Transcript of Public Meeting on GMP Modernization: July 21, 2004

July 21, 2004

Chicago, Illinois

Public Meetings on Current Good Manufacturing Practice Regulations

CONTENTS

1. Introduction - Dr. Donald Zink
2. Taped Opening Remarks - Dr. Lester Crawford, Acting Commissioner of Food and Drugs
3. Introduction of Invited Speakers - Dr. Donald Zink
4. Invited Speakers
   • FDA Research Related to Food GMPs,
     Dr. Richard Williams, CFSAN, FDA
   •  Industry Representative,
     Dr. Bruce Tompkin, VP - Product Safety (Retired), ConAgra Refrigerated Prepared Foods
   •  Consumer Representative,
     Terence Furlong, Chief Operating Officer, The Food Allergy & Anaphylaxis Network
   • State Regulatory Representative,
     Marlena G. Bordson, LEHP, Chief and Dairy Program Manager, Division of Food, Drugs and Dairies, Illinois Department of Public Health
   • FDA National Food Expert,
     Brian Hendrickson, Office of Regulatory Affairs, FDA
5. Question Period
6. Break
7. Small Business Outreach Presentation,
   • Ms. Marie Falcone, Office of Regulatory Affairs, FDA and
   • Dr. Clark Nardinelli, CFSAN, FDA
8. Public Comment Period
9.  Summary of Meeting by Moderator - Dr. Zink
10. Adjournment

 

 

PROCEEDINGS

(2:00 P.M.)

DR. ZINK: I am Don Zink and I am with the FDA Center for Food Safety and Applied Nutrition. I'm involved in the agency's internal working group on food good manufacturing practices modernization, and I would like to welcome everybody to our second of three public meetings on good manufacturing modernization.

This is a very important initiative within the agency. Dr. Lester Crawford, our acting Commissioner, began an across-the-board review of good manufacturing practices regulations in each of the FDA centers, and I guess the first really to start this was SETA, our center for drugs, and they are certainly well ahead of CFSAN, but it was expected that each of these centers would take several years, internally examining good manufacturing practices, and in fact, we began this internally almost two years ago, looking at the regulations and the effectiveness of them, and research gaps and needs, and doing some research, and we're going to tell you a bit about that today.

First, I'd like to give you some housekeeping information. There are restrooms located close by, in the far left corner, men's restroom, far right corner, women's restrooms, in the foyer outside the meeting room. When it comes time to ask questions, if you would, come to the microphone, clearly state your name and your affiliation. The proceedings of today's meeting will be transcribed. Everything that we get electronically or in print will go to our Docket managements group and be entered into the public record, and will be available for anyone to see. A transcript of today's meeting will be available approximately oh, fifteen days after today. We will put everything we can on our internet site, and generally try to make this as absolutely transparent as we possibly can. I would like to, again, emphasize the importance we attach to this. We think good manufacturing practices are a foundation of all other food safety programs. We have a lot of people here today from the agency here in Chicago. We have our Moffet Center research group, at the National Center for Food Safety and Technology. We have a number of our staff from there today. We have a number from Washington, the CFSAN office. And I'd also like to recognize Joann Givens, a district director from Detroit, is here with us today, and we have representatives of the Chicago District as well, so this is something that we really want all of our stakeholders, internally and externally, to be involved in.

I want to say, before we begin, I want to clarify what we mean by good manufacturing practices. When you hear the term "current good manufacturing practices," you think of 21 CFR, Part 110, and certainly that is the current good manufacturing practices and FDA regulations, but a word you'll hear or a phrase you'll hear used around the center these days is universal preventive controls. What good manufacturing practices really are is they are those controlled procedures and practices that you would do to preserve the wholesomeness and safety of food products manufactured under the agency's purview. And, we want you to think when you're thinking about good manufacturing practices and an GMP regulation for the future, we want you to think in the broadest possible sense.

What we want to hear about and understand are current state-of-the-art practices in industry for good manufacturing practices. What is it that's necessary to do universally in the food industry to ensure the wholesomeness and safety of food products. By preventive control, emphasis is on the word preventive. We continue to see, and you'll hear more about this, numerous Class I and Class II recalls, a great many of which aren't failures of a particular HACCP plan, for example, they're the sorts of mistakes that are made when there is not an operating procedure or management oversight or control in place. What I would call GMP-types of failures, and this is what we want you to think about, how we can prevent these.

What sorts of things could we, by regulation, put in place that would give greater visibility, greater importance, and hopefully spur compliance with having these kinds of preventive controls in place. And finally, I want to say we're not coming in here with a draft regulation in our back pocket or a preconceived idea of what we want to do. Obviously we've discussed this.

We've been working on this for several years inside the agency, so we have some ideas. But we genuinely wanted to encourage some meaningful input and some fresh ideas. Now is the time to share your thoughts with us. We have a public comment period that's open. You can send in written comments to Dockets. That's open until September the 10th. And as soon as the Public Comment period closes, we're going to get right to work on a modernization of the GMPs.

We'll begin the rule making process formally at that time.

What I'd like to do is dive right into our agenda. I mentioned that this is very important to the FDA and that Dr. Crawford had initiated this. Dr. Crawford opened our first public meeting in Washington on Monday. He's not able to be here for this meeting, but we have his video presence, and so, with your indulgence, and if I get the technology to work right, we'll have the, we'll give the floor to Dr. Crawford.

 

DR. CRAWFORD: It's called the current good manufacturing practices in manufacturing, packing or holding human food. These rules, which are entitled 21, Part 110 of the code of Federal Regulations no longer serve that purpose as well as they should. They've been there and have not been revised for 20 years, and during that time as we all know, much has changed in the food industry as well as in the eating habits of consumers.

Since the GMPs were last updated, food producers have developed a seemingly endless and constantly changing variety of processed, packaged and refrigerated products, and Americans have made them a big part of their diet. Portable soup, drinkable yogurt, squeezable peanut butter and bagged lettuce salads did not exist 20 years ago. Neither did low carb foods, Tex Mex foods or vanilla sodas, all of which are today bestsellers. Another significant addition to our menu is fresh produce imported in and out of season from around the globe. And although our food supply is as safe as any in the world, over the past 20 years we've seen an emergence of new food pathogens.

In addition, we have to contend with the fact that our consumers have become far more conscious of the hazards of food allergens than was the case two decades ago. All of this makes the need a demand for protection against food associated risk greater than ever. As an agency whose per view includes 80 percent of this nation's food supply, we therefore recently took a close look at how well the food GMPs still ensure the safety and wholesomeness of what we eat.

We conducted three studies focused on the types of hazards associated with the current manufacturing and processing practices and on the available controls to prevent these risks. One of these studies reviewed the extensive scientific and technical literature on this issue.

A second paper summarized views with solicited from experts an extensive knowledge and experience in this area. And the third survey examined the food product recalls in the United States from 1999 to 2002. I'll take just a minute to give you the highlights of this survey which included 842 recalls, 51 percent of which were Class I hazards that can cause death or serious injury, and the rest were Class II, whose health consequences are reversible or temporary. The most striking finding of this inquiry was that 715 of the recalls, 85 percent of the total probably occurred due to GMP-related shortcomings. That included improper or inadequate labeling which accounted for about a half of the recalls, and microbial contamination, which was the reason for about one-quarter of the total.

Among the most frequent process at level problems were ineffective employee training and inadequate standard operating procedures. These results and the information gathered in the two other surveys made clear that the food GMPs need updating. One obvious possibility is adoption of modern sanitation measures in the production of prepared foods, which are usually consumed weeks after they leave the production facility. Employee training and education is another area that may need improvement. But what changes the GMPs may or may not require is not a decision we want to make without consulting with you, our stakeholders.

Stakeholder input is a firmly imbedded principle in FDA's traditional decision-making process that we follow rigorously. We, therefore, scheduled three public meetings to discuss this issue. One in College Park, Maryland on July 19. One in Chicago on July 21, and the final one is in San Jose, California on August 5. What do we want to accomplish at these meetings? We have two overriding goals. One, we want to explore the best, potentially most effective science-based measures that approaches that would help manufacturers reduce the likelihood of producing foods that can be injurious to consumers.

Without ignoring the problems involving labeling, we want to primarily address the most serious risk of contamination with chemical, microbiological or physical impurities. In dealing with these issues, we will be careful to distinguish between practices that may directly impair food safety and those whose effects are likely to be marginal. Our guiding principle will be reliance on science-based systems that are guided by evidence, both regarding problems and their effective solutions.

The outcome we seek is a set of targeted requirements that will enable manufacturers to focus their resources on strengthening the safety of their products. A corollary goal, and I want to emphasize this, is to elicit your ideas on just what should be changed in the GMPs and how. Of course, we'll be drawing on appropriate literature and on the experience of food technologists, microbiologists and industry professionals of all kinds. But extensive thoughtful input from all of our stakeholders is critical. We need your full support for this initiative and your help.

As a general background, I should add that updating the food GMPs is only one facet of a broad modernization process we've recently initiated with a similar reform of the pharmaceutical GMPs. Eventually we intend to modernize the GMPs of all industries whose products are regulated by FDA.

Yet another innovation we've recently launched is the development of standards and methods that would enable drug sponsors to better estimate whether their medications will qualify for marketing. This is an enormously important issue in drug manufacture, where only eight percent of new compounds eventually achieve FDA approval and reach patients.

We're also considering a similar initiative to reduce the technical, regulatory and marketing uncertainties faced by food producers who contemplate the development of new products. A common denominator and overarching aim of these and many other FDA initiatives is to reduce and manage the risk effecting the health of our public, and thereby advance the vitality of our nation. Your participation in today's meeting and discussions is a meaningful contribution to this effort. I very much appreciate that.

