozen.

We also stated that the term "fresh" can be used on food when it's not subjected to thermal or chemical processing, or is otherwise preserved.

In the regulation, we also defined "fresh frozen" or "frozen fresh" to mean that a food is quickly frozen while still fresh.

The regulation provides that blanching of food prior to freezing would not preclude the term "fresh".

We also described what we meant by "quickly frozen", and that is frozen with a system that quickly freezes the food to the center without any deterioration of the food.

We have several processes that we allow to be used on foods and still have the foods be called, be labelled as "fresh". These processes do not preclude the term "fresh".

The first is the addition of approved waxes on produce. The second is the post-harvest use of approved pesticides. And the third is the application of mild acid or mild chlorine mixes.

We allow these processes because they are the routine processes used in the handling of raw produce.

Here we have two more conditions that can be done and the food still be labelled fresh. One is the treatment with ionizing radiation, not to exceed the maximum dose of one kilogram, in accordance with 21CFR179.26, which is FDA's regulation on radiation on foods.

And also refrigeration would not preclude the term "fresh".

As point of background, I would like to point out that FDA decided to define the term "fresh" only in the instance where we saw the most problems. And that is when the term implied or suggested that the foods were unprocessed.

Therefore, we state in the regulation that the provisions of the regulation on "fresh" apply only when the term is used in a manner to suggest that the food is unprocessed.

The provisions of the rule also apply to brand names or sensory modifiers. In other words, this regulation applies when "fresh" is used in a brand name of a product, and it must comply with the provisions of the regulation.

In the preamble of our regulation on "fresh", we give some examples of how certain foods related to the term "fresh". We stated that pasteurized milk can be labelled "fresh" because it does not imply that the food is unprocessed

Consumers know that almost all milk is pasteurized. In fact, unpasteurized milk is not allowed to be sold in interstate commerce. We do know that some states sell within their states unpasteurized milk, but in those cases the milk is labelled raw.

We stated in the preamble that pasteurized juice cannot be labelled "fresh" because that term with orange juice implies, I'm sorry, with juice, implies that it is unprocessed.

The third example is crab meat. We stated that cooked crab meat versus pasteurized crab meat can be labelled "fresh". Consumers cannot obtain raw crab meat. Therefore, the term "fresh crab meat" has traditionally been used for cooked crab meat that has not been subjected to any other process.

Now I'd like to discuss some of FDA's actions against misuses of the term "fresh". One of the big ones here is in 1991 FDA seized 24,000 half-gallon cartons of orange juice labelled "fresh choice".

These orange juice products were made from concentrate and the term "fresh" in the brand name was misleading.

In another case, manufacturers of juice that was actually labelled "fresh and natural" brand, premium, not from concentrate pasteurized orange juice, agreed to remove the term "fresh" from their labels.

After much lengthy correspondence, in 1991 FDA recommended seizure of a pasta sauce that was labelled "fresh Italian pasta sauce". This pasta sauce was made from heat-treated tomato products.

After we had recommended seizure, the company agreed to remove the term "fresh" from their labels.

In another example, a manufacturer of a canned vegetable product who was using the term "fresh-cut" in its brand name agreed to remove the term, oh, no, actually, agreed to revise their labels to read "made with" or "packed from fresh-cut vegetables".

Now manufacturers are developing new technologies to control pathogens. They want to develop technology that are not using heat treatment to control pathogens and make a safer product.

The manufacturers contend that the foods processed with these new technologies retain the fresh-like characteristics.

And they have come to us to ask us if they can use the term "fresh" on their labels.

I have some examples here that FDA is aware of. Such terms as "fresh" or "under pressure" for products such as avocados and oysters.

And I would like to point out that the juice industry has been quite active in developing technologies to control pathogens.

Some of the technologies I listed here are ultra-high pressure, pulse electric arc, pulse light and filtration, just to name a few. Later on we will hear about a more overview of these new technologies.

So I have a question here. Where do we go from here? The answer is we don't know. That's why we've asked you for your input.

Ad Dr. Lewis stated in her opening remarks, we are here in a listening mode, and we have some questions that we want input on.

I would like to reiterate them. They're in the Federal Register Notice and she has also gone over them. But I'd just like to reiterate them.

The first one is, with what characteristics, do consumers associate the term "fresh"? Are these organic -- characteristics, such as taste or mouth feel? Are they nutritional characteristics? Or some other characteristic?

The second is do consumers want a term that will identify foods as tasting or being fresh-like, although processed with these alternative technologies?

The third question is what does industry think the term "fresh" means?

From a labelling point of view, we have to ask is the term misleading to consumers?

Would the term imply to consumers that they are getting something other than what they expect? If the term is misleading, then it would be misbranding the product.

Because the regulation prohibits the term "fresh" for foods processed by heat or otherwise preserved, we have to ask the following two questions: do the technologies preserve the foods? And are the new technologies truly non-thermal?

If someone were in question whether a product was fresh, how would one prove that it was fresh? Are there quantifiable parameters one could measure to prove freshness? For example, could you measure the level of nutrients or enzymes or vitamins?

Is there a term other than "fresh" that manufacturers can use to market their products by letting consumers know that the product had fresh-like characteristics, but had been processed with new technologies?

And would consumers understand such a term? And thirdly, what is the economic impact of all of this?

We will hear a little later about the economic, the needs for economic developments. But I would just like to point out the last two questions that we asked.

What is the economic impact of allowing "fresh" on foods processed with the alternative technologies? And a more specific question is would allowing the term "fresh" on foods processed with these technologies put small firms at an economic disadvantage, because they think it is unimportant to use the new technologies or maybe they did not have the size place to conduct the technologies.

In conclusion, I would like to thank you for coming here and hopefully being able to provide us with some input to help us make decisions on what to do about the term "fresh" on these alternative technologies.

Now with that I'd like to thank you for your attention and turning the podium back to Ms. Lewis.

Thank you.

MS. LEWIS: Thank you, Geraldine. It's a very succinct summary of a lot of FDA thought and action.

The next speaker from our FDA panel is Dr. Brenda Derby, who will address the issue of consumer understanding of the term "fresh".

Brenda.

MS. DERBY: Good morning. We haven't collected and research yet on "fresh", so I'm going to be talking about mostly the issues that this topic raises and FDA doesn't have to do some work on this.

But we would also hope to get comments and information from you, so these are the kinds of questions you should be asking that I might not mention or things that you have already done that would bear on these issues.

"Fresh" is a term originally that consumers had to feel that they know pretty well, as opposed to a lot of other terms that we sometimes have to regulate, like natural, where people feel that it's very hard to -- people perceive that they know what that means at the present time.

And that's based on a long history of experiencing "fresh" foods and what that means. And that is an important thing to retain.

It has a lot of credibility. And we certainly don't want to lose that through any changes that we would make in the regulations.

It creates expectations and depending on the product they may or may not be verifiable until you've already purchased it and tasted it.

So again, that's an important factor to consumers that they understand and make sense of "fresh" so they know what they're getting and that it meets these prior expectations they have.

And for the people selling the products, of course it has great marketing utility, being as it does have a very positive connotation to the consumer and will attract them to a product which has those qualities.

You've heard already quite a bit about the regulatory context we've been working on. We have a standardized definition so people experience this to be quite consistent over time.

That increases the understanding between both the buyer and the seller of what this term will include, what the implications are for any given product.

It may not mean exactly the same thing on every product, but people will be able to understand the difference between "fresh milk", "fresh bread" and "fresh fruit".

It has a meaning even though it cannot be defined identically for each of those different product categories.

And it does have an important bearing on credibility of a product. And in miotic regulations, we minimize any mis -- that could damage that.

Understand that it provides, the new technologies present a number of issues. The markets may change whether or not we change our definition.

There are foods that might be perceived as "fresh" that aren't being called "fresh". So the term will become more ambiguous even if we do nothing to make changes.

Consumers currently have very little knowledge of these new technologies. And unless industry takes the initiative to inform them or change its name that would give them some clue, and they wouldn't necessarily know that these foods are now products from a different technology than in the past.

And so one of the issues is how would they react when they find this out. It may not be something that's on the label, it may not be something that they can perceive looking, but they probably will hear about it at some point.

And so you don't want to be using a term, later they could feel like somehow they have been misled by that term because they thought they were getting one thing and they got something else. Even if the attributes of the product are very positive.

Some of the consequences of doing nothing is that people could have mistaken beliefs about products. They're buying them as they think they understand and that will change in some way.

The discussion of these issues may be truncated unless changes are made and some kind of consumer education has been included in that.

So some of these changes do improve the safety aspects of the food. It probably has positive future if consumers --It be an important factor to them in making choices.

So we do want to have that discussion so consumers realize the world is changing, the market place is changing and that maybe this will be a signal to them when they're making purchase choices.

And we wouldn't want our policy to be inhibiting these technologies in any way, because they should have benefits to the consumer so when the term is set canhave a lot of implications and we want your input on those issues.

The key variables for consumer point of view are what kinds of claims appear on products, or don't appear? What those attributes are that are associated with the terms, whether it's taste, texture, safety, shelf life. There are a lot of different factors that consumers may take into account when they see -- of a product.

And they way they learn about these things is not likely to be from the FDA because we really don't have the resources to do all the consumer education on a broad base.

It's more likely they're going to get it in the store or in the mass media. And so that becomes the responsibility of the industry.

So it's important that they think about some of these issues and what it means to consumers and what trade-offs they're willing to make or how you can alert them to the trade-offs that they could make.

It is likely that until consumers hear something different they will continue to assume "fresh" products are what they have been historically. So unless they're told about these changes or they learn about these new technologies or they learn that we've made a change in definition, they'll interpret "fresh" in the way they always have. They may or may not find the changes in this definition to be acceptable.

And so that's the kind of input we want to get and we want to come and see what you feel about any application of a familiar term to new kinds of products.

You can't predict the future. There's a lot of unknowns here for us and for consumers of what these product characteristics are going to be.

What policy choices are going to be made here, are not necessarily all of the FDA's people in terms of how this would be represented to consumers and all they're going to see it is in the market place.

So those are issues that we're interested in. We want to find out just how important it is that you are able to see that this is a very new kind of product. Is it acceptable if they're informed or would they think it was quality just to say fresh or we'll have to go. The particular technologies involved.

So those are the kinds of questions we would be interested in asking you when you get into some of our more qualitative work.

So the things that need to be done -- communication of FDA getting it out to consumers and then industry as these changes go out into the market place, that they let consumers know some of the things that are changing in food places, food market place.

That we will try to look at different scenarios, depending on the options that FDA considers. So that we see how they affect consumers and to get input both from industry and consumers alike. The consumer side of this discussion.

And then get feedback to the interested parties. We think it's important consumers be well informed so that there isn't an asymmetry of information here.

The consumers know what they need to know when they make purchase, just like industry will know their side of things on the new technologies.

There's always a danger of changing a definition of a very comfortable term like "fresh" that people feel they understand now.

And if you change it and don't tell them and then they discover later, then they may have a very negative reaction.

Or they may reject products out of hand because they feel like they're being manipulated, when in reality they would have been very favorably disposed to the product if it had been handled differently.

And there is some experience with those kinds of reactions from consumers when they feel like they haven't been told about something that is really important but wasn't pointed out that they mistrust the reasons why you did that.

So that we need to take that into account, too, that consumers usually feel a little bit more comfortable with changes if they understand why it was done and don't see it as being done kind of behind their backs.

So those are some of the issues that FDA is going to be looking at when doing our consumer research and that we would like to hear from others about their experiences or research along the same topic.

Thank you.

MS. LEWIS: Thank you, Brenda. Our next speaker is Dr. Clark Nardinelli from the Office of Scientific Analysis and Support. And he'll address the issue of the economic impact of use of the term "fresh" and specifically the role of economic analysis.

MR. NARDINELLI: I'm here partly to let you know that economic analysis does play a role in the decision making process.

I want to tell you a little bit about what we do as economists in -- and then because we are primarily here to listen, what it is we want to hear about.

Economics performs two roles in policy analysis. One is the cost benefit analysis. What are the costs of a particular policy? What are its benefits?

And we also study the effects of our policies on small businesses. How will a particular policy affect the industry structure or the role of small business in that particular market place.

Okay. Let me start with costs and benefits, how we estimate them. Costs we start by asking what changes will businesses and people make in reaction to a policy.

If, for example, there is a new policy with respect to the word "fresh", how will industry, how will businesses react to that? What will they do? What will actually change?

Similarly, how will consumers change? What, when they make decisions, what they consume.

So at first we'll ask what's going to be different. And then we try to put it a dollar value on that. But it's change that we look at.

Now, benefits are what affect will those changes have on public health and well being. With the change in public health, what other aspects of well being will change because of reaction to the policy. And then we put a dollar value on that.

Now, the comparison, this is something what we consider sometimes a little confusing, so let me try to explain what we are asked to do.

