U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition

Center for Science in the Public Interest.

DR. JACOBSON: We thank you for this opportunity to give you some of our views about CFSAN's priorities. I think it is a very sensible process for you and CFSAN to go through to get the opinions of the various parties that are speaking here.

One thing that is off the table, I guess, is the President's Food Safety Initiative. We just wanted to mention that we completely support that initiative as a top priority for CFSAN but do want to emphasize that CFSAN needs to carry out food inspection and food safety activities more effectively.

It needs more authority and it needs more money. We hope that CFSAN and FDA and the Administration will be working very hard to obtain that from Congress and will be working along with the Administration on that.

In thinking about how CFSAN should set its priorities, I think there are a couple of things that are clear. One is that the FDA is a public-health agency and it needs to look at the health impact, where can it get the biggest bang for its buck in terms of promoting health, saving lives.

It is also a consumer-protection agency. In areas that may not directly affect health, the FDA is charged with protecting the consumer's pocketbook. There, again, it is worth thinking about, what are the biggest problems, where is the most deception, where is the most economic harm.

Also, I think, there are some softer things that have to be mixed in with those two criteria. One is where can you actually have an impact, what can you achieve. Again, maybe the biggest bang for the buck, if something is easily done but is somewhat lower, you may want to do that.

Also, in terms of the public's interest in some issue; that has to be factored in somehow, that if consumers, if legislators, are bombarding the FDA with information about special concerns, that has to be weighed into the factor, into the decision-making process--not that the FDA should ever be weighing the number of letters that it is receiving on one issue or another, but I think that those beliefs and feelings need to be factored in somehow.

In terms of specific, I think improving nutritional quality of the American diet should be a top priority for CFSAN even though the FDA is not a nutrition-education agency.

According to a study conducted by HHS, the Office of Disease Prevention and Health Promotion, poor nutrition and lack of exercise account for between 310,000 and 580,000 deaths every year. That is in the same ballpark as tobacco, an enormous problem.

The FDA, CFSAN, should be doing everything it possibly can be doing to promote a healthier diet. That includes improving nutrition labeling. The most important change that should be made right now is to include trans-fat on the label. There is a consensus in the scientific community that trans-fat raises cholesterol in the blood about as much as does saturated fat.

Nevertheless, CSPI's petition to get better labeling has been languishing for four years. We and many academic experts have urged that trans-fat either be included as part of saturated fat or as a separate item within the nutrition label. But it should be an easy thing to do. There is a scientific consensus and we don't understand what the delay is. This simple move could save thousands of lives over the years.

Health claims is an important area that must be governed very carefully. The FDA should promptly approve well-founded health claims that would promote an overall healthier diet. The claims approved for high-fiber foods and high-calcium foods, low-fat foods and low-sodium foods, do exactly that. I think the public is benefitting from having that information on the label.

But CFSAN should not cave in to every company that markets oatmeal or cranberries or who knows what and allow the label to make that product look like it is a panacea for heart disease or some other ailment.

The FDA is saddled with a bad amendment to the law concerning health and nutrition claims but we support the FDA's tentative decision to require that all health claims be supported by significant scientific agreement. That decision should be codified in a regulation.

In addition, such regulations should specify that health and nutrition claims based on authoritative statements of other government agencies are limited to statements that were intended to constitute dietary recommendations. Statements made for other reasons or other purposes, such as in the middle of a scientific paper, could result in misleading label claims if they are pursued by industry and accepted by the government.

A third labeling issue is that many labels feature claims that can deceive people who are trying to choose more healthful foods. These deceptive labels are traditionally looked at as economic fraud but it is really health fraud, also.

For instance, some foods imply that they are made with whole grains, something we should be eating more of to possibly reduce our risks of cancer and heart disease. But, in fact, they contain mostly refined grains, white flour. Other labels imply that foods are made with lots of fruit or a pure fruit yet they contain small amounts of fruit or are made mostly with denatured fruit juices, apple juice or grape juice.

For decades, the FDA has said that it does not have the resources to police label claims that do not introduce a direct health threat. But such claims are still basically defrauding consumers and oftentimes cheating consumers out of the nutrients they think they are getting.

One product that comes to mind is 100 percent spreadable fruit. A naive consumer would think that it is actually 100 percent fruit. It isn't. It is mostly fruit juice, probably grape juice.

It is high time that the FDA made it clear to the food industry that deceptive claims are simply illegal. CSPI filed a petition in 1995 that cited numerous deceptive labels, none of which the FDA has stopped although public pressure stopped food companies from continuing some of those claims.

If the FDA won't stop deceptive claims, it should tell the public that it is not policing this area and then it should work closely with state officials who collectively might have the resources to protect the public. The FDA, also, obviously, should do what it can to stop outright adulterated products such as juices that contain no juice or honey that is not 100 percent honey.

Moving on to the area of dietary supplements, the FDA is burdened with a weak law that limits the agency's authority to protect the public from unsafe and misleadingly labeled supplements. The agency should build a record detailing the need for greater authority.

In addition, the agency should adopt a containment strategy that helps insure that problems with the regulation of dietary supplements do not spread to the regulation of health claims for foods or to the safety and efficacy for drugs. CFSAN should start by monitoring carefully the notifications of proposed structure and function claims and opposing questionable ones.

In the area of food additives, we are concerned about the rigor of FDA's approval process. Most additives serve little health purpose and are completely unnecessary to the food supply. Additives should be as close to perfectly safe as possible. However, at times, it seems that the agency has turned the law on its head. Instead of requiring the company to establish safety to a reasonable certainty of no harm, it seems that others are required to prove harmfulness.

Olestra and acesulfame K are recent examples, but, over the years, the FDA has bent over backwards to excuse problems with a variety of food additives. Also, with regard to food additives, we hope that CFSAN will defend the Delaney clause. That law is essential to protecting the public's health. Without it, industry toxicologists and statisticians will find all sorts of creative ways to prove that cancer-causing chemicals are actually quite safe.

As a subset of food additives, the FDA should carefully watch GRAS chemicals. The FDA has proposed reducing the scrutiny of GRAS substances by asking for just notifications accompanied by brief documentation. We think that that could be very dangerous.

We recently filed comments on one particular food additive that a company is using as a GRAS substance, a fat substance called salatrim, that we think poses some safety problems. But the acceptance of salatrim as a GRAS substance suggests how easy it is to market a chemical with virtually no FDA scrutiny.

If the FDA formally said, "We are not going to affirm GRAS petitions," I think you are opening the doors wide open to problem chemicals gaining easy access to the food supply.

On a somewhat broader issue, the FDA should reconstitute its Food Advisory Committee to increase its credibility. The committee has long been loaded with industry consultants and even industry employees. That committee should include many more bright and independent members whose top priority, as evidenced by their career history, is protecting the public's health. The committee must also include consumer activists to balance the industry activists who have routinely been members of the committee.

In the area of international affairs, we are concerned that the FDA is allowing trade concerns to supersede health concerns. CFSAN should be working hard to insure that the Administration's trade policies are consistent with the Food, Drug and Cosmetic Act, not the other way around.

Also, it should be seeking to further the objectives of the Act by advocating that safety and labeling standards be harmonized internationally in an upward fashion, not a downward fashion, to reflect the best, not the most mediocre, consumer-protection and public-health requirements from around the world. That clearly is going to be an area of greater and greater interest.

One thing that should not be a CFSAN priority is eliminating food standards. Consumers need those food standards. Much of the food industry supports those food standards. The FDA should not be wasting any resources to do any kind of systematic review and elimination of the standards.

Finally, we recognize CFSAN's financial constraints. I applaud you for discussing earlier today the financial bind that CFSAN has been in increasingly over the past twenty years. We urge CFSAN to seek additional funding, either through general revenues or by imposing registration fees on food manufacturers. Small fees can go a long way to raising tens of millions of dollars.

Over the last twenty years, as I believe you pointed out this morning, the Center has actually experienced a 20 percent decline in staffing. The public cares deeply about food safety and honest labeling and I think would clearly support a greater budget.

But CFSAN, the FDA and the Administration must make sure the public knows that CFSAN simply does not have the resources to insure a safe and honestly labeled food supply. I think your statement this morning is a good trial run, floating a trial balloon, about the limitations and resources, but it is the kind of thing that I think the Administration needs to make many more sales pitches on before many more cameras to get the word out to the public that CFSAN simply cannot do its job without further resources. So there; trying to get more money in your pockets.

MR. LEVITT: Very good. Thank you.

Bruce, do you have anything prepared to add?

MR. SILVERGLADE: No. I am just here if there are any questions.

MR. LEVITT: First of all, thank you for coming today and for having a nice list for us to work with. Let me start with the whole area of health claims and notifications that you mentioned there. I want to be sure I heard it right. You said, Mike, that the health claims that we had approved so far, by and large, were good ones. Are there additional ones lurking out there that you think deserve greater attention than we have got?

DR. JACOBSON: We haven't been thinking about that. It is the kind of thing that would be well for us to think about. But when you consider the major dietary problems in this country are too much fat, too much saturated fat, too little fiber, too much sodium and so on, clearly the ones that the FDA has issued are very important ones and ideally would be used much more by the food industry.

MR. SILVERGLADE: I think the point we are trying to make on the original health claims is the first eight or nine, depending on how you count them, were general claims about generic dietary patterns that Americans should follow for better health. The last couple of approved health claims dealt with oatmeal, essentially one type of food product.

The most recent amendment dealt with psyllium and there is only, to our knowledge, one nationally available brand-name food in the United States that contains psyllium, a brand of cereal. What we disfavor, and I think most of the public-health community disfavors, is that approval of health claims for specific food products.

That is not what we believe the law was intended to facilitate and we believe that that is not the best way to assist consumers in improving their diets because a consumer will benefit by a health claim, for example, discussing fiber and heart disease if it is a general claim that could be used on many food labels rather than a specific claim that can only be used on one brand name of food because it would be more sources of fiber for them to consume.

DR. JACOBSON: Advertising Age recently made fun of the oatmeal claim which is being used in Cheerios ads and I think Cheerios labels where the ad says if you eat three bowels of Cheerios a day, you can get a 4 percent reduction in cholesterol levels. It says, "Well, how many people are going to be eating three bowels of Cheerios every day of their life to get that kind of a minimum benefit?"

MR. SILVERGLADE: On the other hand, the agency, since 1993, has had an improved health claim for diets rich in foods containing soluble fiber, and that could be cereal and many other foods. That type of generic health claim gives consumers a better education in nutrition and how to improve their diets as opposed to steering them to one type of food.

MR. LEVITT: The second question; international. this morning, we heard a lot of interest in the international area for some industry representatives. In addition to your general statement of we ought to use the international area to harmonize up and not down, are there any specific kinds of international goals that we ought to be pursuing affirmatively?

MR. SILVERGLADE: I think, within the Administration, FDA needs to be a spokesperson for public health. The whole drive behind international harmonization are trade concerns. In the U.S., that means increasing our agricultural exports and making it easier for companies to do business across borders.

That may be fine from an economic standpoint but it has nothing to do with FDA's public-health mission. FDA needs to be there as a break on the process to say, "Wait a second. We have to put public health here, if not first, at least equal to trade concerns."

Frankly, other agencies within the Administration, such as the Environmental Protection Agency, have been a better advocate than FDA. EPA representatives come to Administration meetings, intergovernmental agency meetings, and they speak up on behalf of consumer and public-health concerns more than FDA.

On the other hand, of course, you have USDA which is just totally advocating increasing exports as represented by the Foreign Agriculture Service, and so forth. So we hope that FDA is a strong voice within the Administration for public health.

The other point I would make is that now that we are in a global economy, and there is no question that we are, and now that we are bound by international agreements to harmonize regulatory standards in the area of food regulation, this presents not only a threat but an opportunity because if we are going to go about harmonizing regulatory requirements, we can go up or down.