Thank you for coming and I am looking forward to your information and views.

   

DR. ZINK: I would like to introduce our first speaker, Dr. Richard Williams. Richard is a scientist in the Center for Food Safety and Applied Nutrition. He joined FDA in 1980 after receiving his Ph.D. in Economics from Virginia Tech, and he's currently the Director of the Division of Market Studies in CFSAN. This is a division that includes a variety of scientists, statisticians, epidemiologists, physicians, sociologists.

This is that division of the Center that conducts much of our outward reaching research, the economic analysis of cost benefit of rules, et cetera. They do very diverse research, even things related to first amendment issues, labeling, biosecurity, gathering and analyzing epidemiological data, and Richard has been responsible for the analysis of the impacts of regulations, or things like nutrition labeling and education act. He's an expert in various regulatory matters pertaining to the U.S./Canada Free Trade Act. He helped negotiate that, and he's responsible for developing a series of courses in risk analysis and food risk management as a part of our relationship with the University of Maryland, a center we call GIFSAN, and our staff college. He's an expert in risk analysis and risk management and he's published numerous papers on risks and trade-offs, and is an expert on regulatory flexibility for small businesses. Richard?

DR. WILLIAMS: Good Afternoon. Thank you, Don. As Don says, my portion of this will be to talk about the research that we've been doing that is ongoing right now into preventive controls. And this research is just one of the many inputs that will go into the final decision on how we reform the good manufacturing practices. As Dr. Crawford said, we hope that any reform we do will be science-based and it will be based on evidence of things that work, and I think that's a recurring theme that you will hear.

Okay, so how do we start? We always start by saying what is the question that we're being asked to answer in terms of research, and the question that we think we're being asked to answer is what significant hazards are associated with FDA regulated food that can be addressed by preventive controls, and then what are the most effective preventive controls for those hazards?  And as always, we do consider sort of the big three grouping microbial hazards such as pathogens, chemical hazards such as allergens, and physical hazards such as glass or metal.

So that's the question that we were asked to answer and as Dr. Crawford said, we have done three studies, and I'll go over those a little bit more in detail.

This next slide really talks about sort of how we think about the evidence that we need to go after good manufacturing practices and there are sort of two big sources of evidence that we went after. The first is what are the current problems right now in food processing that are related to good manufacturing practices? In other words, what things are happening right now? There are outbreaks of illness and they could either be because, simply parts of the food industry are not following the good manufacturing practices, or maybe it's things that should be in the good manufacturing practices but that aren't there now.

So that's one type of evidence that we want. What hazards are out there now that are related to preventive controls more broadly? The other thing is we want to make sure that when we go to rewrite the good manufacturing practices, that we don't lose anything that's effective now. In other words, there may be practices that manufacturers are using now that are either in the GMPs again or not in the GMPs. They are actually solving problems and we want to make sure that we capture those as well to make sure that we get a complete set of good manufacturing practices that are effective and that will address the problems.

Okay, so let me go through the first one now, the current problems. As Dr. Crawford said, we are in the process of conducting these three studies: a literature search, an expert elicitation and a recall study, and we regard stakeholder input as just another source of data because we will be getting that also. These studies will be completed around the end of September. However, we will have a summary of the overall findings, and these findings will not change, up on our website within about a week or two, and we would very much like for you to read them and comment on them and tell us what you think.

In addition, as I said, we're going to look at, you know, what potential problems are there that are being solved right now that we ought to capture in the good manufacturing practices. We intend to survey the food industry starting sometime either, I think, this fall or winter, as to what all the existing practices are that people are doing, and that's going to be focused not just on good manufacturing practices, but again, more broadly on preventive controls. And again, stakeholder input we hope will play a big role in what's working now, what manufacturers are doing.

Okay, let me go through the individual studies. The literature survey, interestingly about three-quarters of the literature that was related to preventive controls addressed microbial hazards, about a quarter addressed chemical hazards and virtually nothing on physical hazards. Two of the big repeated themes that we found in the literature, one was poor worker hygiene was a leading problem in food manufacturing plants. The other one that was at least somewhat of a surprise to me was that training was mentioned over and over and over again. The absence of effective training, and they mentioned various reasons why the training might not be effective.

Language barriers, for example. I know in my county, in Fairfax, Virginia, in the retail food industry they speak a 120 different languages. I'm sure food manufacturers have problems with this as well. A lot of discussion about whether or not generic training is needed, or more specific training that's plant related, and even getting very specific on what training is needed in hygiene, cleaning, pest control and preventive maintenance. More findings, contamination of raw ingredients in the literature was seen to be a big problem, whether it was incoming raw materials or actual in-plant contamination. And then, a lot of literature has emerged recently on allergens, allergen contamination by raw materials. Residue problems where the residues aren't removed, and label review policies, another thing that very easily could be in the good manufacturing practice rule. It was found that not a lot of plants had good label review policies in some of the literature. And finally, design. Either plant design where you had zoned areas that led to cross-contamination. They were improperly zoned. And equipment designs. Some literature on that where you have niches and equipment is just simply difficult to find.

Okay, the next study we did was an expert elicitation. This was a method for eliciting data from experts. It was actually developed in World War II and it's been adapted in the risk analysis field and we made use of it. It's just simply a method for getting information from experts and getting them to agree on things. We are in the process now of just finishing up four rounds of interviews.

We had seventeen experts, national experts that are from around the country, experts in microbiology, experts in food processing and so forth. And what we asked them to do was tell us what the most important risks are and then what are the most important and effective controls for the food industry. We asked them to do it both generally and by sector. And let me give you just a little bit of an overview as to what they found. Again, the theme of training came up.

Training, training, training, and in this case, the experts felt that everybody needed to be trained. That employees needed to be trained, managers needed to be trained and suppliers needed to be trained. Again, this finding of training went all through the three studies. The experts felt that record keeping for standard operating procedures was necessary. Another interesting finding that cleaning needed validation, as to whether or not your cleaning SOPs were working. Periodic audits of facilities and raw materials. Sanitation SOPs and environmental sampling.

Preventive maintenance programs. Again, labor review and verification, again related to allergens. And finally, one really interesting thing is they thought that firms needed incentives from FDA to comply. Don't know how we'll handle that one. Okay. And then last was the recall study. Now the previous two studies were done for us by a contractor and are being finished. The recall study was one we did in-house by our epidemiology team, and as Dr. Crawford mentioned, we have done Class I and Class II records. You'll see more recalls than he mentioned there because he taped his remarks earlier and we've been working away. We actually have done 1,055 recalls and as he said, about 85 percent of the recalls were due to GMP violations or labeling. And a big percentage was incorrect packaging or labeling.

Again, you see that theme, ineffective employee training, 33 percent, standard operating procedures for processes failed and so on. Contamination of raw materials, mistaken or excess addition of chemicals, and ineffective use of sanitation principles. The way we did this study is with Don Zink here and others, we actually went through the recalls and they went to look for these root causes of what actually caused the problem in the plant. So that's been taking them quite some time. Again, we will have that, we will have the results of all three of these up I hope in a week or two. You can look on our website for it, and the final studies will not be done until the end of September.

That's not all we're doing to do. As Don mentioned, we have a staff of economists who will be looking at the costs and benefits of all of the different regulatory options for preventive controls. We're also going to need, and you're going a little bit about this later, we're going to need any information as to whether or not different provisions are needed for small businesses. And finally, any information that you would like to submit to us on that will help us make the new rules easy to follow and effective. And, thank you for your time.

 

DR. ZINK: Our next speaker is Dr. Bruce Tompkin. Now while most of us were here because it's our job, Bruce is retired. Bruce is retired as vice-president of Product Safety for ConAgra Refrigerated Prepared Foods, and Bruce has had a long and very successful and esteemed career in food safety, food microbiology. His expertise is internationally recognized. He got his Ph.D. from Ohio State. We won't hold that against him, and he has spent his entire career with a company that underwent a number of name changes, proving that you can continually survive many reorganizations. Beginning when it was called Swift and Company, then Beatrice Refrigerated Foods, and Swift Eckridge, and Armour Swift Eckridge.

Throughout all these years, Bruce saw the arrival of listeria monocytogenes as a problem in ready-to-eat meats, and he was a leader in how to deal with it. He serves in numerous professional capacities. He is a member of the International Commission on microbiological specifications of foods which has published perhaps the most lucid works on how to implement, process controls and microbiological controls and microbial hazards. He's a member of the National Advisory Committee on microbiological criteria for foods. He's a member of the Joint FAOWHO Expert Consultation on microbiological risk assessment, particularly listeria monocytogenes in ready-to-eat foods, and salmonella in poultry and eggs. He's authored almost a 185 research papers and reviews, publications and presentations, chapters in more than 30 books.

So his experience is considerable, and this is exactly the kind of person we like to hear from when they can look back on their years of experience in the industry, what they saw about good manufacturing practices, what worked, what didn't, and where we ought to go for the future. Bruce?

DR. TOMPKIN: Thank you, Don. I hope that doesn't have to deduct that from my ten minutes. But it is really a pleasure to be retired, if you haven't experienced that yet.

The current GMPs are based on a long history of learning what can go wrong, and then how to prevent similar problems from occurring in the future. So, what we have is a result of a lot of experience, an evolutionary process to get to where we are today. The information currently in the GMPs is comprehensive. It is still current, and I don't think it needs major changes, but certainly it can be modified to further clarify and improve. GMPs are very important to the food industry. They provide the foundation for industry's food safety control systems and in particular, the HACCP systems, where that is appropriate.

