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Transcript of Public Meeting on GMP Modernization: August 5, 2004

August 5, 2004

San Jose, California

Public Meetings on Current Good Manufacturing Practice Regulations

DR. ZINK: We would like to welcome everybody to this, our third public meeting on good food, Good Manufacturing Practices modernization.

This initiative is really the brainchild of the acting commissioner, Dr. Lester Crawford.

Dr. Crawford, when he first assumed the post of acting commissioner before Dr. Mark McClellan became commissioner, began a GMP modernization effort across all FDA centers. In fact, I guess it began with our center for drugs, and has been progressing rather rapidly there.

Dr. Crawford thought it has been a long time since we looked at GMP modernization, so he tasked all of the centers of the FDA for look at GMP modernization.

Dr. Crawford is not able to be with us for this meeting. He was able to open one of our meetings, but agreed to tape his remarks.

And with that I will introduce Dr. Crawford on videotape, if I've got the right button here.

(The following is the taped presentation by Dr. Crawford.)

DR. CRAWFORD: Welcome to the public meeting on the modernization of a Good Manufacturing Practices for the food industry.

We're holding this meeting and have asked you to come because we need your help to update regulations 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 their 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 yoghurt, 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 best sellers.

Another significant addition to our menu is fresh produce imported in and out of season from around the globe. 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 packages.

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 risks greater than ever.

As an agency whose purview includes 80 percent of this nation's food supply, we therefore recently took a close look at how well the food GMPs still ensure and wholesomeness of what we eat.

We conducted three studies focused on the type 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 we solicited from experts and 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 1 hazards that can cause death or serious injury, and the rest were Class 2 whose health consequences are reversible and temporary.

The most striking finding of this inquiry was that of the 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 half of the recalls, and microbial contamination, which was the reason for about one-quarter of the total.

Among the most frequent level of process problems were ineffective employee training and inadequate standard operating procedures. These results and the information gathered in the two other surveys make 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. 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 embedded 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 19th; 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 and approaches that will 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 of science-based systems that are guided by evidence, both regarding problems and their effective solutions.

The outcome we seek is a set of targeting 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 will be drawing on appropriate literature and on the experience of food microbiologists and industry professionals of all kinds, but extensive, thoughtful input from all of our stakeholders is critical. We need your full support for your 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 will enable drug sponsors to better estimate whether their medications will qualify for marketing.

This is an enormously important issue in drug manufacture, for 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 in the overarching aim of these and many other FDA initiatives is to reduce and manage the risk affecting the health of our public and, thereby, advance the vitality of our nation.

Your participation in today's meeting and discussion is a meaningful contribution to this effort. I very much appreciate that.

Thank you for coming, and I'm looking forward to your information and views.

(The end of the videotaped presentation.)

DR. ZINK: As Dr. Crawford said the purpose of this meeting is really to gain meaningful input. And I want to tell you that we aren't sitting here with, you know, codified language in our back pocket.

We haven't by any stretch decided what we want to do with 21 CFR Part 110. Obviously, some things have been discussed in the course of the last two years of our deliberations, but we're genuinely seeking input from all of our stakeholders at this time.

The public comment period on this announcement will be open until September the 10th, which I realize is a very short period of time, but we're looking for innovative ideas and suggestions on what we can do with the food GMPs to better communicate to the industry what our expectations are.

You should bear in mind that as Dr. Crawford said, quite a lot has changed in the food industry. One of the changes is, perhaps -- people in this audience are more keenly aware of the fresh produce area, where 20 years ago when this existed, we didn't have the kinds of fresh produce products we have on the market today. We weren't as global as we were today.

One of the things we have to think of is does 21 CFR Part 110 communicate to overseas suppliers what expectations are. What can we do to make it more clear, make it more effective.

What I'd like to do now is -- we've arranged for a series of invited speakers to address various aspects of this issue, and who I'd like to introduce first is Rachel Lange. Rachel is not Richard Williams. Rachel is on Richard's staff.

She joined the FDA in 2003 and is currently an economist in the Center for Food Safety and Applied Nutrition. She attended graduate school at the University of Kentucky, and is still completing her PhD in economics.

Her primary interest is health economics, and is writing a portion of her dissertation on obesity.

Rachel.

MS. LANGE: Good morning. Thank you for -- well, I'd like to thank Richard for asking me to fill in for him.

Like Don said, my name is Rachel Lange. I'm an economist at the Center for Food Safety at FDA.

I'm here to discuss briefly with you all the research that we're doing at FDA that will go into the decisions that we make in the modernization of the food GMPs.

Our research revolves around one main evidence-based question. And that question is, what significant hazards are associated with FDA-regulated food that can be addressed by preventative controls and what are the most effective preventative controls for those hazards.

So when we talk about hazards, we're obviously talking about the three main groups of hazards: Microbial, chemical and physical.

When we talk about effective controls, we're getting at those controls that have demonstrated efficacy but are not burdensome.

In approaching our research question we feel like we need two types of evidence. The first evidence in that top box are -- points to current problems that result from lack of compliance with current GMPs, firms simply not following the GMPs, or problem resulting from controls that are not currently in the GMPs.

The second type of evidence in the bottom yellow box are potential problems that are avoided because manufacturers are complying with the GMPs or they are otherwise utilizing some control that works but is not currently required.

So how are we going about approaching each type of evidence gathering? Well, let's first take a look at our current problems.

We're gathering evidence on current problems caused by absence of effective controls by four different ways.

One, we've conducted a literature search; we've conducted an expert elicitation; and we've conducted a recall study. And I'll talk about each of those three briefly here in a moment, but also stakeholder input.

Just like Dr. Crawford said, we really need your all help in modernizing these GMPs. And through these public meetings, we begin the long process in trying to get that input.

And for our purposes, the most important input will be evidence of food safety problems relating to preventative controls and evidence of effective controls, rather than simply opinion.

In trying to gather data on potential problems -- potential problems that have been avoided because of GMPs that are being followed or other controls that are not being required that are currently being followed, we're doing two things: One, we're planning on conducting a GMP survey of existing practices. And, of course, we still need your all's input.

Keep in mind we're still in the planning stages for the survey. We have not conducted it yet. But through the survey, we hope to get at what manufacturers are doing, regardless of whether it is required or not.

And, again, with your all's help, we can -- we can get at some of these problems, but we want to stress we want evidence. We want input on what is effective, but evidence being the most useful type of input.

As a way to begin tackling our research question, the question that I outlined at the beginning, we contracted with Economic Research Group to perform a literature review. And they looked at a lot of literature and they categorized the findings of this literature. Much of it addressed things that can go wrong in food manufacturing, and how we can correct them.

As you can see, most of the literature revolved around microbial problems. 74 percent of the literature was microbial, 25 percent chemical. I'm assuming the last part was on physical problems.

But in looking at the literature, they found that poor worker hygiene was the leading theme, the leading problem, that went through this literature review.

Training issues mentioned often included language. I'm sure you're all not surprised to hear that language differences often make up a huge barrier to effective training.

Also there were issues as to generic training versus specific training. And also training needed in hygiene, cleaning and pest control and preventative maintenance.

Other large themes in the literature review include contamination of raw ingredients. Allergens, that was a very large theme. We saw a lot of talk about allergens, no label review policies, contamination by raw materials, residues not removed, et cetera, and also poor plant design.

And plant design, just to clarify, includes creation of segregating processing areas. And decent, good equipment design simply makes equipment easier to clean.

Again, with the help of Economic Research Group, we've conducted an expert elicitation. Now, if you're not familiar with what an expert elicitation is, it is exactly what it sounds like it might be. It's simply a method of eliciting quantitative and qualitative data from experts. And we conducted four rounds of interviews with 17 national food safety experts.

The purpose was to help identify important risks and preventive controls for the food industry as a whole, but also different food sectors individually. And the risks were based on frequency and severity.

And here you can see the top findings, just briefly the findings by our experts.

You can see training is a very important theme, training is needed, but not just for employees. Our experts stated that managers and suppliers also need proper training.

Record keeping for standard operating procedures was another point. And cleaning. Cleaning, the sanitary -- the SSOPs, and the environmental sampling, label review and verification was the themes.

And, lastly, we've conducted a recall study where we reviewed Class 1 and Class 2 recall records from 1999 to 2002.

And just to clarify something that Dr. Crawford said in the video.

We have at this point looked at 1,055 recalls. I think he said something about 800 or so. We've done -- we've looked at more recalls since he recorded his comments, so now that number actually more accurately reflects what we've done.

But I think the results are very interesting in that we were able to connect 87 percent of those recalls to some GMP failure or some labeling issue which, as you probably know, is not currently in the GMPs.

But of those results, 65 percent were attributable to incorrect packaging or labeling.