We are, from Executive Order 12866, we are asked to promulgate policies for which the benefits justify the costs.

So ask the question, do the benefits justify the costs? Now that does not mean that the benefits must be higher than the cost.

If the benefit cost is just information provided to the risk managers, to the decision makers, and the decision makers decide, do the benefits justify the costs?

That doesn't necessarily mean that the dollar benefits are greater than the costs. Just that in the opinion or in the judgement, I should say, of our decision makers, the benefits from a particular policy justify the costs. So it's not just an accounting exercise.

And again let me emphasize the cost benefit analysis is just one of many bits of information that decision makers use when coming out with policy.

So our role then is, as we're the Office of Scientific Analysis and Support, is to provide support to decision makers.

Small business synopsis. In addition to estimating the, what we think of as the total social benefits and total social costs, we're also asked to look at the effects of policies on small businesses.

Now in food processing, the small business administration defines "small" as a firm with fewer than 500 employees. So the official definition of "small" is a firm with fewer than 500 employees. For most of food processing. There are two or three exceptions.

For our purposes, however, we sometimes break it down further and talk about very small. This isn't an official category.

But sometimes there might be within a particular industry the actual dividing point in the industry might be something in the number of other than 500. We always use the 500 criteria, but sometime we might look at firms with fewer than 100 employees, and call that "very small". In some cases we can even use 20 employees as a cut off.

So we look at the effects on firms of different sizes. And our first job is to count up how many small businesses would be affected by a policy.

Then we ask how large will the effect be. Will this policy place small businesses at a disadvantage relative to larger businesses?

And if we have it broken down into various size categories, we might ask, well, where's the breaking point?

At what size does this policy start to have a differential effect? Maybe it's only for firms that have fewer than 20. Maybe it's for everybody in the larger small business category.

The final part of our small business analysis is to consider options for relief for small businesses. On the economic analysis, we simply look at various ways that the effects on small businesses could be mitigated.

We present those again to the decision makers. We don't, we neither support nor object to a particular policy. We put it forth and the decision makers have these option sin front of them.

But we put together options for the, generically there are several kinds of options we consider. Often things like a longer compliance period, sometimes slightly different reporting regulations. It varies. But these are such things that we consider. This is the small business analysis.

Okay. So that's what we do, but as everybody has emphasized, we're here to listen.

So I want to tell you again what, in our point of view, we want to hear. First of all, what industry can tell us.

First of all, how would allowing the use of the term "fresh" for foods processed with new technologies affect your production? How would it affect your marketing?

Would you adopt new technologies? Or would you not? How would it affect marketing? How, if there is a change in definition of the word "fresh", what will you do with it? How would this affect how you market and produce products?

And let me emphasize that specific examples really help. Name the product. Name the process. Say we would, we would use process X on product Y. Or we would not. Or you should not use process X on product Y.

Okay. So specific examples are really helpful. So that's what we want to hear. Be as specific as possible about how this will affect your production and your marketing decisions.

And again this holds also for small businesses. Say, as small business, we couldn't use this technology. Or, as a small business, we couldn't mount the sort of marketing effort that it would take to produce the product in this way, or market it in this way.

Finally, consumers. What can consumers tell us? What do we want to hear from consumers? What we want to hear is how it will affect consumption decisions.

What would allow the use of the term "fresh" for foods processed with new technologies? How would that affect the consumption decisions of households?

And again, specific examples. We're very interested. Brenda Derby touched on this as well. What consumers might think about particular processes and particular products.

Are there are some products that only the raw state should be "fresh", is this what consumers think? Or are there some processes that just are, seem inherently unfresh or seem to be okay?

And again, what do people think about these things? And again, we're very interested in particular products and particular processes. The more specific the better.

So that's what my colleagues and I are listening for then. What is going to change? How will industry change? How will consumers change? And again, the more specific the better.

Thank you.

MS. LEWIS: Thank you Clark. That concludes FDA's effort to set a little bit of context for this meeting. And we do have one other context for our presentation.

We've asked Charles Sizer of the National Center, or National Center for Food Safety Technology Group to give a little bit of an overview, again to set some context, this time in terms of technology.

Dr. Sizer.

DR. SIZER: Thank you very much. I am going to remain seated so that I can use the computer. I hope you don't mind too much.

We're going to be talking about a number of new processing technologies that are emerging. And we classify them as non-thermal technologies.

But in fact, with any process we have, there is going to be some effect of temperature on the chemical and biological changes that occur. So in reality, there is a thermal element to every process we look at.

But the technologies we're going to take a brief look at will include high-pressure processing, high-pressure CO2, UV light processing, different forms of irradiation, chemical treatment of exterior fruit, mild thermal treatments, and that definitely is a thermal treatment, and post electric field infiltration.

High pressure processing is a real interesting and very promising technology that's coming out. And you merely subject the food to very high pressures. Pressures up to 130,000 pounds per square inch.

And it's roughly equivalent to pressures at nine times ultimate depth in the ocean. So these are phenomenal pressures.

And under these pressures there are a lot of reactions that are going to be going forward and we're going to see an activation with enzymes and bacteria.

It results in a product that has better retention for flavor, texture, color and nutrients. And in some cases, with all of these new technologies, we may have products that are better than fresh, because they will have an unchanging quality that the consumer will see as very beneficial.

You have uniform pressure application that enables processing of non-palpable foods including things like oysters in the shell. So it's a really broadly applicable technology.

Here are some of the products that are possibly coming up: juices, seafood, jam, avocado, purees, sauces, coffee drinks, pasteurized and shelf-stable high-acid foods, low acid foods, and eventually possible shelf-stable low-acid products like canned foods.

Equipment processing cost factors are similar to other processes and I've heard cost estimates in the ranges of five cents per pound for foods processed by this technique.

Here are some examples of some products that have been made commercially stable with high pressure by Dr. Farkas and it's very easily achievable. You see a broad range of products.

There are basically two different systems that could be used. One is a batch system for non-palpable foods, where you take and place the food into a high-pressure vessel, pressurize it for two or three minutes at, let's say 100,000 pounds per square inch, and then remove the food afterwards.

In operation, it's similar to actually like a retord operation in that you'd be putting foods into crates moving into a pressure chamber, and then removing it.

Then the second system is a continuous system where a food would be pumped into a high-pressure vessel, treated and then be skeptically removed from that vessel and put into a package.

A variation of this process uses high-pressured combination with CO2. And it's interesting because the pressure can come down by at least one order of magnitude. And likewise it can be done at ambient temperatures and it's a continuous system.

The system looks something like this. Typically a juice product is mixed with CO2. It goes to a pressure pump. And then it is held under pressure for a period of time with the CO2 in the juice.

At the end of that time it goes through a let-down valve, the pressure let-down valve. And at that time the CO2 flashes off and is removed.

And it results in a juice that is quite stable and has a fresh flavor. Bacteria inactivated. Stability of the cloud seems to be quite good. And enzyme activity is also reduced.

This is a nice way of extending the shelf life of a product that the consumer would say it appears to be fresh.

Here's some of the pathogen results. You can see that we get a significant reduction. And if you look at the log reduction on just naturally occurring yeast and mold, once again we get a quite nice inactivation of bacteria and yeasts.

Sensory analysis wise untrained panelists can't tell the difference in this technique, and descriptive tests with the trained panel show no significant results or differences as well.

Another area that we're seeing a lot of development work going on is in the radiation. There are four types of radiation that are currently being used. UV light has a very narrow window of application right now, but there's a petition that has been filed to use UV light for juices and other products.

There's gamma radiation, electron beam radiation and X-ray radiation, the latter three being ionizing radiation that can penetrate through the packaged material and also through the foods.

The UV light systems are bacteriocidal and they have a bacteriocidal effect in the range of 240 to 265 nanometers, and there's a number of different lamps that can be used including mercury lamps or Exemer lasers.

The bacterial inactivation mechanism is very well documented and is quite well understood. One problem with UV light is there is a tendency for shadowing to occur and there have to be steps taken to eliminate the problem with shadowing or to at least be aware of it and compensate for it.

This is a diagram of one of the systems that is being proposed to be used. And basically it's a coil of tubing where if the tubing is surrounded by ultra violet lights, you can see it this way. It's concentrically wound, tubing around a whole battery of lights.

The juice passes through the turbulence load and gets exposed to the UV light. And during its exposure the bacteria are inactivated. So it's quite a simple process. And the nice thing about UV systems is that they're quite inexpensive and can be used by small juice producers, typically like in a cider operation or other small operators.

Some of the criteria established for juice have been published and it's pretty well recognized that you can achieve a 5-log reduction of pathogens that the resulting product will be much safer for the consumer. And there are some appropriate surrogates that have been identified so that you can test systems in the field.

Another aspect of that is that the cumulative log reduction of the entire process can at times be added, so that you can achieve a 5-log reduction using a combination of treatments. You may get a certain log reduction from one piece of equipment and then there would be other pieces of equipment that contribute to that.

On the ionizing radiation side there are three types. There's E beam, gamma and X-ray. And I think ten years ago everybody thought that gamma radiation was going to emerge as the tool of choice. There are a number of gamma facilities around the country being used primarily for packaging material and for medical devices.

But what has happened recently is that electron beam, and potentially X-ray have started to emerge as the tool of choice in the future for radiation of foods. We've seen a lot of activity and a lot of interest in the electron beam and X-ray radiation as well.

But it works well for inactivation of micro-organisms. There's broad inhibition in enzyme inhibition. Here's a picture of some exotic fruits that have been treated with gamma radiation and it makes them have an extended shelf life and also improves the safety of the product.

On the external treatment side, there are a lot of treatments that are available. There's chemical cleaning methods. There's mechanical cleaning methods. You can achieve a certain log reduction and improvement of safety with grading and coling. The extraction process may result in at least a reduction in the number of bacteria per gram of the product.

And we also are seeing the external sanitizing treatments in hot water and steam treatments also, improve the safety of the product, particularly for juices.

Another new thermal treatment that today is coming along is pulsed electric field. What pulsed electric field is merely subjecting food to a very high voltage field and that voltage field tends to disrupt the membranes of bacteria and results in bacterial death. So you have a minimal effect on the product.

You may or may not have enzyme inactivated and the resulting product quality is very, very nice. In fact, a consumer would look at it and say it looks very similar to a fresh product.

I included one thermal process in there. This is a minimum treatment that would result in a safe product, but it would really have a very small effect on its use and in fact, enzymes would not be inactivated.

If we took something like orange juice and subjected it to a ten second treatment, at 70 degrees, it would be virtually identical to a raw product, but I don't think you'd be able to tell it apart from fresh.

The last technology we're going to take a look at a microfiltration of milk. Here we have a bacteria which is in the range of about one to three micron and we're going to try and pass it through a membrane that has a port size smaller than the bacteria.

The result is that we separate the bacteria from the product. And it works very nicely for clear products or products, even things like milk. And what happens is that we get a separation.

Bacteria come in different sizes. We have a lot of thermal sensitive bacteria that are quite small, in the range of .3 microns up to maybe one micron and we get a significant reduction of those.

The spore formers are a little bit larger. They're up to 0.5 and we see about a nine decimal reduction for the larger size bacteria and for the smaller ones we can quite easily get a 4-log reduction in a tangential flow filter system.

The systems look something like this. The milk is circulated through a porous ceramic or other type of plastic material membrane and the bacteria are retained on one side of the membrane and then the purified product goes through the other side.

So the bacteria physically are removed from the product. One of the key elements of using a technology like this is to have an automatic check of the integrity of the filter. You must know that the filter is intact before you start processing.

And then also at the end of processing, to make sure that you haven't pulled out any bacteria to go through the system onto the finished product side.

The interesting thing is now this technology is moving along and you can achieve just about a total bacteria reduction, at least equivalent to traditional thermal treatments. And you get very good results in removing spores and in milk, the result is quite similar to just regular pasteurized product.

What can we say in conclusion about some of these new processes? Well, the new processes can preserve the fresh characteristics of the food. The processes are often superior to raw unprocessed foods, meaning that they will have some enzymes inactivated, will have more unchangeable quality.

And then lastly, the new technology have blurred the distinction between fresh and processed. And this is going to be the challenge to address.

MS. LEWIS: Thank you very much for that overview. I think it does set a context.

We've been very generous on the agenda in terms of the time allotments. As a result we're running a little bit ahead of time. I think what we'll do, however, is go ahead and take a 15 minute break. And unless there's strong objection, we'll begin with the presentations directly after that break.

If we could all be back here about ten of 10:00, we'll start the presentations then rather than at 10:30. Thank you.

(Whereupon, a recess was taken.)

MS. LEWIS: Okay. Let's begin. The component of the program that is the opportunity for various persons to address the issues we've asked to be discussed today, and just to go over the ground rules, we can.