So we do use them, and it's very, very important that they be sufficiently comprehensive that we can draw from them. Picking up on what you said, Dr. Williams, food safety really should be driven by epidemiologic data that identify hazard food combinations. And if you think back, what has happened since 1986 when the last revision of the GMPs were revised, listeria monocytogenes in ready-to-eat foods certainly comes to mind, and the larger issue, perhaps in terms of recalls and some other areas, is the undeclared allergens, and we will be hearing about the allergen issue so I won't go into that. But relative to getting at the science basis for the food control systems and GMPs, there are a number of things that we can draw upon. Well, for example, even since 1986, FDA, USDA and other public health agencies have established public health goals for healthy people 2000-2010.

So, we have specific public health goals for which we are striving as a nation, and essentially the GMPs are a foundation that's going to help us get there. And, if there are weaknesses, we should be identifying those as we move along. In 1999, Meade, et al., published its document on the number of cases, hospitalizations and so on and it was rather revealing that viruses really account for 67 percent of cases of food-borne illness in the U.S. today, and bacteria 30 percent, and parasites three percent. But that flip-flops when it comes to the public health impact to the individuals involved. So that actually bacteria account for 60 percent of the hospitalizations and 72 percent of the deaths.

So I think it's that kind of information that we can draw upon from CDC that could help provide guidance as to where we need significant improvement.

Other sources of information are the Food Net, EPI studies from CDC which are very important to us, and I think that needs strengthening. Even the old MMWR annual reports of disease allow us to track trends, as well as the food net data. FDA and others do conduct product surveys that's helpful information, and inspections, compliance, and recalls are additional sources of information. These various sources really are, should be used to better understand the significance of chemical, physical and biological hazards in our food supply. And this information, this scientific-based information should be used to monitor trends and assess whether the GMPs do need modification.

The question could be asked then, are failures in our food safety system due to something missing or that is not clear in the current GMPs, or are they due to improper implementation?  I think that's a similar question to what FDA has tried to address on its own. In going through the GMPs, I do have one comment to make. The CDC has a responsibility on an annual basis to list the diseases that are food-borne diseases that are food-handler origin, and it would be helpful to have a link to the CDC website so that when we talk about diseases transmitted by workers in the production facilities and so on, we'd know specifically what CDC thinks is important at that point in time.

Now, I think the real crux of this GMPs comes to this one paragraph where it states that "if food is adulterated, if it's been manufactured under such conditions that it is unfit for food or the food has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health."  That essentially sets forth the purpose for the GMPs, and as I view it and I think others in industry would, the GMPs essentially define the conditions then that are considered acceptable or unacceptable and that are necessary for producing, storing and transporting safe and wholesome foods.

So, essentially it's the rules of the road and it's very important from that perspective. But considering the wide variety of foods, processes and establishments that the GMPs that fall under FDA, the GMPs should be broadly written, and not too prescriptive. And then it is industry's responsibility to implement the GMPs to meet their specific, unique circumstances. I think more specific guidance can be developed for segments of the industry where greater control is needed, and FDA has taken that initiative for example, for the juice regulations, and then for sprouts.

In concert with that, industry also has played a role in providing specific guidance. For example, there is a guidance document now that's been generated by the smoked fish industry for control of listeria monocytogenes. There also is a guidance document on how to control listeria monocytogenes in processing environments where ready-to-eat foods are exposed and subject to contamination. Many of us have been through allergen-control workshops that have been essentially developed and sponsored by industry.

So, there are a number of activities that can essentially be generated and used to highlight specific problems and enhance control, essentially taking the GMPs that are rather broad in nature and bringing them into focus for those specific issues where additional help is needed. And thinking through the GMPs, I believe that new guidance for food operators is needed on how to think through their operations and decide which hazards are important for control. And I think the 1997 National Advisory Committee on microbiological criteria for foods document on HACCP does contain very good guidance on how to conduct a hazard analysis, and I think it would be helpful.

I don't want to put the idea of a regulation in someone's mind, but I think that that material is well-written and it could be modified and converted into a thought process, a check list, however you want to do it, that food operators could use to think through their GMPs. What hazards are more likely to occur in their specific operation and how, which GMPs deserve greater emphasis for control of those specific hazards. I think that guidance is currently missing and that could be helpful with regard to the training aspect.

And finally, the GMPs that are adopted by federal agencies should be compatible with a Codex general principles of good hygiene practices adopted in 1997. And, as is the case with the FDA GMP regulation, the Codex document is very thin for their good hygiene practices, but this document from Codex has not only the general principles, but specific additional guidance documents for specific segments of the food industry at the international level.

So, we're all going in the same direction, but it is very important for equivalency and world trade that whatever FDA undertakes in terms of modification, that they be in at least compatible with what we're working with at the international level. I'd like to thank you.

 

DR. ZINK: I'd like to introduce our next speaker. Terry Furlong is co-founder and chief operating officer of the Food Allergy and Anaphylaxis Network and has been with the organization since June, 1997. He's responsible for FAAN's business and governmental affairs, research and operation. He's been intimately involved in the development and progress of the food allergen labeling and Consumer Protection Act, changes to 25 state laws or regulations relating to the availability of epinephrine from emergency medical technicians, and is a FAAN's expert on traveling with food allergies, especially on commercial airlines.

Terry's research focus has been on the epidemiology of food allergy and includes peer-reviewed published studies on peanut and tree nut allergy including reactions to peanuts and tree nuts in restaurants, schools and airplanes. He sits on the anaphylaxis and adverse reactions to food committees of both the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology. As co-founder of FAAN, he has a personal interest in food allergy.

His youngest daughter was diagnosed with milk and egg allergy as an infant, and I think that's certainly enough to spur anybody into concern about food allergies. Before joining FAAN, he spent eight years as a senior vice-president of the American Trucking Association, 20 years with Time-Life's book, music and video publishing operation, and he has a Master's of Science degree in business policy from Columbia University School of Business. Terry?

MR. FURLONG: Thank you very much. First of all, I'd just like to note that the food allergen labeling and consumer protection act passed the House yesterday, so we're very pleased with that, and if President Bush signs it, it will become law effective January of 2006.

I'm going to briefly touch on today a little bit of background on food allergy and then articulate what our causes for concern are in the areas of undeclared allergens, precautionary allergen statements, and rework.

About 11 million Americans are allergic to some sort of food. The vast majority of them are fish or shellfish and/or peanut and tree nut. Six and a half million is a number that was just published this month in the Journal of Allergy and Clinical Immunology. And peanut allergy in children has doubled from 1997 to 2002. But the buying behavior of many more millions are affected. All of those children with peanut allergy have mothers and fathers, aunts and uncles and grandparents and teachers and childcare workers who are making buying decisions based upon the needs of the food allergic child, so there's a big leverage in this number. And as I'm sure you know, milk, egg, wheat and soy are the other major allergens.

The concerns we have in this area that in the incidence of food allergy may not yet have peaked. That trace amount of allergens can cause fatal reactions. There's no cure for food allergy. Strict avoidance of an allergen is the only way to prevent a reaction. Severe allergic reactions to food result in about 30,000 trips to the emergency department every year, and about 200 deaths in the U.S. In the health and safety of food-allergic individuals depends upon clear, accurate and reliable food labels. In a survey we did last year of almost 700 attendees at our conferences across the country, we asked them "have you ever called a food manufacturer for more information about a product's ingredients?" And 75 percent of them reported that they had. We think that suggests that there's either not enough information on the label or not the right kinds of information, or it's not clear enough.

Food allergy is clearly a significant food safety and public health issue. People's lives depend upon knowing with certainty what is in a food item. Some companies have embraced the issue, others have ignored it. Compliance can't be optional. In the 1999 recalls, 35 percent were due to undeclared allergens. That's a staggering figure. They were caused by three principle factors. Ingredients statement omissions and errors, cross-contact from shared equipment, or human error. The area of undeclared allergens FAAN members regularly call in to food manufacturers and the FDA to report reactions. Dozens and dozes of products that have been suspected of causing allergic reactions due to undeclared allergens have been confirmed in tests by the food allergen research and resource program at the University of Nebraska.

I'm going to run through a couple of cases briefly just to illustrate the kinds of things that these folks are up against. A FAAN member reported that his daughter had had a reaction to a cookie. The manufacturer told him the item was made on shared equipment and the company acknowledged that cross-contact was the problem. Another member told us that her 16-month old son had a reaction to a frozen fudge product. The company told her that there was a possibility it contained milk because it was made on the same equipment as milk products and employees aren't careful these days.

Another FAAN member reported a product, indicating that it contained traces of peanuts. Her tree nut allergic daughter had had a reaction. The company told her that the product was made on the same line with walnuts, not peanuts, and there was no indication that it may contain walnuts. In this case, a FAAN member purchased a half-gallon of ice cream. The label stated that it contains milk. While she was eating it, ran into a sliver of nut. The company informed her that all their ice creams are made on shared equipment, but no nut warning was given.

On the precautionary allergen statement front, the allergen advisory or "may-contain" statements were developed by the food industry as a way to better communicate additional allergen information to those with food allergies, and we applaud those efforts. The statements are voluntary. There is no standardization of messages, no rules for what they mean, and no rules for when they can or should be used. There's a 1996 FDA letter that says that "may-contain" statements cannot be used in place of good manufacturing practices, and we're afraid that that's where a lot of them have gone.

There's a tremendous proliferation of the types of messages and the numbers of products that contain them. About a year and a half ago, one of our staffers went to a local super market in Virginia and sampled precautionary allergen statements in four product categories: candy, cookies and crackers, snack foods and other cereal, bread and baked goods, et cetera. She found 28 different precautionary allergen statements on the packages. Some companies use them, some don't. Some of them use them sparingly. Others put them on all of their products. Consumers are confused, and forced to spend more time decoding the messages.