Just to clarify a point here. 26 percent were connected to failures for SOPs. What we want to stress is that the standard operating procedure itself did not fail, it is that the standard operating procedure was not followed. Just to clarify that.

And you can see what some of the other issues were in the recalls.

One thing that is not up there that we want to mention too is that 34 percent of the recalls involved undeclared allergens.

So what do we still need? And this is where our stakeholders can help us out. We need information to compare the benefits and costs of different regulatory options.

When you are submitting comments, and I think this will be addressed later on, specific numbers will help us out.

We need information to assess whether provisions are needed for small business. Small businesses and large businesses often have different cost structures, and it can help us to know if we need to make special provisions for them. And any other information that can make new rules easy to follow and effective.

Are there any questions?

DR. ZINK: What we will do, we will let everybody get through, and then take the question-and-answer period after that.

MS. LANGE: Thank you.

DR. ZINK: I want to make some comments about this research. We -- Dr. Crawford has us under a very tight timeline here. He's a tough master.

And we've been struggling to get a summary of all of this research onto our Internet website, and we are hopeful that all of the research will be on that website within, oh, certainly within a week and hopefully even a little bit sooner.

Clark is nodding his head.

MR. NARDINELLI: We plan to have it posted this week.

DR. ZINK: It is supposed to be on our website this week. We would have liked to have gotten it up sooner, but as you can see, a lot of this research is still ongoing. So that's the planned schedule.

I'd like to introduce our next speaker, Laurie Girand.

Laurie's daughter was hospitalized with kidney failure after drinking apple juice contaminated with E. coli 0157:H7. Her family's experience inspired her to join Safe Tables Our Priority, a nonprofit organization that is motivated by victims of food-borne illness, their family and friends.

She has spearheaded STOP's produce programs now for over seven years.

She's authored over a dozen public comments, documents advising FDA and USDA on scientific and microbiological grounds for changing proposed regulations.

In 1999 she received a director citation award from the Center for Food Safety and Applied Nutrition at the FDA for her work in the area of warnings to consumers.

She holds an electrical engineering and computer science degree from Princeton University, and an MBA from Stanford.

You can find more information about STOP on their website at WWW.SAFETABLES.ORG.

Laurie.

MS. GIRAND: Thank you very much.

My name is Laurie Girand. I work with Safe Tables Our Priority. STOP advocates the elimination of pathogenic contamination in food.

Some of our organization's members are people poisoned in multiple unpasteurized juice outbreaks, where less than sanitary processing failed to prevent deadly microbial contamination, people poisoned by sprouts in which the growing process exacerbates underlying contamination, and people poisoned in mixed lettuce outbreaks, in which the most basic GMPs were simply ignored.

We want everyone here today to understand that the food-borne illness we want to prevent is not just a little diarrhea. It is a very real poisoning of the body with foreign organisms known in laboratories as biohazards.

These organisms and their toxins can be life-threatening to children, the elderly and people that are immune compromised, including pregnant women.

In some outbreaks, children five and under make up as many as 50 percent of the detected cases. Most young children are unable to contain the bloody diarrhea that virtually explodes from their rectums. They scream in agony, begging their parents to help them.

Babies that survive birth with listeria infections may be left with lifelong disabilities.

We all need to be working from the same facts, and the facts are these: Epidemiology has concluded that initial contamination can come into a plant on raw materials. Either because -- yes -- either because they were contaminated on the farm or in transport.

Epidemiology has shown that pests in the vicinity of an open plant can also introduce initial contamination.

Epidemiology has shown in retail environments that sick workers can also be the initial source of contamination.

Once contamination is in the plant, studies have shown that organisms can be aerosolized or adhere to equipment, exacerbated cross-contamination. Organisms can be spread from a few raw materials throughout a lot by contaminated water.

And the size of a lot or batch really matters. One contaminated apple can spoil 100 gallons, 1,000 gallons or 10,000 gallons of juice. Contamination can also be amplified through a lack of temperature control, either in the plant or in transportation related to the plant.

With these facts in mind, Safe Tables believes that revisions to the CGMPs must take into account three key control points: Initial contamination of the food with pathogens; cross-contamination of one food to other foods or an entire batch; and the growth pathogens to higher levels within any contaminated food.

CGMPs must be applied uniformly to processors, whether large or small, because food poisoning is no less deadly if it comes from a smaller processor.

CGMPs must be clear and intelligible to foreign producers.

In order to reduce environmental contamination risks on the farm, infield processing should be restricted exclusively to the processing required for harvesting. All other processing should take place in as an enclosed controllable environments as possible.

STOP believes the following 10 areas must be addressed: The raw material pathogen testing. A popular adage is "Garbage in, garbage out," and with food this holds as true as ever.

Initial contamination coming into a plant on raw materials has been a source of many outbreaks. Current CGMP recommendations that processors obtain raw materials and other ingredients under suppliers' guarantee of certification are not scientifically supported prevention methods.

I might add that my own daughter was poisoned under such a guarantee, which proved to be worthless. Incoming raw materials must be tested.

Transportation. Transport affords opportunities for initial contamination of foods and the growth of organisms. Trucks used to haul manure or animals can then be used to haul produce.

Clearly, vehicles used for the transfer of animals, animal meats or animal byproducts, should be prohibited from transporting produce or produce products.

Truck beds should be steam power-washed to sanitize between food loads. In addition, the temperatures at which fruit and vegetables in warm climates are transported encourage the growth of organisms.

Postprocessing products should bear temperature-abuse indicators so the consumers and retailers can be aware if the system has failed.

On refrigerated vehicles carrying foods, records of temperature variations should be automated.

Worker health and hygiene. Workers represent a potential source of initial contamination. STOP believes that current CGMPs leave too much room for interpretation. Gloves must be mandated.

With emerging diseases such as SARS so easily transmissible, we believe that food workers that travel to other countries should be required to wait for up to a week after returning to the US before working with food again.

Water quality. Water can be a source of initial contamination but also contributes to the spreading of organisms within a plant. FDA simply must develop a scientific definition of water quality and stop using phrases such as "The water supply shall be derived from an adequate source and shall be safe and of adequate sanitary quality."

Temperature settings must be specific to keep produce from absorbing pathogens from water. Water quality must not only prevent microbial contamination but also be high enough that sanitizers actually work; therefore, the quality of water in use over time must be tested periodically.

Small patches and lot sizes. I hope this really seems obvious to everyone. One of the key factors exacerbating our large multistate outbreaks is the supersized batches developed at large processing facilities.

FDA must encourage processors to create small batch sizes and to sanitize equipment between batches. This single measure will dramatically reduce cross-contamination.

STOP believes that, to the greatest extent possible, foods from a single farm, orchard or seafood harvest should be packaged together and not mixed with those of other farms. They should then be shipped to as few retail facilities as possible.

Doing so would reduce the size of outbreaks, the number of illnesses, and the difficulty of trace-back.

Record keeping and validation. Current CGMPs recommend that processors have proper equipment that take measurements, but there are theories about what should be done with pH, temperature, sanitizing and other data.

Food processors should be required to document control steps taken for minimizing the potential for contamination and growth of organisms.

Proper record keeping should be supplemented with periodic verification steps, for example, with a routine sampling program.

Key elements of such record keeping would be written SSOPs, written records for sanitation between batches, validation of control measures and an audit program.

Final product testing. Raw or undercooked produce products that are chopped or mixed, such as salsa, cole slaw, guacamole and salad mixes should be subjected to final microbial product testing, as should raw or undercooked diary and seafood products.

If the company cannot afford the testing, it shouldn't be in the business.

Traceability and accountability. All facilities must keep records of the sources of raw materials, the destination of final products, and information about which raw materials ultimately went there.

When an industry visits multiple, repeated outbreaks on consumers, FDA should mandate that all the products of that industry bear warning labels until FDA can assure that those foods are as safe for consumption as the average food.

Inspection. As a farmer once told me, you get what you inspect, not what you expect.

FDA needs to stop treating regulations as though the work is done once the document is printed. That's just wishful thinking.

Certification. Processors should be required to prove that they are aware of current regulations and food safety guidelines or they should not be in the business.

The government needs to create a system for ensuring that fly-by-night operators can't sell food. Certification of food safety, education and training should be required as a condition of commerce.

I would like to close with this quote from Marc Isaacs who ran an unpasteurized orange juice company.

In 1998 Mr. Isaacs attended a technical workshop where he described in great detail the experiments his company was conducting to find new ways to improve the safety of orange juice that was going unpasteurized.

Within eight months of this recommendation, Sun Orchard's orange juice would be responsible for the single, largest outbreak of juice ever in the United States.

Over 400 people would be sickened and one person would die. Incredibly, despite Mr. Isaacs' advice to others, Sun Orchard's plant was found to have multiple strains of salmonella.