We can look for the lowest common denominator and say that is the common level and that is what the international standard will become, or we can shop around the world and say, "Various countries have interesting regulatory requirements that may protect their consumers better than we are currently protecting American consumers," and these other requirements for other countries might serve as a model for the United States.

While our current requirements may not be that high, we should raise our requirements and advocate the stronger requirements to become the international standard and a model for the U.S. Certainly, in the area of dietary-supplement regulation, it is a clear example.

But, unfortunately, FDA personnel go to international meetings such as those of the Codex Committee on Nutrition and advocate the current dietary-supplement law in the U.S. While we have to follow that law in the U.S., nothing in that law says that we have to advocate that internationally, that FDA has to advocate that internationally to facilitate trade. So that is a good example.

MR. LEVITT: Let me share some time with my colleagues.

DR. CARNEVALE: I guess I will stay on the international area for just a moment. I appreciate your sending me the recent CSPI report on food labeling where you actually did a comparison of food labeling approaches in other countries compared with that of the U.S. It is actually a quite interesting analysis so there is some free advertising for your report. That is just a comment.

I also would wish that, perhaps, you could elaborate a little bit on a statement that you said right at the beginning where you said that consumer interest should weigh heavily on what we do at FDA. And then you added the caveat that it should not be based on numbers of letters received.

DR. JACOBSON: I didn't say weigh heavily. I just said it should be factored into a priority setting.

DR. CARNEVALE: If you could elaborate a little bit.

DR. JACOBSON: If you have millions of people concerned about something and some number of members of Congress, perhaps, I think it is something that deserves to be looked at even if it didn't show up on an intra-agency list of the ten highest priorities and I don't know of a specific example of that.

DR. CARNEVALE: Let me put it a little more in context. This morning, we heard a fair amount about setting our priorities based on risk, risk-based priority setting. I guess I am interested in how you see this compared to that type of priority setting.

DR. JACOBSON: I think the health impact of something should be the top priority. And then economic impact should also be considered, economic impact on consumers should be considered as a major priority. Maybe the agency would come up with ten priorities based on that but if the fifteenth priority is something that millions of people care deeply about, are affected by, but it is not--I don't know; reactions to MSG, perhaps. I am not sure if that is a great example but it is something that wouldn't be in the top ten list of health threats or economic problems to consumers.

But if you had tens of thousands of people writing to the agency saying, "This is something you have got to deal with; it ruins my quality of life even though it is not sending me to the hospital," then I think that needs to be factored in. Maybe it needs to be pushed up to No. 13. I am not sure.

But it is something that if you have a mob at walls of FOB-8, you should pay some attention to the interest in the consuming public.

DR. BAILEY: I would like to ask a quick question about the Delaney clause. There is quite a differing opinion in the scientific community about where we are in understanding mechanisms and how we can make decisions and apply risk assessment. It is beyond my knowledge of it to comment on the science, but I would like to ask, do you see a framework where Delaney could be altered and still preserve the important public-health decisions that need to be made.

DR. JACOBSON: It might be. I could envision something, a chemical that causes cancer in rats, through a mechanism because the rat has an enzyme that converts the chemical, an otherwise safe chemical, into a carcinogen that humans don't have and it simply could not cause cancer in humans.

If it were demonstrated that that is the only mechanism by which it causes cancer in rats that that would suggest that there could be an amendment saying that if the animal studies, whatever studies, are irrelevant to human concerns with a very high burden of proof, then that could, conceivably, be an appropriate exemption, adding that to other exemptions from Delaney.

But converting Delaney into a risk assessment, there are a lot of creative statisticians out there who will always find some way to meet the one in a million, or whatever number you want to choose. So the Delaney Amendment doesn't always make scientific sense but, as a public-health protection, I think that it has worked reasonably well and it sends a signal to industry and to the administrators that health is the top concern that if a food additive, a generally unnecessary chemical, introduces any risk of cancer, it shouldn't be tolerated.

We haven't addressed cosmetics at all, and I don't know if anybody out there today or tomorrow will be addressing it, but I think it is unfortunate that the laws are not stronger. The burden is so heavily on the FDA to find problems and then get rid of them.

There was a nitrosamine problem twenty years ago, fifteen years ago, with awesome levels of nitrosamines in cosmetics introducing a cancer threat. Ideally, FDA would seek stronger legislation. This is not the most propitious time for that. We probably have to wait for a crisis but I would like to build up your little division, also.

DR. TARANTINO: Your comment about the GRAS notification; I know we have your comments, but I wanted to make sure I knew what you had said today. It sounded as though you were suggesting that we ought to maintain GRAS affirmation as such. I suspect you are aware, and this is about priorities--I know you are interested in our spending more time looking at food-additive reviews and that one of the problems with the process that we have now is it probably has discouraged people from coming to us because of affirmation process, the rulemaking and such, has taken so long.

One of the notions of notification was to get more folks in to us so that we would know more about what is in the market. When you say affirmation, are you proposing the system as it exists now with the rulemaking or are you really talking about scrutiny no matter how it takes place administratively?

DR. JACOBSON: I think these chemicals need scrutiny. So far, there really hasn't been a great deal of scrutiny. I think the FDA may be acknowledging resource realities by saying, "Just let us know and we will track you down if we don't like it."

But, in a way, that is an invitation to companies to go the GRAS route rather than the food-additive route. I certainly could envision Procter and Gamble having done that with olestra, saying, "It is not absorbed; it is safe." So things kind of work both ways.

In terms of companies informing the FDA of what they are using without the FDA's knowledge, maybe there are other ways to do that. But one certainly would like to know.

DR. TARANTINO: Thank you.

MR. LEVITT: I have one more question and then just one comment after that. My question, and I asked this a couple of times this morning, a year from now, if we reconvene a year from now, if you could identify maybe two or three maybe medium-sized boulders that it would be nice, a year from now, to see done or merely complete.

DR. JACOBSON: Trans-fat labeling is an easy one. As I understand, CFSAN was supposed to be doing something on that, but just nothing happens, it seems. It should be easy for the FDA to find, and if FDA can't, we can help, half a dozen deceptive labels. You should hold a press conference with those products explaining to the public and the food industry why the labeling is deceptive, choosing examples that represent, perhaps, larger issues than one obscure type of deception. In our 1995 petition, we gave a few examples like that .

MR. SILVERGLADE: I would just add final rules on the new health claim notification procedures under the Modernization Act that require that new notifications be immediately placed on the public docket. We understand that that is going to be the practice--the FOI office told us that is going to be the practice but we would like to see that codified by regulation.

Final rules on obstruction function claims for dietary supplements. And, just, again a word in international issues, that every time the President says that he will protect, or seek to protect, labor and environmental concerns when negotiating trade agreements, it would be nice if he said, "Labor, consumer and environmental concerns," including FDA's work.

DR. JACOBSON: One last one would be reconstituting the Food Advisory Committee.

MR. LEVITT: This may not be exactly the same point you were mentioning but the Food Advisory Committee has membership renewals and about a third of the people rotate off about every year. I just gave certificates to seven people which means we are in the process of recruiting and identifying. So if you or other people in the audience--I'm sure you know the process and announcements, but as long as it is raised, I want to be sure that people know there is any opportunity to suggest names.

That is the best way, for people that want us to try to think of different places and different kinds of expertise, by all means, give us specific names so we can follow up on it and evaluate.

With that, let me thank you very much for your participation. Again, I hope that you are able to stay and hear some of the other speakers as well. We will welcome any additional specific written submissions for the record. We are going to hold that open for 30 days.

Again, we thank you very much.

DR. JACOBSON: Thank you.

MR. LEVITT: Our next panel is going to be devoted to food-additive issues. We have a representative from the Enzyme Technical Association, a representative from the Calorie Control Council. And we have an additional representative not on your printed agenda from the Alliance of Food Additive Producers.

If my notes are right, I have Nancy Zeman and Richard Cristol and Pamela Graves-Moore. Let's just start with Nancy and we will move right down. We are giving you about seven or eight minutes for presentation. If you start going over, you will see a little sign held up right there in front of you.

Enzyme Technical Association

MS. ZEMAN: Good afternoon. I am speaking on behalf of the Enzyme Technical Association. I would like to thank you for the opportunity to present the views of the ETA with respect to the program priorities for CFSAN.

ETA is a trade association composed of the majority of enzyme manufacturers and distributors in the United States. As such, ETA members are directly affected by the priority decisions that are being discussed here today.

ETA recognizes that the center faces many difficult decisions in the coming months and years. Obviously, as was pointed out in the Federal Register notice announcing this meeting, funding and resources for the President's Food Safety Initiative is a top priority for the center.

However, in addition to this important initiative, ETA would like to point out four additional areas that demand immediate attention and provide the center with an opportunity to complete programs that will benefit both the public and the food industry.

First, the center should conclude its review of GRAS Petition 3G0016 which recognizes the safety of a number of enzymes. The GRAS 16 Petition was accepted for filing by the agency in April of 1973, over twenty-five years ago. The petition seeks GRAS affirmation for a significant number of enzymes that are used in food products today.

While the enzymes from animal and plant sources have been affirmed as GRAS, there is no final regulation for the remaining enzymes. The GRAS 16 Petition is the lynch pin for much of the food biotechnology industry. The source organisms and the enzymes listed in the petition are the basic building blocks of biotechnology.

Furthermore, any safety concerns related to these organisms and enzymes have been resolved long ago. All that remains to be done is the publication of the applicable GRAS affirmation regulations. At the recent Food Update '98, you said that you wanted to abandon the center's traditional method of trying to push thousands of tiny pebbles up a mountain and, instead, focus the center's efforts on programs that can be accomplished in a timely manner.

You spoke of getting a few boulders up and over the mountain. We feel the GRAS 16 Petition is one of the those boulders that should have been cleared a long time ago.

Another program that needs to be pushed over the mountain is the GRAS notification regulation. The regulation is currently in the proposed stage and needs to be made final. ETA is not alone in its frustration over the current GRAS affirmation petition process. The system has been a dismal failure. Not only does it keep new and safer food products off the market, the current system has an adverse effect on food safety.

One of the questions asked in the Federal Register notice announcing this meeting was whether there are any issues that directly affect consumer safety that are not being adequately addressed. We believe that the failure of the GRAS affirmation process falls in this category.

The resource-intensive GRAS petition process needs to be replaced with a more streamlined notification system so that vital agency resources can be redirected to address food issues that are a priority with respect to public-health concerns.

In addition, a simpler, more effective, GRAS notification system would provide an incentive for manufacturers to inform FDA of their GRAS determinations. This would improve FDA's ability to insure safer foods by increasing the agency's awareness of the composition of the nation's food supply and the cumulative dietary exposure to GRAS substances.

The process would also allow BATF and USDA to improve their review of ingredients by providing the food industry with an FDA statement on the ingredients instead of delaying the review while securing an FDA consideration. A final GRAS notification would go a long way towards fulfilling these vital needs.

Finalizing the GRAS notification process also help address many international concerns. International marketing is hit particularly hard by the failure of the current GRAS affirmation process. It is difficult for manufacturers to globally market even unquestionably safe products under a self affirmation. And, as we noted earlier when discussing the GRAS 16 Petition, they can wait a quarter of a century for an FDA affirmation of GRAS status.

By finalizing a GRAS notification regulation that provides a public statement of FDA's acceptance of notifications, the agency could, with one easy step, provide the public with a vastly improved and safer food supply.

While commenting on the notification process, we also encourage FDA to add the notifications to its Internet website, similar to what is being done for biotechnology products.