What do all of these statements mean? I'll give you some examples. One FAAN member asks "Is there a big difference between may contain traces of peanuts and manufactured in a facility that uses peanuts."  How is a consumer to know? Should we follow the same precautions for both of these warnings?  After acknowledging cross-contact as a result of an allergic reaction, a company told our member that when they order new packaging, they would add a warning to the label. However, it might take a few weeks.

In another, a FAAN member reported that a chocolate bunny that she had purchased listed no peanut, no tree nut ingredients and featured no allergy warning. Identical products in the store had "may contain peanuts" on the label. The manufacturer said that all the bunnies made on the same equipment, were made on the same equipment, and all should have had the same warning. This is consumer confusion.

Consumers often don't read the ingredients statement if a product has a precautionary allergen statement. So, if it says one thing, it needs to be consistent. Sometimes they're inconsistent, thereby increasing a risk of a reaction. Examples are that some companies think that peanuts are the only allergen that warrants advisory labeling. They have "contains peanuts" statements even though it also contains other major allergens. And some companies think that peanut and tree nuts are interchangeable. One company that put "contain traces of peanuts" on the label of a product that is manufactured on equipment that is shared with walnut containing food.

But the ultimate we think is this one. We've paraphrased it for brevity here, but it says "may contain peanuts and other allergens not listed on the label." Anybody have a guess at what's in there? We sure don't.

Rework is our other area of concern. There are no regulations regarding rework in allergens. It's mentioned in the compliance guidelines. But the result of not taking food allergen control seriously or keeping like into like when handling rework can be deadly. A 21-year old boy with a known allergy to peanut died after ingesting chocolate chip cookies. Peanuts were not listed in the ingredients nor was there a precautionary statement. Testing after the fact revealed three thousand parts per million.

A prominent allergist with a known peanut allergy nearly died after ingesting ginger snap cookies. The product had undeclared peanuts from rework. If it wasn't for his training and his ability to recognize his own symptoms and his access to epinephrine, he would not have survived.

So, in conclusion, we believe that food allergic consumers depend on the FDA to protect them. Their lives depend upon accurate, clear and reliable labeling. The agency must take the lead in food allergen controls, especially as it relates to labeling and good manufacturing practices. We heard some discussion the other day about guidances versus regulations. We think guidances are merely suggestions, and therefore, optional. Regulations include lots of "shalls", and consumers lives are dependent upon compliance. We need the "shalls." 

In an ideal world we would have manufacturers using separate equipment for allergens and non-allergen containing product, but that's not the reality. We think FDA must provide regulations regarding GMPs, rework and labeling so that all companies that are doing the best they can regarding separating, cleaning, packaging and labeling of allergens.

Food allergen control measures should be part of the HACCP plan of all companies who use allergens, not just the few industry leaders who get it. Consumers can't manager their food allergies alone. They need the help of the FDA and the food industry. They must have accurate information on the label and proper food allergen management at the plant in order to avoid a reaction. Lives depend on it. Thank you very much.

 

DR. ZINK: I'd like to introduce our next speaker, Marlena Bordson. Marlena has been with the Illinois Department of Public Health, Division of Food, Drugs and Dairies for 32 years in a variety of positions in food and dairy sanitation. She currently serves as Division Chief and Acting Dairy Program Manager.

Prior to accepting the position of Dairy Program Manager, she served as Regional Supervisor for the Division in the Champaign regional office, covering sixteen counties in East Central Illinois. During that time, she was certified by the FDA as a Retail Food Evaluation Officer. She serves as Chairman of the National Conference on Interstate Milk Shipments Executive Board. As a member of the National Conference on Interstate Milk Shipments FDA Liaison Committee, the Halling Practices Committee and the Program Committee.

Currently, she serves on the Illinois Department of Professional Regulation, Board of Environmental Health Practitioners, the Illinois Department of Agriculture, Yonees Disease Advisory Committee, the Illinois Food and Water Security Work Group, and as an advisory member of the Illinois Milk Producers Association. Marlena?

MS. BORDSON: Thank you. I appreciate the opportunity to present comments on behalf of the state regulatory agency on the issue of updating the food current good manufacturing practices.

Our agency participates fully with the Food and Drug Administration in the conduct of regulatory inspections and related activities such as enforcement and sampling under our contract for food processing and warehousing inspections, and under various partnership agreements. Illinois has adopted enabling legislation and rules patterned after the Federal Food, Drug and Cosmetic Act and the current good manufacturing practices and utilized these as the basis for our direct inspection and enforcement activities.

We believe, in general, that the good manufacturing practices have been very good in providing a framework for safe and sanitary manufacturing, processing, and holding of food for human consumption. These regulations have provided a strong foundation from which food category-specific regulations, compliance policy guides, passive regulations and industry-quality programs could be implemented. However, there are improvements that should be considered in order to provide greater assurance of food safety. When considering any changes, it is important to remember that the success of these current good manufacturing practices has been their applicability to many different types of food industries.

We recommend that the regulations remain basic and to the point. In order to more effectively control the three types of hazards identified in this public notice, physical, chemical and biological, the regulations should be more specific in the statement of the hazards in connection with the regulation or recommendations. For example, under the section on personnel, controls for physical, chemical and biological hazards are intermingled. Inspections staff prefers to evaluate compliance with rules in broad categories such as personnel, building and facilities, equipment for example. But we recommend that within each of the categories, the regulations be arranged to group control requirements or recommendations for like hazards together.

In reviewing the questions posed in the notice for these public meetings, I was struck in particular by the request for recommendations for how the effectiveness of preventive controls be most accurately measured. I reflected on the struggle to document and measure for our own agency how effective our programs have been. How do we measure what we have prevented? Is a control for metal objects in the finished product best measured by how many pieces of metal are found or by a reduction in the number of consumer complaints on pieces of metal in finished products? Should we look at large populations over several years such as the healthy people 2010 objectives for reducing specific food borne illnesses, or do we measure the reduction in numbers of violations in broad categories that are attributable to factors causing food borne illness? 

In comparing CDC data to our own data collected in Illinois, we see that the factors contributing to food borne illness replicate the five leading causes identified by CDC: improper holding temperatures, poor personal hygiene, contaminated equipment, foods from unsafe sources, and improper cooking temperatures. In the years 2000 to 2003, Illinois factors varied slightly by adding ill food handlers to the list instead of foods from unsafe sources. However, each of these factors can be directly attributed to some failure to control a biological hazard. Similar reporting systems would need to be utilized to allow us to look at large numbers of reportable illness or injury attributed to physical or chemical hazards.

Another question dealt with controlling the presence of undeclared allergens in food. The principle contributors to the presence of undeclared allergens in food may be as simple as a lack of understanding of the serious nature of allergenic reactions to as complicated as preventing product carryover in large multi-product production facilities. Both labeling errors and cross-contamination contribute.

Frequently such reactions occur because the presence of the allergenic substances in the food is not declared on the food label. Allergens may be unintentionally added to food as a result of practices such as improper rework addition, product carryover due to use of common equipment, and production sequencing or the presence of allergenic product above exposed product lines. Such practices with respect to allergenic substances may be unsanitary conditions that may render the food injurious to health and adulterate the product.

However, the current GMPs do not adequately address allergen control, although control measures could be inferred for the controls for physical, chemical or biological hazards.

The section of education and training of employees only includes the dangers of poor personal hygiene and improper food handling techniques. It should also include education and training in all aspects of hazard control including allergen control.

I recommend that FDA look to existing quality systems that have modernized in recent years including the pasteurized milk ordinance, the food code and the shellfish ordinance. These programs have had the benefit of the involvement of individuals from all sectors, regulatory, industry and consumers. In recent years, greater efforts have been made to assure that changes to provisions of the model ordinances are science-based and are implemented under proper legal authority.

As stated previously, any revision to the current good manufacturing practices should take into consideration the variations within the food industry and provide broad recommendation for those areas that can be handled generically. However, there should be different sets of preventive controls for identifiable segments of the food industry. With particular reference to temperatures, the temperatures for cold and hot food storage in sub-part E, production and process control, Section 110, point ADB3 should be changed to reflect temperatures adopted by the conference for food protection of 41 degrees Fahrenheit and 135 degrees Fahrenheit in the food code. Sufficient time for industry-wide correction of temperature control equipment and facilities must be taken into consideration.

In addition, in Section 110, ADB4, the term "adequate" is used to evaluate measures such as sterilization, irradiating, pasteurization, et cetera. The definition of adequate is not well defined. This poor definition remains one of the biggest stumbling blocks to evaluating compliance with measures and this is a quote "that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance." It would be preferable to use terms such as measures that can be demonstrated, validated or documented.

Also noted in the questions for consideration were a number of measures, procedures and programs that could be used to ensure that preventative controls are carried out adequately. Without listing each item individually, we recommend that all of these be required items that a plant or warehouse must abide by as part of a current GMP program. Although small or basic operations may not have a sophisticated training program, they nevertheless must be responsible for the training of their employees. Likewise, written records may be on a clipboard or in a computer, but records must be maintained. Validation of control measures as previously mentioned, must be routinely documented.

Finally, inadequate attention is given to the prevention of all types of hazards in the warehousing and transportation of foods. Circumstances that are unique to warehousing and transportation are not addressed at all, are frequently neglected, and are critical to the protection of the food supply.

Thank you for the opportunity to comment.