Two months after the outbreak, FDA would allow Sun Orchard to begin processing again, and four months after the outbreak, Sun Orchard would again recall thousands of gallons of juice.

In the context of hindsight, I believe that Mr. Isaac's situation serves as a warning to us. We cannot afford to treat CGMP improvements lightly, nor can we move quickly enough to implementation.

People's lives and well-being, and those of children, in particular, hang in the balance.

Thank you very much.

DR. ZINK: Thank you very much.

On your agenda our next speaker, Dr. Jeff Farrar, is unable to make it this morning, so we're going to move right to the next speaker on the agenda.

Debra DeVlieger. Debra works for FDA's division of field investigations and serves as one of their national food experts. As such, she's involved in some of the complex food inspections and investigations and assists in the design and implementation of top priority food issues.

I should add that this system of national food experts, ORA, has experts in various fields that they can -- that have a great deal of depth and training and experience in particular issues and particular processes that they can call in. And Deb is one of those experts.

Some of her most recent projects have included the development and implementation of seafood HACCP regulations, juice HACCP regulations, arrangements with New Zealand and the equivalency agreement with Canada and the European Union.

She's participated in numerous training courses in the seafood and juice area, and she's helped develop and write several of our guidance documents, including low-acid canned foods inspection documents and seafood hazards and controls guide, and the guide to inspecting fish and fishery products.

She's also a board member for our seafood HACCP certification program and a member of AFDA.

Deb.

MS. DE VLIEGER: Good morning. As Don said, my name is Debra DeVlieger. And I work for FDA's Office of Regulatory Affairs, division of field investigations, which sounds like a big, long name, and it is, and is located in Washington, D.C., but miraculously enough, I have the opportunity to actually just be a field investigator.

That's really what I am. I get out in the field and do quite a bit of inspections, and I have great opportunities to work on great programs that FDA is working on, one of which I think is working on the current Good Manufacturing Practice modernization.

The first thing I'd like to say is that good sanitation is mandatory for all foods.

Section 402(a)(4) of the Food, Drug and Cosmetic Act deems food to be adulterated if they are processed under unsanitary conditions.

The food -- the current food Good Manufacturing Practice regulations in 21 CFR Part 110 actually articulate the kinds of conditions and practices that need to be followed in order to avoid producing an unadulterated food.

But, nevertheless, while FDA has been forcing the sanitation standards for many years, it has not really completely succeeded in developing a culture throughout the food industry where processors actually assume an operative role in controlling sanitation in their plants.

Previous surveys have found that the statistics relating to the incidents of insanitary conditions that were actually cited in the preamble to the seafood HACCP regulations and also observations from USDA's HACCP rules for beef and poultry, clearly demonstrated that such a culture was not in place in 1995.

Further, the requirement of standard sanitation operating procedures, or SSOPs, sanitation monitoring and record keeping in the more recent juice HACCP regulations further highlights the significant need to motivate a portion of the food industry to comply with sanitary requirements.

Now, as previously mentioned by Rachel Lange, the FDA/CFSAN Division of Market Studies examination of food recalls from 1999 through to 2002 found that out of a total number of 842 food recalls, 715 of the recalls or 82 percent were related to Good Manufacturing Practice problems.

Some of those GMP issues outlined in the study, which have already been discussed, were things like incorrect labeling, specifically allergens, ineffective training, product cross-contamination, lack of routine maintenance, poor equipment and plant design, lack of temperature control, and ineffective employee hygiene.

Now, all of those, with the exception of labelling, are addressed in the current Good Manufacturing Practice regulations.

Now, although we look at that number of food recalls relating to sanitation and we think, gee, that seems really high, it actually makes sense because, as FDA's own database shows, the top 30 food inspection observations relate exactly to these types of Good Manufacturing Practice deficiencies and more.

I believe that taking a look at the CGMPs is long overdue. FDA, consumers, the regulated industry and other interested parties really need to take the time to evaluate these regulations and make suggestions for revisions.

If successful, we would hope that these revisions would help FDA assure that firms take full responsibility for sanitation in their plants, which, of course, has a direct relationship to the production of safe and wholesome food.

Now, revision of these current regulations could attempt to strengthen the current requirements in some of the following areas:

1. Requiring specific daily sanitation regimens that incorporated 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 has shown that this type of requirement has helped with compliance. In fact, in 1998, the percent of firms that had adequate sanitation controls, including GMP's sanitation and record keeping, was 21 percent, while in 2003 it was 54 percent, an over 100 percent improvement in five years.

2. Including additional definitions for terms used in the food industry. An example would be the term "pasteurization" where the definition of pasteurization varies greatly depending on the application.

3. Requiring specific records for verification activities, such as calibration of monitoring equipment, in order to ensure that the accurate instruments are used to measure and control process parameters.

4. Requiring documented validation of equipment design, process establishment and process delivery to ensure that the process is designed and delivered to control or eliminate the specific targeting hazard.

5. Addressing more stringently the training requirements for food plant operators, as well as employees, and documentation of that training to ensure the food plant operators and employees understand their responsibilities for producing safe food products.

6. Defining allergens and requiring monitoring and record keeping to assure the products are properly labeled.

And 7. Requiring each food processor to determine hazards that are associated with their product in manufacturing processes and controlling those hazards throughout the process.

Now, that is just naming a few of the things that we would try to take a look at to incorporate into the current Good Manufacturing Practices.

But today we truly hope to elicit responses from you for other suggestions in order to help FDA foster a culture of, and a commitment to, Good Manufacturing Practices that may well have been lacking in a significant portion of the food industry.

Thank you.

DR. ZINK: I'd like to thank all of our speakers this morning.

We did also offer opportunities for industry representatives to speak, but we're unable to get anyone that was able to speak.

What I'd like to do now is open it up to a question period to you, the audience. Feel free to ask questions of any of the speakers.

If you have questions for the FDA on the topics, we'd be interested in trying to answer those as well.

All I would ask is that you come to the microphone, and maybe someone there can make sure that thing is turned on.

Come to the microphone and please state your name and your affiliation. We're transcribing this meeting. A transcript of the meeting will be available approximately 15 days after the meeting. And we will make those transcripts part of the docket. And we want to be sure to capture whoever makes comments if we have to contact you for clarification.

So with that, I'll open it up. And please just step up to the microphone.

Do we have any questions?

MR. TABARES: Frank Tabares, T-A-B-A-R-E-S.

I did register to make some comments. Currently I'm the director of manufacturing for an organic snack food company in Santa Cruz.

Since 1987 I've been working with corporations like Ralston Purina and General Mills and Quaker Oats and writing GMPs policies and SSOPs for their companies.

So I have a -- past five years have been going to companies and helping them implement HACCP programs in the industry.

Listening to a lot of stuff you guys said, I have a couple points I think -- I think you guys are heading down the right way in what you're trying to do.

Some of the things that I keep hearing is writing exceptions for small business. I believe it was Laura that made -- Laura from STOP made a very good comment.

From my experience -- I've written for small companies that were doing batches that have maybe five employees, whereas also with Quaker which had, you know, almost 100,000 employees.

The costs that are evaluated -- the costs that are connected with GMPs really are very proportional to the number of employees you have. It is a cost you can figure out.

A small operation has a lot less things to worry about than a large operation because the size of equipment they're using, but the requirements of GMP and the requirements of the sanitation and such are the same. It should be the same.

I take exception when I hear that we are going to -- it makes me money because I'm consulting, and I can go out and interpret for the smaller companies, you know, how to comply and where their loopholes are. But they shouldn't be there.

Part of the problem is that there is too much ambiguity and vagueness in the current GMP as was very clearly stated earlier.

One of the big things that I feel they need to do is go through and clear up all ambiguities. Write up clear and concise guidelines that from company to company to company would stay the same and is very easily understandable.

One thing I would highly recommend is that GMPs and SOPs be submitted for approval to either an agency that is approved by the FDA or to the FDA themselves, similar to the HACCP programs that are required currently for meat, poultry, fish and fresh juices.

They should have that be a final way of checking to verify it is not some fancy written up that sounds good but isn't being implemented.

Another thing I would point out would be that HACCP -- it has been for years now that the FDA only mandated HACCP for those three industries, and that they were soliciting comments from the rest of the industry as to how they were going to implement it, how they would do it.

In the past three years, it has become a big issue with a lot of companies that aren't required to have HACCP and is merely consumer driven.

I think the FDA should start, as part of the GMPs, instead of treating HACCP as a separate entity, HACCP should be one in the same with the GMPs and pulled right into it.

A lot of the issues that you are looking for addressing are addressed under HACCP. And if that policy became part of 110, sort of a separate subpart, I think that would be very beneficial and a good way of going through clearing what is required.

A couple things that I don't agree with that Laurie brought up with STOP is the small batch idea.