It's a ten minute presentation. Because we are doing transcription, we would appreciate your both speaking clearly and giving your name and affiliation. As we mentioned there is a timer at the front table. The person in charge of the time has promised to try and give a signal after nine minutes, if for some reason you're still speaking. But again, you do have the full ten minutes.

We have at least at this point approximately 19 presenters. And again with ten minutes apiece, we'll try to move along at a reasonable rate.

Our first presentation, at least on my list, is Leslie Zinn. The affiliation is Ardeu's Garden. Is Mr. or Ms. Zinn here?

AUDIENCE: She was earlier.

MS. LEWIS: She was earlier.

AUDIENCE: Maybe she hasn't come back from the break yet.

MS. LEWIS: Okay. Then what we'll do is go to number two, and come back to number one in a moment.

Number two is Mr. J. Peter Chaires of the American Fresh Juice Council.

MR. CHAIRES: Again, my name is Peter Chaires. I work for Florida Fruit Shippers Association, a small agricultural co-op in Florida specializing in fresh fruit and fresh citrus juice sales. And I'm here today representing comments from the American Fresh Juice Council.

We're a national trade organization of fresh fruit and vegetable juice producers scattered across the country.

The meaning in the use of the term fresh is the cornerstone of our industry. And the identity on which we have built our businesses and that consumers have come to identify themselves with our product.

Our American Fruit Juice Council positions on questions posed for this meeting, they're clear and concise, as in our opinion this is a pretty straight forward issue. And my positions that I'll describe directed specifically at juices, but also in most, if not all cases, maybe applicable to other foods. And I'll just kind of go on a run down through those questions that were highlighted earlier in the presentation.

Do consumers associate the term fresh with organoleptic characteristics, nutritional characteristics or some other characteristics?

People seek fresh juice products for three reasons. One, taste; two, healthful properties; or three, the desire to consume a product that's as close as possible to the fresh fruit or vegetable from which it was extracted.

Regarding taste, despite the fact that juice from low heat and emerging technologies taste better than more highly processed juice, taste alone does not and should not define fresh.

New technologies improve the flavor of foods and additives every year; however, it makes little sense to allow a good tasting processed food product to be labeled as fresh.

Knowledgeable consumers are intelligent and experienced enough to know that taste like fresh is not necessarily fresh. Good taste and fresh are by no means automatically synonymous.

In regarding healthful properties, many consumers seek unprocessed juice because of the healthful benefits that they derive from it. Whole food and natural food experts will attest to the fact that the body can better assimilate the vitamins and minerals from fresh fruits and juices than those that have been processed.

Consumers in this category deserve a fresh alternative. They deserve to know that what is labeled as fresh is indeed fresh. And juice that's been subjected to intense light, heat, electricity, pressure, X-rays, radiation, etcetera has clearly undergone a process of some kind.

Processed product is not fresh. Consumer association with the term fresh may not necessarily have a bearing on what is fresh.

Now, regarding the question, do consumers want a way to identify products or identify foods that taste and look fresh but have been processed to control pathogens. Consumers simply want to make informed decisions about the foods that they consume and purchase for their families.

Any bending or manipulation of the term fresh would be tantamount to purposeful misleading the American consumer. Some consumers prefer to purchase a processed juice for various reasons.

Surely these same consumers would prefer that that juice have a superior taste and/or appearance. It's not unreasonable to incorporate adjectives to describe superior taste, appearance or perhaps a process. However, whether the labeling is addressing the appearance, the taste or a process, use of the term fresh should not be permissible.

The word fresh defines a unique and special product, that its application to a processed product we believe would be untruthful. So what does the industry think the term fresh means?

Well, the American Fresh Juice Council maintains that the definition of fresh that was previously read in the Code of Federal Regulation from 1993 is very clear and it's understandable.

The language within this definition is well understood by industry and some of those terms are very specific. The food is in its raw state and its not been frozen or subjected to any form of thermal processing or other form of preservation, is well understood.

Well, is the term fresh when applied to foods processed with these new technologies misleading to consumers? Well, the purpose of labeling laws is to prevent verbiage on packaged food items from misleading consumers.

When consumers want to make informed decisions about their food purchases the use of the term fresh on processed juices or foods would clearly mislead consumers and would be untruthful. Fresh food is food that has not undergone a compositional change.

So do the new technologies preserve foods? Any process that extends the shelf life of a product is a means of preservation. This can take place via a reduction in spoilage organisms or an alteration of enzymatic activity.

Any process that goes beyond maintenance of quality, processes such as chilling, and that changes the actual composition of the juice are a means of preservation.

So are the new technologies truly non-thermal? We heard some talk about that a little bit earlier. And the American Fresh Juice Council does question whether any of the known treatments are truly non-thermal, but it's probably more appropriate to consider whether this is a relevant question.

It seems more appropriate to question whether these new technologies are a process. And if these technologies are indeed a process, do they constitute a means of preservation?

The answer to both of these questions in our opinion is clearly yes. So the next logical question is whether nominal heat preservation processes should be permitted on fresh foods and products that are marketed as such.

In our opinion, no, they should not. Are there quantifiable parameters or the level of nutrients, vitamins, etcetera that could be measured to determine if a food is fresh? And we think that this particular question is very pertinent today.

The introduction of arbitrary measurements of nutrients in order to quantify the use of the term fresh is no more sensible than an arbitrary assessment of taste.

This would indeed be a slippery slope for the agency. Such an approach would leave the definition of fresh flexible and at the mercy of political winds, economic clout and process innovations.

FDA could conceivably find itself conducting annual debates among emerging technologies for which is fresher and by what degree. Fresh is not a measurement. Fresh is a state of being.

Gray areas and quantitative measurements do not serve the agency well or the American consumer. So is there another term other than fresh that could be used for foods processed with these new technologies?

Certainly there is potential for new language to identify new products with superior taste and appearance to traditionally processed products.

The American Fresh Juice Council chooses not to comment on this issue other than object to the inclusion of the word fresh in description of these technologies.

So would consumers understand a new term? There was some comments to this issue earlier. The most likely outcome is that educated knowledgeable consumers will continue to differentiate fresh product from processed product.

Others will continue to be manipulated by tricky verbiage or product labels and advertising puffery. Many consumers do not currently differentiate juices from drinks.

Pasteurization in relation to non-dairy application is not well understood or not as well understood as it should be now. So the bottom line is that no, consumers are not likely to understand a new term but these new technologies, if they in fact do produce a product that is superior to traditional processing, do deserve some descriptive differentiation. But differentiation should not involve the word fresh.

Finally, what is the economic impact of allowing the use of the term fresh on foods processed with these new technologies? Well, the American Fresh Juice Council maintains that manipulation in the expansion of the word fresh to include preservation processes would benefit equipment manufacturers and large food processors.

In the case of juice the market for fresh product is an attractive expansion for large processors, because these emerging technologies are economically feasible for many small firms. Large traditional processors would be better able to adapt.

Soon, consumers could be mislead into believing that the newly available juices, with flavor superior to traditionally processed product, were fresh. They would have no reason to believe otherwise because a rule would have been passed to allow the product to be identified as such.

Small fresh juice producers would not be able to compete with the scale of large processors. The economic damage to the current fresh juice industry could be catastrophic.

The allowance of the term fresh on processed products would reach beyond small juice producers. It's currently estimated that up to 40 percent of the fresh oranges to fresh orange crops in Florida goes into the production of fresh unpasteurized juices. When fresh juice producers cave under economic pressure from their inability to compete with large processors, the growers would be left without a market for their product or they'd be forced to sell it to larger processors at a reduced price.

Florida packing houses which rely on small fresh juice plants could be impacted heavily. Some estimate that a 30 percent loss in fresh orange sales for these firms is not outside the realm of possibility. Thank you.

MS. LEWIS: Thank you for those comments. I understand that our first scheduled speaker, Ms. Leslie Zinn has returned. If you could come to the microphone and identify yourself, please. Thank you.

MS. ZINN: Hi, good morning. My name is Leslie Zinn. I own a fresh juice company in Atlanta, Georgia called Ardeu's Garden. I apologize for not being here earlier. You guys are moving a little ahead of schedule.

We are a fresh juice processor. We make a variety of fresh juices from fresh produce ranging from carrots, apples, pineapples, oranges, grapefruit, cucumbers, just to name a few.

We take the fresh produce, we clean it, we press it, we bottle it, we refrigerate it. It has a shelf life of between four to ten days. And it's on the shelf the next day after it's processed.

So when I received notice that this meeting was taking place about redefining the word fresh it was very near and dear to our heart because this is exactly the industry that we're in.

We talk about fresh characteristics, and I think that there are basically three things that are associated with fresh. One is taste, the other is nutritional value, health benefit basically.

I think taste is important. I think that people like a fresh taste. But I don't really think that that's the most important thing associated with fresh.

In our business really the nutritional value, the health benefit to the consumer is what people are looking for. And in fact, we have several juices, mostly in a vegetable variety, that truly don't taste very good, but their nutritional value is tremendous and the public really wants that sort of juice.

And I think that changing the name fresh to include juices that won't have that nutritional value is really doing a disservice to the general public.

It really wasn't surprising to me when I received a notice that we were thinking about enlarging the definition of fresh because fresh is a booming industry.

If you look over the past five years the increases in fresh juices, fresh cut fruit is tremendous, and it's not surprising that larger producers want to enter this industry because it's a booming market.

But these alternate technologies, whether they're thermal in nature or not, are processing the food. They're extending the shelf life. They're changing the nutritional value, and it's a different food.

It's not in its raw state. It's not a fresh food; it's not unprocessed. So I think that if we change the definition of fresh to include these alternate technologies then we're actually tricking the general public.

The fresh market right now, it's a niche market. It's a difficult market. You have to work within a very short perishable time period. And that's part of the benefit, the nutritional benefit to the consumer. But if we're changing that then we're changing the entire industry.

When you talk about economic impacts, we're a small business. I have 35 employees. We fall well within the small business parameters. But our business is doing well and I could afford some of the alternate technologies, as you say.

But that's not our industry. We want to be fresh juice producers. We don't want to process our product. So we choose not to use these alternate technologies because that's not what our consumer wants.

However, if you look at the economic impact of changing this definition to a company such as mine, it's huge. If you allow everybody to say fresh on their product, no matter how they're processing it, if they're using high pressure, UV light or radiation, then you're confusing the consumer.

People don't understand. The general public does not even understand pasteurization. So when you talk about non-thermal versus, you know, thermal or whatever, you're really talking above people's heads.

I think that there is a somewhat understanding of what fresh is, but I think that if we change this to include these alternate technologies, it will be very similar to what's happened with the Organic Labeling Act.

And if I can take a second to talk about, I believe that that changes, the lowering of the standards in regards to the Organic Labeling Act was met with a huge response, negative response from the general public.

People want to know what it is that they're eating and they want things to be labeled according to how they understand them. And lowering those standards for the Organic Labeling Act was going to confuse people and made them realize that they might be buying something that they didn't consider was organic.

I don't know the exact numbers of letters of responses that you guys received but I think it was in the range of 350,000. So a pretty good response in a pretty small industry. And I think it was a very clear message that the public wants to know what it is that they're buying, that they're eating. And I think that this falls right along the same lines.

Now, I was really encouraged to see that the organic proposal was changed and that you guys stuck with the original definition of organic. And I'm hoping that the same thing will happen with fresh.

My concern is that how do you let the public know that you're considering changing the definition of fresh? The fresh juice industry is not as large as the organic industry is. And I don't know that people really understand what it is that we're talking about here in Chicago or D.C. or wherever it is that we discuss the new proposals.

So I strongly urge that we keep fresh intact to mean an unprocessed, raw, fresh product. There's a big difference between processed and not processed and I really think that we owe it to the public to stay true to the original definition. Thanks.

MS. LEWIS: Thank you for your comments. Our third speaker is Dr. Charles Sizer, the National Center for Food Safety Technology.

DR. SIZER: Thank you very much. I'd like to speak again about this very difficult topic. And it is extremely difficult to define. But there are a number of definitions. Let me back up.

I'm the director of the National Center for Food Safety and Technology here in Chicago, Illinois. Webster's has a very nice definition of fresh: Newly produced, gathered or made, stored, cured or preserved having its original qualities unimpaired. And there are many other definitions.

The FDA has the definition that was mentioned earlier. And I think that we can possibly come up with some definitions for some man made products, for example, fresh bread. I think everybody knows what fresh bread is.

But it becomes a lot more difficult when we talk about products like fresh juice, because juice in nature does not exist. And in fact, it's a man made product.

We can take a look at this, and this is, to all appearances, a fresh product, but in fact, this is a God made product. And when it's picked it is no longer visited by a bee but instead attracts a fly. So even bees know the difference between what is fresh and what is not.

Another example of this is a peach. The peaches on the left are growing on the tree and the ones on the right have been picked. The minute we pick the fruit the composition of it starts to change.

If we're looking at the head space volatiles of the fruit, you can see within a matter of hours the composition has changed dramatically, and it no longer tastes the same.