 

DR. ZINK: Our next speaker, Mr. Brian Hendrickson, is with the Food and Drug Administration, Office of Regulatory Affairs. Brian is one of our national food experts in the Division of Field Investigations. As such, he's regarded as a national authority in food inspections. He conducts inspections related to the most complex, controversial and precedent setting scientific and regulatory problems, both nationally and internationally. He has been involved in developing agency policy and in developing and presenting national and international training programs to FDA, state and foreign governments in the area of low acid canned foods, acidified foods and packaging. He has 32 years experience as an FDA field investigator. He holds a Bachelor's Degree in Food Science and Technology from Oregon State. He's a member of IFT and the Institute for Thermal Processing Specialist in the North Central Association of Food and Drug Officials. Brian?

MR. HENDRICKSON: Good afternoon. As the last speaker, a lot of my speech has already been presented, but it shows that really, we're in sync, which is very interesting, but I didn't have the privilege of seeing their speeches.

As a member of FDA's Division of Field Investigations, Office of Regulatory Affairs, I am going to present the following comments from a regulator's perspective because I'm really out there in the field doing inspections, doing GMP audits, training other people in the field to do this activity, and also we do a lot of classroom training, so we're really using the food GMP, and what I'm going to do is I'm going to talk a little bit about the updating of this very important regulation.

Good sanitation is mandatory for all foods. Section 402A4 of the Food, Drug and Cosmetic Act deems food adulterated if it has been prepared, packed or held under insanitary conditions. Those conditions or practices that are necessary to produce a food that's not adulterated are outlined by the food GMP. For years FDA has been regulating the food industry under this GMP, 21 CFR as we know it now as Part 110. It goes way back. I came in the FDA in 1972 and at that time the food GMP was known as 21 CFR, Part 128. And I think it was the late 1960's when it first became effective. So, we've been using it for over 30 years, long time. However, the agency has not been completely successful in developing a culture whereby food processors take a, assume the role of operative controls in assuring sanitation within their plants.

The statistics relating to the incidence of insanitation cited in the preamble to the seafood HACCP regulation, and observations from USDA's HACCP rules for beef and poultry, clearly demonstrate that such a culture was not in place in 1995, and this is just a year or so before these rules became effective. Further, the requirement of standard sanitation operating procedures, SSOPs, sanitation monitoring and record keeping in the more recent juice HACCP regulation further highlights the significant need to motivate a portion of the food industry to comply with sanitation requirements. As previously mentioned by Dr. Williams, an FDA CFSAN division of market studies examination of food recalls from 1999 to 2002, found that a majority of the recalls were related to a good manufacturing practice problem.

Some of the good manufacturing practice issues outlined in the study were as follows and I'll just briefly just mention them again, and they've already been mentioned before but, incorrect labeling and we're talking about allergens here as a big problem; ineffective training, and this is really been stressed before in presentations here; product cross-contamination; lack of routine maintenance; poor equipment and plant design; lack of temperature control; and ineffective employee hygiene. All of which, with the exception of labeling, are addressed in the food GMP. Although the number of food recalls relating to sanitation seems high, it makes sense as FDA's own database shows, that the top 30 food inspections observations made by FDA investigators during inspections, relate exactly to these types of GMP deficiencies and more.

Taking a look at the GMPs, the GMP regulation for food is long overdue. FDA, consumers, the regulated food industry and other interested parties need to take the time to evaluate the these regulations and make suggestions for revisions. If successful, these revisions would help FDA assure that firms take full responsibility for sanitation in their plants, which, of course, relates to the production of safe and wholesome food. Revision of the current regulation should attempt to strengthen the current requirements in the following ways.

Requiring specific daily sanitation regimens that incorporate features such as monitoring, corrective action and record keeping, to help the processor track sanitation in their plants. Statistics from the seafood HACCP program as it relates to sanitation have shown that this type of requirement has helped with compliance. For example, the seafood HACCP regulation, when if first became effective in December, 1997, 1998 was the very first year that it was really used by the food industry and FDA started to do inspections, GMP inspections to enforce this regulation, Part 123.

In 1998, the percent of firms that had adequate sanitation controls, including GMPs, sanitation, and record keeping was 21 percent. While in 2003 or five years later, after being inspected by FDA, by FDA audits over those years, it was 54 percent, an over 100 percent improvement in five years.

Okay, the next point I want to make is requiring specific records for verification activities such as calibration of monitoring equipment to ensure that accurate instruments are used to measure and control process parameters. Requiring documented validation for equipment design. Process establishment and process delivery to ensure that the process is designed and delivered to control or eliminate specific targeted hazards.

The next point: addressing more stringently the training requirements for food plant operators as well as employees, and documentation of that training to ensure that food plan operators and employees understand the responsibilities for producing safe food products.

The next point: defining allergens and requiring monitoring and record keeping to assure the products are properly labeled. And in addition, defining additional terms used the food industry such as pasteurization, for example. Pasteurization, we think of pasteurization, we think of milk processing for a certain number of seconds, holding food at a certain temperature has been pretty well defined, but really, many products are pasteurized. Crab is pasteurized, acidified vegetables are pasteurized. Acid fruits are pasteurized. Pasteurization can include high intensity light, and new processing techniques such as high pressure processing, what exactly is pasteurization? It needs definition.

The next point here is requiring each food processor to determine hazards associated with their products and manufacturing processes in controlling those hazards throughout the process.

These are just a few items that not only I feel that needs addressing, but it's a kind of collective opinion of the other national food experts that work for the Division of Field Investigations. Today we hope to elicit responses from you and other suggestions to help FDA foster a climate of and a commitment to good manufacturing practices that may well have been lacking in a significant portion of the food industry. Thank you for your time.

 

DR. ZINK: What I'd like to do now is, you've heard the invited speakers. I'd like to open it up for a period of questions. We will encourage anyone in the audience to ask whatever questions might be on your mind. We'll do our best to deal with it. If you would like to direct it to specifically one of the speakers, please say so. So, if there are any questions, please come to the microphone and I ask you again, to identify yourself and your affiliation. Not everybody at once now.

MR. FOWERS: I'm Mike Fowers, coordinator of product quality, Amalgamated Sugar Company. The question I have is with Dr. Tompkin. You mentioned that he was involved with the role with FDA in trade agreements. I'm curious as how much is the FDA involved with those trade agreement regulations and, like CAFTA, and how will the FDA evaluate if the importers are complying with the GMPs?

DR. WILLIAMS: I heard a 2-part question, and I want to make sure I understand. First of all, the second one, let me start with the second one, because I think we got that one before. You asked how will we ensure that manufacturers from overseas that are exporting to this country comply with this?  That was the second part of the question? The first part was about trade agreements, and I am not involved in those trade agreements. Nega, would you like to, because you've been so, anything you want to say with that? Our regulation right now is just focused on, first of all, let's do first things first. First of all, we have to see what we're going to do with this regulation. And then in terms of enforcement, we're going to enforce this regulation just like we enforce all our regulations on imported foods. I don't think any changes there, Don, do you?

DR. ZINK: Well, one thing we recognized in looking at this is, and one of the reasons Dr. Crawford cited it in his introduction is 20 years ago it was a different story than it is now. We have a very much more global food supply now than we did say 20 years ago. I imagine myself being overseas, either working for a foreign government or a foreign manufacturer, looking at 21 CFR, Part 110 trying to decide what it is that's required. And certainly, words like adequate and things like that might be confusing to them. The very broad nature of that which is important for general applicability of the regulations, you know, is an issue, and so, clarification of these regulations, yet while keeping them broadly applicable is one of the challenges and perhaps, you know, guidance documents to make it more clear to all of our trading partners what's required. We're in a different world today than we were when those were first written.

MR. RUSHING: John Rushing. I'm from North Carolina State University in Raleigh. One of the things that concerns me a little bit is the state intent of the GMPs is to be able to regulate other 402A4 of the regulation, I mean of the statute, and I guess my concern is I hear from more and more regulators that you cannot really follow up very well with violations of 402A4 based on the GMPs, and I'm wondering if the new GMPs will be able to correct that or will that just come as a ruling from counsel, or will it develop into the same concerns we have now, or what do you think's going to happen there?

DR. ZINK: I smile because we've heard this before. It got so bad at one point that we've had to declare a moratorium on this debate within our working group. That are some that will tell you that it's difficult to enforce, and there are some that will tell you it's enforced all the time. And both are true. We take enforcement action under 402A4 all the time and for GMP violations. I mean, not a week goes by that we probably couldn't cite a case history where we do. However, if you speak, you know, from a lawyer's perspective perhaps, lawyers would love something, you know, stronger and more specific. But I believe, you know, we can enforce 402A4 and we do it all the time.

DR. WILLIAMS: I would just add that we are following up on that very question, but thank you for asking it.

DR. ZINK: Any more questions. Bruce, did you have anything?

MR. TOMPKIN: I had just one comment relative to international situations. A number of my colleagues in other countries wonder what is GMP is. They think only of good hygiene practices or GHP and they continually ask me what is a GMP? And if you put the Codex general principles, the outline, create an outline for the components, along side the FDA GMPs, they are basically identical. The words are different but all the parts are the same. And then FDA has added some portion onto it with regard to process control. There are some differences that way. But, some clarification is from an international perspective, and I don't know how you do it in a federal register, but it would be to actually for our foreign trading partners, explained how do the GMPs, U.S. GMPs fit in to the international concept of GHPs.

DR. ZINK: Any more questions? Yes?

MR. RAY: My name is David Ray with NewlyWeds Foods. I'm interested if the agency has any plan to set up the minimis or minimums for allergens in terms of either parts per million or some level so we can set up a validation studies and so forth?

DR. ZINK: I have not been an active part of the group working on food allergens, and so I really can't speak to that directly. I don't know, is there any, Fay, do any of you, Nega, have you been more involved with it? This is Nega Beru, from the Office of Plant of Dairy Foods.