My experience in the industry has been that small batches, although you think that you can contain stuff down -- if you have a contaminated product, yes, if you are only contaminating a smaller part or smaller area of food. So you think, okay, then your smaller area is either contained and out it goes.

But the reality of that is when you are a producer producing things, you want as much productive time instead of nonproductive time.

Sanitizing and cleaning is nonproductive time. You're not doing anything that is making you money other than when the machine is packaging product.

What happens is, when you have smaller batches or require smaller batches, the companies are constantly looking for a way to not -- shorter sanitation period. A quicker way to clean something, which is not necessarily the best way or necessarily doing its job.

But what it's doing is, it's meeting the minimum requirement on the paperwork, yes, I did this check, check, check, get this up and running.

We can have larger batches. What it tends to do you is, you can filter that fixed cleaning time. For example, at the facility I'm at right now, we have a particular piece of equipment, that to do a total teardown and clean takes an hour and a half. No matter what you are running, no matter how big of a batch, it is going to be an hour and a half.

Well, if you do a small run, you have less product to dilute that overhead costs of nonproductive costs into. The larger the batch you now have, it induces you more to not worry about the cleaning time because you have diluted that cost over a larger number.

I think requiring smaller batches would actually make -- induce companies to try and get around properly cleaning their equipment. I think that would be the wrong way to go.

DR. ZINK: Let me stop you right there with a question of my own to try to get you to maybe comment a little further in that area.

Frequency of cleaning. Do you, either do or do you think it is a good idea, to do scientific studies or studies to determine how frequently a particular piece of equipment must be cleaned?

It occurs to me that in some products and processes you might very well be able to go four hours without an accumulation of microbial growth, and maybe in others you could go several days. Depends on, I guess, the physical chemical characteristics of the product and process.

Do you do those types of studies in determining how frequently you clean, or is it more organizational and operational?

MR. TABARES: I'm in a unique position since I consult and write what needs to be done and also the initiative to make sure it happens. We actually at our facility to do that testing.

I would applaud recommendations to do testing to create -- to see what the frequency is needed.

Obviously, in the fresh food industry, you have equipment that is very specifically made and it -- basically you have a piece of equipment that runs the exact same type of food the rest of the season.

No cross-contamination, just quick washdown. Keep on going, which is obviously just common sense says no because you're going to have a large batch of products going to start molding from the beginning of the season to the end of the season. Yes, there should be testing.

Other processes, which the equipment changes products, those should be tested in between, simply to verify that you are not getting cross-contamination.

So in response, yes, I think that -- yeah, we do do that testing. I do -- we do swab testing that we send out to verify, and also after a cleaning, we use a luminoscope to verify that all the surfaces have been completely cleaned.

That goes back to small businesses. A luminoscope costs you about 4,500. It is a calibratable machine. If a small producer is so small that he can't afford that basic tool for testing to verify that his equipment is clean, as Laurie said, shouldn't be in business.

I think we have a big push to grow the business and to have -- support small businesses, but even a small business needs to be held to the same standard. We have to keep it always in focus.

I don't know if everyone knows what a luminoscope is. It tests to see if there is any type of living organism on the equipment. It can't tell you if it is a bacteria or left over product.

What it does tell you is that there is something there your cleaning procedure did not do its job, so it is a quick -- takes about 15 seconds to run the test, and it is a quick test to verify that you are SSOP is working and your crew did their job before you go to the next product.

Let's see here. Another thing that was submitted and registered to comment on was the use of gloves in the industry. That is another point where I disagree strongly with STOP.

It has been proven through testing and records -- and we don't have a copy -- I'll submit a copy electronically to the FDA so they can review the research data that I brought in.

The glove use actually increases the chance of microbial growth in the industry. There is a conception of, you know, I'm wearing gloves. My hands are clean. So to the casual observer walking by, oh, look, this is a safe product because the person is wearing gloves.

It has been proven, A, that you touch the same thing with gloves on as with gloves off. Okay. You cough, you touch your hands. Well, the glove's now dirty, but people think, I'm wearing gloves, it's safe. For some reason workers adopt this philosophy that it is clear.

Also it has been proven that the bacteria on the hand, the natural flora on the hand, helps fight off contamination of the hand, where the gloves doesn't have that, so contamination will stick to the glove.

Workers tend to not change the gloves as often as they should to maintain them cleanly. And a clean, dry hand is more bacteria-free. As soon as the hand gets put inside a glove, because of perspiration, immediately E. coli counts and other flora propagate to twice as much as the hand that didn't have the glove on.

So in that same process, a glove gets a pierced hole and you're now going to be introducing more bacteria and pathogens to your product and equipment than you would have if they had a clean, dry hand.

I think the FDA should look at verbiage to clarify the gray area between if gloves are required, if they're not. Currently the CFR to cover cuts and sores, and that, of course, is common sense to be required.

But they should clearly specify, in my opinion, that gloves not be worn unless it is for a specific indication of either prevention of getting cut by the equipment you're working on or protect with a bandage on or something like that.

You have foreign -- foreign material gets in the product, pieces of gloves breaking off in the workers' hands. Sanitation crews dropping a piece of glove in the product. You have the microbial issue as I mentioned before.

A lot of companies use latex gloves, which have the whole allergy issue, latex allergens. Introducing that. They are less expensive, and trying to enforce them using a nitrile glove -- it depends on the budget of the companies. It would be easier to go there.

The proof on the information I have, scientific data I'll be submitting, shows a clean hand -- and they even outline some procedures on how to do it, a single stage and a two-stage procedure.

They talk about how a clean hand dropped the count of an introduced salmonella chain on the hand from -- from I believe it was 99.1 percent. So it was almost a 346 percent -- 346 count drop.

So all the data and all the testing, they reference over 20 different sources of information they've come from in this paper. And it shows that everything -- all the data supports that they should make a stance that gloves should not be worn because -- to prevent -- a clean, dried hand, having proper cleaning methods, is a safer way of handling the foods and work.

DR. ZINK: Frank, I'd like to question you a little bit on that.

First of all, let me say if you have a hard copy of your research, you can give it to us, and we'll give it to dockets, but you can also send an electronic copy to the dockets addressed in the announcement.

We have heard, of course, of a lot of pros and cons about gloves over the years. Often we hear people speak about the advantages of gloves because of the difficulty in training and supervising people to properly and thoroughly wash their hands. And then there is the exact other side of that coin. That is, there is a training and supervising issue with the proper use of gloves.

It is quite true. You can't let someone put on a glove and then behave as if they're immune.

Do you think a lot of the problems with gloves could be addressed more easily or about the same or more -- or would it be more difficult than with supervising proper hand washing?

MR. TABARES: It would be more difficult, because all the data shows that the first thing you have to do before putting on a glove is clean your hand properly. So now you will take all the requirements of cleaning your hand properly and then add the extra requirement of the glove on top of it.

By putting the glove on, within 60 seconds your hand is no longer clean. You're adding that added risk.

I can tell you from experience on the production floor, people working, gloves get punctured so they stop. If you have well-trained people, they wash -- take off the gloves, rewash their hands, put the glove back on. But at the point of puncture, all that bacteria just got on that surface.

The one thing that doesn't happen is, production line shuts down, resanitized the whole area, get rid of the product that was contemplatively, possibly contaminated or testing to see the reason they won't want to do that.

It would be much better, the gloves are solely for the production of the worker, you know, dealing with fish fines or dealing with equipment and danger of cutting with knives, to protect the worker from getting injured, but there should be definitely guidelines of, if anyone is wearing gloves, these are the procedures they have to do, what is recommended.

Unless necessary for worker safety, gloves should not be worn, or product contamination, meaning they have a bandage or something.

MS. DE VLIEGER: Because I'm out in the field a lot doing inspections, structurally the firms aren't set up right for glove usage; in other words, they will wash their hands in some area and come in and handle a whole lot of things and put their gloves on.

Structurally, in a facility what you -- I mean ideally and what I assume some processors do, is if their gloves sit right above the wash sink. In that case, they can go to the wash sink, wash their hands, and take the gloves and put them on, and then sanitize the gloves.

But I don't see that in very many cases where, structurally, or even in implementing their training, that they're set up that way. But that would need to be the way they need to be set up. If you were going to tell them that gloves are necessary, I would have to train them on gloves.

MR. TABARES: And also you have to have wash stations and glove stations as close to the area they were going to be working as possible. Because as she said, you wash your hands and put on your gloves, now go punch in your card, put your lunch in. Your gloves are filthy now.

It is a matter -- which, of course, that becomes the plant design, would be having some type of area, you know, last area. This is where you wash your hands and you do nothing from this point -- design this plant so there is no opportunity to do anything and contaminate from point A or point B where they are working.

As far as cleaning and training the employees, in the past couple of years, there have been a lot of technological innovations addressing that. There are automatic hand washing stations which work excellent. Unfortunately, most companies that I've seen that have implemented them, put it at a visitor area.