Our third recommended top priority is the continuation of the center's final consultation program for biotechnology products. Since 1994, developers of biotechnology-derived food products have been encouraged to submit summaries of their safety and nutritional assessments to the FDA.

This provides the FDA with important information concerning what products are being produced and gives the agency a chance to address issues before new products are marketed. The FDA's biotechnology system has been very successful. This is, in part, due to the center's use of new technology. For example, a list of products that has undergone the final consultation process is maintained on the FDA's Internet web page.

This is helpful both to the biotechnology community and the general consumer. Up to this point, FDA has recognized the vital role that biotechnology plays in assuring a safe food supply for an ever-increasing world population. ETA would like to encourage the agency to rely on science rather than emotion when addressing the issue of biotechnology-derived foods.

For example, several special-interest groups recently filed a law suit against the FDA claiming that the agency should require special labeling on genetically modified foods. The thrust of their argument appears to be emotional. They are attempting to stir up a public outcry by preying on an uniformed public's fear of new technology.

The FDA had it right when it published its policy on biotechnology in 1986 and, again, in 1992. With proper safeguards, biotechnology can provide a safe and more abundant food supply. Therefore, we urge the center to continue to monitor the safety and nutritional value of biotechnology-derived foods through the consultation process.

Lastly, ETA recommends that the center immediately renew its contract with the Food Chemicals Codex. The five-year contract between the Codex and the FDA expired last year and the agency has yet to renew its agreement to fund this essential service. Although the Codex has been able to survive through contract extensions and frugal use of its resources, the Codex will be totally unfunded as of October, 1998 if nothing is done.

Without funding, the Codex may cease to exist altogether. This would deal a severe blow to both the food industry and the FDA. Despite the FDA's recent decision not to renew the Codex contract, the agency has long recognized the benefit of using the Codex as a reference for specifications and methodologies.

The Codex is incorporated by reference in a multitude of food-additive regulations including amino acids, aspartame, and polydextrose, to name a few. Likewise, Section 170.30(h) of the FDA regulations specifically states that any substance listed or affirmed as GRAS must conform to all applicable food-grade specifications of the Codex.

One reason the FDA has found it convenient to reference the Codex is that it is continuously updated. This is an invaluable service to the FDA. If the Codex ceased to exist or is not updated, the agency would not only have to go back and revise all the regulations that reference the Codex but it would also have to continuously monitor the specifications and methodologies contained in those revisions.

It is not hard to imagine that, due to budgetary constraints, much like those addressed here today, updating these regulations could be delayed for years, slowing the process of innovative new food processes.

We realize that many in the FDA believe that industry does not do its part in funding the Codex. While it is true that industry does not provide direct monetary support, industry has a long history of investing heavily in the Codex by providing invaluable information and analysis. This is in recognition that industry and the FDA need the Codex.

Additionally, as the Federal Register notice announcing this meeting pointed out, the Codex has grown in significance as more and more of our nation's food supply is either imported or exported. Food regulatory bodies around the world, including the FDA, have begun to recognize that harmonized international standards are not just a good idea. They are essential of the country is going to compete in today's global marketplace.

I will just close and say thank you for your time and we appreciate the opportunity to speak here today. Thank you.

MR. LEVITT: Thank you very much.

Next is Richard Cristol, Calorie Control Council.

Calorie Control Council

MR. CRISTOL: Good afternoon. My name is Richard Cristol. I am the Washington representative for the Calorie Control Council which is an international association which, for over 30 years, has represented the low-calorie and reduced-fat food and beverage industry. We currently have over 60 member companies including manufacturers of products reduced in calories and/or fat as well as companies which make ingredients for these products; for example, manufacturers of low and reduced-calorie sweeteners, fat replacers and low-calorie bulking agents.

The responsibility for FDA's Center for Food Science and Applied Nutrition are of primary importance to the members of the Calorie Control Council. The Council's brief comments today focus on CFSAN's request to comment on activities which should receive top priority in the center.

More extensive written comments will be submitted by the July 15 deadline.

For the past several years, one could hardly glance at a magazine or a newspaper without finding some mention of the need to reduce dietary fat intake to 30Êpercent or less of calories. Numerous health and government authorities including the surgeon general, the National Academy of Sciences, the American Heart Association, the American Heart Association, the American Dietetic Association and many other professional health groups advocate this reduction in fat intake.

Even the percent daily value of fat now appearing on food labels is based on the 30 percent of calories. Today, an equally important message needs to be underscored. Calories still count. With increasing rates of obesity in the United States, Americans need to be concerned about both fat and calories and, most significantly, they are.

Consumer research conducted by the Council in 1998 shows that nine out of ten adult American, 178 million people in this country, consume light or reduced-calorie products. The majority of these consumers want a further increased variety of products reduced in fat and calories to become available.

A significant number of the food-additive petitions and generally-recognized-as-safe petitions before the U.S. Food and Drug Administration address this need and are of primary importance to both the Council's member companies and the American public. The approval of these petitions would make possible the increased variety of products consumers desire and could assist Americans in decreasing significantly their fat and caloric intake

The premise was posed this morning by Mr. Levitt that, "Where can we," meaning the agency, "do the most good for consumers?" We certainly believe this is one area. The perception of many outside FDA with an interest in the food-additive approval process is that the FDA process is open-ended, prone to inaction and lengthy delays and without sufficient administrative accountability.

The food-additive approval process thus is costly to the petitioner, to the FDA and, ultimately, to the consumer. As a result, the current system which fails to give sufficient priority to these petitions discourages innovation in the development of new food ingredients and the submission of food-additive petitions to FDA.

This has substantial deleterious effects. First, innovative and potentially important new food ingredients are delayed for years or never make it into the U.S. food supply because manufacturers cannot rationally plan for their approval and use.

Many of these ingredients might assist in achieving healthier diets by substituting for fat or otherwise eliminating calories. Thus, delays in ingredient approval or decisions not to pursue petitions have cost to the public health as well as to the petitioner.

The Council urges CFSAN to make the approval of new food additives as well as the approval of additional uses of approved food additives a priority.

The Council also urges CFSAN to pay increased attention to the affirmation of long-pending GRAS petitions. The Council supports the concept of a simplified GRAS notification procedure that would allow the Food and Drug Administration to redirect resources from the more resource-intensive GRAS affirmation process to the food-additive approval process.

The Council, however, opposes the proposal to eliminate the current GRAS-affirmation process altogether. The GRAS-affirmation process should remain in place for GRAS petitions currently pending before the agency should petitioners wish to receive affirmations. For example, GRAS affirmation by the agency may be essential in certain commercial situations to assure recognition from other federal or international regulatory bodies as well as from commercial customers.

Many of the GRAS affirmations pending have been before the agency for many, many years and petitioners have submitted substantial data and dedicated significant resources in support of these petitions. In many cases, FDA also has dedicated significant resources to these petitions and has reviewed the scientific data in support of pending GRAS affirmations very thoroughly.

In some cases, FDA has supported additional review, for example, through FACED, of the petition substances. The will to act does not really require additional resources. It simply demands that decisions be made. So we would urge FDA to make affirmation GRAS petitions, particularly where significant data is available and has been thoroughly reviewed, a major priority.

The Council requests that CFSAN expedite approval of appropriate nutrient content in health-claim petitions and citizens' petitions related to food labeling. Approval of such petitions would increase recognition of "good for you" products and increase understanding and provide useful information about the contents of products for the consumer.

Citizens' petitions are particularly problematic. Apparently, since there is no statutory time frame in which FDA must act on citizens' petitions, FDA appears to rarely address these petitions. The Council has filed a number of citizens' petitions which would assist in providing consumer-friendly information.

For example, the Council has requested that FDA allow the term "polyal" in lieu of the term "sugar alcohol" on the food label. This request was supported by a nationally projectable survey demonstrating that the consumer is terribly confused by the term "sugar alcohol." However, as too often, FDA's response, when received, generally has been, "We have not been able to reach a decision on your petition within 180 days for the filing of the petition because of limited resources."

I have a printout here, as of last February, of the citizens' petitions pending before the agency. There are well over 100. Some of these are more than ten years old. Most of these really are not lightning rods. They are not the kind of thing that is going to cause a great deal of criticism to be heaped upon the agency if these things are approved.

To be a little glib about it, some of these are really no-brainers, at least in our opinion, and they do provide significant public benefit. The Calorie Control Council has offered an extensive comment through one of these citizens' petitions for how the food-additive approval process could be streamlined. That was offered to the agency in February of 1995 and, frankly, we have had little or no response relative to whether the agency thinks any of these provisions have merit or not.

Finally, I would like to come to a close by speaking also to the global food marketplace, as many of your earlier speakers have done. It is critical that FDA promote international harmonization. Specifically, we believe improved leadership in the Codex would be most helpful.

My experience in Codex meetings historically has been that U.S. delegates are often reticent to speak out for fear of being viewed as the bully on the block. The political issues do tend to interfere sometimes with the scientific ones. We think that the U.S. has to press Codex for more lead time in responding to documents.

Our process in this country appears to be significantly more transparent than that of other countries around the world, particularly those in Europe, and it takes a little more time to get things done.

When delegates come to various stakeholders with Codex documents a week before they have to prepare and submit a position, it is simply just not enough time to do this. In many cases, we would prefer to see the process extended a bit as opposed to a hasty response that doesn't really reflect the full constituency.

We do appreciate the opportunity to address these areas and I guess I would also, even though I didn't have it in my prepared remarks, endorse Nancy's comments about the Food Chemicals Codex. We feel that is an extremely important resource for the FDA, for the industry and, certainly, benefits the public. We would, certainly, again, endorse the continuation of activity.

Thank you very much.

MR. LEVITT: Thank you.

Finally, we have Pamela Graves-Moore.

Alliance of Food Additive Producers

MS. GRAVES-MOORE: Thank you. Thank you for adding me to this important panel this afternoon. My name is Pamela Graves-Moore. I am the Director of Federal and International Government Affairs at Monsanto and am here today on behalf of the Alliance of Food Additive Producers.

This is a coalition of eight companies including Monsanto that are leaders in the research, development and production of the majority of the food additives in the marketplace today.

So, on behalf of the Alliance, I would like to respectfully provide comments to CFSAN for its consideration in determining its program priorities in accordance with Section 406 of the FDA Modernization Act of 1997.

First, the agency is to be commended for its work to date towards improving the efficiency of the food-additive approval process. However, in our judgment, CFSAN should also seek additional advancements. We believe that there is need for significant improvements to modernize the current FDA food-additive approval process. Today's system lacks the efficiency, predictability and accountability and committed resources necessary to approve new food additives and, ultimately, to enable producers to market high-quality healthy foods.

To this end, our Alliance strongly supports legislation which would amend the food-additive rulemaking process, establish specific agency performance goals and authorize user fees for the sole purpose of food-additive review and approval. These steps would augment resources available to FDA.

Specifically, the Alliance would propose to improve the food-additive approval process by strengthening the scientific quality of food-additive petitions and the petition-review process, improving the timeliness and predictability of the petition and review process and enhancing the opportunity for timely and meaningful input from the scientific community and interested members of the public.

It is important to note that not one of these provisions changes the safety standard or FDA's scientific approach to safety evaluations.

In closing, the Alliance would encourage that CFSAN deem as a priority the securing of real improvements to the food-additive approval process. We believe that a more efficient, predictable and accountable system will promote consumer safety, improve efficiency of CFSAN operations and will have positive impacts on the food industry, FDA and, most importantly, the American public.

Thank you and we look forward to working with you.

MR. LEVITT: Thank you very much.

Let me begin. First of all, I appreciate the notion that somebody might give us additional resources, but, for the purpose of my questions, let's assume that we have the level that we have since that is what we have right now.