So your perspective is also being influenced on what is fresh and what is not. For example, this is a picture of some old grapes, but it's also a picture of fresh raisins.

From the scientific perspective there's a lot of thing that affect the fresh character. The storage conditions, microbial spoilage, chemical changes, enzymatic changes, storage conditions, time, temperature, relative humidity, gas composition and packaging.

And to give you an example, I have some fresh flowers. They're stored under very similar conditions, except that the vase on the left has water.

And my computer has just locked up.

(Laughter.)

DR. SIZER: You live by the new technology, you die by the new technology.

(Laughter.)

DR. SIZER: Well, let me sum up that even raw products eventually reach a point in their life when they're not fresh. The reason for that is that there's micro-biological changes that occur.

Let's take fresh orange juice because it's a very good example. After a period of 15 to 20 days, the micro-biological growth with increase so much that the product will be spoiled. Likewise with enzymatic changes going on and other things that are happening to the composition of the product.

At some point it is no longer fresh. And it's kind of like the example that's going around now, that the people of Iceland have got 49 different definitions of snow. For each product there probably needs to be a very precise definition of what that product is and how to maintain its fresh qualities.

And I think with that, I'm just going to unplug my computer. Thank you.

MS. LEWIS: Thank you very much. I've been at meetings quite a bit lately, and usually there's a comment on how technology is changing the meeting, but that almost no time do we make it through a meeting without a Power Point freezing or doing something. Thank you for showing that we're not unusual here today.

Our fourth speaker is Dr. Dennis Olson, Titan Sure Bean Corporation.

DR. OLSON: I'm Dennis Olson with Titan Sure Bean Corporation. We build and operate food and irradiation facilities, using ionizing electrons or X-rays.

Irradiation destroys pathogenic organisms on food without changing the nature of the food. We believe the term fresh describes a meat and poultry product in its raw state. Of the physical, chemical, sensory and micro-biological properties of a food, we believe it is the physical properties that consumers use to distinguish food from its raw state to a processed state.

The primary difference between fresh, cooked and frozen products is the physical nature or texture of the product. Non-thermal processes that don't change the physical characteristics of raw products should qualify for using the term fresh.

I think I'll just stop there.

MS. LEWIS: Thank you. Our next speaker is Mr. Edmund Ting, Flow International.

MR. TING: My name is Ed Ting. I am with Flow International Corporation located in Kent, Washington.

High pressure technology is a direct intervention technology that can improve the quality of a fresh product by increasing its safety and its useful shelf life. This is done without significantly changing the sensory and nutritional aspects of the product.

High pressure can be and is being used with many foods, ranging from juices, fruits, seltzers, even shell fish. I recommend that a technology be characterized by the outcome achieved on the food rather than by what machine it goes through.

If the result is that the fundamental characteristics of the food are substantially unchanged from fresh and without thermal exposure, then the process and the product should be given the option to be described by fresh.

The fact that high pressure and other non-thermal technologies is an active intervention technology should not prevent it from a fresh status. This precedence has already been set by low level irradiation.

Substantial scientific information exists showing that high pressure can leave the taste, color, aroma, mouth feel, texture, vitamin and many other nutritional aspects unchanged.

The resolution of this labeling issue should help consumers identify products that are of highest quality and increase the likelihood of industrial acceptance.

We will be submitting additional scientific information to support these statements. And I have one slide that I would like to show.

This is just a quick summary of many papers that exist investigating the effect of high pressure on nutritional aspects. Vitamin are retained exceptionally well, and beta carotene has been studied, even antimutagenic activities.

There's a fly buzzing around me here.

(Laughter.)

MR. TING: We will be providing this information and other information, our own scientific results as well as references in the literature on studies that help support the fact that high pressure does not alter the nutritional aspects. And the sensory aspects have also been well studied and characterized. Thank you.

MS. LEWIS: Thank you for your comments. Next is Ms. Regina Hildwine from the National Food Processors Association.

MS. HILDWINE: Good morning. I'm Regina Hildwine, senior director of food labeling and standards for the National Food Processors Association or NFPA. NFPA is the voice of the $460 food processing industry and scientific and public policy issues involving food safety, nutrition, technical and regulatory matters and consumer affairs.

In NFPA's three scientific centers its scientists and professional staff represent the food industry interests on government and regulatory affairs, and provide research, technical services, education, communications and crisis management support for the association's U.S. and international members.

And NFPA's members produce processed and packaged fruits and vegetables, meat and poultry, seafood, drinks and juices or provide supplies and services to food manufacturers. We are grateful to have this opportunity to present our views on the applicability of the term fresh to foods produced with new processing technologies.

We will respond to several of FDA's questions, at least in part, and we expect to provide additional information and perspective in written comment. I would like to start with a recommendation.

It was very nice to see the slide show by the FDA presenters, and I would urge FDA to put the slide shows on the CFSAN web site as they are very informative.

The food industry believes that it should be recognized, frankly, that the original rule making to define the term fresh, which concluded in 1993, was undertaken by FDA to remedy what it perceived to be a specific marketplace situation.

Nearly ten years later the situation is quite different regarding the availability of new processing techniques. We expect that new technologies will continue to emerge and become commercially viable.

This reality makes FDA's task quite a difficult and complex one. Nevertheless, NFPA believes it is appropriate to re-examine the rule at 21CFR101.95, at a minimum to accommodate new processing technologies. There may also be an opportunity to reconsider certain products that have come on the market during the past decade to evaluate whether their characteristics should also enable them to use the label claim fresh.

Fresh is a powerful term to describe foods. And it is clearly a word that conveys a strong message of product quality in the mind of the consumer. Fresh could mean that the food product is recently harvested or recently prepared or that it possesses certain nutritional attributes and organoleptic properties such as color, aroma and moisture conditions that are associated with recently harvested or recently prepared food.

Frankly, it is the goal of all food processing technologies to treat a food in a manner that optimizes as many of these nutritional attributes and organoleptic properties as possible. The realities of modern agricultural practices, food distribution and marketing and a location of population centers distant to the agricultural centers means that most foods have to be treated in some manner to retain nutritional characteristics and organoleptic properties over the time to reach the consumer.

Technologies are needed to keep foods fresh and thus, it is important to accommodate new technologies to help achieve this objective. Fresh does not necessarily mean the same as raw.

The two words may have some overlapping meaning but they are not synonyms. Raw connotes that the food is unprocessed. FDA in fact recognizes this meaning in its nutrition labeling rules for raw produce in Sub-part C of Part 101.

Many NFPA members recently have been using the word raw to characterize juice products that are not pasteurized or otherwise treated, using the same terminology as is commonly applied to milk in states that permit the sale of unpasteurized milk.

Fresh could be applied to an agricultural product until such time as it begins to lose significant amounts of nutrients or key organoleptic properties, such as color, aroma and moisture.

Clearly, produce and other agricultural products can no longer be considered fresh when they begin to show signs of spoilage, an off flavor or color, shrinkage that reflects the loss of moisture, the visible appearance of molds or manifestations of other spoilage organisms.

This approach is reflected in FDA's exemption for pasteurized milk in the current fresh regulation. Consumers consider pasteurized milk fresh until it begins to spoil.

NFPA believes that it is appropriate to allow the use of the term fresh on foods that have been treated to sanitize, phytosanitize or generally protect products' organoleptic property characteristics, properties that are characteristic of recent harvesting or preparation, food packaging or coding methods.

In terms of the new processing technologies listed in the report to FDA, it appears that pulsed light and ultra violet processes would best fit this approach regarding the applicability of the term fresh. These are non-penetrating processes and they're actually more readily characterized as sanitizing treatment.

Other new processing technologies might fit this approach to the utilization of the term fresh but there may need to be some limitation placed on the applicability of those technologies.

In addition, there are other technologies not mentioned in the report to FDA that could be considered appropriate for use of the term fresh, such as treatment of food by sanitizing gases like ozone.

We also wonder if it is not appropriate at this time to ask the question of whether foods treated with all approved levels of ionizing radiation should not be considered fresh, since foods treated in this manner typically do retain organoleptic properties of color, aroma and moisture characteristics of foods recently harvested.

In today's Federal Register, in fact, FDA is publishing a final rule amending 21CFR179.26 to authorize the treatment with irradiation to three kilogray, of fresh shell eggs for control of salmonella.

While the current fresh rule would permit raw foods treated with up to one kilogray of irradiation to carry the term fresh, today's action raises the important question of whether fresh shell eggs treated by up to three kilogray of irradiation are any less fresh than untreated shell eggs.

Certainly the irradiated shell eggs would have to be held under the same refrigeration conditions as untreated eggs. NFPA believes it would not mislead consumers to claim that irradiated shell eggs or any foods irradiated within the limits approved and regulations are indeed fresh.

Above all, the term fresh should be used on food labels and in labeling in a truthful non-misleading manner. We believe that FDA should propose amendments to 101.95 to accommodate those technologies that help to retain product characteristics that could be considered fresh.

NFPA will provide additional perspective on this issue in written comment. Thank you.

MS. LEWIS: Thank you. Our next speaker is Mr. John Martinelli, Orchid Island Juice Company.

MR. MARTINELLI: Good morning. I'm John Martinelli, the assistant CEO at Orchid Island Juice Company. I appreciate the opportunity to speak on behalf of the growing number of people who appreciate the government's efforts to offer a safer food supply.

We believe there is a common sense approach to food safety that does not entail food sterilization, but of a processor's integrity in conjunction with a regular inspection program.

Orchid Island Juice Company has been in business for ten years. By definition we are considered a small food processor. We employ about 100 people. In the past two years we've been participants in the Food and Drug Administration's pilot program in the fresh juice industry to test the feasibility of the implementation of the HACCP program into a fresh juice facility.

The report came back, the program was a great success.

In response to the questions posed in this meeting, the term fresh to consumers means washed, extracted, bottled and refrigerated. People don't expect fresh things to last 30 to 60 days, as in the case of a dozen roses.

To apply the word fresh to a post-extracted treated product would be misleading to consumers. I think to avert any confusion, we should stick as closely to a term already very widely understood like pasteurization or cold pasteurization or minimally pasteurized or ultra lightly pasteurized or flash pasteurized or gently pasteurized or I can see the term on the horizon, almost not even pasteurized.

Consumers aren't uninformed, as we think. You can't believe the shock, then anger, then disappointment felt by consumers when they find out the product whose name includes the word fresh, that they have paid a handsome premium for, has been gently pasteurized.

They wonder, where are the people who are supposed to guard us against these abuses. Consumers expect something from the word fresh, as in organic. Mrs. Smith can buy a much cheaper head of lettuce, one that looks and probably tastes just like a regular head of lettuce, but she doesn't.

She pays a premium and has made the organic category in the supermarkets that has this growing category in the markets. In the juice industry alone we now have pasteurized and concentrate juices that proclaim on their labels that they taste just like fresh juice.

At one time before the FDA stepped in, there was a label that actually read freshly squeezed pasteurized orange juice. These companies and companies like them are waiting for some ill-conceived legislation to take shape so they can pounce on unsuspecting consumers, armed with the word fresh and the blessing of the FDA in their deception.

In 1998 Dr. Elizabeth Campbell answered some questions in reference to the word fresh, and one of the questions that stood out in my mind was, if juice products themselves have been treated to achieve the 5-log reduction in other ways than heat pasteurization; e.g., high pressure treatments, sodium benzoate, etcetera, can they be labeled fresh?

It wasn't as great to Dr. Campbell as it is here today. She said, no, juice products that have been preserved or otherwise processed are not unprocessed and therefore, cannot be labeled fresh.

The Orchid Island Juice Company would like to reiterate our position on the proposed rule in reference to mandatory HACCP with a 5-log performance requirement for the production of all fresh squeezed juices.

We fully support the FDA's mission to maintain a safe food supply for all Americans. We also support the people of the United States in their efforts to feed their families the freshest and most natural foods possible.

Please, do everything in your power to preserve the meaning of the word fresh. We don't need more deception in the labeling of foods we consume. Fresh should stay synonymous with unadulterated. And everyone should be confident that this issue is not available for compromise.

Please be vigilant of the small but precious detail. Orchid Island Juice Company also believes that every fresh juice plant in the United States should operate under strict guidelines mandated by the Food and Drug Administration, and not just the State of Florida's juice facilities.

Documentation and standards such as HACCP must be in place and monitored with regularity. And the Food and Drug Administration should not have a gray agenda. They must have the power to intervene swiftly and severely where these guidelines are not upheld.

Do this for the good of the American people who we set out to protect in the first place. Orchid Island Juice Company believes Americans have the right to drink delicious, fresh squeezed juice without compromising the safety of themselves or their loved ones.

The unnecessary legislation of sterilization, pasteurization, ozone treatments, irradiation of citrus should be averted. This only benefits the processors looking for shortcuts to longer shelf life, transportation problems and processing deviations.