When they have visitors, they can show what we're doing, and have the visitors wash their hands automatically. The workers don't do it. It looks great to the visitors coming in.

It is a cost. You're looking at about -- the last time I got a quote on one of those, about $3,500. There is some really fancy ones that do boots. And that is great for the fish industry. It cleans the boots that you're wearing, as well as your hands.

But it takes a matter of less than a minute. About 35 seconds. Stick your hands in and the jets swirl around with water. And lots of them have a little type of antimicrobial thing, a type of lotion so you don't get dried out hands from repeated use. Have jets shooting into the fingernails to take care of scrubbing. And you take your hands out and get a paper towel and dry your hands.

Let's -- other issues that are brought up in this handwashing document are air dryers. A lot of places say, well, we'll save pollution by not having a trash can and using a hot air hand dryer. It will also keep them from touching things.

It is proven that -- they have some citing in here where you are actually recontaminating your hands. The hot-air dryers do not kill everything that flows through them. They're typically located in locker rooms or rest rooms, so they share all forms of bacterial matter being blown onto the hands, and saying that it is coming from the digestive track.

It is in the air. You're now blowing it through these dryers. In doing testing of some of these dryers, the dryers are fully contaminated. So it's not a way to go.

The only good way, proven way, is to have paper towels or some other type of towel that is a single-use towel to dry the hands afterwards. They show great, you know -- the data shows that that is the best way to do it.

As far as training the employees to properly wash their hands, doing a manual method, it was proven -- my notes here.

They said the main component above any type of antibacterial soap or even use of soap, was just large quantities of water. That is the number one thing. Using water -- even just water alone, in a bowl of clean water, reduced the levels of something like 80 percent.

Cleaning, using a fingernail brush and just water to scrub the fingernails, dropped the bacterial levels up to -- for a total of 90 percent. That is without any types of soaps or detergents.

So if they just get their hands in water for X amount of time, you're going to reduce the bacterial levels, which is where my experience has been, most of the contamination happens.

In automated equipment, your contamination is going to come from a failure or inadequate SSOP, because -- or -- or not following it. Okay.

A lot of companies that I write policies for, you know, I think when they're done they have a great policy -- and I always mandate if I'm going to write policies they have to let me to do training with their employees. But the enforcement and following procedures, when I come back and do audits, falls by the wayside.

Paperwork looks great. Records show they're not doing what they're supposed to do.

DR. ZINK: Do you think it is necessary to maintain records of this type of thing?

MR. TABARES: 100 percent. 100 percent. That is the only tool to mandate -- only tool an investigator has, other than sitting at the facility 24 hours a day, to force the company to ensure the companies are doing what we're requiring of them.

Yes, there is an added cost in that, but all you -- put down just like with HACCP. Build a committee at the company, and you build it and you build it into your standard operations.

DR. ZINK: What do you think the magnitude of that added cost is?

MR. TABARES: I would say it is minimal, because most companies I'm dealing with are spending the money to create the paperwork of what they're going to do, just a matter of getting the philosophy to the workers. Instilling in the philosophy of the workers that were serious about doing this. We are serious about it.

There would be -- in my opinion be a very insignificant cost.

DR. ZINK: It would be helpful to us if you could submit written comments or take a scenario of a company of a certain size, making a certain kind of product, and this is how many manhours a week it would take, in addition with the records --

MR. TABARES: Actually, I have those from the company I'm working with right now. We're evaluating all those costs. I can submit those.

DR. ZINK: Okay.

MR. TABARES: It wouldn't be an issue.

I think I covered everything. There is a couple other things.

Temperature abuse and incoming raw materials being tested. I support 100 percent that, even though there is an added cost, that all incoming raw materials be tested, especially since the majority of incoming raw materials are coming from outside of the country now.

That it is the reality of, you know, the times we live in. Most of the products are coming from outside the country or have a component coming out of the country.

As Laura said, the -- the continuing letter of guarantee from the company means absolutely nothing. I can find a company say, yeah, we tested it. It is perfectly fine, outside of this country. And they've never seen your product. Costs foreign countries are trying to avoid. The homeland security thing, checking the product coming in.

DR. ZINK: What would you test for particularly?

MR. TABARES: I would test -- I would test for all of your standard things. Listeria, salmonella, E. coli, plate counts. Those are the main things I would be concerned about. Depending on the product, there would be other items. Alpha toxin levels --

DR. ZINK: Would you still test for those things if the product was going to go through bacteriocidal processes in manufacturing?

MR. TABARES: Yes, because it is going to contaminate your facility all the way up to that point.

And to me, the biggest thing you want to avoid is the contamination getting into the facility.

DR. ZINK: What about the value of auditing a supplier and determining that that supplier has adequate process controls, validated processes and things like that as a -- does that diminish the need to test for that supplier?

MR. TABARES: To a point. That would get you -- you could deem the suppliers as reputable. Sort of like the NOP does currently with organic suppliers.

When they first start, you got several different hoops you're going through and a lot of regulated testing. And they establish themselves as being a safe -- quote, unquote, safe supplier. It goes down.

But that you -- I would recommend at minimum, biannually, they would be tested, twice a year. They would have to be tested to make sure -- that they keep the honest people honest. Because there is a tendency, oh, we went through all the hoops, paid our dues, breathe easier and slack off.

Unfortunately, when it comes to food safety, the worry of big brother is not a bad thing. Knowing there will be a test, knowing there will be repercussions to you, finding that you are not meeting the requirements. I can't emphasize that more.

There is an added -- I strongly recommend also -- and, actually, with the Homeland Security Act and how it's affecting the food industry, we're having to check all our inbound stuff anyways for possible, you know, contamination.

DR. ZINK: Tampering.

MR. TABARES: Tampering and stuff coming in.

So I think if the two agencies get together, there is a lot of overlap that you could, with a minimal governmental cost, add an extra step.

You got people checking stuff anyway. It is not too much extra to have somebody in there and do an extra test or an extra look at things.

DR. ZINK: Okay.

MR. TABARES: The other one here.

Temperature-abuse indicators. My company right now is looking at doing a cost analysis on what the cost would be for temperature-abuse indicators since the actual price for them has come down significantly, and putting them on the package.

We're looking at it -- we're concerned about the storage issues after it leaves our facility. We ship it out. And we may load it in a refrigerated container but the docking station gets transferred, shows up in New York. They complain the product looks bad.

Then becomes, you know, a two-month battle to find where it went bad. Check all our records and check who was at fault. We're looking at it for our own protection, basically.

I would recommend that there be clearly outlined requirements from the FDA as to temperature, storage temperatures for products, as well as means of providing that. Chart recorders, some new --

DR. ZINK: Bearing in mind that these regulations apply to all the foods we regulate, what temperature would you pick?

MR. TABARES: There is no one. For example, if but you have chocolate, chocolate blooms if they get too cold and they have warmed up. Chocolates are very susceptible. They need to be between 55 and 65 degrees, and they will stay stable.

Once you get above 65, if you cool it back down, they bloom. If you get it too cold and warm it back up, they bloom.

You talk dried fruits. Dried fruits love to be frozen. Anything below 40 is a wonderful storage temperature.

Being that I deal organics now, there is also the added shelf life that you get from storing your products, your raw materials, properly.

What I find is a lot of suppliers that supply you with ingredients from all around the world, and locally, you know, they want their product to last as long as possible, so they -- what I'm finding is they do store their products at the correct temperatures. And they send manufacturers, this is the correct storage temperature.

But there is no regulation in the GMPs that says, hey, if your produced says it is supposed to be stored at X temperature, you need to store it at X temperature.

If not, you know, there should be some testing. It would require some further testing to find out how long it could be out of that temperature before it is considered unadulterated.

DR. ZINK: In your written comments you might want to think about how we can codify something like that. We've struggled with it. We know some things require lower temperatures and some require higher temperatures. And what is an all-encompassing way that you can do to make such a statement, or should we just focus on things that support the growth of pathogens?

MR. TABARES: Yeah, I would. You're going -- from my experience, there is about -- we deal with a very broad spectrum of products. We don't deal with any meats, but we deal with fruits, vegetables. We deal with dried fruits and vegetables, as well as raw. We deal with nuts, seeds. We have a very large spectrum of products.

And we've got categorized in four areas. We looked at all different products and reviewing everything. There are four distinct areas you can set temperatures zones for. Because there are certain ones that overlap so that you can get it down to four manageable chunks.

All that information -- we didn't do any special testing. This is a matter of getting all information out in the industry to all our suppliers.

I'm a little upset that --

DR. ZINK: If you could share that with us in your written comments, I would appreciate it.

MR. TABARES: And then was there anything else?