I guess for any of the three, whoever feels moved, when I look at the Office of Premarket Approval and I see a number of related but, nevertheless, in some ways, different parts--you have got the direct additive, you have got the indirect additives, you have got the GRAS affirmations, you have got several other different specified little areas.

And different people spoke to different parts of them. Is there any consensus that we ought, if we have the amount of resources we have now, to put more in one at the expense of another, knowing it is at the expense?

MR. CRISTOL: I will be happy to lead off on that one. I think, obviously, that depends on who you ask and which petitioner you consult with.

MR. LEVITT: That is why I left it open.

MR. CRISTOL: You have got a situation, I think, in the center where a lot of the work has been done. It is just a matter of something has been put on a shelf. Perhaps, there are some that are old and need to be update and, if that is the case, then the petitioners need to be so advised.

But I have a feeling that there are many of these that are ready. It is just a question of moving them along. One of the things that the Calorie Control spoke to in its citizens' petition is an opportunity for more informal exchange during the review process.

Obviously, that is a difficult situation based on the statutory authority you operate under but, nevertheless, if there is some way that we can make the system a little more flexible so that the petitioner knows when there are questions, instead of having to wait two years to find out, "Well, the reason that was shelved was because there was a significant issue over this particular study."

So if there could be more back-and-forth, I think a lot of this could get resolved a lot more quickly. But, to answer your question, I really don't think you can give focus to one area at the expense of the other because, in many cases, the petitioners will feel that they have invested their time and resources like anybody else.

MR. LEVITT: Thank you. I will say, in the spirit of comic relief, that I got an invitation recently to attend an event which was the twelfth anniversary of the filing of the X petition. I think it was a citizens' petition. I don't think it was a food-additive petition. There was a little asterisk, "Of course, if FDA would grant the petition prior to that, the invitation could be discarded."

Kidding aside, I think the issue of old petitions of different kinds is a troublesome one. I guess I would like to ask--let's see if I get a different answer this time--not asking between different areas but, at some point, should something that is old be given a higher priority than something that is new, even if the thing that is new, on its merits, looks more important--or more "something?"

In other words, should there be--we are going to spend this month clearing out the closets, or will people say, "No, no; my new product is so important, I don't want anything getting in the way." Any help on the old versus the newer?

MS. GRAVES-MOORE: It sounds like you are supporting a senior citizen status for food additives. No; I think that is very legitimate and I think any proposal would have to work out the dilemma of some of the pending petitions. I know our proposal, that is something that we would want to negotiate and collaborate with you on because I am sure many of us have pending petitions as well as hope to introduce more recent new petitions.

MR. LEVITT: Anyone else want to touch that one? I will just observe it is very hard when you get down to the setting of priorities to say, "I want something done before something else." But we will continue to probe and you are entitled to continue to give the best answers you can to it. But for our program to be successful, we have to be willing to do something before something else and that means it is at the expense of something else.

So I would encourage you to continue in your written submissions to be willing to say, "I am willing to let something else sit." Maybe it is easier for one company to say, "Among my hierarchy that I control, I would like you to do this one before the other."

But if there are ways that we can find ways to identify, "Yes; there is agreement. This should be done before something else," instead of just, "Do your best to streamline and do everything," I think that would be helpful to us.

Let me ask if there are other questions up here.

MR. CRISTOL: Could I just comment on that for one second?

MR. LEVITT: Yes; please.

MR. CRISTOL: Obviously, the Council deals with new ingredients that have tremendous impact because of the volume in which they are used; fat replacers and sugar substitutes and items like that. It seems, in the past, if I go back over the last twenty years, that is the very thing that has made the agency so reticent to approves these things is for fear that if they have somehow made a mistake, and I realize I am projecting my own opinion here, but if you fear that the agency somehow has made a huge mistake.

That seems to, frankly, have really slowed the process down. So while, certainly, I think our Council, because of the nature of the ingredients it works with, would advocate, "Sure; let's give more attention to those that have the greatest impact, particularly when it is a positive impact or reducing fat and calories in the diet."

DR. TARANTINO: A couple of things. I guess one back, I guess, Dick to your comments on the GRAS Notification 2. I agree. I think we have plenty of evidence at the table today that the GRAS Affirmation Petition, the way it is now, is broken partly because I think, in some of those cases where the scientific review has been done, the rulemaking is resource-intensive. It is time-intensive and resource-intensive and there has been, in the notion of priority setting, the notion that food-additive petitions where something can't go to market perhaps get higher priority than GRAS affirmation petitions which is part of the reason for the situation you talked about.

Having said that, I am interested to find why you think we should retain GRAS affirmation. In what circumstances do you think people would need a regulation for a GRAS product? I guess I fail to understand that.

MR. CRISTOL: With respect to the self-affirmation process, certainly it has been the fastest way to get any ingredients to marketplace. The food-additive process has been so cumbersome and so delayed that it has offered the alternative. Obviously, we are the only country in the world that has this process.

I think that if the agency, the industry, the consumer groups, if everybody could come up with some system that worked very efficiently, it certainly would be worth taking a look at. I am certainly not prepared to comment that we should throw out the GRAS process until I see what that would be.

DR. TARANTINO: And that is not the GRAS notification, presumably, that you are talking about now.

MR. CRISTOL: No.

DR. TARANTINO: I guess one other that was kind of related, and I think it goes back to Joe. Right now, today, you think we should be working on spending the resources to do the rulemaking on pending GRAS affirmation petitions or should we be concentrating on finishing up the GRAS notification rulemaking and working on food-additive petitions.

There will be three answers to that, I suspect, but I am interested to hear what they are.

MS. ZEMAN: Of those, I guess I would choose the GRAS notification process that should be finished. With that, you may get some of your GRAS petitions taken care of. But I will also add that the ETA still wants to see GRAS-16 issues. Maybe not all of would need to be, so you might be able to kill two birds with one stone with that.

MR. CRISTOL: I guess I would respond something that you probably don't want to hear and that is all of the above. But I think you have got a number of petitions and pending food-additive petitions and GRAS petitions that really are largely done. Now, maybe I am wrong, but it seems to me it would take very little effort to move a lot of these off your plate.

I think some of these that have language for so long should be given probably a little bit higher priority and there certainly is an argument to be made for helping the most number of people, obviously, in terms of the consumers.

DR. BAILEY: Just one quick question. Do you have in mind alternative approaches for funding through Chemical Codex?

MR. CRISTOL: I guess I have to agree with what Nancy said that the industry invests an awful lot of time and effort in terms of providing company staff time to develop data, to travel expenses to provide people to serve on the Food Chemicals Codex. That is a tough issue but we certainly would be willing to help the agency out in terms of calling upon Congress to make more funds available for that.

That is going to be a pretty tough sell, I think, just as a small item but we would certainly endorse that. We just feel it has been in place for a long, long time. It is part of the reference library that FDA and the rest of the world, frankly, refers to. Without it, we would be in real trouble.

DR. CARNEVALE: I heard you talk about certainly a call for increased resources in premarket approval. Even though I heard you mention that we need to give increased support and leadership within Codex committees, I would say that we have a very strong presence in the Codex Committee for Food Additives and Contaminants and certainly have had a very strong leadership role there.

I guess my question is, either for now or later, to ask you if you see any way that our Codex or other international activities, harmonization activities, might assist us in our resource problems within Office of Premarket Approval.

MR. CRISTOL: I hate to dominate to conversation here, but--

MS. GRAVES-MOORE: I represent a single-focused coalition so my topic is limited, so go ahead.

MR. CRISTOL: I am not sure I really know how it is going to help you resourcewise. I think that a number of years ago, particularly in the early days where I attended, back in the '70's, of the Codex Committee on Food Additives, that was before they got concerned about contaminants and changed their name.

But we used to have a tremendous number of industry observers that attended that meeting. I know there are still a significant number. I think FDA relied on them a great deal for input to generate technical data, to assist in that regard.

The consumer groups are now participating and I think that FDA ought to call upon them as well to put some significant resources into this thing. The food industry has long supported this activity and, as we all know, the consumer groups don't seem to have a shortage or resources for other things so, perhaps, they can put some into the Codex process.

MR. LEVITT: I just have one final question for the coalition member. You mentioned, and I am paraphrasing--I didn't write it down exactly--you are supporting legislation that includes user fees, performance goals and what I call process efficiencies.

On the last point, on the process efficiencies, do you have a specific lineup of items that you know you are interested in, kind of with or without legislation? I mean, I understand the informal/formal rulemaking thing would be legislative, but do you have administrative things that are within there, also?

MS. GRAVES-MOORE: Just a few of the specifics. What we want to try to do is engage communication, or more communication between the petitioner and your group. So we would envision having more of an informal rulemaking process which would allow for a prefiling consultation period where the petitioner could come in and discuss what the food additive is, its purpose, functionality, et cetera, and agree to a plan for a petition.

Then you would come about 30 days later and have a prefiling review before the petition is formally submitted to the record. Then the informal rulemaking process would ensue and it would have more specified time frames in terms of accomplishing the objective.

Finally, the agency would have increased access to outside experts per your discretion.

MR. LEVITT: So that sounds like a major emphasis is on increased, early-on, collaboration on, "Is this a good petition, what is needed, are we ready?" so when it comes in, it goes more smoothly rather than submitting it and coming back with it.

MS. GRAVES-MOORE: Correct.

DR. TARANTINO: Can I ask the others on the panel, how they feel about that proposal, what you have heard of it?

MR. CRISTOL: I would agree with that particular aspect of it. The earliest that a petitioner can get feedback, it seems to me, the faster the process is going to move along.

MS. ZEMAN: I would agree with that, too. I seems like, early on, you can have more informal discussions and possibly move along quickly. Once something is filed, as Dick said earlier, the communication gets more difficult and you have to go through more steps. So things can sit on the shelf when they need a piece of work done and that information doesn't get transferred back to the petitioner as quickly.

So if you can get through the problem areas initially, I think that would be the way to go.

MR. LEVITT: I can tell you, just as an aside from my experience in other FDA product areas, while there is a considerable investment in time and energy devoted to such early consultations, it really seems to pay off. As somebody said, everybody is a lot more open before you spend your money. And that goes to both sides in spending your money.

MS. ZEMAN: Right.

MR. LEVITT: So we will look forward to working with you on that.

Let me thank this panel very much. Again, we will have the record open and we will look forward to any additional written submissions that you may have.

In response to an earlier question on whether or not there is going to be a break this afternoon, recognizing that they didn't pass out catheters up here for those on this side of the room, we have taken an informal vote among us and I voted for the group that we take a ten-minute break, that we will reconvene at 3 o'clock. That should give us time to finish by 4:30, which would be our goal.

Thank you very much.

[Break.]

MR. LEVITT: Let's get started for the second half of our afternoon session. We are pleased, for our next group, to have representatives from the cosmetics industry, both the Cosmetic, Toiletry and Fragrance Association, Ed Kavanaugh, and the Independent Cosmetic Manufacturers and Distributors Association, Penni Jones and Winnie Baden.

Again, in terms of just general procedures, we would like each of you to talk between seven and ten minutes. If you start going over, you will see little signs that pop up down there. Then, after you are both done, we will open it up for some questions. Afterwards, we will have the record open for an additional period of time for written submissions.

For those in the audience that have been patient with us all day, our goal will be to end by 4:30. I think with the number of speakers we have without too much trouble, we will be able to do that.

So, with that, Mr. Kavanaugh, why don't we start with you.

Cosmetic, Toiletry and Fragrance Association

MR. KAVANAUGH: Thank you, Joe. My name is Ed Kavanaugh. I am President of the Cosmetic and Toiletry and Fragrance Association, the CTFA, which is the national trade association that has been representing the cosmetic industry now for over a century; in fact, since 1894.