Orchid Island Juice Company believe conscientious processors of fresh citrus juices have a safety record that should be the benchmark of all food processors. Thank you.

MS. LEWIS: Thank you for your comments. Our next scheduled speaker is Dr. C. Patrick Dunne of the U.S. Army Natick Soldier Center.

DR. DUNNE: We're back with technology, except mine is a little lower tech than Dr. Sizer, conveniently loaded by process. We were told to introduce ourselves. It's on the screen. I happen to be a bio-chemist by training, nutritional bio-chemistry as an expertise, vitamin chemistry and entomology, and I've spent 20 years doing food bio-chemistry in support of an advanced process development.

And in the last two years, because of the growing interest of appropriate application of new technology, the IFT approved a new division of non-thermal processing and I happen to be the first chair person. Some of the other division Executive Committee members you will see shortly, and we've heard Dan Farkas' name mentioned.

I should mention he resurrected the technology of high pressure that was first established in the 1890's in the West Virginia agricultural experiment station, using I think surplus cannons from the Civil War, showing you could indeed pasteurize milk and other products using high pressure.

So technologies have been around for some while, and nature uses them, too. We're just advancing nature. I will give you a disclaimer. There's no formal position taken on this issue by either the DOD Combat Feeding Program, which employs me. And my boss asked the same question as the minister. You mean you're going to spend the whole day talking about fresh? And I said, yes, we are, but that's only scratching the surface.

And we could spend a whole day on several of these issues, if you really want to do the science. And I've got less than ten minutes to give you some personal reflections on some of the science behind the definitions and the application of these technologies.

Why are people doing this? Well, I have a, quote, "halfway." They want fresher taste and texture. The consumers want that. We're seeing that we can do pasteurization with safety benefits with minimal chemical and physical changes.

And safety assurance is an assumption, but as we see lately, we need to question that assumption for many of the extended distribution systems we now face in our current modern society. In the military it is especially important.

We do not want any casualties from food borne illnesses. We do see improved nutrient content in some cases with processing, and that's under-appreciated because you have to be able to measure viability, bio-availability of the nutrients and that's a non-trivial process scientifically.

We see an increased high quality shelf life. That means retention of high quality for long periods of time and we see whole product categories where you have nutriceutical products that are inherently molecules that are very labile chemically, many of them. But you still want to make those things safe so these minimal processing offers some advantage.

The first criteria is make it safe. You have to be able to control both native microflora and environmental contaminant pathogens in regards to vegetative organisms and spores. I will turn over these papers.

I will not go over all the details, but we're employing a lot of micro-biologists and we're finding too many young people want to do modern molecular biology and there's not enough people to do the real good food type micro-biology.

And where we've been talking today in this meeting, and I had some pictures that didn't show up on this one. If I have time at the end I'll show a view graph or two. But we really want to say that we can use consumers, and the first stage as FDA has done was surveys or focus groups and we've done that with some of our military.

In fact, the nine point -- scale, as I recall, came out of studies done originally with -- and its predecessor. We do a number of those things with some of the new technology products that are going to give us extended shelf life, foods, and we compared a specific benchmark; i.e., prepared fresh from scratch on one hand. On the other hand would be processed product and we'll even go take out one of our MRE pouches that's been thermally processed to set one level of quality on one end.

We use specific attribute training panels where you actually can get quantitative measurements of certain of these qualities, like texture, appearance, flavor. And you could pick out certain attributes specific that might help indicate fresh.

I think a very good point was made, these are indeed going to be very product specific. So an overall definition of fresh needs to be having several major sub-sections.

I think the bottom line is people eat it. Do they select and purchase it? So we actually go and measure consumption of military in the field and we're suggesting that's the kind of approach that needs to be in at the end.

Now, where some of us earn a living is doing chemical physical bio-chemical measurements. And this is several days and we may indeed have a symposium on some of these topics of the IFT.

They're instruments to back up those sensory panels measuring color and texture. A quick one is Ph is a safety indicator, and it says something's happening to this food when it's stored and refrigerated storage, the Ph will indeed change with time. And that's indicating some physiology and bio-chemistry going on.

And then you can get into what is changing. Sugars are changing. Sucrose gets -- to the two components. Aldehydes change, and this is a good indicator for any kind of thermal abuse, whether it's a process or in storage. You get cyclic compounds, one of them is called hydroxy metholferferal (phonetic) which -- apples you eat a lot of. And those kinds of things can be used as indicators for changes in storage or processing.

And the nutrient content is, as they say, when we're doing a chemical analysis we have to extract it out some way, and the extraction is part of the secret to the trade, and doing extractions to mimic biological process help you estimate viability and sometimes the actual minimal process increase the bio-availability.

And then you've seen some nice examples of aroma and flavor volatiles profiled. And you can do that but I just want to make this other note from my own personal statement. Yes, they're good in letting fresh frozen foods be called that after thermally blanching.

If anyone has ever done any home gardening and tried to freeze some green beans and forgot to blanche them, big mistake. Tastes like soap. That's because enzymes work when it's still frozen.

So there was a whole study and I was somewhat aware of with Professor Whitaker Davis that NFPA sponsored. Which enzymes do you really need to track for quality of frozen foods, not just the ones that are easy to measure.

I have a slide I'll put in with the proceedings that gives you some of the other technologies that give you the positive and negatives. I can read a couple.

High pressure, as you heard, has very broad capability. It can treat any food practically, as long as its in a flexible container. Or you can treat fluids and package them later. And you'll see, unless you go up and add the temperature factor, you're probably not going to inactivate those spores.

So here, temperature will be a factor. And other people are working on equipment costs and reliability and get those down. Having the label appropriate to the characteristic will indeed help that and help the small producers come into the market.

We see pulsed electric fields having brought applications only in palpable products. -- activity will limit its applications but will work with most vegetable juices or fruit juices.

On the slide that didn't make it to Chuck Sizer's computer, pulsed light can inactivate all classes of organisms and probably including viruses. But it's only good at working at surfaces or clear liquids so the design of that equipment is really critical to its success.

And there's a whole field of chemistry called photo chemistry that what you're doing is you're minimizing the chemistry. You're not doing zero; you're doing minimal chemistry because you expose for a minimal period of time.

And that same strategy applies to high dose and moderate dose of radiation. You can control the pathogens. You can control the spoilage. You will do some chemistry, but you can minimize by doing the process correctly.

That's what bought me to Natick some 20 odd years ago. People said you're going to make cyanide when you irradiate meats because it's got vitamin B-12 and they knew vitamin B-12 had a chemical name called --

I said, wrong. That's produced by those fermentations from vitamins that are sold for pharmaceutical tablets and the body -- or a very complex molecule that's got an organic -- on the top. So I did a nice year of chemistry irradiation of those things. No cyanide.

Okay. Why do we want to invest in this? Well, since Napoleon invested in a technology that went to canning, we need to bring the food with us when we go into all kinds of good places. We see business partners need to get involved. And we're jointly sponsoring these business impacts.

And I would close with a couple quick ones that says we have a division that has working groups, and publish proceedings that led to a division and we're going to consider supplying them as part of the docket response. And we invite people to follow up with this, and those of us who want to engage in a scientific dialogue we will have a workshop in March in Delaware, and we will invite people in this room to attend.

They can contact me, Don Quass or a number of other people. And see our web site. Thank you.

MS. LEWIS: Thank you. Our next speaker is Dr. Howard Zhang, Ohio State University.

DR. ZHANG: Good morning. I will talk slowly but flip my chart fast, so I can go through this with you.

I would like to give you a brief update as to what happened to pulsed electric field. The example I give you relates to processing of orange juice.

The scenario I wanted to present to you is let's say if OJ got up this morning and takes a shower, we still call him OJ. So what I see here is if you have a process of food or you have anything that involves processing and handling, you have a chance of contamination.

In that case the decontamination process may or may not result in a fresh or processed non-fresh food. Pulsed electric field has been in the horizon for a few years. At this time it's still in the laboratory test stage. It's not commercially used.

The idea is to inactivate micro-organisms and enhance food safety. It has very good effect in terms of extending shelf life, keeping the food quality.

Giving you an example of microbial inactivation, if you look at e-Colli 0157H7, this new graph shows roughly about five, six logs reduction. And we also look into its -- Those experiments were done in laboratory scale.

In order to show that it works in close to industrial scale, we put together an integrated -- plant system with pulsed electric field processing and aseptic packaging.

Some of the components look like these. The fluid handling system, treatment chambers and pulse generators. The product after treatment will either pack them in either an aseptic packaging machine or use a sanitary grow pots. We have several products running through.

Today I will show you the data with fresh orange juice. If you look at system mode, in response to the electric field treatment, if we run at 35 -- meter we roughly have about 7-log reduction. And that reduction does not recover.

Look at PME at 35 -- meter we have about 90 percent reduction. If you look at color, the PF processed juice actually is slightly brighter than the original fresh juice.

Looking at flavor, there are a group of flavor components you actually see an increase, and there's a group that you see of no effect.

Shelf life evaluation were done for about 110 days. If you look at a processed juice, PEF process or heat process, they are stable under the storage temperatures. We tested four degrees C, 22 and 37 degrees C.

The particle size after processing is slightly reduced. Ph and break number does not change, along with storage. The flavor can be changing during storage, depending on the packaging material.

We find if we keep either glass or PET under low temperature conditions, the flavor does not change. Visual quality stored at four degrees C for 56 days, there's no difference under different packaging material conditions, and if you look at 22 degrees C, you see a discoloration with some of the material such as high density and low density polyethylene.

Vitamin C, during the storage was kept with a glass packaging material and PET has a slight decrease in the vitamin C. So we found it's very important to keep the quality by using appropriate packaging material.

Sensory evaluations were done. We found no significant difference in perceived color intensity. And there's also no significant difference in flavor intensity in those packaged materials.

This project funding was provided by the U.S. Army Netick Center, and the MSF Caps Center.

The recent development, at this time we are looking at scaling up for commercialization. We have a project funded to -- it's a PEF consortium for commercialization process, mainly geared towards a commercial scale production evaluation. There are several partners in this program, American Electrical Power, Ameriqual Food, -- Technologies, Hershel Canning Company, General Mills, Kraft Food, Tetropak and a carbonated beverage company.

We are still inviting new members, if you're interested in investigating or evaluating the technology. we have a membership set aside. The first year has been completed.

We have completed the equipment design and contracted a building of the equipment. The second year we have studied -- the main purpose of the second year is to optimize the process at OSU, Ohio State University.

And then the third year we'll conduct industrial evaluations. Those members will have the system in their facility and evaluate for their own purposes.

So at the end we will have a mobile PEF plant. It will run a 1,000 per hour liter flow rate for evaluations. Also there will be a business plan developed for commercialization.

So with that, I think I still have time. Wow. I guess I went through a more or less technical presentation with this group. I hope you have the information to take home.

I certainly think that the fresh is a term to describe the product rather than something that has to be restricted to the use. If the product has the fresh quality, it should be given the opportunity to be named fresh. Thank you.

MS. LEWIS: Thank you. Our next speaker is Dr. Donald Quass of Imbroglio Cures, Incorporated.

DR. QUASS: Hello. My name is Don Quass. I'm the president of Imbroglio Cures, Inc., a privately held consulting corporation. As Pat Dunne pointed out, I'm also the secretary of the Non-Thermal Processing Division of the Institute of Food Technologists.

I'm also a consultant to other food processing organizations and information companies. My comments do not pertain to the non-thermal processing division's opinion nor to the opinions of other clients for who I consult.

I went into a restaurant the other day and she asked me what do you want to drink. I said, well, what do you have? She said, well, we have fresh hand-squeezed lemonade. I impulsively looked at her hands.

I'm afraid that with the warning label on fresh juice that there is an implication that fresh means not safe. Consume at your own risk. Don't blame the FDA if you get sick.

My own informal consumer survey before this meeting concludes that the majority of respondents feel that the term fresh connotes something about a time frame, a short time, like less than 24 hours between preparing and selling or serving.

Fresh squeezed juice was squeezed just now. Fresh baked bread was baked this morning. Fresh picked sweet corn was picked this morning.

However, in the grocery store we already see farm fresh eggs that we know were not harvested this morning. Fresh frozen poultry that we know was not slaughtered this morning. Fresh pasteurized milk that we know did not have its shelf life extended this morning.

Hence, I agree that the consumer is already confused about this term fresh. When the body politic undertakes tasks that are being presented to us today, they seem to rule in favor of the minority, not the majority. So we see high school sports teams changing their names to avoid a perceived probably offense.

Fundamentally, in my opinion, the term fresh connotes a flavor attribute. Any food regardless of processing history which carries this desired attribute should be permitted to carry the term fresh.

If the public concludes that this processor is using this term falsely, they will let the seller know by not purchasing that product. The increase in success of the broad efforts by food preservation scientists in this country and abroad to create viable processing alternatives to thermal processing should not be discarded by preventing the use of the term fresh on the label.