DR. ZINK: It was just mentioned to me too, distinguish in your comments where you are talking quality issues from safety issues.

MR. TABARES: Definitely. There are two distinct issues.

Two other things -- or actually three.

I haven't heard any mention of Senate Assembly Bill 71 that just passed. I don't know if that is going to -- if that is going to be incorporated into the GMPs or be incorporated in the nutritional aspect of it.

That addresses the allergens specifically.

DR. ZINK: I don't think we know the answer to that either.

MR. TABARES: I think -- personally I feel it -- I strongly feel it should be put into the GMPs. I also feel -- again I also feel the whole nutritional portion should be part of the GMPs. That has to do with your labeling issues.

If you treat them as separate entities like most companies do, this has one priority, this has another. Oh, the government is getting down on GMPs, if we pay attention to this, we can ignore a little bit on that and not worry too much.

There really should be -- treated as a subchapter, whatever. I strongly feel that the whole nutritional labeling section of CFR 21 -- was it 110, I believe, is the nutritional labeling, that should be part of the GMPs. Addendum to it. The whole --

DR. ZINK: What would be the advantage of making them part of 110, incorporating them into 110.

MR. TABARES: I believe it would send a stronger message as to the importance. Everywhere since 1989, I started seeing a strong recognition by the industry that the GMPs was something the government was serious about.

They really wanted you to do GMPs. Of course, there is lots of vagueness. That is why I'm hired to interpret what would work, what does this mean to their facility.

Labeling and nutritionals, on the other hand, have always been a pain to the industry. Basically, you know, what -- there is always treated from -- from every small company to every large company I've been.

Yes, it is important because of liability to me, but it is really not that important to the consumers.

It is important to me. I don't want to get sued. That's about it. Rather GMPs -- oh, this is important to the government. For some reason it matters more.

The nutritional labeling has always been what's the cheapest way, least expensive way, I can do this. Yeah, I know it might not be accurate, but it's okay.

There used to be several people, department managers, I've run into years ago and say the government says you have 20 percent leeway, it doesn't matter. Within 20 percent change, I don't need to worry about it.

That is not true. I have to explain to them that is testing, and break it all down for them. That is the conception of the industry. The importance of it, the seriousness of it, isn't felt, you know.

Either all or some part I would -- firmly recommend at least the ingredient statement and allergen statement portion at a minimum be incorporated in GMP as part of the review process --

DR. ZINK: Manufacturing control.

MR. TABARES: Manufacturing control.

And it falls into the last thing I want to talk to. You have hit it several times, and it is a serious problem, which is the language barriers at the workplace.

We're getting more and more diversified. And you will have many, many different languages on a production floor. Sometimes you will have -- especially here in California -- on production floors where English is the second language.

DR. ZINK: I think we've heard of one plant that has 21 different spoken languages.

MR. TABARES: Yeah. What I find is, I'll write GMPs, training SSOPs, I'll do training over there. I can do English and Spanish. I have colleagues I'll bring in that I can do Chinese, Vietnamese, Cambodian Italian, Russian. You get that picture. You bring in -- I -- I make the effort when I'm contracted to bring in people.

Because what we do, we do training with individuals that need it in that language. Everything gets translated into that language and the people get taught in that language. When people sign off on something --

DR. ZINK: You're saying that we should require training in the native tongue or in an understandable format?

MR. TABARES: The way I would word it would be the employees that are doing the checks, and they're required to have training, need to have training in the -- in a language they understand, whether that be -- you know, requiring them to read and write English or require the company to supply it to them in their language.

Because what I find is -- I walked into a facility four months ago; I was doing consultations for HACCP. And they -- going through their HACCP program, they had a very well put together HACCP program, trained and signed-off training sheets.

And I start reading the names. Can I see this person? I walk up to them I start talking to them. They're shaking their head. Only spoke Spanish. They didn't read any English.

Where are your training manuals that are in Spanish? The person got trained. No, no, we gave the meeting and somebody -- the manager talked in Spanish to them.

Did you give them anything hard? They go, no.

I asked the employee. They go, that was in the record of attending a meeting. They didn't know what they were signing. Hey, I'm signing I'm at the meeting.

They didn't know they were signing, above it in English, it was saying they were adequately trained and understood all the operating procedures they've been trained on.

MS. GIRAND: I think your points are very well taken. I actually live right now in the Netherlands.

And I wanted to mention something else which fits in with this, which is a cultural difference that underlies, as well as a lack of understanding.

So we may train, which is go wash hands, scrub fingernails, do all this stuff. But if you never bothered to explain to them what a germ is, and they never took high school biology -- and I don't mean anything about a worker that has come from another county -- the reality is, if they don't have the educational background to understand what the purpose of this is, and they have a cultural background that says the germs aren't that big a deal, then you've undermined your training in the first place.

So I think, clearly, language alone is an incredible barrier, also cultural understanding, that really needs to be addressed in training and education.

MR. TABARES: Yeah. That's -- yeah. I agree with you 100 percent.

Here in California we have a large Mexican population where I'm working, consulting on. And the cultural difference is, from where they come from, their background, very, very different.

They -- the biggest problem, again, is getting them to buy into the reason for doing it.

I don't think a company or a government -- or the government is going to change their minds. I don't think you are going to get through that barrier.

But what needs to be clear is, is it part of your job -- and this seems to work, you know. This is what is required. I know you may not agree with it, but guess what, this is required by law. This is what we have to do. And they will buy into that.

They can follow the procedures, whether they agree with them or not. But the demonstrated philosophy of the company from the management level has to be that it matters to them.

DR. ZINK: I need to cut in a minute. In order to give some other questioners some time. We will have some more time at the end of the meeting for public comments if you would like to add more then.

But just before we have a break, I would like to get a few more in.

Actually, public comment period was going to be towards the end of the meeting. That is fine. We capture everything.

But do you have -- either you gentlemen have a question?

MR. TABARES: No. More comments than questions.

DR. ZINK: Anybody have any further questions?

What I'd like to do is have a brief break. There is a little cafeteria across the way where you can get drinks and restrooms.

Let's take ten minutes, if you would, and we'll reconvene ten minutes of the hour.

(Brief recess taken.)

DR. ZINK: We're going to begin the next phase of our meetings. This specifically targets small businesses, but I have to say, the information we provide for small businesses is also quite good for a business of any size.

I'd like to introduce to you Marcia Madrigal. She's been with FDA for 20 years. She worked as a FDA field investigator in the San Francisco district office for 16 years, conducting all types of FDA inspections.

Her last few years as an investigator were spent for the district's food team. She conducted food inspections and served as a domestic food team leader for a short period, and she became the Pacific specific region small business representative in 1999.

Her present duties included all FDA regulated industries, such as drugs, cosmetics and devices. In her capacity as a small business representative, she organizes workshops, answers industry inquiries about how to get an FDA-regulated product on the market, product labeling and good manufacturing.

Probably a lot of people didn't know this kind of support was available.

She holds a bachelor's of science degree in nutrition from the University of Berkeley.

Marcia.

MS. MADRIGAL: Good morning. It's a pleasure for me to be here this morning and be able to participate in this meeting.

Out of curiosity I was wondering how many small businesses were here today.

Great. Quite a few of you. Glad you guys could make it. Okay.

The FDA regional small business representatives, they help implement the provisions of the Regulatory Flexibility Act. This act describes procedures for regulatory and informational requirements to assure that the special needs of small businesses are considered.

Some of the goals of the act are to improve the relationship between government and small business, to encourage small business 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 opinions, to provide regulatory options which are least costly to small business, and to help small business understand and comply with FDA regulations.

Okay. To that end, the FDA regional small business representatives, which I am part of, assists FDA-regulated businesses, such as manufacturers, processors, owners and their employees, operators and entrepreneurs to understand FDA's legal requirements, whether that be food registration, manufacturing or labeling issues.

The small business representatives answer questions, provide guidance and explain the intricacies of dealing with the FDA to industry. When new guidance documents or new regulations are issued, we contribute to the general effort to FDA to respond to questions about them.

We make referrals to other FDA offices for inquiries which require more technical expertise. We work in conjunction with the small business outreach and assistance offices of the FDA centers and the office of the commissioner.

The small business representative brochures, and that is these right here that are on the table back there, that were provided to you today contain our contact information.

And on the back here there is a listing of the five -- I'm sorry, four small business reps regionwide.

And you will find contact information on the FDA small business office outreach if you go to the FDA website, WWW.FDA.GOV.

If you look inside the brochure on the blue page, it's listed there.

In preparation for this series of meetings, the small business representatives assisted FDA Center for Food Safety and Applied Nutrition and outreach to small businesses to make them aware of the opportunity to attend the public meetings and voice their concerns or submit comments to the dockets, either individually or in conjunction with their associates.