Because the regulatory program for cosmetic products has been in CFSAN since 1969, we have a strong and direct interest in these priorities. Today I will focus on two areas; first, the need for FDA to continue a strong cosmetic regulatory program in order to insure that cosmetics remain safe and properly labeled throughout the United States and, second, the need for FDA to maintain a strong leadership role in efforts to harmonize regulatory requirements around the world.

We support a vigorous CFSAN program for cosmetics. We want to strengthen our long-standing cooperation with FDA through our industry voluntary programs. These industry programs complement CFSAN and help save, I think, the agency's resources. We support appropriate efforts to secure the funding necessary for the agency to maintain a credible cosmetic program.

We recognize that cosmetics are not, and clearly should not be, CFSAN's top priority. Joe talked about pebbles and boulders this morning and 100 pebbles rolling up the hill and maybe you only get half way. If you focus on a few boulders, you may get over the top.

We are certainly not a boulder, but I don't think we are a pebble either. Maybe we can characterize us as a stone or a rock or something that fits into this. There are certainly millions of consumers every day who use our products, starting in the morning with shampoo and conditioning and shaving cream and toothpaste, deodorant and sunscreens, skin-care products, color makeup cosmetics and fragrances.

It would be, I think, a disservice to the public health to let the cosmetic regulatory program wither away for want of resources and attention.

In recent months, the CFSAN program has sustained significant cuts. The agency has announced cancellation of its inspection and compliance programs for domestic and imported cosmetics. The staff of the Office of Cosmetics has been cut nearly in half by shifting responsibilities. FDA has announced the suspension of Parts 1 and 2 of the FDA voluntary reporting program, announced the limitations on industry and consumer assistance provided by CFSAN as well as reductions in laboratory studies for cosmetics.

We are concerned that this action will have detrimental effects for both the consumer and the regulated industry. It will undermine FDA's credibility and ability to maintain adequate and appropriate national standards for cosmetic safety and labeling. It will undercut the FDA industry cooperative efforts which have fostered efficient and effective industry voluntary programs and will seriously impair the ability of FDA to provide strong and credible enforcement of the law.

In short, this action runs the risk of destroying what has been an effective and credible cosmetic regulatory program. And we believe that a credible cosmetic program must include compliance, safety and science. The most important of these is compliance which is as vital to the regulated industry as it is to consumers.

Without it, unscrupulous marketers can defraud consumers and undermine legitimate industry. The cosmetic industry needs to know what regulatory requirements apply and that they will be enforced fairly and consistently against all products, imported or domestic, marketed in the U.S.

To put it in simple terms, if there is no enforcement, there is no law. A crippled cosmetic program will undermine the stature and credibility of the FDA and, I think, encourage states to ignore the agency and establish their own regulatory requirements.

Now, the cosmetic industry shares, I believe, an important part of the responsibility for the effective regulation of cosmetics. To help meet that responsibility, we support voluntary self-regulation programs. These industry programs not only complement the FDA but, I think, also conserve FDA resources by reducing the need for extensive regulation and by performing functions with industry dollars that would otherwise be funded by FDA.

CFSAN has historically cooperated and participated in a number of these voluntary programs. The agency's involvement, no doubt, has strengthened these programs immeasurably and has provided the industry with valuable input from FDA personnel. The FDA-industry cooperation has benefitted all concerned; consumers, the agency and the industry. And we believe that this cooperative effort should be expanded and strengthened.

The recent cuts in the FDA cosmetic regulatory program, however, undermine the cooperative approach and certainly jeopardize a number of important programs.

For more than 25 years, parts 1 and 2 of the FDA Voluntary Cosmetic Reporting Program have provided the agency and our industry with valuable information about the ingredients that are used in cosmetic and personal-care products. These parts 1 and 2 were suspended by FDA a few months ago.

Part 3 of the FDA voluntary program was revoked completely by FDA because the information, as FDA stated, was sufficient to establish a national baseline for product adverse reactions. But the promised FDA publication of that important information I think is now in jeopardy because of FDA program cuts. We need that information. We urge that this document proceed expeditiously.

When FDA began to establish inspection checklists to assure adequate practices, we responded by developing the technical guidelines. These guidelines advanced the process substantially and expended the scope and depth of the FDA outlines. FDA has cooperated fully by reviewing the guidelines and providing the perspective of experienced personally who view these matters across the entire cosmetic industry.

When FDA required cosmetic ingredient labeling in the early 1970's, we responded by developing a dictionary of our ingredients used in cosmetic products. Our work on this publication has benefitted greatly from the direct and ongoing participation of FDA scientific personnel.

The current dictionary is the standard for cosmetic ingredient nomenclature officially adopted by FDA by regulation for use in the United States as the primary source of ingredient labeling and is now being used by numerous other countries around the world and, as this chart shows, there are some 30-odd companies with many more considering proposals to establish the nomenclature recognized by this dictionary in the U.S. as their nomenclature throughout the world, obviously harmonizing the packaging and listing of ingredients.

I want to emphasize that our most deep and serious concern is that the cuts in the FDA cosmetic program will limit the agency's ability to participate in the cosmetic ingredient review, the CIR. CIR is the cornerstone of our efforts to insure the safety of cosmetic ingredients. The CIR program brings together all available published and unpublished scientific data on the safety of cosmetic ingredient for evaluation by an independent-expert panel of seven leading academic scientists and physicians.

The expert panel members are subject to the same conflict of interest requirements that apply to FDA Advisory Committee members. We initiated the CIR program in 1976 at the direct suggestion of FDA when Commissioner Max Schmidt stated that FDA did not have the resources to undertake such a program and asked that the industry do it instead.

This was some 22 years ago and this program costs now the CTFA more than a million dollars a year and I am sure it saves CFSAN at least that amount. The Director of CFSAN's Office of Cosmetics serves as a non-voting liaison between the FDA and the CIR panel. He sits with the panel. He attends the meeting and participates in all the CIR proceedings.

He is kept up to date on CIR activities including the setting of the program's priority list of ingredients for review. And he conveys to the panel any comments FDA may have. The panel certainly gives, obviously, great weight to comments voiced by FDA and it is very important that a strong FDA liaison function with the CIR continue and actually, I think, be strengthened.

The expert panel publishes its findings in a peer-reviewed scientific journal. As of May of this year, CIR had released final reports covering the 720 ingredients most widely used in the industry. I think you can see from this chart that, of those 720, 390 were found safe as used; 228, or almost a third, are safe with qualifications as to product type, area of use or concentration.

95, or 13 percent, had insufficient data for the panel to reach a conclusion and 7, or 1 percent, were found to be unsafe.

For over two decades, CIR has been a remarkably successful joint effort by academia, industry, government and consumers to advance the public health. The extraordinary achievements of this program should certainly not be undermined by a lack of FDA resources.

We unequivocally support the funding of adequate field resources to assure that both domestic and imported cosmetics meet all applicable legal requirements and standards, and consumers and industry need a good cop on the corner. We urge FDA to reverse its announced decision to cancel inspection and compliance programs for cosmetics.

In addition to providing for uniform and effective regulations of cosmetics in the U.S., it is essential that CFSAN give priority to international activities. This will insure that FDA maintains the international leadership required to foster harmonization of regulatory requirements for cosmetics throughout the world.

In conclusion, let me say that cosmetics are safe and we, in the industry and, I think, FDA alike, want to keep it that way. Despite the difficult resource decisions facing the agency, CFSAN simply must maintain a credible cosmetic regulatory program and the necessary resources to do the job.

We are deeply committed to working with you in this effort and we want to continue and strengthen our cooperative programs with the agencies. Let me reiterate what I think is our primary message here. If you have no enforcement, you have no law. Both industry and consumers need that cop on the corner.

Thank you.

MR. LEVITT: Thank you very much.

Ms. Penni Johnson.

Independent Cosmetic Manufacturers and Distributors Association

MS. JOHNSON: Good afternoon. I am Executive Director of the Independent Cosmetic Manufacturers and Distributors, a trade association that started in 1974 with eight companies and today we represent 660 independent manufacturers, distributors and suppliers.

With me today is Winnie Baden, ICMAD's Vice President and Legislative Chair. ICMAD is the voice of small cosmetic businesses. Our small business members represent a portion of those 99.7 percent of the nation's employers who employ 53 percent of the private work force, who contribute 47 percent of all sales, who are responsible for 50 percent of the private gross domestic product and 53Êpercent of exported products.

Most of our 660 members do not have legal staffs or research and development departments. That is why they rely on us and the FDA to keep them informed of current regulations. In 1983, we started cosponsoring with the FDA cosmetic education workshops to inform members and nonmembers alike of what they need to know to manufacturer and distribute safe and properly labeled products.

At these workshops, attendees have the opportunity to have hands-on experience in labeling, to ask FDA representatives questions, to hear our legal counsel's opinion on regulatory matters and to interact in a constructive way with the FDA on issues of mutual concern.

We have worked within FDA budget constraints in the past. For example, several times, we have printed the FDA handbook for cosmetics to give out at these workshops because FDA simply lacked the funds. Today, however, the cutbacks in the Office of Cosmetics and Colors are having a negative impact on the cosmetic industry.

These cutbacks particularly affect small business. In these circumstances, we would like to respond to the first five questions that were listed in the June 3rd Register. Number one was issues affecting consumer safety. Failure to restore adequate funding to the Office of Cosmetics and Colors will directly affect consumer safety.

We feel, and Ed backed it up, cosmetics are among the safest products purchased by American consumers. However, issues do arise from time to time. There are too few FDA employees to respond to inquiries from small business owners on safety and labeling matters.

There are too few employees to monitor safety questions when they occur. Consumers trust the FDA to protect them from unsafe cosmetic products. Cutbacks in the Office of Cosmetics and Colors directly and irrevocably undermines this trust.

One concrete example of how consumer safety is being threatened by funding cuts is the elimination, in 1996, of the adverse-reaction reporting part of the voluntary reporting program. Ed also mentioned the registration and product ingredient statement portions were suspended in March of this year.

The part of the program calling for the reporting of adverse reactions we feel demonstrated again and again that cosmetics have an excellent record of product safety. We know the database line did exist, or does exist, and we are waiting for that report. However, products change because of new formulations and new raw materials.

Some of these raw materials may have questionable byproducts. We feel this part of the voluntary program helped FDA monitor safety issues and, without that program, FDA will not be able to respond as quickly to safety problems when they arise.

Question No. 2 was program areas we feel should be top priority for CFSAN. That would be the Office of Cosmetics and Colors. They need to be able to answer consumer questions, alert the public to genuine issues, to set the record straight when inaccurate publicity creates unwarranted concerns.

The office receives approximately 2500 phone calls annually from scientists, chemists, manufacturers, consumers and the press. The calls require time-consuming technical research. We need a properly funded Office of Cosmetics and Colors to insure that consumer trust in the cosmetic industry does not diminish.

Criteria for setting priority; we feel the criteria used for CFSAN regs seem applicable to all program areas. In addition, ICMAD advocates criteria that will minimize consumer deception in the purchase of cosmetics. Cosmetic manufacturers strive to label their products in a truthful and accurate way. We are not advocating technical regulation. However, we are advocating that FDA be available to small businesses that do not have the luxury of full-time lawyers and regulatory staffs.

The next two questions I am turning over to Winnie .

MS. BADEN: Thank you for this opportunity to be here. Since 1998, I have been a member of the Board of ICMAD. For the last five years, I have served as their legislative chair. Although I have been a small business owner for 18 years, my first projects, upon completion of my formal education, were funded by the National Institutes of Health and the National Cancer Institute.

Consequently, I have first-hand experience as a public servant having programs and projects funded or budgets cut and divisions and offices eliminated. I speak today, however, on behalf of ICMAD's other 659 member companies who are all small business owners of cosmetic and cosmetic-related businesses, many of whom reside in the grass roots of America.