If it is accepted that the consumer has gained an understanding that fresh milk is typically pasteurized, even considerably over-pasteurized for economic advantage but have not yet complained about the inconsistent use of this term fresh, then the government should not engage in confusing and ultimately misleading the public by attempting to draw a fine line around the definition of fresh.

Establishment of quantifiable parameters to determine if a food is fresh would only serve to increase the cost of nutritious foods. It seems likely that fair competition and the astute public mind could work this out without government intervention.

In debate, whether these new technologies are truly, as in the printed notice, non-thermal, regs for definition of the term truly. In debate this ploy was called victory by definition.

The antique cooperative notion that the more mature members of the marketing community have a responsibility to protect or subsidize the fledglings is contrary to the working dynamics of the competitive market.

Finally in conclusion, I would agree that the government, the FDA should initiate rule making changes to amend 101.95. My recommendation is that they allow the use of ozone wash, in addition to chlorine wash. The effect is the same.

They allow the use of modified atmosphere packaging or ozone fumigation during storage. They allow the use of ionizing radiation up to ten kilogray, given that thermal pasteurization is 500 jewels per milli-liter, they should allow the use of other electrical or acoustical energy absorption up to ten jewels per milli-liter.

Or they allow the use of pulsed electric field in energy input to 200 jewels per milli-liter or allow the use of high pressure processing energy input to 200 jewels per milli-liter. Thank you very much.

MS. LEWIS: Thank you. Next scheduled is Donna Denison, United Fresh Fruits and Vegetables Association.

MS. DENISON: Good morning. My name is Donna Denison, director of governmental affairs for United Fresh Fruit and Vegetable Association. As a part of industry's oldest national trade association and public policy advocate, we appreciate the opportunity to share with you our views on behalf of the fresh fruit and vegetable industry.

While United will submit more extensive written comments as a part of the formal comment period, my remarks during the oral presentation today will be brief.

As FDA begins deliberations on whether or not to modify the definition of fresh as it relates to labeling, we ask that the agency give careful considerations to the many ramifications of modifying the present definition of fresh.

Specifically any changes considered should be examined by FDA to insure they do not misrepresent sound science or research supporting customary food safety practices that are proven not to alter taste or consistency of fresh agricultural products or mislead consumers.

At this time the industry strongly supports the present definition of fresh, and is very reluctant to endorse any proposed any regulations at this time that seek to make any major changes based on new food processing technologies.

In closing, the industry is carefully examining the proposed need to change the definition of fresh and will provide you with additional comments relating to the specific topics discussed here today.

Again, thank you for the opportunity to present our views today, and we look forward to further reviewing this most important issue. Thank you.

MS. LEWIS: Thank you. Our next presenter is Dr. Jim Gorny, International Fresh Cut Produce.

DR. GORNY: Hello again. My name is Jim Gorny. I'm the technical director for the International Fresh Cut Produce Association.

The International Fresh Cut Produce Association represents and provides technical expertise to commercial suppliers of fresh cut produce, as well as companies affiliated with the fresh cut produce industry, including equipment manufacturers, retailers and food service operators.

We represent over 500 corporate members who are actively involved in the $10 billion a year fresh cut business. I'd like to address the questions regarding what does the industry think fresh means, and what do consumers associate with the term fresh.

In the fresh cut industry, no definition is more important than the meaning of the word fresh. The International Fresh Cut Produce Association industry membership purposefully chose the word fresh cut which includes the word fresh to describe the products which they produce, because it clearly identifies and differentiates our products in the marketplace.

The International Fresh Cut Produce Association, which has as members both suppliers and buyers of fresh cut produce, defines fresh cut produce as any fresh cut fruit or vegetable or any combination thereof, that has been physically altered but remains in the fresh state.

These products are familiar as, but not limited to, items such as bagged salads, fresh cut carrots and broccoli florets. The fresh state of produce including fresh cut products means that the produce item is still alive, actively respiring and carrying out the metabolic and bio-chemical activities we call life.

With regard to our other quantifiable parameters which can define fresh, this point clearly differentiates fresh and fresh cut produce items from processed fruits and vegetables. Is it alive?

Produce which is alive and fresh will consume oxygen and produce carbon dioxide, but like we do. And common laboratory techniques are available to determine if produce is in fact actively respiring, alive and fresh.

Fresh and fresh cut produce, in essence, in deterioration have been traditionally delayed by the use of cold storage and/or modified atmosphere packaging. These slow produce metabolism and keep produce alive, that is to say, in the fresh state.

Do these new technologies preserve foods? New technologies such as pulsed light and pulsed electric fields may have applications in the fresh cut produce industry, to reduce the risk of contamination by human pathogen.

But these new technologies do not reduce the primary cause of produce deterioration which is tissue aging, -- and death and thus, they do not preserve the foods per se.

High pressure processing technologies are not applicable to the fresh cut produce industry, as these technologies rely on a processing method which not only kills potentially harmful micro-organisms but in the process of doing so, also destroys the ability of fresh or fresh cut produce to remain alive and actively respiring.

The IFPA is not opposed to the use of emerging new technologies to improve quality or enhance food safety. We encourage our membership to continue development of new products and technologies so long as the finished products are labeled appropriately.

Produce must be alive and respiring in our opinion to be labeled fresh, and marketed to consumers as fresh or fresh cut produce. If this criteria is met when new technologies are utilized, then no new labeling requirements should be imposed.

More labeling may actually confuse consumers by implying that there may be a problem, safety or otherwise, with labeled products where no problem exists.

Fruits and vegetables which have been processed by new and/or emerging technologies which do not leave the produce items alive and respiring after processing could be termed minimally processed but not fresh.

The word fresh and fresh cut clearly and poignantly relays the message to consumers that the produce item is alive in a raw state and it has not been cooked, partially cooked, frozen or treated with chemical preservatives.

To determine whether or not fresh or fresh cut produce, the FDA need only place one criteria on these products. Is the product alive and respiring? If so, it should be allowed to be labeled as a fresh produce item.

Fruits and vegetables which do not meet this criteria and have been processed with non-thermal technologies and may appear to consumers to be fresh could be termed minimally processed or some other term to prevent confusing consumers.

This term has appeared in the scientific and trade publications ostensibly, to describe a number of the technologies which we are reviewing today. This term would make it clear to consumers that the product that they are purchasing has been processed and it is not in the raw state.

With regard to the economic impact, the fresh cut industry has flourished because consumers can clearly differentiate and actively choose fresh produce items, unaltered from their fresh state, that are flavorful, nutritious and convenient.

The IFPA believes that the term fresh in product labeling must be reserved only for produce that is in a fresh state, that is still alive and respiring. We oppose attempts to confuse consumers over these matters.

The economic consequences could be dire to our industry if consumers are unable to differentiate between alive fresh cut produce and products processed with new technologies, which do not meet the criteria of being alive and fresh.

In summary, the IFPA, the International Fresh Cut Produce Association supports the use of new and emerging technologies that may more effectively maintain or enhance quality and/or safety of fresh produce products.

We also, however, believe that fresh and fresh cut produce are unique food products and the use of the term fresh must be reserved for fruit and vegetable products which meet the criteria of being alive and respiring.

I would hope that the information that I've provided with was informative. I'd like to thank you for having the opportunity to communicate with you the IFPA's views on this matter. And our written comments will further amplify our views on whether or not the regulation requires amending. Thank you.

MS. LEWIS: Thank you. Next is Dr. Jur Strobos, The Fresh Juice Company.

DR. STROBOS: Good morning. I was thinking that since you're running so far ahead of time, I'd try and get us back on schedule.

(Laughter.)

DR. STROBOS: I was given the opportunity to supplement the remarks. My name is Jur Strobos. I'm representing the Fresh Juice Company. And I basically just wanted to make four comments relating to the questions you've asked.

The first relates to the fact that we think that fresh citrus juice represents a special circumstance. I think we've heard before from other players that there are different issues with regard to different products. And I think I'd like to make three points with why fresh citrus juice represents a somewhat unique circumstance and the word should be defined carefully or approached carefully in that context.

The first is that in 1998 FDA promulgated a rule, labeling rule applicable to fruit juices and that either basically requires the juices to be pasteurized or if they are not pasteurized, to bear a 5-log, demonstration of a 5-log reduction in pathogens or be labeled with a warning label.

To my knowledge fresh citrus juice is the only commodity within this, covered by this rule that is currently been able to demonstrate the 5-log reduction and therefore, the meaning of fresh within this sub-category of juices should be preserved and uniquely made available to the companies that are able to do this 5-log reduction.

The second reason is somewhat related to that, and that is that in May of 1998 FDA promulgated or published a proposed rule relating to a HACCP program relating to juice products.

And most recently, in December of 1999 the National Advisory Committee on Micro-biological criteria for food evaluated basically the special circumstances applying to citrus juice. The focus of the meeting was largely on the impermeable nature of the peel and to a certain extent the ability to use the processes that we've talked about here today in terms of waxing and cleaning the surface of the fruit without affecting the interior juice, and then to be able to extract that juice, engaging no post extraction process and produce a safe pathogen free product.

Why is that relevant? I think it's relevant because one of the reasons that we're here today is to address these new technologies. If we are going to adjust the meaning of the word fresh to encompass new technologies, I think we have to have some sort of public policy to say why we would want to do that.

These new technologies are apparently designed to reduce microbial content of food products, and to the extent that microbial content or pathogen content of fresh citrus juice is not an issue, then I think the question as to whether or not we need to address the issue of fresh in the context of citrus juice is really off the table.

And the National Committee on Micro-biological Criteria Food did virtually unanimously vote that it was possible, fairly easily to make safe fresh citrus juice using the 5-log surface treatment reduction.

I think the third reason why citrus juice is a unique situation relates to these previous two; and that is that, as John Martinelli has talked about before and Peter Chaires has mentioned earlier, the creation of these two rules and the development of the State of Florida HACCP program has created an industry that provides fresh citrus juice for the consumers who want that juice.

If it were to turn out that you could process juice, make it microbially free, as it were, and then still label it as fresh, I think we would see the demise of that industry. And that's fairly easy to realize.

In other words, if we are spending has much time and effort and attention to the detail that we do, as was presented at the National Advisory Committee, to insure that the juice is pathogen free with no post extraction treatment, obviously a company that does not take that care and consideration in the juice product and then engages in some post extraction processing in order to eliminate pathogens, is going to be able to produce a product that is less expensive.

If they can produce a product that is less expensive and nonetheless sell it with a label that's distinguishable, I think you can see why the industry would be eliminated.

I'd like then, moving to that, to go to the issue raised by FDA with regard to organoleptic characteristics. It's clear that taste is important criteria with regard to fresh juice. I think there are other criteria which I will go into as to why consumers want fresh citrus juice.

But I also believe that there's some confusion, at least some confusion in my mind between the concept of taste, organoleptic tests. It is possible to train individuals to detect particular flavors, for instance, the flavor of trymetholomene which is the particular flavor that comes from spoiled fish.

And one of the panelists, one of the previous speakers talked about having trained testing panelists. I think the concept of having organoleptic test, however, and taste is a very different concept. And the reason has to do with the physiology of taste and the sayings, as they go, that there's no disputing taste, that everyone has a different taste.

There's actually a physiology behind that. Taste buds and olfactory senses are genetically controlled. Each individual has thousands of these olfactory and taste sensors. The binding characteristics, the distribution of those sensors and whether there are particular sensors for particular chemicals varies not only to individuals, but varies in an individual over time, which is why of course our tastes change as we get older.

That means that if you take an organic product that is as complex as fresh citrus juice, you may be able to measure 30, 40, 20, 10 of the particular odorificants that come out of that juice, but there's no way that you're going to be able to assess all of the odorificants because, frankly, they're not all known.

And the taste is very complex. My point is that organoleptic testing is an objective. In other words, whether or not a particular flavor has, you know, that particular chemical flavor has been maintained is an objective test. The taste itself is a subjective test.

And no one person can taste a substance, organic substance and say that product has not changed in taste, and have that statement be applicable to someone else's taste. There have been many efforts, we're going to submit additional data on this, but there have been many efforts to try to categorize taste and olfactory senses.

What's interesting about them is that the most major effort was done by an individual named Henning who used some 400 different flavors and created a table and using many different people and he was unable to basically validate the test, the testing prism, Henning's prism, any new subjects.

So I think we need to recognize that taste is very individual and I think it's just inconceivable that with regard to fresh citrus juice you're ever going to be able to demonstrate taste identity for every consumer that is interested in fresh citrus juice.

The third issue relates to what FDA mentioned as quantifiable, other parameters. And again I think we're dealing with the same issue, the content of fresh orange juice has thousands of different chemicals in it. To look at a few chemicals and say that they have been maintained is basically not the question that people want to know.