The FDA needs to hear the concerns of the small businesses. We hear their concerns and questions on a daily basis. About 40 percent of our inquiries pertain to food regulation issues. Questions range from the general to the very specific.

To be in FDA compliance with the GMPs consist of a whole range of activities and controls. That results in a product which is not adulterated within the meaning of the Food, Drug and Cosmetic Act.

What these activities and controls consist of, small businesses want to know, for many callers seek information on what to do that is not addressed in the food GMPs.

For example, they ask how they can select safe food contact surface materials, whether a specific cleaning compound is acceptable on a food contact surface. They want to know whether product testing and shelf-life studies must be done and whether an expiration date or a pool date must be affixed to their food packaging.

They want to know how often they should clean their equipment. They want to know whether their food manufacturing equipment must have insulation, operation and performance qualification.

They are concerned about their suppliers and they want to know how to be assured that their suppliers provide ingredients and packaging are in compliance.

I'm sure we've heard a lot about that today.

And concerns range from tamper-evident packaging to employees' health certificates.

It is my impression that many small business owners and starting out entrepreneurs express the view they want to be in compliance and do everything right.

They are looking for details and information on how to be in compliance; in other words, if they just understood what to do, they would do it.

Small businesses generally do not have budgets for extensive research, nor do they have their own regulatory affairs departments. They need the GMPs to provide unambiguous directions to help them achieve their desire to be in compliance. They want this without the extensive -- without extensive and costly research they cannot afford.

The generalities of title 21 CFR Part 110 provide latitude in meeting its requirements and allows for technology changes, but at times this approach runs counter to the needs of small businesses who seek clarity and details in order to operate an FDA-compliant firm.

Thank you.

DR. ZINK: Marcia, thank you very much.

Our next speaker, Dr. Clark Nardinelli. Clark has been with FDA since 1995. He's an economist and serves as our team leader for economics. He's worked on cost benefit analysis in small business for CPSAN regulations, including foods, dietary supplements, infant formula and others.

Prior to joining FDA he taught economics at Tulane, University of Virginia, Clemson University and the University of Maryland.

Clark.

MR. NARDINELLI: My topic is very specialized. I'm going to talk to you about how to comment on FDA policies and regulations. And my remarks are aimed especially at small businesses, but they apply to anybody who wishes to comment on anything we do.

The importance of commenting particularly on the record to the dockets, is that it allows you to directly participate in our rule-making process.

Now, there are two laws that require the FDA to ask for and consider comments from small businesses. These are the Regulatory Flexibility Act of 1980 and the Small Business Regulatory Enforcement Fairness Act of 1996, which we in the government call SBREFA.

These two laws require all federal agencies to ask for comments from small businesses and to consider the effects on small businesses of our rules.

Now, if you are going to comment, some of the things that I think -- we would like you to think about, and very helpful to think about.

First of all, we're talking about various provisions. And you've heard a lot of suggestions today, is there a need for the requirement.

What will you, as a business person, as a plant manager, have to do to comply with the requirement.

Do you think the requirement will accomplish the stated goals. The stated goals, for example, of modernizing food products so there are fewer human illnesses and fewer product recalls associated with microbiological, chemical, physical hazards in food.

Also, are there other ways to accomplish these goals from what has been presented.

When you actually submit a comment, describe how a provision will affect you. How will it change how you carry out your business.

Remember, however, that any information that you do submit will be on the public record, so please don't submit sensitive information, information that you do not want to be made public.

Now, we're -- what do we do with this information? Well, we use the information to estimate costs and benefits of particular provisions.

So what kind of data help us? One thing we want to know, changes in tasks. What will you have to do differently. How many of your employees or other workers will be affected, the number of employees. Time it takes to do something. And also the types of employees: Production workers, management, quality control.

And be specific as you can. Tell us who is going to do what and how long it's going to take.

Let me take an example from something we talked a lot about today: Training.

What kind of comments would really help us? If you need to train new workers in these procedures, there are likely to be two types of costs.

One type will be to plan the training, design the training, train the trainers. And the second cost is the actual training. How long will you have to train workers, how many will you have to train.

So tell us about that. And, in fact, something that would -- we really would love would be numerical examples.

I have a very simple example here. We start by identifying who will be affected. Then we will estimate how many, what they will have to do, how long it will take. And in this case, I've even thrown in some wage rates to give us dollar costs.

It is extremely effective in comments. And the more detail you can lay it out -- you can lay out for us, the better.

Okay. So let me conclude with just a short list of things to do and things to not to do.

Do send specific numbers if possible. Do send comments in on time. The docket, the comments, dockets, usually have deadlines.

For example, for these public meetings the docket closes September 10th. But let me also emphasize in this whole GMP initiative there will be many, many more comment periods. This is not the last time we're going to ask for public comment.

Send comments to the docket. Many of the handouts have the FDA address and have the docket there. Do if possible send combined comments through associations, perhaps in the form of surveys.

Do not, as I mentioned before, send sensitive information. And do not send unsupported opinions; in other words, we know that many of you will not like what we do, that's okay, but it really doesn't help us much to say "I hate this."

Tell us why. Give us something we can work with to try to understand what the problem is.

Thank you. I would look forward to getting comments from you.

DR. ZINK: What I'd like to do now is open the meeting up for public comment period. And we want as much comment and input as we can. We don't always know who wants to comment.

We did have a registration process here, but I understand there may have been a glitch in our computer, and the people who checked the box they wanted to comment, if they registered electronically, it may have not have carried through to our database.

I am aware of one other individual that wants to comment. Jim Gorney. I believe you want to comment. And introduce yourself and comment. If there is anyone else after Jim, we will make time.

MR. GORNEY: Good morning. My name is Jim Gorney. I'm with the International Fresh Cut Produce Association, and we'll be submitting these comments to you through the stenographer.

First and foremost, I would like to thank the FDA agency representatives who came out to meet with us this morning and give us an opportunity to provide comments to the FDA Good Manufacturing Practices regulations for foods and the possible need to modernize them.

First I'd like to introduce IFPA, International Fresh Cut Produce Association, bagged salads, as mentioned by Dr. Crawford and Dr. Zink.

We represent and provide technical expertise to commercial suppliers of fresh cut produce, as well as companies affiliated with the fresh cut produce industry, like equipment suppliers, retailers and food service operators.

We have about 400 corporate members who are actively involved in the 10 billion dollar fresh cut business.

Our industry has taken a very active role and initiative to enhance food safety in this food category as a commitment to our customers and ensure the industry's long-term business success.

One of our reasons our association even exists is to serve as a clearinghouse for food safety information for anyone involved in the industry or the fresh cut industry.

We're acutely aware of the importance of food safety.

With regard to the current Good Manufacturing Practices, there are currently that are set forth in 21 CFR 110, and they provide guidelines that assure the foods for human consumption is safe and has been prepared, packed and held under sanitary conditions.

The CGMPs provide food processors, such as fresh cut produce processors, with the core principles of sanitary food handling. They serve as well-recognized and agreed-upon standards of conduct and operation.

The current CGMPs are well written. They provide general guidance regarding regulatory expectations of performance and conduct without being overly specific or prescriptive.

And this aspect of the CGMPs accommodates the many diverse, specific situations that are encountered in the food industry today.

The regulations as currently written provide flexibility for the diverse formats under which these regulations are applied.

By use of terminology such as "adequate facilities where appropriate," "necessary precautions" and "adequate control," this flexibility allows the CGMPs to comply to the plethora of situations encountered during the production, handling and distribution of food products.

Also, and very importantly, by not being overly prescriptive, the CGMPs allow for the incorporation of new technology and innovation, without the need to revise the regulations.

The CGMPs currently formulated are commonly agreed upon and scientifically based standards by which industry and regulators effectively and harmoniously communicate the standards of performance and conduct when food products are being prepared, packed or held.

As such, the CGMPs are centrally important in reducing the risk of product adulteration and food safety risk to consumers.

Because the CGMPs are effective, flexible and commonly agreed upon by industry and regulators alike, the IFPA believes no significant changes or amendments to the CGMPs are needed.

As CGMPs form an effective basis for the sanitary and hygenic preparation of handling and distribution of foods, further guidance which assists in interpretation of the existing regulations with respect to specific areas of concern, is the recommended and a more appropriate and effective approach to addressing new or emerging specific food safety issues.

The FDA data, which we saw this morning, indicates that the most common causes of food product recalls are, one, incorporation of undeclared ingredients in foods, food allergens; and, two, contamination of ready-to-eat food products with listeria monocytogenes.

The CGMP regulations as currently formulated adequately address both of these issues, and it is unclear as to how the CGMPs could be revised to more effectively address either of these food safety issues.

Specifically, 21 CFR 101.4 requires that all ingredients be declared on the label, and the Food Allergen Labeling Protection Act of 2004, which was recently signed into law, assures consumers are informed and understand the language that one or more of the most common food allergens may be present as an ingredient in a food product.