MR. BERU: Yes, my name is Nega Beru, Division of Plant Product Safety. There is some work to try and look at what is a threshold that elicits and allergenic response, and there's some studies being done. Studies, reviews of the literature, but I think we're quite a ways from declaring that level at which, because science is just not there, what is the minimum amount that elicits an allergenic response. We're just not there.

MR. RAY: Well, just to follow up on that. We'd be very interested in having that based on science and having a level at which we can then track to, because right now we're, of course, making our own decisions and driving it down to irreducible minimums, but the cost certainly is a factor there, so, anything you all could do to help out there would be helpful.

DR. ZINK: We certainly share the desire to have it science-based.

MR. FURLONG: May I make a comment on that. There are some studies under way to look at that very issue. But they keep coming up with people who are ever more sensitive and that's the problem. There is no completed study yet that is defined with the minimum elicitation doses for any of the major allergens at this point.

DR. ZINK: Anyone else that would like to offer a question? If not, what I'll do is, we'll adjourn here for, let's say, what, oh, another one. Oh, in the back? Can you come to the microphone?

MR. SONI: Sure. I represent Solo Cup Company and we make packaging items --

DR. ZINK: Okay, and your name?

MR. SONI: My name is Hari Soni.

DR. ZINK: Okay.

MR. SONI: And, our customers sometimes expect us to meet the same requirements like a food manufacturer. Is the GMP going to address the needs of packaging industry stuff?

DR. ZINK: The GMPs don't explicitly address a manufacturer who is, say, producing packaging materials, although I guess you would expect those materials to be handled in a hygienic manner, in a way that they don't contribute to the adulteration of foods. I don't believe we've extended them to, we haven't them to actual regulation or inspections of packaging producers. Brian, do you recall any time in which investigations or inspections are carried back to the packaging supplier itself?

MR. HENDRICKSON: No, none. No, I haven't. I don't think there's no regulation that goes back.

DR. ZINK: Yes, I think we've kind of put it on the manufacturer to deal with their suppliers and ensure that their supplier is delivering them packaging that complies with the regulations and is handled in a sanitary manner. Otherwise, it's that manufacturer that's got the problem. Okay?

MR. SONI: Okay, thank you.

DR. ZINK: Okay, we have some more questions?

MR. REEGERS: Yes, Arnold Reegers, Step and Company. To follow up on the packaging question, will the GMPs then comply or apply to situations where food producers say order chemicals from chemical companies that would then enter the food chain. And I'm thinking of, say, as a for instance, surfactose.

DR. ZINK: Yes, I mean, I think we would, you know, if you'd like to make a written comment or suggestion of how we could or should incorporate that, we'd sure like to see it. Certainly, the GMPs would apply to any situation in the plant where a chemical could, you know, be an adulterant of the food product. Anymore questions?

MS. BLAIR: Betsy Blair with AIB International. Back to the comment about international perspective. We have an office in the UK and we do U.S.-style inspections in Europe, and one thing that we've seen is they're much more interested in paperwork. You may be familiar with the BRC audit, the registration tripod. It's where you spend maybe a day in a fifteen-line plant and you'll spend six to seven hours looking at documentation and maybe an hour in the plant, and that's good enough for a legal defense. And coming from our background, where we've had enforcement of our May clause for quite a long time and it's expanded as time has gone on, it's given us a lot different perspective over there as, okay, we're going to come in and we're going to spend time in the plant, and if you've done any inspections outside the U.S., it can be a little startling sometimes. So, even though the legislation is the same, I think the perspective of how they enforce it, you know, we have our May clause, Canada has it, but over there it's more due diligence defense. I've got truckloads of paperwork, you shouldn't prosecute me, so, something to keep in mind if you're going to look at expanding into quality systems and things like that.

DR. ZINK: I don't think our philosophy will change and that whatever you do in terms of paperwork, you know, when you walk into the production area, it has got to be a sanitary environment and they've to be producing food that's not adulterated, irregardless of the paperwork they may have to the contrary.

Further questions? What we'll do is let's take a 10 minute break. Let's say we'll convene back here in 20 minutes before the hour, and at that time we'll open it up for public comment and we have some other small business-related presentations for you as well. Thank you very much.

(A short recess was taken.)

 

DR. ZINK: Come in and take a seat. We have two more brief presentations before the public comment period. I'd like to introduce to you Marie Falcone. Marie is the Regional Small Business Representative for the FDA's 15-state central region. Before that, for five years she ran FDA's southwest region, Industry Outreach program headquartered in Dallas, Texas, and she draws on her career knowledge and experience as an FDA investigator and investigation supervisor to assist those regulated by FDA in understanding and complying with FDA requirements. Ms. Falcone has received several FDA commendable service awards, and the FDA Award of Merit for leadership in promoting FDA's mission. Marie?

MS. FALCONE: Thank you, Dr. Zink, and hello everybody. It's a pleasure for me to participate in this meeting because it is the FDA's regional small business representative's job to help implement the provisions of the Regulatory Flexibility Act, which specifies procedures for regulatory and informational requirements to ensure that special needs of small businesses are considered. Some of the Act's goals are: to improve the relationship between government and small business, and by the way, could you just show me by raising your hand, if you consider yourself a small business.

So, there are some of you here. I'm very happy to see that you're here, and I hope that more find out about this GMP revision process. Another goal is to encourage small businesses to participate in the agency's decision-making process; to provide small business with easier access to all levels of the agency; to provide regulatory options which are least costly to small business; and to help small business understand and comply with FDA regulations.

To this end, the FDA regional small business representatives assist entrepreneurs, consultants, owners, operators and employees to understand FDA requirements. We answer questions, provide guidance and explain the intricacies of dealing with the FDA. When new regulations issue, we contribute to the general FDA effort to respond to questions about them.

We make referrals to other FDA offices for those inquiries which require more technical expertise and we work in conjunction with the small business outreach and assistance offices of the FDA centers and the offices of the Commissioner to smooth the regulatory pathway for small business.

How many of you knew that FDA had small business representatives before today? Well, that's good. Okay, but that's not even half. The information on us, small business representatives, is in the brochures that were, that you picked up as you came in, contact information about us and it's also on the FDA website at www.fda.gov and on the industry activities page.

In preparation for this series of meetings, we assisted the FDA center for food safety and applied nutrition in outreach to small businesses to make them aware of the opportunity to either attend the public meetings and voice their concerns or to submit written comments to the FDA either individually or in conjunction with their associates, and I'm happy to say that at the last meeting at College Park, I was talking to a representative from Rutgers, and she said she's going to get together with some of the small business outreach groups in the area and maybe talk about making come comments, so I was really happy about that. And FDA does need to hear the concerns of small businesses, and the next speaker, Dr. Nardinelli, will explain a lot more about how to be effective in doing that.

We SBR's hear the concerns of small businesses and hear the questions on a daily basis. About 40 percent of the inquiries I receive are in the food area. And many callers seek information on what to do with regard to food manufacturing requirements on issues that are not addressed in the current GMP. They ask if shelf life studies must be done and whether an expiration date or use-by date must be on the food package. They ask about standards and test methods, how often and how much to clean their equipment, how to assure their suppliers provide compliant ingredients and packaging. They ask how they can select safe food contact surface materials, and their concerns range from tamper-evident packaging to employee health certificates. They ask when they will be inspected and what records must be kept, and whether the records of lot numbers are required. They ask what the acceptable chlorine limits are in sprout washes, and what kind of processing is necessary for bottled ice tea or salsa. They want to know whether food manufacturing equipment must have installation, operation and performance qualification, how GMPs apply to commercial kitchens used by a variety of small manufacturers, whether they can produce food for commercial distribution in their homes, whether a specific cleaning compound is acceptable on a food contact surface. They want to know where they can find reliable testing laboratories for their products.

While the current GMP was written in general terms so it remains a flexible standard as technology changes, the broadness of its language at times creates special problems for small businesses, because now there are more questions on how to comply, and the need for investigation and research by small businesses to locate information in order to comply. Small businesses in particular may not have the time or money to do this research. And here's just one example: in the 21 CFR, 110.40 Equipment and Utensils, it mandates that the design, construction and use of equipment and utensils shall preclude adulteration of food.

It also states they shall be made of non-toxic materials. 21 CFR, 110.80 states that appropriate quality control operation shall be employed to ensure that food packaging materials are safe and suitable. The indirect additive regulations which are separate from the GMPs and the FDA food contact notification website exist, and you can get them, but they do not together, provide a usable, well organized listing or reference for small businesses to select food contact materials with competence. They are compliant with FDA requirements and do not present potential long-term hazards through migration of chemicals into the food supply.

Food packaging has changed dramatically in the past 20 years. Think of how many food products now that are packaged in plastics and polymers from dressings and sauces to acid fruit drinks that were not packaged that way 20 years ago. In the 12 years I have dealt with concerns of small businesses, my impression is that they could benefit from a review of 110 as well as how FDA organizes and presents information needed to comply with the generalities of 110 to the goal of developing a more assessable, specific, understandable and integrated system of requirements and supporting information in order, ultimately, to reduce health risks in food supply. FDA has shown in many arenas that it's capable of this kind of activity, and I'm to meet specific needs of the regulatory community for information.

The steps taken have resulted in smoothing the pathway to compliance while eliminating the need for redundant research by businesses. People have mentioned the food code and it actually, the food code is for retail food service sanitation and it actually does contain specific and understandable information, for example, on food contact surfaces.

21 CFR 110.110 immediately following the food GMP addresses defect action levels, or those low levels of natural or unavoidable food defects that are not hazardous to health, and in another area of FDA called the Center for Drug Evaluation and Research, they have what's called the Post-Approval Changes Program, and what they did was they adopted an equivalent equipment list that was created by one of the trade associations, ISPE, that makes it easier for drug manufacturers when they make equipment changes. They have a list of equivalent equipment that FDA recognizes that way.