And I have some concern that the taste or the quantifiable parameter maintenance is going to relate only to, let's say, the nutrients that are listed in 21CFR101(9)(C). When, as we've heard today, there are other issues with regard to these products that are extremely important.

We've heard about enzymes today, and the need to maintain enzymes. We've seen that some of these new technologies that apparently don't affect some flavors, do in fact effect enzyme content. And I think that maintenance of enzyme content and the maintenance of that enzyme activity is also one of the benefits that people see in fresh citrus juice.

Let me give you an example actually of FDA's own regulations. There are three health claims that relate to fruits in FDA, in the Federal Register. One is at 101.78, one is 101.76 and the other is 101.77. They relate to the protection from cancer and heart disease.

FDA states specifically in these rules that the specific roles of the numerous potentially protective substances in plant foods are not yet fully understood. That was some time ago. We're dealing today with a time period where I don't think that science about what we know of the contents of fresh orange juice and their healthful effects are totally clear.

Since my time is up, let me just mention one other thing. And that is the perishability that was mentioned before. I agree with Dr. Sizer and Dr. Quass that what consumers understand a fresh juice product to be is one that is perishable.

When the product has lost its perishability it's not fresh and we believe that a fresh citrus product should have freshness dating and that that would be consistent with what consumers understand.

To conclude, we think the word fresh as applied to fresh citrus juice, should apply only to juice that has undergone no post extraction processing. Thank you.

MS. LEWIS: Thank you. Our next scheduled speaker is Dr. Sevuga Palanippan from the Minute Maid Company.

DR. PALANIPPAN: Good morning. I was worried about catching the 6:15 flight and now I'm worried about getting an earlier flight.

I'm Sevuga Palanippan, manager of technology innovation at the Minute Maid Company. At Minute Maid we are evaluating alternate process technologies to produce good quality fruit juices.

The purpose is to avoid thermal degradation of sensory and nutritional quality, and at the same time, I emphasize this, at the same time to assure food safety.

One of the ways to let consumers know that the products possess fresh quality, is be labeling the product fresh. Labeling fresh would help these innovative technologies benefit consumers in terms of food safety and quality, the benefits of some of these new technologies that we study.

There is a long list of nontraditional process technologies in the FDA study report. Some of the alternate process technologies with no or minimal thermal components include pressure technologies such as high pressure, pressure and CO2 treatment. Dr. Sizer mentioned that technology; pulsed electric field technologies such as pulsed electric field, arc discharged, light technology such as pulse light and ultra violet, irradiation, pulsed X-rays and oscillating magnetic field.

Microbial effect of nontraditional process technologies has been the major focus of many of these studies in the past ten years. Some of the alternate process technologies inactivate micro-organisms with minimal or no thermal component. That's been established and well documented.

Effectiveness in pathogen destruction is well documented in the literature. Micro effect has been studied in high and low acid foods and there is articles available on the subject. It is possible to obtain the minimum log reduction on pathogens such as suggested by the National Advisory Committee on Micro-biological Criteria for Food.

Thus, the new technologies can assure food safety without any thermal degradation of food quality. Speaking of food quality, let's get into nutritional and sensory quality of products processed using these new technologies.

We've done extensive studies on nutritional and sensory quality of some of these alternate technologies. The key issue is the capability of these technologies to preserve nutritional and sensory quality of raw products.

Extensive work has been conducted on citrus juices in recent years, not just by Minute Maid, but by other researchers and universities and research institutes. We have data that suggests the following.

The peel of juice undergo bio-chemical changes similar to untreated juice. Lab tests show no difference in nutritional quality compared to raw juice. Enzyme activity in juice separation is very similar to untreated juice.

Consumer panels found no significant difference in taste, aroma or appearance as compared to raw fresh juice.

Okay. Ultimately consumers are the judges. It boils down to consumer benefits. Implementation or commercialization of the ultimate process technologies depend on real consumer benefits. Some of these innovative technologies deliver tangible benefits to consumers.

They are, one, juice that is safe, are pathogen free. Two, juice that retains its original sensory properties. Three, juice that retains its nutrient composition. Four, juice that is less perishable than raw. And fifth is the juice that is produced is significantly improved, product integrity than raw juice.

The conclusions I have from our fruit juice research are the treated fruit is fresh. Why is it fresh? Because is not frozen. It is not heated. It is not chemically preserved. And it's not different from untreated juice in terms of physical, bio-chemical, nutritional and organoleptic properties.

Our interpretation of current fresh definition is the following. Current fresh regulation is adequate and it fits the products treated using some of these alternate process technologies that are coming up.

However, clarification is needed on unprocessed because juice is a result of processing fruit. It is naturally available. In conclusion, I would like to end my presentation by stating our position that any food treated to kill pathogens without heating, freezing or chemical preserving or affecting sensory and nutritional qualities should be fresh.

I thank FDA for giving me a opportunity to present our views on fresh claim for foods treated with nontraditional process technologies. Thank you very much.

MS. LEWIS: Thank you. Next is Harriet Adams from Juice Tree.

MS. ADAMS: Good morning. My name is Harriet Adams and I'm vice president of marketing for Juice Tree, Incorporated. Juice Tree manufacturers commercial juice that extract on site by supermarkets and juice bars.

And my comments of course then will address the fresh juice industry. It is in Juice Tree's interest to speak on behalf of the retailers who squeeze fresh juice on site of sale. And also their consumers who want to purchase that fresh juice.

We've heard this morning several times the definition of fresh, and what I think most of us agree is the definition of fresh, just by the very fact that we're talking about, it tastes like fresh, it looks like fresh, knows in our mind that we know what that means.

And also Webster's definition of fresh as being newly produced, gathered or made and having its original qualities unimpaired.

It's been Juice Tree's position for a long time and continues to be that currently there is a certain amount of confusion in the marketplace about fresh squeezed juice. A lot of processed juice that is unpasteurized is not what we consider to be fresh juice.

Juice that is squeezed in one location, put in a tanker, shipped thousands of miles, blended with other juices and then shipped again hundreds or thousands of miles in our view does not meet the criteria or the definition of fresh.

It's our condition that the time from squeezing till the time of consumer purchase should be a consideration in the definition of fresh squeezed juice.

And if the new technologies in any way, any way, change the original qualities of juice, the juice cannot then meet the definition of having the original qualities unimpaired. The general public believes that fresh or fresh squeezed descripters for juice are juices made from quality fruit, squeezed on site and sold within a very limited period of time, probably 24 to 48 hours.

Juice prepared on site of sale meet the criteria of the generally accepted definition of fresh. Consumers want and deserve a way to identify foods that taste and look fresh but have been processed in any way.

The purpose of labeling regulations is to give information to the consumer for making an informed choice. When information is withheld the consumer no longer has that choice.

I don't know, we've talked about the milk being called fresh. My milk is labeled pasteurized on all the cartons of milk that I purchase. It does not say fresh. It says pasteurized.

We label with nutritional information. We label now fresh juice with warning information. We label if food has been pasteurized or frozen. Why would we not tell the consumer if the food has been processed with any other kind of technology?

The consumer wants to know and I believe the consumer has the right to know.

And just as pasteurized or frozen describe a technology or process that are understood by the consumer, they may not know the details, but they understand essentially what pasteurization and freezing of a product does.

Terms for foods processed with the new technologies should describe the technology or process in some way so that the consumer has an idea that there has been some treatment of that juice. And it would just be incumbent upon the users of the new technology to educate the consumer, to understand the new terms, to give the consumer the information so that they can make, in fact, an informed choice.

Allowing the term fresh on foods processed with technologies place small firms not able to use technologies at a great economic disadvantage. In fact, I think it threatens their survival.

Those providing consumers with truly fresh products, not products that taste like fresh or look like fresh, would be placing them at an unfair disadvantage. They would have no way to differentiate their products. They would be forced to compete with products that are allowed to be marked as the same, when in fact they are not the same.

As it relates to fresh orange juice, Juice Tree respectfully requests the FDA leave the definition of fresh alone. And not allow that the definition of fresh be changed so that the consumer can be either mislead or misinformed. Thank you very much.

MS. LEWIS: Thank you. The next scheduled speaker is John Vechdhuis from the Florida Citrus Packers.

MR. VECHDHUIS: Thank you. I'm John Vechdhuis from the Florida Citrus Packers. The Florida Citrus Packers, fresh citrus, represents about 70 million cartons from the State of Florida. I'm also the general manager of a co-op that's been in business since 1906, 94 years.

We pack fresh fruit. We have shipped it to our customers for a long time. And it is my understanding that a good deal of our product was squeezed and consumed as fresh squeezed juice.

As times have changed and people are looking for a different sort of product, so easy to eat, fresh cut, fresh peeled, fresh squeezed, there have been a lot of people that have gotten into the fresh business.

We have proved ourselves over time has having a very unique product. Fresh citrus is very unique, very complicated.

I support the position that FDA has now in describing and defining fresh. I am concerned about what I've heard today. I'm overwhelmed by what I've heard today, all this new evolving technology. But I've not yet tasted a product, seen a product, felt a product, I think to change things right now, to allow some of these products in as fresh is premature.

It may be a long time premature. I think we need a lot more research. I would encourage these gentlemen with all their new technologies, but I think that we need to go slowly. I think it would really harm the consumer by messing up his conception of what fresh is, if we just allow it.

Now, again, I've never tasted it. Maybe some of you have. But I think some more research, time and duplication of research is necessary to then award a title as precious as fresh. Thank you.

MS. LEWIS: Thank you. Our next scheduled speaker is Don Bowden, Avomex.

MR. BOWDEN: My name is Don Bowden. I'm with Avomex and we're in Texas. We've had a high pressure facility in Mexico doing guacamole and other avocado products and various products for four years.

We've had a plant in Mexico doing avocado products for ten years. And basically I want to read you a letter that I got from a customer named Pancho's Mexican Buffet, that we have been doing their products for ten years. In the last year we have only started doing high pressure products for them.

Previously we peeled the avocados, packaged them in a package, pull the vacuum, delivered them three times a week. This is what we did. As of the 1st of the year, then we got enough high pressure equipment that we started -- we've always sold mainly guacamole and other things. But this is a pure product with nothing added to it whatsoever.

Pancho's Mexican Buffet, a reasonable restaurant chain of 50 locations has used Avomex brand avocado product for several years. The product is packaged fresh and shipped unrefrigerated to our distributors.

Then delivered twice a week to our various locations in refrigerated trucks. Recent product improvements have provided a significantly longer shelf life without the addition of preservatives or other ingredients. We consider this to be a fresh product which is used as ingredients in our kitchens.

I have been in Chicago for two days, going around to restaurants and basically we'll go into a restaurant. We'll take some of our pulp, we'll have them go to their kitchen and make some guacamole and we'll come out and try it, between the two. There's absolutely no difference.

So we think that at least ours, we don't want to argue with the juice people, we think ours should be able to be defined as fresh.

(Laughter.)

MS. LEWIS: Thank you. I can tell we're approaching lunch time. We're coming to the point in the program where we're getting close to lunch. But to be perfectly honest with you, we have two more scheduled speakers.

With your permission we'll go ahead with our last two scheduled speakers. The next one is James Curver from Selcor, Incorporated.

MR. CURVER: Being the 18th speaker, most of what I planned to say has been said. So what I'm going to do is comment on a few things that have been said by others, and then leave a lot of my talk out because there's no point in reiterating it.

Selcor, Incorporated, you saw a slide earlier in Dr. Sizer's presentation of an ultra violet system. We have developed an ultra violet system that is designed for juices and other fluid products.

And California Day Fresh Foods has submitted a petition for the use of this type of process to the FDA. It is under review by FDA at the present time.

Our ultra violet process I think fits the criteria for freshness as well as anything. I'm not totally familiar with every other process. But as far as retaining the original properties of the product unimpaired, which is the same dictionary definition I looked up, that on the nutritional tests, vitamins, fat soluble vitamins, water soluble vitamins, enzymes, we can't see any changes.

The organoleptic properties appear to be unchanged. We've tested on apple juice, orange juice, carrot juice, other mixed vegetable green juices, smoothies and goes on and on and on.

There's definitely a shelf life extension. It doesn't appear to change the characteristics of the juice. It does change the characteristics of the micro-organisms that come in with the juice or are incorporated into the process.

But they're not really supposed to be there. And so if you define them as part of fresh, then we have destroyed something. But essentially our original intent was to come up with something that would allow you to have a fresh juice and make it safe from a food standpoint.

I believe we've come very close to this. I believe some of the other technologies have done the same. I think to be able to solve this problem, if you really took a very pure definition of it, really the only thing that would really be fresh would be the juice bars, because there's a time element involved.

Things start to change chemically, immediately when the fruit is removed from the tree. And maybe even with the juice bar, the age of the fruit or vegetable that you use to make the juice.

I know apples and oranges are sometimes picked and stored for many, many months before they're juiced. And is this a definition of fresh? Because you're starting with a product that has been stored.