In addressing No. 4, research and scientific information, the first priority is funding. Consistent decrease in funding over the last ten years caused a critical mass of expertise and cosmetic technology to erode. In recent months, our small-business manufacturers have experienced a lag in FDA response time to scientific and technical questions.

It has brought to our attention that the situation will get worse over the next three to four years as career scientists retire and resources to hire and train replacement staff are unavailable.

Immediate funding is required in order to insure an ongoing credible scientific research program that is adequately staffed with scientific expertise. Ongoing in-house research and testing must continue in order to maintain safe products and trained field workers who must be in place.

It is essential that scientists from the Office of Cosmetics and Colors be able to interact with cosmetic ingredient review scientists. Sharing of information from public and private sectors can continue in partnership to maintaining an enviable safety record of the cosmetic industry.

However, unless adequate funding is made available, the Office of Cosmetics and Colors will not have the resources available in order to participate in a meaningful way with the CIR program.

Of critical priority is to develop and maintain state-of-the-art databases and information systems. At a minimum, sufficient funding must be made available to enable the Office of Cosmetics and Colors to make sure that it is an information system which avoids problems associated with the Year 2000 problem, otherwise known Y2K bug.

Looking beyond the Year 2000, it is imperative that funds be allocated to enable all federal and state regulatory agency information systems to be capable of interfacing with each other. It is equally vital that agencies that regulate cosmetics internationally also be able to communicate with one another.

To do so, standards will need to be established and a uniform code and nomenclature defined. An allocation of funds will need to be in place for international travel to allow FDA's cosmetic scientists to interact in the decision-making process in order for the U.S. to remain a leader in the new world market.

The ability of the Office of Cosmetics and Colors to work efficiently across international boundaries will be a key element in the global marketing of cosmetics when we enter the 21st Century.

This brings us to Issue No. 5, international activities. By Year 2002, the European Union will become America's largest competitor. It boasts 370 million potential consumers. Its gross domestic product is 8.5 trillion compared to 7.3 trillion for the United States. French workers were described in the June 1998 issue of Newsweek to be the most productive in the world with a rating second only to the Japanese in manufacturing.

Nations everywhere grasp Europe's new global economy and the high-tech infrastructure required to make it flow. Its unified monetary system offers potent potential. France, not the United States, is moving at the speed of light with its extraordinary wealth of science and technological talent.

It is a very well-educated population with quality and skilled labor and high quality of lifestyle. Interestingly, the American consumer can expect to see an increasing number of foreign products entering the United States marketplace. The American consumer is entitled to expect that imported cosmetic products will have the same level of quality and truthful labels that has been associated with American cosmetic products.

And adequate amount of funding for the Office of Cosmetics and Colors is necessary to allow American small business to compete effectively with foreign cosmetic products. Without sufficient funding, we are faced with economic and safety issues.

Conclusion; to maintain the cosmetic industry's outstanding record of marketing safe products in a non-deceptive manner, ICMAD respectfully urges that both CFSAN and Congress take note that it is absolutely necessary to restore adequate funding to the FDA Office of Cosmetics and Colors.

Governments all over the world have looked to the FDA for guidance on how to regulate their own cosmetic industries. Compromising the office in any way by not restoring budget cuts and not increasing funds beyond the projected $5 million to meet the demands of the European Union will ill-serve American consumers and small business.

We should make every effort that this system, which has well-served the American consumer and American business, is not jeopardized.

Thank you.

MR. LEVITT: Thank you very much.

I have a couple of questions and then we will go over to John Bailey after me. You all talked about the need for adequate funding. In your minds, do you have a level that is adequate? I will let whoever answer it who wants to.

MR. KAVANAUGH: I think, as you know, we have tried to work with the Appropriations Committees on the Hill to at least restore funding to the levels it was at in the past year. Obviously, and I think we have heard before, that these levels have come down over a number of years and I think we ought to seek to try and get it back to that level of a few years ago.

But we are trying to take one step at a time with the Congress and get Appropriations at least to restore the moneys, if not, necessarily, the same programs. I think that is open for discussion as to what are the priorities and why we are here today. But at least the money to try and do the job right.

MS. JONES: And there is a bill in the house with a set amount.

MR. KAVANAUGH: That's correct.

MS. BADEN: $2.5 million, which really isn't enough.

MR. LEVITT: You beautifully led right into my second question which is were the amount of funding restored, would you reallocate it in the same way or would you shift some of the priority for that funding around and, if so, how would you do it?

MS. BADEN: I certainly feel that education of staff is one of the most important things because if we don't have scientists in place to answer the questions, to do the research, we are at a loss to help when problems arise.

We must have educational programs in place. They must be funded.

MS. JONES: I think we have to be able to keep up with EEU as a competitor, our country. We need to FDA's help to do this.

MS. BADEN: And field workers certainly have to be in place.

MR. KAVANAUGH: I think, as our remarks indicated, that we feel very strongly that the compliance function is the most important and to cut inspections is our understanding from some 120 to 0 and to cut field resources allocated to cosmetics, you are taking that cop off the corner and we know what happens if you do that in other instances.

I think we have had a good relationship with FDA. I think the industry and consumer are working on a number of programs together, but without that enforcement action by FDA or the potential of that, I think we are going to be fortunate to keep the status quo in terms of the high level of safety of these products.

MS. JONES: Right. We don't want to encourage fly-by-nighters, so to speak. There is no enforcement so they can put out any product they want.

MS. BADEN: And label it any way they want.

MR. KAVANAUGH: Joe, there is another issue there, too, that I would emphasize and I stated and I think we can have further discussions on this later, but, in terms of priorities, what is so important to us is the Cosmetic Ingredient Review Program. Perhaps that program, after 22 years, as successful as I think it has been and I think FDA believes that it has been as well, it may need some tinkering.

If it does, in order to get that to where everybody wants it, then we certainly would consider anything in discussions with you about that.

MR. LEVITT: Thank you. My final question, at least for this round, is do you think that FDA needs any new legislative authority which was commented on earlier by one of the other speakers that FDA has a hard time regulating cosmetics because the legislative authorities are more limited than some other product areas.

Are there any areas that you would think we need more authorities in?

MR. KAVANAUGH: Are you referring to Dr. Jacobson's remark? I think it is interesting that the example he raised was a 20-year-old issue and, I think, was an example of, really, the cooperation between industry and FDA because I think we resolved the nitrosamine issues, at least for cosmetics, in a pretty satisfactory way to reduce any danger of that.

I think that was a very successful example of a cooperative effort between the agency and the industry. There may be some areas. Clearly the legislation that is place with the FD&C Act certainly gives FDA adequate authority to regulate cosmetics. Our position, at this point in time, would be, without further discussions with you, that there is no need for further need for further legislation but there is that need for the enforcement mechanism, the compliance function, to be a strong one at the agency.

MS. BADEN: I can only think that down the road if we have more imports there may, at that time, arise a situation where we may have to relook at legislation.

MR. LEVITT: Thank you.

DR. BAILEY: I have a couple of questions. The government, in attempting to address some of the resource problems is entering into more public-private partnerships. I think the GFSAN structure is a good example of that. I would ask the question, number one, do you see this as an effective way to address emergent safety issues or to address other non-safety issues in the area of cosmetics.

And, secondly, how would you see this divided between industry responsibilities and FDA responsibilities? In other words, what kinds of things can industry do under a partnership and what kinds of things would we keep? Easy question.

MR. KAVANAUGH: I think the idea of cooperative testing efforts, as I understand it, would be we would have to look very carefully at that because I don't want it to duplicate what the Cosmetic Ingredient Review is all about. I would like to see that function be supported even more so with FDA. Let's look at it. Let's look at what it may need in terms of strengthening that.

Maybe FDA needs to look at what may make that even more credible and more functional for FDA to alleviate some of that burden from CFSAN. We are willing to consider any of those aspects.

I think until we were satisfied, or both of us are satisfied, with how that function is working, it would be premature to talk about something that I think may duplicate or go beyond that, but we certainly do want to talk about that.

I might say one other point on this. Years ago, there was a--I forget the title of it, John--but an FDA liaison committee with industry which periodically met with industry members, especially on the technical side. I think it may be time try and reinitiate some sort of regular basis between industry, especially in the scientific area, and FDA to identify those kinds of projects, whether it is what you are talking about here or otherwise, that we can work together on.

MS. JONES: Perhaps an advisory panel.

DR. BAILEY: One other question. There have been a number of safety issues that have come up over the past relating to certain ingredients, nitrosamines being one, certain fragrance ingredients, and so forth. The way these have typically been addressed is that the industry and FDA work to define the problem and then to solve it.

But they are rarely captured in a regulation. My question is do you see a need, a benefit, or what, in terms of capturing these safety issues and guidance documents, for example, or regulations or is the current way of sort of dealing with them on an ad hoc basis, working to protect the public health.

MR. KAVANAUGH: I think the current process works pretty well, but there may be some areas where formalization by FDA would be appropriate.

MS. JONES: And to post it on the website, I think, would be wonderful, as certain issues have been. That site has improved greatly over the past couple of years and I can get a lot of information off it, which I like.

MR. LEVITT: Laura, do you have any questions?

DR. TARANTINO: I will try one as sort of the naive questioner in this area in that, following up on one of the comments of the previous panel, I know you talked about possible greater industry cooperation and industry support for some of the voluntary programs. At least part of your industry does have direct experience with fees, user fees and certification fees and such.

Do you see places where that is something that the industry could support?

MR. KAVANAUGH: In terms of user fees to support regulatory functions; no.

MS. JONES: It may be something coming, but, in many cases, it would be a worst-case scenario.

DR. TARANTINO: As the naive questioner, I could ask.

MS. BADEN: I could see how it could work, but it would be very difficult and it would increase price and make us less competitive with the European market. It is important we have safety.

DR. CARNEVALE: Just a couple of quick questions. Just briefly, the cosmetic hotline, I was hearing you talk about education and outreach efforts. Do you consider that a major success, something that needs to be continued?

MS. BADEN: Yes; we do. We have excellent attendance at our conferences.

MS. JONES: She is talking about the hotline.

MS. BADEN: Oh; the hotline. I thought you meant the outreach programs that we have had in conjunction with FDA.

DR. CARNEVALE: You can talk about that as well, but I was talking about the hotline.

MR. LEVITT: Especially since you are so enthusiastic. Please take an extra 30 minutes.

MS. BADEN: The program with FDA has been extremely successful. It has good attendance. People have learned from it and I think it has helped, particularly with labeling.

MR. KAVANAUGH: We have an 800 number that complements the worldwide web, so I guess the question is does that 800 number serve the intended benefit.

MS. JONES: I don't know how many people know about it.

MS. BADEN: In fact, I didn't know about it until someone on the Congress, talking about this on the Senate floor, mentioned it.

MS. BADEN: That is helpful to know. You mentioned specifically imported cosmetics. I know there was some mention of maintaining the EU market, but I guess my question was not only enforcement for insuring that domestic product is safe and keeping up consumer confidence, but are cosmetic imports a significant issue at this point? I was hearing from you that they are not.

MS. BADEN: It is an issue but it is becoming more of an issue. As we look to the Year 2002 with the EU market coming together, we are faced with a tremendous potential increase of products coming in. If we don't have standards in place, we don't have a way to register those companies and products and we have no way of tracking and tracing.

It is very time consuming to attempt to if you don't have something in place.

MR. LEVITT: I have just one final question which relates to adverse-event reports. I gather there was a more organized program a few years ago than there is now, but are there things we could do now that would enhance, even within the current framework such as it is, that we could enhance adverse-event reporting by companies?

MS. JONES: The voluntary program was discontinued in '96. Correct, John?