The Center for Devices and Radiological Health, which is another arm of the FDA, recognized a series of standards and tests set non-FDA organizations which device developers can select from when developing data to show their products work. Of course, it would be beneficial to small businesses if any such standards which are not FDA, and therefore not on the internet, or not assessable without cost, would be affordable to small businesses.

In the Center for Device Evaluation and Research also integrated their quality system regulation 820, which is the device equivalent of 110, and for example, they said that device companies have to review compliance and if a complaint meets the level that has to be reported under the medical device reporting regulations, 803 and 804, then they have to report it.

So it's linked right from quality system to the other regulation. That's just an example of the kind of integration and linkage that I'm talking about. And the cosmetic regulations incorporate by reference the cosmetic, toiletry and fragrance association dictionary which is the list that FDA recognizes of official acceptable names that you can put on the cosmetic ingredient list. So that's another example of making it easier for a business to comply. And, I just thought of another one in listening to all the conversation here and the talk about globalization and how to create a regulation which is understandable to foreign manufacturers.

Actually, the FDA has done this. In working with the international conference on harmonization in the drug area, because Japan, the E.U. and the U.S. created an active pharmaceutical ingredient guide that all three entities agree and have implemented, and that explains how to make active pharmaceutical ingredients that comply with, in our case, the FDA requirements. So there is a way, and there are examples on how to cooperate internationally that, you know, that we can take advantage of.

I've heard so often from small businesses that they want to comply. They just want to know what to do. The FDA needs to hear more from small businesses about how the current GMP effects their ability to comply, and what FDA might do to clarify its regulatory requirements and integrate them into a practical information system that facilitates compliance. If the FDA does not incorporate such specificity into the regulation itself, it could help small businesses by a better articulated, clear and understandable overall information system that is organized intuitively or in a more user-friendly manner and that supports compliance with the regulation. Thank you.

 

DR. ZINK: I'd like to introduce our last speaker, Dr. Clark Nardinelli. Clark has been with FDA since 1995. He's an economist and serves as team leader for Economics in CFSAN. He's worked on cost benefit analysis and small business effects for CFSAN regulations including foods, dietary supplements, infant formula and others. Prior to joining FDA, Clark taught Economics at Tulane, University of Virginia, Clemson, and the University of Maryland. Clark? I want to say one thing. While all this talk here is directed at small business, large business should take stock of this, too. This is an excellent road map of how to make an effective comment that we can really use.

DR. NARDINELLI: Yes, as Don said, I'm here to talk to you about how to comment on regulations. My sub-title is advice to small businesses, but large businesses are welcome to listen as well. Let me emphasize that comments are how businesses can participate in FDA rule making. This is before the rule even comes out. This is how you can actually play a role in the development of our regulations.

Now, two laws require FDA to ask for and consider comments and concerns particularly of small businesses. These are the Regulatory Flexibility Act of 1980 and the Small Business Regulatory Enforcement Fairness Act of 1996. These acts require us to ask for comments and also they require us to consider the possibility of different regulatory requirements for small and large businesses, and in fact, even different regulatory requirements tailored, not even just the large versus small, but to maybe a range of size of businesses, so we often use three categories. We will use a very small business category, a small business category, and then everybody else, I guess the large category.

Now, when commenting on potential provisions that might go into a modernized good manufacturing practices regulation, we have some suggestive questions for you to consider. First of all, is there a need for the requirement? Secondly, what will you do to comply with the requirement? Another thing to think about is do you think the requirement will accomplish the stated goals? So, in our modernization of food GMPs, the stated goals are fewer recalls and fewer human illnesses associated with the microbiological, physical and chemical hazards that a modernized GMP will attempt to reduce. And also, are there other ways to accomplish these goals? We are looking for the best way to get there, not for a particular set of rules, but for a particular set of outcomes.

Now, when you submit a comment, it's very helpful to us if you describe how the provision will affect you. How will it change how you carry out your business? But in doing so, remember too, that comments and information submitted are available to the public usually on our website, so don't submit sensitive or private information that you don't want in the public domain.

Now, we use this data and other information that you submit to help estimate the costs of regulations for small and for large businesses as well, so data can be particularly helpful would be changes in tasks that you perform because of a particular provision or requirement. The number of employees affect it. Time to carry out a provision. And also, the type of your employees who might be affected by a particular requirement. Is it management, is it quality control, or production workers? Let me give you an example.

Training. Let's suppose that because of a particular provision, you'll need to train workers in a new procedure. Well, we can divide training into two types of costs. One-time development cost, where you learn about the provision and plan how to train workers. And then the ongoing costs of the training itself, which could be on a weekly, monthly or even an annual basis. I've just put up a very simple numerical example, but numbers help. So, in my numerical example, let's suppose two managers spend two days developing the training, learning about the provision, and we'll say, again, hypothetical cost, this comes out to an $800 one-time training cost, just to set it up. And then, the ongoing training involves, we'll say one hour per worker per month, and there are eight workers who will have to undergo this, so that comes out to $1,500 per year. This kind of calculation, of course, may be more complex, but this really, really helps us. This can be a very effective comment.

Okay, so let me conclude by just a short list of do and do nots for comments. Do send specific numbers if it's possible without sending in sensitive information. Do send comments in on time. We do have time limits. Do send comments to the Docket. In the meeting notice, there's an actual Docket number that you should refer to. Do, if possible, send combined comments, perhaps through associations.

Surveys are very useful. Do not, let me repeat again, do not send sensitive information and do not send unsupported opinions. We know that we have regulations that people like or don't like. It really isn't terribly helpful just to tell us you hate the regulation. Okay. I look forward to getting your comments. Thank you.

 

DR. ZINK: Before I open up to public comment, I'd like to remind everybody that some of you may have gotten here early, before we had our registration or our attendance sheet out front. If you didn't get a chance to sign in as an attendee, please do that before you leave. We'd like to know everybody who came.

I'm aware of two individuals that would like to make a public comment. It's not a problem if there's somebody here that I'm not aware of. I will give anybody that wants to a chance to comment, but the way I'll handle this is the ones that I'm aware of, I'll just take them in turn as I became aware of them, and invite them up, and I guess the first commentor I'd like to invite up is Mr. Joe Corby of the Association of Food and Drug Officials. Joe?

MR. CORBY: Thank you, Dr. Zink. I'm a volunteer and serve as the Director of Public Policy for the Association of Food and Drug Officials, AFDO, and I'm please to come here today to provide comments on behalf of that organization.

AFDO is the preeminent organization in the U.S. of federal, state and local regulatory officials having promoted science-based food safety through the development of model laws and regulations in providing uniform training over its 108 year history. AFDO is well-recognized for having advocated an integrated food safety system for the U.S. to eliminate duplication and gaps in our current system of regulating foods. It is from this perspective that AFDO is providing comments relative to the proposal to modernize what we believe are critical regulations.

Many states have adopted 21 CFR, Part 110 in whole or in part, and it is generally recognized that this regulation serves as a foundation to others which have been promulgated at the state level. Regulations specific to smoked fish, custom slaughter houses, acidified foods, food salvage dealers, and other food establishment types are built from the regulatory standards provided in Part 110. For this reason, AFDO believes these regulations must be comprehensive, science-based, and have a clear food safety focus. Not only do these regulations serve as a foundation for these other state regulations, but they also provide a prerequisite foundation for mandated HACCP systems. AFDO has always believed that HACCP is systematic and the concepts of HACCP should be employed universally to all food industry sectors. Good manufacturing practices as a recognized prerequisite to HACCP should also be universally applied.

Undoubtedly, uniformity among all regulatory agencies is very important to FDA, to the states, certainly to industry, and to consumers. As states conduct more than 80 percent of food safety inspections at food processors and distributors, and approximately 8,000 contract inspections for FDA, AFDO believes FDA must seek buy-in from the states on what proposed new changes our philosophy the new GMPs may have. While AFDO strongly believes there is reason to update these important regulations, we also recognize the value and flexibility their results from the broad fashion in which these regulations are written and can be interpreted. From a regulatory perspective, this is a true strength of the regulation. Because of this, there is an excellent regulatory history at the state level associated with the application of the GMPs. This is particularly true with Section 110.80, Processes and Controls.

This section has allowed states to require food plants to take all reasonable precautions to assure manufacturing practices do not contribute to contamination. Absent such reasonable precautions, enforcement actions are taken until compliance is fully accomplished. Additionally, this section requires manufacturing, packaging and storage to be conducted under controlled conditions, and this is allowed state programs to take appropriate intervention steps when it is believed that healthy consumers may be impacted.

Examples of this: New York was able to prohibit the processing of uneviscerated fish following botulism outbreaks that occurred there in the late 80's and early 90's, prior to New York promulgating specific regulations. Many states have been able to require the refrigeration of shell eggs, following the outbreak of salmelosis that have occurred in their states. And also, many states are able to require HACCP concepts within the structure of a scheduled process for food processing plants where HACCP plan requirements are not mandated. Typically these scheduled processes are developed by processing experts, land grant universities or colleges and trade associations.

Food safety is always evolving as a result of emerging pathogens and new control technologies. Additionally, many new issues and concerns such as food allergens remind us how critically important sanitation, labeling and good manufacturing practices in food plants are. We believe Part 110 must also evolve, and updating this regulation is appropriate in our view. We offer the following specific recommendations:  1) As Part 110 is a regulation and not a guideline, we believe any requirements within this document must be mandated in a context of "shall" and not "should".