So it appears that some compromise has to be made in fresh. It's not going to be a very pure term, unless we do limit it just to something that has just been juiced and rushed to the consumer.

So our position is this. If objective criteria can be developed that are not too extensive and this could very well be the measurement of a few selected vitamins, and I think it's very important that they measure the enzymes.

And since there are a whole bunch of enzymes, perhaps acid and alkaline phosphates might be a good choice as a representative enzyme. If something simple could be done that can be measured without great cost, then I would be for the expansion of the term fresh.

If this can't be done, then I think we should stick with the way it is now. Thank you.

MS. LEWIS: Thank you. Mary Grace Sexton, Orchid Island Juice Company.

MS. SEXTON: I just wanted to clarify that I'm not representing the company. Mr. Martinelli did. I'm representing the consumer.

I have two beautiful children, and when I go shopping I want to know exactly how the food is handled or processed. And these new technologies, they're saying that they are blurring the term fresh. I don't think so.

I think the people are blurring the term fresh, because we know what fresh is. And if they want to bring on this new technology, everyone has a right, just like we had the right to go to the moon. But we as a consumer have the right to know how we're getting there.

Now, when you go in the grocery store it is extremely overwhelming for myself, and when I got into the produce department, I feel very, very comfortable that the fruit that is laid out there -- yes, an apple may be washed and waxed for storage. But I know it is fresh; it is not processed.

And I feel very comfortable that when I got in the produce department I see what I'm getting. I'm not a good public speaker at all. But that's what I want. And I know that the world is so big that I can't keep my child from every processed food, but if I know what is fresh, then I can certainly balance their diet to benefit, nurturing their bodies.

So I don't think -- new technology is a wonderful thing, but I do think that the honesty on the label is the most important thing. We as consumers have the right to know what has been done. Thank you.

MS. LEWIS: Thank you for your comments. That does conclude the scheduled speakers that we have for today. But of course, in the interest of an open dialogue, we would give anyone in the audience one last chance or for someone who hasn't spoken, if you would like to speak.

I know Dr. Sizer, you were a little bit short changed before. So given that we have some time, I'm sure we can accommodate you or others. We'll try to keep it in limits but again, we are interested in the dialogue. Dr. Sizer?

DR. SIZER: Thank you very much. I hope the technology bears with me on this. I think a lot of the speakers have caught the essence of what the issues are, that fresh is a very brief duration of time.

I had started on this. I think this really dramatically shows how rapidly you lose the fresh character of some harvested commodities. This happened over a period of six hours.

The interesting thing is we had the flowers out of the vase for three minutes before they were put in the water. They had drooped significantly in three minutes.

So the storage conditions also dramatically effect the length of time that you have a fresh product. Micro-biological growth limits shelf life of products.

Raw doesn't necessarily equal fresh, even raw juice will eventually spoil and is no longer fresh. So there need to be some definitions based on the micro-biological qualities.

The vitamin C content of products has been mentioned, and raw products also lose vitamins and sometimes at an accelerated rate versus processed product.

Enzymes perhaps produce the greatest change in products. This is a real dramatic demonstration of what happens with time. This is over a space of about six hours, and you can see that the different areas of the fruit with time start to brown. The top of the banana is turning black. The apple also has brown regions.

You notice some texture evolving as we lose water on the surface of the fruit, and likewise the banana has drooped now. So these changes are very, very rapid.

In conclusion, in nature fresh is defined as living plant or animal. Fresh is fleeting. Chemical, enzymatic and microbial deterioration limit quality. Fresh is subjective. It's a perception.

New technologies preserve the fresh character of food by inhibiting degradation. And there's a need for common agreement of what can be called fresh. Thank you very much.

MS. LEWIS: Thank you. Could I have a show of hands of people who would like to speak. We've got one, two, three, four. Dr. Strobos, you as well? Four.

Okay. If we can keep it to about three minutes. Please come to the microphone. Dr. Strobos, you can go first. Re-identify yourself to those who were not here this morning.

DR. STROBOS: Jur Strobos of the Fresh Juice Company. I just wanted to go over the perishability issue again.

One of the other ingredients I think that is present in fresh citrus juice is lactobacillus species. And while it's all very nice and good to create pathogen free products, I'm not so sure that the goal of the consumers who purchased our product are interested totally in a microbe free product.

Lactobacillus species, as you know, as used medically for people with resistant infections for which medical treatment isn't appropriate and those people are advised to look for fresh products that contain lactobacillus species.

If those consumers cannot be directed to food products that are safe, that are labeled -- if they cannot be directed to products that are fresh, that are known to contain lactobacillus species, but in fact end up purchasing products that are labeled as fresh but do not have lactobacillus species, they will not be getting what they're looking for.

I think the other issue with regard to perishability and freshness and the need for freshness dating on a fresh product relates to the fact that in fact a fresh product does change over time. And that's what people are looking for.

So a fresh product, unlike a preserved product, is one in which maintenance of the chemical constituency over time is more difficult to maintain and to certain extent therefore, consistency of chemical composition over time is a demonstration of non-freshness. Thank you.

MS. LEWIS: One of our other three, if you could identify yourself when you get to the microphone.

MR. SNYDER: My name is Paul Snyder. I'm the sales and marketing manager for Flow International. I had a few observations over the course of this morning.

First of all, fresh is a description of product quality. It's not a description of a process. The example was something that's a rotten piece of fruit that I pick off of a tree.

I don't think there are any consumers that would call that a fresh piece of fruit. Preservation or safety improvement techniques have not and should not preclude a definition of freshness, or we couldn't put bread into a bag.

Could we refrigerate a juice? Why do we refrigerate juices? Because we're trying to preserve them. Even if it's just for a day. The word fresh is understood by consumers independent of what has happened in between the time when a food product is first made available, compared to its state at the time of consumption.

It's a statement about a product's essence. Consumers are upset, not when they find out that a product has been processed in some manner. They're upset when they feel they've been mislead as to the effect of that processing.

Some technologies people are afraid of -- they're not afraid of them, because of the technology itself in most cases. They're afraid of them because their fear is that products themselves have been altered. I think that's an important consideration to the consumers.

A last thing that I'd like to talk about is the concern of the small producers that a change in the labeling of the word fresh might put them out of business. There's nothing to preclude a small manufacturer from putting on his label the way that he has not processed foods. So they could differentiate themselves from other fresh products by stating we squeeze this, then put it into a jar.

Nothing would preclude them from doing that. Thank you very much.

MS. LEWIS: Thank you. And we had two more. Okay. We're down to two minutes apiece. Please come to the microphone.

MR. DUNNE: Patrick Dunne. Technology failed us somewhat so I'd like to turn on a switch, I wanted to show a couple of pictures that speak to points other people made.

The one on the bottom is the first one. In New England -- Farms does put a big fresh label on their milk. They used to say natural, but they stopped using vitamin D isolated from fish oil, so they couldn't say natural anymore, even though it's a minute, minute component. So they changed their label and made a big hoo-ha about this in the last few months.

So you do see this out in the industry. The other thing, I snapped this out of the California Agriculture publication that you see Davis Ag extension puts out about commercial handling, influenced quality and brightening of Bartlett pears. It's an excellent article, and it tells you anything you do triggers certain changes in that fruit. So yes, they do respire, but there are other things that happen.

And the enzymes that cause the browning that Dr. Sizer so nicely showed, or perhaps a natural response of this plant to the injury. And people who process fruits make a living for understanding how to grow them in certain minerals, conditions that they'll handle their processing better.

I think we're going to come to that kind of understanding as we move the new processes. So we can control the enzymes that are deleterious to quality but we can retain those enzymes that may produce some benefit or perceived benefit for the consumer.

I will say some of the chemical additives and even pulsed light, it's all in the kinetics and you can see certain changes where the polyphenal oxidase sets the technical name for that browning thing. There's seven isozymes and it depends on a given fruit.

Some apples don't brown when you cut them very rapidly; others do. And the cutting injures the tissue and it separates the enzymes from where it's bound up away from other parts of the fruit.

So just starting that process triggers some physiology. And we're learning how to understand and control that, and I think that's where we're going to have better products. Thank you.

MS. LEWIS: We're down to two more. If you could identify yourself.

MR. BOWDEN: I forgot to mention that Avomex is a very, very small company. Avomex is the only company here with a high pressure facility, working today. So we say that it's a disadvantage to the large companies because of the new technology. It takes them too long to make a decision.

(Laughter.)

MS. LEWIS: You did it under 30 seconds. And the last speaker.

MR. ROBBINS: I don't know if I can follow that piece of logic. My name is John Robbins. I'm a registered professional engineer working primarily in the fields of chemical, physical and biological systems. I'm a process designer.

For the last few years I've been working specifically in citrus research in the development of new processes for treating pathogens. And like some of my colleagues here, I'm also a member of IFT's Non-Thermal Processing Division.

Just a couple of editorial comments and then a very specific comment. We're here for obviously to identify solutions to issues, from what I see, converging points of view.

The Surgeon General has stated that the best way to get us off of long term health care issue is to increase consumption of fresh fruits and vegetables, fresh fruits and vegetables.

Though, we've got incidents that are occurring in our treatment of our foods that are causing illness, and this has shown up in the case of a child dying from E-colli 15787. So it behooves us as designers to come up with methodologies for increasing the consumption of fresh foods. But also to make them safer.

And being a process developer I am personally aware that it's possible to treat the bug within a food product without necessarily altering the food product.

Case in point would be the requirement when a piece of citrus fruit passes the culling line after disinfection and no one spotted the micro imperfection in the peel that allowed the interior portion of that piece of fresh fruit to be interiorally contaminated and that condition is called black heart.

Anybody that's ever worked on a culling line has seen it. You split the fruit open with a fruit knife, the interior portion of the fruit is as black as the ace of spades, but a culler would never see it.

So the issues of post extraction treatment are a reality. We've got to come up with ways to treat the fruits and vegetables after they've been harvested and cleaned, otherwise we're going to wind up with things like -- coming off of people's hands in a culling line and entering the food product.

So there are methodologies out there. Some of them were identified in chart form. There are non-thermal techniques for treating the pathogenic organisms that are beginning to show up in our food systems. The technology does exist.

Whether or not the methodologies can be implemented will be as a result of the way the words are being allowed to be used. There are ways to product fresh juices by the application of technology without changing those characteristics that we call fresh. Thank you very much.

MS. LEWIS: Thank you. That was the last one. But I see we've got one last one that really will be the last one.

MR. ACUFF: I'll be real quick. I'm Gary Acuff. I'm a professor of food and micro-biology at Texas A&M University. So I come to this from a slightly different perspective.

I think everybody here agrees that consumers want product that has not been altered, and that's why we have all these terms like organic and natural and fresh, and that's what they're looking for.

And these terms have actually become a marketing tool. I think that one thing that I would like to make sure is that consumers know that none of these terms mean that the product is safe.

They mean that it's natural, organic or fresh. We need to make sure that we don't conveniently allow consumers to think that these terms mean something that they're not. Thanks.

MS. LEWIS: Thank you for your comments. I do want to thank all of the presenters for their time and their input. From my perspective, and again I am the new office director, I've been with FDA 16 years and I always find public meetings to be one of the best parts of my job, believe it or not.

So I do appreciate your time. I would not want the fact that today's program moved along rather rapidly, I wouldn't want that fact to belie our complete understanding that this is both a complicated and an important issue for the agency, for the manufacturers in the industry as well as for the consumers.

And we would like the opportunity to give it as much time and thought as is needed to basically do the right thing. I'm sure the question in many people's minds here and other places are what are the next steps for FDA.

What I can best point you to is the new set of program priorities for the agency. Each fall we sit down, and as a center for the food safety and applied nutrition, and we develop a new set of program priorities, the A list and B list.

And with limited staff and limited resources we focus first on what's on the A list and as time allows, what's on the B list. Fresh has been on the B list, and the question remains, I'm sure in your minds as well as ours, as to whether it will get pushed to the A list this fall.

In any case, meetings like this are very helpful to prepare the ground work for whatever action might occur. And in all honesty at this point, I'm not sure.

It's why we did have the meeting and why we're very interested in getting ourselves well grounded in the issues. So thank you again for coming.

I believe the meeting will officially be closed by our FDA person from Chicago, Ray Mlecko. I do want to thank all of you again for coming and Chicago for being an excellent host. Ray, I know you have a few closing remarks.

MR. MLECKO: Not really. In keeping with the pace of this meeting, I don't have too much to say, except I'd like to thank our colleagues from headquarters for coming here to give us the opportunity to present the views of the public.

And also I'd like to thank you folks in the audience. You've given us some really terrific input, and as a consumer and as a lover of orange juice, I've learned a lot here. And I can hardly wait until the new policies come out so I as a consumer will know what I'm getting.

Thank you very much for coming here and for giving us your input.

(Meeting adjourned at 12:10 P.M.)



This meeting was held on July 21, 2000.
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