DR. BAILEY: That's correct, the voluntary reporting. But the standing program that we have had in place for taking reports directly from consumers is still in place.

MS. JONES: And they can use that 800 number for that; correct?

DR. BAILEY: Correct. There is information about how to report.

MR. KAVANAUGH: Joe, the report I referred to earlier which has been discontinued was, I believe, a ten-year summary of baseline by product category which would be very helpful for the industry since FDA won't accept any more adverse-reaction reports. It would be helpful for the industry to know where they stand in a particular product category as compared to the rest of the industry.

Clearly, that would become less relevant as time went on but, for the next couple of years, it might be very helpful.

DR. BAILEY: We are working on it but resources are limited.

MS. BADEN: Not only does it become as relevant but, as time goes on, you may not even be able to get into the system. So it has to be maintained in order to be able to use it.

MR. LEVITT: Thank you.

DR. BAILEY: One other question; of the hundred or so pebbles that we are trying to push up the hill, which would you put as most important at this time?

MR. KAVANAUGH: I think we stated that, certainly, the compliance function which includes inspections, which has been drastically reduced or virtually eliminated. Secondly is to work out the best possible partnership we can in cooperation on the CIR program which is critical. Without FDA, the CIR program would be jeopardized and I certainly don't think anybody wants that, least of all the consumers.

MS. BADEN: I would have to agree; compliance and enforcement.

MS. JONES: And training.

MS. BADEN: And training, more scientists trained working in the Office of Cosmetics and Colors.

MR. LEVITT: With that, we thank you very much and, again, we encourage you to submit written comments for the record, also.

We will now move to our final group of presenters for the afternoon. We have three trade associations, the International Dairy Foods Association, the In Flight Food Service Association, and the International Sproutgrowers Association. Mr. Tipton, Mr. Simpson, Ms. Snyder.

While we are getting ready for the final group of speakers, as the agenda indicates, tomorrow morning we will start again at 10 o'clock in this room.

If everybody is settled, why don't we begin with the International Dairy Foods Associations. If you will please introduce yourself.

International Dairy Foods Association

MS. FRYE: Thank you. Mr. Tipton was unable to attend today so I will be presenting the comments. My name is Cary Frye and I am the Vice President of Scientific and Regulatory Affairs and we appreciate the opportunity to provide comments on the program priorities to FDA's Center for Food Safety and Applied Nutrition on behalf of our members that represent the diary processing industry.

The International Dairy Foods Association represents processors, manufacturers, marketers, distributors and suppliers of dairy foods. These include milk, cheese, ice cream and frozen deserts. IBFA serves as an umbrella organization of three constituent groups, the Milk Industry Foundation, the National Cheese Institute and the International Ice Cream Association and we represent 85Êpercent of the U.S. dairy-foods industry.

We compliment the Center for Food Safety and Applied Nutrition for requesting input on their program priorities. We have some general observations and also some specific responses to the question that addressed the program priorities of CFSAN.

The dairy-foods industry is supportive of effective food-safety regulation. Dairy processors recognize that a strong, effective agency is necessary to provide public confidence in the government that is effectively monitoring and insuring a safe food supply.

The dairy industry agrees with the current five priorities set forth by CFSAN and we believe that the CFSAN priority of dedicating resources to regulations mandated by statute is important. In fact, eliminating expenditures of resources in the areas of enforcement and regulations that are not mandated by statute may prove effective in providing additional resources.

The dairy industry fully supports moving towards a science-based assessment in the form of HACCP-type programs. The dairy foods industry does not believe that the mandatory HACCP program should be enacted for dairy products. The key principle of a sound HACCP program is that it specifically developed around the individual manufacturing process, that it is not mandated by set predetermined checkpoints.

A HACCP plan must be able to be customized, allowing for flexibility when changes occur and new monitoring tools become available. The extent of the proposed juice HACCP regulations should be reevaluated with regards to risk before committing as many CFSAN resources for implementing and monitoring this program.

Juice processing plants that pasteurize their product prior to packaging should not be included in this regulation. Also, dairy-processing plants that are processing both milk and juice should not be included if they are regulated under another food-safety program such as the National Conference of Interstate Milk Shippers or the USDA Dairy Plant Inspection Grading Program.

The CFSAN outreach program that most closely affects our dairy processors is the Federal State Cooperative Milk Safety Program. The Pasteurized Milk Ordinance and the National Conference of Milk Shippers Program have been successful in providing uniform regulations for states and allowing a cooperative process of changing, improving regulations that insure food safety.

The program is falling short, though, of utilizing cutting-edge strong science-based concepts to evaluate food safety. The NCIMA program still relies mainly on a check-list inspection and prescriptive plant processing regulations. We applaud the recent efforts of the conference in 1996. It formed a resolution to make necessary changes to move towards a HACCP science-based system.

However, state regulatory agencies who must approve the changes were not willing, at that time, to fully embrace the change. As a result, the milk sanitation regulations remain under study until May of 1999. Hopefully, with a higher priority and a higher level of involvement by CFSAN, this program could move towards a voluntary HACCP-based system.

With regards to comments to the specific questions, I would like to talk a little bit about the areas that directly affect consumer safety. We have concerns regarding imported foods. In many cases, the hygienic requirements for production and processing of a food in the United States are more stringent than in countries with competing foods that are exported into the United States.

More effort needs to be focused by CFSAN in reducing the risk to the consuming public from the imported foods.

The second issue related to the activities of the programs for CFSAN, which should be top priority, we believe that there is a greater need to find outreach education programs such as Fight Back. This would insure safe food-handling practices beyond the control of both diary and food-processing plants and facilities with the majority of Americans for line on meals away from home, education programs for consumers and food handlers require an increase in resources for retail food safety.

The priorities set forth by other CFSAN programs may differ than the applicable regulations. We support an expansion of the health-related product labeling priority to include other product labeling, updating of standards of identity and review of health-claim petitions.

Food product labels are important venue for the consumer information. As new ideas develop to streamline labels of dairy products, CFSAN should be willing to commit resources to review these ideas.

Also, we feel that the CFSAN priorities need to include resources to review requests to modify the existing standards of identity for dairy products. Many of these standards were developed in the 1970s and early '80s and require updating. A lack of resources to review new proposals for standard of identity will restrict product development and limit wider availability of dairy products to the American public.

Requests for health claims have a more direct effect on public health by providing information on the food package that could improve consumers' choices when selecting foods. The availability of scientific-based health information on a product labeling could also have along-term effect of the health of the consumer.

We support a higher level of resources to addressing labeling standards and health claims.

In keeping with food safety as the highest priority, we believe that research or modeling in the areas of infectious dose for pathogens in food such as Listeria, E. coli 0157H7 and Salmonella should be considered. Current CFSAN policies on the levels of pathogens in food were developed under a crisis mode many years ago and a zero tolerance for policy for pathogens does not reflect always the current scientific information or international public health policy.

CFSAN is a primary food-safety agency that is involved in international food-safety activities and we believe it should continue to be a top priority. We support that more resources are allocated in CFSAN's international activities including involvements in bodies outside of Codex. This should increase the U.S. influence in many final Codex food-safety standards and product standards of identify.

We place a high priority on the continued maintenance and administration of the Food Standards Program which is important to Codex. The comments received in the recent ANPR in food standards made it clear that a number of existing standards presently serve as a barrier to the utilization of new technologies and the use of required ingredients to improve existing products.

It is also apparent that the U.S. delegation in recent Codex committee meetings was restricted to promoting the effective U.S. position in light of the outmoded standards that are now in place.

As a result, petitions have been prepared and filed related to new standards. The goal of the ANPR is still important and the standards need to be updated and modernized. Therefore, FDA needs to have resources in this area.

In conclusion, the dairy industry strongly supports CFSAN in making food safety as a top priority in its efforts to focus the resources. The U.S. dairy industry would like to be a partner in this effort. We believe that the dairy industry plays an important role in insuring food safety to the consumer.

We agree that more emphasis is needed in the area of international Codex activities, increased resources, need to insure uniform application of food-safety requirements for imported foods and we recommend that CFSAN expand their resources in the area of health-related labeling and it is important to include the review of other labeling needs for products such as advances in technology, streamlining existing labeling, and updating the standards of identity that are outdated.

International Dairy Foods and our members intend to cooperate with CFSAN and to maintain consumer trust and confidence in the safety, purity and wholesomeness of dairy products.

Thank you.

MR. LEVITT: Thank you. Next will be a representative from the In Flight Food Service Association, Mr. Simpson.

In Flight Food Service Association

MR. SIMPSON: Good afternoon. My name is Joel Simpson. I am representing the International In Flight Food Service Association. I want to thank you for the opportunity to be here and to provide our input.

IFFSA members include nearly all airlines, airline caterers and the food-product suppliers to the airline industry in the United States, Canada, South America and many overseas locations. Airline caterers in the United States alone provide nearly 300 million meals to the flying public each year, to give you an idea of the magnitude of our industry.

We would be inexcusably remiss at this point if we failed to point out that the current atmosphere of communication, cooperation and proactive approach to food safety being practiced by the retail food-protection team and the cooperative food program in CFSAN is extremely encouraging to me and IFFSA as a whole.

The past several years, and the past two years in particular,Êhave been the most productive and enjoyable and the more than 35 years that I have spent both in industry and state regulatory agencies working with FDA. This is not to say it has been or will be easy. I think we are regulated by the Interstate Travel Program just as strictly if not more so than we have ever been. The difference is that we strongly feel that the current atmosphere is simply more efficient and more productive.

I will now attempt to address the specific questions relating to program priorities. Obviously, we think that the President's Food Safety Initiative should be given first efforts. When the Administration speaks, agencies listen. I am concerned, however, over recent articles concerning the funding issues regarding the FSI and, also, CFSAN because, in my experience, inadequately funded programs have long been a deterrent to food safety success.

Beyond the Food Safety Initiative, we feel the highest priority for CFSAN should, obviously, be those regulations, standards and program activities that are intended to enhance consumer safety and those that are mandated by statute, including import regulations because of the increasing trend toward globalization and harmonization and the increased amount of imported foods coming into the country.

Next in line should be those program activities that will lead to improved efficiency of operations. This brings up the issues of program location within the government. Speaking again for IFFSA, we feel that the current location of the Interstate Travel Program with in the FDA, within CFSAN and the retail food area, is close to ideal.

Again, having worked with a state program and with the USDA, I am very concerned at recent mentions of program relocation and, particularly, talk of delegation to the states. We realize the limitations of funding, but we also realize that program uniformity and an efficient chain of communication and the uniform applications of standards are absolutely essential to efficient food-safety efforts.

I dealing with 30 to 50 different sets of standards or different sets of regulations with 50 different state program heads with hundreds of different inspectors does not bode for an efficient food-safety effort in our minds.

In talking about efficiencies, we have to talk now about HACCP. I notice a number of other speakers talked about HACCP. It comes to mind as a potentially very efficient consumer-protection program. I say "potentially" only because of the tendency for HACCP programs to be drowned in micromanagement and in paperwork if we are not careful.

IFFSA has been engaged in a HACCP pilot project based out of the Seattle District of FDA for the past three years. This pilot, which has been assembled as a joint IFFSA-FDA project with equal input from both partners is tailored specifically to the application of HACCP at retail where multiple menu items are customarily produced daily.

The pilot recognizes that airline catering kitchens which commonly produce 100 or more very different menu items daily and that these menus which may change monthly cannot be treated the same as a seafood plant or any other processing plant where one or several products at a time are generally run in production at one time.

So the joint pilot project is process-based rather than product-based. It depends on the process you are using rather than individual menu items. Thus, it is very achievable and efficient for our industry. This efficiency has been official recognized within the past year with the awarding to both FDA and IFFSA of Vice President Gore's Hammer Award for cost efficiency which I proudly wear in this lapel over here today as we speak.