This, in our opinion, would have a much greater impact on strengthening the regulation and creating uniformity between state and federal regulatory agencies. 2) As a GMP serves as a prerequisite foundation for HACCP systems, and it is well recognized that HACCP cannot work effectively without food manufacturing firms adhering to them, AFDO would like to see the GMPs evolve from more of a quality-control system to more of a required strategy for food safety intervention. Much of what we find weak in Part 110 is its focus on certain areas on quality issues rather than food safety issues. 3) Definitions for bad or blanching and quality control operations are examples of what we mean about quality issues, and these definitions to us seem out of place. Definitions for ready-to-eat foods, HACCP plan, food allergens.

A sanitation standard operating procedure would seem more food safety focus inappropriate for occluding the regulation. We also believe these definitions within the document should be uniform with other federal food safety regulations. 4) Food plants and manufacturers that handle high-risk foods should be required to meet a higher standard. For plants whose products are identified as high-risk for listeria monocytogenes, AFDO believes that a formalized action plan to effectively control or minimize the potential for this pathogen contaminating finished product should be developed and implemented by them. AFDO has just recently endorsed a plan developed by the smoked seafood working group of the National Fisheries Institute and the National Food Processing Association which we have included in our own cured, salted and smoked fish GMP guideline document. 5) FDA should require food safety competency and food safety training for select personnel in food plants, particularly where high-risk foods are handled or where food plants are unable to gain compliance. 6) AFDO supports lowering cold-holding temperatures for potentially hazardous foods to 41 degrees Fahrenheit to be consistent with not only the FDA's own food code, but many of the state requirements. 7) The regulations must remain flexible enough to allow new technologies for combating food safety concerns to be introduced.

And finally, AFDO recognizes that the regulatory community will be changed fundamentally by revising these regulations, because much of what we do in our food protection strategies is guided by law which stems in many parts from Part 110.

We view FDA's efforts here as very critical, and we are thankful for the opportunity to comment. Thank you.

DR. ZINK: Dr. John Rushing, North Carolina State University, Department of Food Science.

DR. RUSHING: Thank you, Dr. Zink. Ladies and Gentlemen, I'm afraid my comments don't, are not as eloquent or as organized as the previous speaker's. Some of them were developed as we were talking here, but I wanted to kind of get some things on the floor if I could.

I am a professor of food science. I'm a department extension leader of food science at North Carolina State University. I teach a course, a generic course in good manufacturing practices, and a generic course in HACCP at NC State, and one of the requirements that I have is students have to deal with the different regulations and critique them for me, and I get some interesting perspectives on how these regulations are written and how they're carried out. I think the students find a lot of things that we, ourselves, would find in these things.

There's three things that I'm interested in asking that we consider. One of them you've heard before. I'd like to see it consistent across the commodities. I'd like to see these regulations where they're harmonized not only within the regulations here in the United States, but with international Codex requirements. In all cases, I think that these regulations are only as good as the people who are putting these things together in the plants.

So, the aspects of training and supervision are very important, and as you heard before, there was a request that there be some method of determining competency. I think that there needs to be a requirement for competency of those people who are actually supervising sanitation and training the people in the plant in sanitation.

The big question that I think comes up in good manufacturing practices now after we've seen the seafood HACCP regulations and the juice HACCP regulations is what do you do with SSOPs? Should they be incorporated into the GMPs? I think that we should really consider possibly removing those from those two HACCP regulations and putting the SSOP requirement into the GMPs so that you'll have a good definition across the board throughout the nation, and what the components are of each category.

One of the things that we found when we were taking a look at the HACCP requirements for dairy manufacturing is that there seemed to be a confusion when we were trying to use the same SSOP requirements that seafood and juice use between adulteration and contamination.

I think we all know in our mind what adulteration and I think we all know in our mind what contamination is, and I think I saw a slide up here that generally said that contamination dealt with microbiological problems and adulteration dealt with other issues. I don't think that we have consistent definitions there and those things need to be clarified in my thoughts.

The next point that I'd like to make is that HACCP does have some shortcomings. I'm very much a proponent of HACCP. I've worked very hard to help implement the HACCP program in dairy manufacturing. I've also been on the HACCP committee that put together the training programs for the juice HACCP. One of the things that is a shortcoming in HACCP is our processing plants simply do not have the technical expertise. They don't have the technical expertise to do a hazard analysis in many cases. They don't have the technical expertise to design the appropriate controls for critical control points, and many times, they don't have the technical expertise for validation of the process. We need a lot of guidance there. I don't know whether that needs to come from a regulation or whether it needs to come from a guidance document, but we do need to take care of that. Somehow we have to develop that expertise or have enough guidance for the plant that that expertise can be followed. And, the last thing that I'd like to mention, and it has already been mentioned, too. I've been on a lot of committees over the years, where you bring experts in from a lot of different industries and buddies like my friend here from Kraft, and my friend here from Dean Foods. Those guys show up at these meetings. Their expertise is unquestioned. Their companies are committed to the things that they know have to be done. Their companies know how to do it. Smaller companies simply don't have that kind of expertise. They don't know what needs to be done, and I want to ask that you'll do what you can when you put this together to bring those companies along, so that they can get the things accomplished that we want to get accomplished. Our goal is not necessarily compliance. Our goal is to reach a certain level of public health. But I want to thank you very much for listening to the comments. Thank you very much, appreciate it.

 

DR. ZINK: Is there anyone else that would like to make a public comment? You don't have to come to the podium, you can do it just from one of those microphones, if you like. Okay, if not, what I'd like to do is begin to wrap up the meeting by briefly reviewing some of the things I think that we heard you say. I want to emphasize that a transcript is prepared and we're have captured every comment and every presentation, so if I don't mention it here, it's probably a deficiency of my note taking and ability to review it on the fly rather than us not being interested in hearing it.

We've heard from a number of speakers that GMPs are important. They're important to state regulators. They're to important to the industry. They reflect past learnings and how to prevent problems in the future. I think it's been said that they don't need major change, that one of their great strengths is the broad way in which they are written now and that we shouldn't lose that in any revision or modernization. We should keep them from being too specific. Where specificity is needed, perhaps this can be done with guidance. There is a great value in guidance, perhaps in supplying some of the technical information that might not be needed, but it might not be available, excuse me, to everyone in the industry. Particularly, the industry needs help in how to look at their operation and identify hazards, and use this hazard identification information to tailor the GMP program to their operation. Several speakers have told us that the GMPs should be compatible with Codex. This is certainly something that we were thinking and something that's going to get, you know, very strong consideration as we try to modernize this regulation.

We've also heard that the GMPs predated our appreciation for food allergens and the need to control them. Presently there are regulations about food labeling. There aren't presently any regulations about management practices or requirements for how to go about being sure that food allergens, undeclared food allergens don't get into food products, and that's an area that we're going to be giving attention to.

There are no regulations regarding the use of rework, specifically. There is no standardization of "may contain" statements on labels or criteria for when to use them. Some of you expressed concern that where a food safety focus exists, this should be in the regulation to ensure compliance rather than in a guidance document. That where possible, we should revise the format of the regulation to state the hazard connected with the control and arrange it in a way that groups control requirements with like-hazards.

Current GMPs do not adequately address allergens, another speaker. Training was hit at by a number of speakers. There was generally comments that training should include training on hazard identification and control. That this should include allergens. That training should be especially important for those responsible for supervising and conducting sanitation operations.

The term "adequate" which is often used in the current regulations is not particularly well-defined and that we should perhaps consider use of words like demonstrated, validated or documented, and that the inclusion of a requirement for records and validation as appropriate is important.

The current regulations don't address unique issues associated with transportation and warehousing. I think we would like to hear more in written comments on that about, perhaps unique segments of the food industry that should be included in this. There was a suggestion to change this to reflect some of the temperature requirements currently in the food code, particularly for potentially hazardous foods. There was a comment that we strengthen sanitation requirements to include monitoring, verification and record keeping. A request that we define pasteurization requirements in light of some of the new technologies. And require identification of hazards and controls by each manufacturer.

There were comments that 21 CFR 110 is very important to each of the states, and that the states have a very significant role in food safety, inspections, and in fact, conduct the majority of food safety inspections, and that the states must buy-in to the types of changes that we're proposing. That GMPs are a foundation for other systems, such as HACCP. There was a suggestion that we examine the use of words "shall" and "should", with greater emphasis on the use of the word "shall". That we should revise definitions, deleting perhaps some inappropriate definitions and adding other definitions, particularly those that have greater food safety impact. That we should consider a more stringent or higher standard for high-risk ready-to-eat foods. There was a suggestion that 41 degrees Fahrenheit would be most appropriate for potentially hazardous foods.

I might add we struggle with that definition of potentially hazardous foods from time to time. That we should make the regulation consistent across commodities and with international requirements.  That we should require competency, and a number of speakers had mentioned both training and competency, and I do see a difference between those two. It's one thing to receive training. It's quite another to take it in and be competent. That we should make SSOPs a part of the GMPs and perhaps that we should even consider where other areas where we use SSOPs and ensure that our implementation of SSOPs is consistent across the foods we regulate. That there is a problem with a lack of the technical expertise to identify hazards and design control plans and that we need guidance in this area, especially for small companies.

And on the matter of guidance, I think we have recognized, we do so with a great sigh because so much work is to be done in drafting guidance documents that can apply in many areas of the food industry. But I think we do recognize the value of guidance documents as a means of interpreting the regulation and how it should be implemented.

With that, I believe, if there are no further questions or comments, we'll go ahead and adjourn the meeting. Thank everyone for coming and please encourage all of you to send us written comments. There's instructions on how to do that in the federal register announcement, and once again, if you did not sign up as an attendee when you came in, please do so on your way out. Thank you very much.

(Whereupon the above matter concluded at the hour of 4:25 p.m.)