Based on these results, IFFSA encourages CFSAN to assign a very high priority to the further development and expansion of this pilot project to other FDA regions and to use it as a potential model for HACCP retail.

Please bear in mind, we are not advocating HACCP regulation at this point. It is far too premature in the pilot process. But IFFSA strongly supports HACCP as a voluntary program at this juncture.

On the subject of those products, are consumer safety issues not being adequately addressed by CFSAN, I can only comment for our industry and my feel for what is happening within CFSAN. As I said, I feel we are better regulated now than at any time in my career. But I also feel it can be more improved and made even more efficient through the judicious adoption of HACCP as embodied by the pilot projects that are happening out there now.

We do have some concerns, as other people have spoken of, about CFSAN's ability to sustain this current level of productivity over time, given the current staffing and funding levels. I think it is IFFSA's intent, in our written comments and in our other activities, to try to deal with what some of the organizations have said, and that is to press for some funding to return to former levels.

It is human nature for good workers to overachieve. Without adequate staffing, funding for adequate staff, staff training and development, even the most dedicated employees will eventually fail because of their human limitations.

A second concern we have is a relative lack of visibility of both the retail food and the ITS programs. I think it is common for middle management, in allocating program resources, to read into message from top management and those programs which are visible in downward communications, they are going to get a larger allocation of staff time whereas, if no mention is made of other programs, what happens commonly is the resources are pulled away from less visible programs and allocated to more visible programs when push comes to shove.

We notice sometimes the interstate travel sanitation people have other responsibilities and they are pulled away to do other things. Although we are certainly not in favor of overregulation, we realize that, without FDA's oversight of the Interstate Travel Program, we would not be nearly as strong as we are in the area of food safety. Although each member has their own program, just about, we must have the FDA oversight.

So IFFSA would encourage CFSAN to give more visibility to retail food protection and ITS programs in as many of its downward communications as possible.

Finally, and I don't know if anybody in the room knows me, but, if they do, it won't come as a surprise for me to say that we agree, basically, with CFSAN's priorities and the methods for setting priorities as are outlined in the documentation which came for this meeting.

One priority we would like to see, though, is a push for adoption of the 1997 Food Code with a few modifications. We were happier with this food code than we have been with any edition of the Food Code that has come out in the last several years

I think with the few modifications, what we would like to see is the HACCP pilots be used as the basis of retail food safety programs with critical control points in there and then the Food Code serving as a basis for the standard operating procedure, SOOPs or SOPs.

Again, I want to thank you for this opportunity. It represents to me a new direction in food safety, a very exciting positive direction and one I hope to participate in for many years to come. Indeed, IFFSA sees the upcoming July Interstate Travel Sanitation Program meeting in Kansas City with an industry panel on the program as a start to our reinvigorating and ITS program and as an enhancement of program efficiencies for all constituents.

But it is only a start. These meetings should be a priority of CFSAN's scheduled at least every other year if not annually.

Thank you very much.

MR. LEVITT: Thank you. Our final presenter for this afternoon is Nancy Snyder from the International Sprout Growers Association.

International Sproutgrowers Association

MS. SNYDER: Thank you. I am Mrs. Snyder from International Sproutgrowers. I do appreciate this opportunity to appear before you.

To introduce my subject, I would like to give you a few statistics. Worldwide sprout sales are approximately $1 billion with the U.S. market being about $250 million. There are approximately 5,000 sproutgrowers worldwide which excludes China as we have no statistics for China, with about 475 billion in the U.S. and Canada.

The sprouting industry in the United States and Canada is an exact parallel to the farming industry varying in size from $5 million to $50,000. There are many benefits for eating fresh sprouts. Not only are they rich in proteins, vitamins and minerals but government and independent nutrition and health authorities agree that Americans should increase their consumption of fruits and vegetables to at least five servings a day.

These same studies show that generous servings of fresh fruits and vegetables in our diet are protective against many cancers and lessen the risk of coronary heart disease. The UDSA and government health officials continue to remind the American people they are not eating enough vegetables.

It is interesting to note that Americans are still undereating vegetables in spite of the fact that the fresh-cut vegetable industry has grown by leaps and bounds as has vegetable consumption in general. More people are eating sprouts. The recent anti-cancer benefits attributed to broccoli sprouts will help bolster the vegetable and sprout industry.

Warning labels on vegetables, fresh-cut vegetables or sprouts will certainly impede the goal of increasing consumption of these items. Considering the minimal risk of food-borne illness, creating anxiety about eating vegetables and sprouts, would be counterproductive to public health.

Further, there is no scientific evidence that demonstrates that sprouts are a greater health risk than fresh-cut vegetables. In addition, warning labels on sprouts would seriously jeopardize the ability of the industry to compete with fresh-cut vegetables.

Sprout producers are small farmers. They operate with small profit margins. A drop in sprout consumption would be disastrous to this industry. Considering the small risk of contracting illness from sprouts, the similarity of sprouts to the fresh-cut industry and the demonstrated benefits from eating fresh produce, singling out the sprout industry for negative labeling, in my view, cannot be justified.

Then what does the sprout industry need from the FDA? If I can give you a little history. Dr. Thayer and Dr. Kathleen Rajkowsky of the Agricultural Research Center, Philadelphia, have demonstrated that the radiation D value for E. coli 157H7 and Salmonella on sprouting seeds appear to be similar to the d values for meat products.

They believe that they are able to eradicate both of these pathogens from sprouting seed through irradiation. Further large-scale radiation testing as well as large-scale germination testing of irradiated seed is continuing. When this work is completed, ISGA and ARS will present this data to FDA for approval.

We request that the FDA give this approval a high priority and, since sprouts are a secondary product, they not be required to be labeled as irradiated. ISGA, again, is very grateful to ARS for this work.

ISGA needs a high priority from FDA to approve more GRAS products as food additives. We have found that hydrogen peroxide as well as ozone to beneficial in the processing water of sprouts. These products leave no residual chemicals on the final product. However, ISGA needs more research in this area and hopes that ARS Beltsville, who is conducting this research, will continue to support these projects.

ARS Beltsville has explored various chemical treatments that will sanitize seed. The most promising is calcium hyperchoride at 2 percent. We need higher priorities assigned to the approval of new products as they become available that can be used to soak seed prior to sprouting.

Again, we are grateful to the efforts of ARS Beltsville for the generous help and efforts in our behalf and hope they will continue to support these research projects.

MR. LEVITT: Thank you very much.

Let me begin with the subject of HACCP. At least two of you mentioned HACCP. What is your view in terms of what I will call passive readiness. Let me start there. What is your view of HACCP readiness to your segments of the industry, if I could ask everybody that.

MR. SIMPSON: I will go first. I think, like I said, we have this pilot project in the Seattle District only. We have been trying to expand it to other areas of the country so, at this point, I am not sure that I could say that we are ready to proceed much further.

One of the things that we are lacking, not from CFSAN but part of FDA, is that we have had our pilot in front of them for review for quite some time now and we have not gotten the review that we have asked so that we know that we are in the right direction to move forward.

As far as our pilot is concerned, we are going in the right direction but we need greater exposure in different districts.

MR. LEVITT: Thank you.

MS. FRYE: The dairy industry, too, was involved in a pilot program with FDA in the cheese plant and worked very closely with them on that. But, most importantly, is the industry embracing HACCP voluntarily. It goes back a number of years. In 1994, we had a task force made up of industry that looked at developing a voluntary program and also a model program for specific products.

We published a dairy-product safety manual that our members embrace and use and that goes also along with a computerized system of record keeping and also can take them through the principles of the process and assessing the critical-control points.

So the industry has stepped up to the plate. We have tried to facilitate that with training and consensus in our industry.

MS. SNYDER: The sprout industry has a voluntary HACCP plan. We have identified one critical control point which can be verified which is the chlorination of seed. We are working on an ISGA seal of approval. We are down to, really, two possible candidates, I think, at this point to help us complete the development of this, so we are pretty far along.

We expect to have this whole program to present to our convention in August. Then, at that point, we would ask for membership approval and for the membership to start participating in this program. It is not a voluntary program. The seal of approval would involve outside inspections by an outside certifying agency that would inspect sprout facilities and certify those facilities as adhering to observing the critical-control point of seed sanitizing and whatever other areas are identified as being critical by the companies that we are working with.

MR. LEVITT: Thank you. Let me move down the table here.

DR. CARNEVALE: I guess I am going to ask a Joe Levitt question because I heard a lot of suggestions for those priorities that we ought to consider important. I guess my question, then, is if you each had to choose two boulders, what would they be?

MS. FRYE: I think there are really two areas that are very important to us. One is moving more towards science-based in the NCIMA program. And we certainly support that. And we welcome the cooperative forum that that occurs in. Secondly, is that there is careful and prompt consideration of labeling and health-claim issues that come forward in our industry to provide a solid base for consumers and also standards for international, as well.

MR. SIMPSON: Two boulders? I would say, from listening to just about everyone I have heard here, that one of the boulders, even there is no program for it, would have to be considered the funding issues. I think somebody classified it not as a boulder but as a stone. I think moving toward a more universal application of HACCP programs, whether voluntary or mandatory, I think is a stone because, again, of the tendency that I see for HACCP programs, if we are not careful, to be overwhelmingly paper-heavy.

I think that an efficient HACCP program would be a stone, be considered a high priority.

I want to make one comment. I have with me Carol Heaver who is Chairman of IFFSA's Government Affairs Committee. I would certainly defer any questions you may have to Carol if she chooses to answer them in my stead, but those are my boulder and stone.

MS. SNYDER: I think I would be very inclined to agree with the Grocery Manufacturers where he mentions research on emerging food pathogens and a more science-based approach in making risk assessment for both food-borne pathogens and chemical contaminants is certainly very close to some of our problems.

The other problem, the major problem, that we have in the sprouting industry is finding a method to sanitize our seed to a point where there would be no possibility of any E. coli 157H7 or Salmonella contamination slipping through to our final product.

I think we are getting very close to some research answers. Once we have the science, we would like very much to see quick approvals to use whatever methods the science would suggest to clean up our seed.

MS. HEAVER: My name is Carol Heaver. I am with the In Flight Food Service Association. Thank you, Joel. The only other boulder that I might add is to keep ITS in CFSAN. We feel very, very strongly about the progress that we have made in the last few years and the cooperative program that we have going right now is very, very, very helpful to our industry and we feel that it is very efficient way to guarantee public safety, public health.

Thank you.

DR. BAILEY: I think I will pass to Laura if she has some questions.

DR. TARANTINO: Only one. You mentioned, in terms of the dairy standards, that many of the ones we have on the books are outmoded and not very useful and need updating and looking for resources to do that, knowing that that may not be your top priority and it is difficult to do.

I gather you do not support notion that we should eliminate the food standards, at least, ourselves?

MS. FRYE: Would we support eliminating food standards?

DR. TARANTINO: Right.

MS. FRYE: We have looked at it from the standpoint of trying to look at the present standards, where some can be consolidated. Some are obsolete, specifically on cheese which is a commodity that is internationally traded. And then that could move forward in going towards Codex and the position.

We have truthfully not considered advocating the elimination of standards at this time, so I can't comment on that.

DR. TARANTINO: Just curious. Thank you.

MR. LEVITT: If there are no other questions, again, let me thank the three of you for coming and your colleagues, also. Again, the record will remain open if you want to submit written comments.

I thank those in the audience that have stayed and listened and participated, and we will reconvene tomorrow morning at 10 o'clock a.m.

(Whereupon, at 4:15 p.m., the proceedings were recessed, to be reconvened at 10 o'clock a.m., Thursday, June 25, 1998.)

Summary of Proceedings | Panel A | Panel C