Also the FDA considers any food product which tests positive for the presence of the human pathogen to be adulterated and unfit for human consumption.

Specific guidance for effective control of food allergens and listeria monocytogenes in ready-to-eat foods have been developed outside the framework of CGMPs by collaborative efforts of industry and regulators.

Continued use of this effective strategy of addressing specific food safety issues by issuance of food safety guidance practices is recommended over potentially amending the CGMPs.

The fresh cut produce industry strongly believes that HACCP is an effective means of enhancing food safety by control of chemical, physical and biological hazards that are reasonably likely to occur in the absence of these controls.

CGMPs are the cornerstone prerequisite that certain hazards will not be likely to occur and, therefore, need not be addressed in a HACCP plan.

HACCP ultimately relies upon CGMPs and other prerequisite programs that are outlined in the FDA's CGMP regulations; therefore, voluntary adoption of HACCP by the fresh cut produce industry, and processors in particular, has driven effective and appropriate implementation of CGMPs.

However, HACCP is not the first, nor it will be the last, food safety program developed, and other new food safety enhancement programs will rely upon the keystone principles that have been put forth in CGMPs.

Because current good manufacturing practices are commonly agreed upon and understood, they provide the basis for many other food safety programs. And it will be unwise to potentially alter CGMPs and cause confusion for the food industry.

Regarding current Good Manufacturing Practices' role in assuring food security, clearly current Good Manufacturing Practices are not intended to address intentional adulteration of food products.

Recently passed laws and regulations and provisions of the Bioterrorism Act of 2002 clearly and specifically address food security concerns. And, again, industry and government have collaborated to develop and implement guidelines and assistance which enhance our nation's food security.

The agency is also inquired as to whether or not it will be appropriate to mandate or recommend a number of programs that help assure that preventative controls are carried out adequately, including training programs, audit programs, written sanitation operation procedures and testing programs.

These programs are routinely implemented in the fresh cut produce industry to various degrees and are routinely monitored by fresh cut processors, independent third party auditors and customers. As such the agency should not mandate these programs, as it would reduce the ability of industry to be flexible in implementing appropriate and effective programs that work best for specific applications.

In summary, the fresh cut produce industry welcomes this opportunity to enhance the safety of our nation's food supply. And we believe that the current flexible CGMPs supplemented by guidance documents for specific products and/or processes are the most effective means of assuring food safety.

I'd like to thank the FDA for this opportunity to offer comments, and we look forward to working with the agency.

I want to make one more comment of what was brought up earlier -- and I'll speak extemporaneously -- about testing finished products or testing raw ingredients.

I've heard Dr. Bob Brackett say on a number of occasions that absence of evidence isn't evidence of absence.

What he means by that is just because you you've tested product and you don't find pathogens there, it doesn't mean that it is safe to eat. You may just not have taken a large enough sample size.

Really, it is not an issue of detection, it's really an issue of sampling and statistics. And we all know that is one of the reasons HACCP is so well embraced by our industries, because it's a preventative approach. And we all know we can't test our way to food safety.

So with that, I would like to close and say thank you to the FDA panel.

DR. ZINK: Thank you, Jim.

Anyone else that would like to make a public statement?

Introduce yourself and your affiliation.

THE AUDIENCE: Kevin Gillies, G-I-L-L-I-E-S. I'm with Gencor International, based in Palo Alto. I would like to comment briefly.

First on a couple of things that were mentioned earlier in the presentations, and then comment in more general terms on -- in the area that Jim talked about.

For those of you who are not familiar with Gencor International, we're an enzyme manufacturer. We're quite a bit different. We're governed under food GMPs for the food ingredients that we produce, but we're very much different than a fresh cut produce manufacturer.

One of the things I would like to say in general terms is that understanding that the food industry is such a diverse manufacturing environment is one of the -- is really the essence, the genius, of food GMPs as written today, is that generality.

Now we can look at that generality in two ways. One, it is too general and doesn't guide enough. And as Jim mentioned, the other way, though, is to look at it that it is generally enough to act as guidance for this very diverse industry.

I would like to encourage FDA in their deliberations on this modernization effort, that they take counsel from this diversity and understand that what they're looking at is -- continues to modernize a device that has to serve the entire industry.

And Jim mentioned quite -- quite nicely that other agencies have used different devices rather than modern -- or changes in GMPs to address specific risk-based issues.

I think the listeria rule is a clear-cut example of the ability to identify where our maximum risks are and be able to address in a very forthright way, with very specific remedies, a clear-cut food safety problem.

So as a manufacturer of enzyme products where we have a complete supply chain and validation of raw materials manufacturing steps, supply chain steps from ourselves to our customers, where we are actually today without demand from the agency documenting, validating, auditing that supply chain.

We feel like we're in full compliance with the GMPs, both letter and spirit.

I would encourage the agency to understand that there are parts of the industry that the GMPs are certain as well.

To go to specifics then from the earlier discussions, I want to talk about a little bit about testing of raw materials.

And I want to support Jim. I'm not going to go into a lot of details, but clearly testing, we know all of the scientific evidence demonstrates that testing is not the solution to the presence of microbial hazards in something like a fresh cut produce comment.

I just want to support his statements in that regard.

One last specific comment to Laurie's comment on lot size.

In particular instances, it seems like the right solution. Decrease your lot size, understand where it goes, understand who uses it, understand the supply chain completely.

If the world were that simple, that would be fantastic, but the manufactured food today is much more complex than that. I want to -- I want to -- from a relatively large company, not a huge company, but a relatively large company that relies upon our chain of validation for raw materials in the manufacture of product and then ship them to our customer, that the economy of the industry requires the ability to be able to use validated lots in multiple lots of products.

For an industry like ours, it would be debilitating to have such narrow lots put around the raw material.

With that, I'll give you the floor. Thank you very much.

DR. ZINK: Thank you. Do we have any other comments? Okay.

Please state your name and your affiliation.

DAVID MOORE: My name is David Moore. And my affiliation is a small winery and vineyard operation called Savannah vineyards.

I'm the vineyard manager. The vineyard is wholly-owned by the adjacent winery. And I'm here to talk about the rank and file of the small businesses relative to these regulations.

There is a phrase that goes around, which we've all heard: Be a manager, go to jail.

And small wineries have one thing in common with other small businesses, and that is, what the boss wants most for us to make is money, and the boss has the final say.

As the manager, I want to encourage the FDA to consider the ramifications of the rank and file of small business who work to execute and implement compliance coming up against their job security and their direct employer who is looking at a bottom line. Maybe looking at the government regulations with a different eye.

And then I'll just add to the issue of testing. I'm a lot of years removed from my degree, but when I was in school a lot of microbial testing was very -- long incubation times. I know there is some changes in technology.

We can't have, maybe the process here -- we can't have produce sitting in a cold room or sitting on the dock while we look for a bug. And I'm sure there are technologies that get us beyond that, but we process a fresh product, and we're looking for a quality raw material coming in. But I'm not sure there is a lot of technology available for us to validate that quality before it comes into the process.

That's all I have to say.

DR. ZINK: Could you elaborate a little on -- maybe by example, in the GMPs where there is a problem between what a CEO, who may not be a technical expert in food processing or the law, and their management where they butt heads, or how we could clarify or make the -- if you will, make the GMPs more understandable to the layman what the requirements are.

MR. MOORE: Well, for example, the old model wineries in the growing regions were often operating off of agricultural wells, which -- you know, you talk about something about the water.

To convince a small winery owner they have to put in a water treatment plant for the winery may be the right answer, but convincing an owner of that may be -- may not be easy to do. And there may be an intermediate way of doing it.

Processing. For example, packaging. My understanding is some of the big dedicated bottling operations have elaborate GMPs in place. Everything comes to a halt. Any potential problem is very meticulously isolated in both directions, and meanwhile the CFO is pulling his hair out because the machine is not making any money.

I'm not saying we should be cavalier about it. But as the responsible person on the machinery floor, I've got one person on one side of my collar, and perhaps the government breathing down the other side of my collar.

DR. ZINK: Okay. Thank you very much.

Do we have anyone else?

MR. EARP: Yes, sir. Rick Earp, E-A-R-P, with Dryers Grand Ice Cream. I work with the corporate quality assurance management group.

I'll be very brief on four points that I want to make sure that, at least in the consideration of the writing, that we don't overextend ourselves or don't get too much involved within the same situation as Jim might state. Missing the point.

Particularly, allergens are our biggest concern. In the seven different products, product lines that we make, it is by far our number one consideration.

Involved with allergens, it is very important that FDA, in establishing the regulations, recognize there is very limited, if not no way, to be able at the production level for incoming ingredients to be able to detect allergens.

We have to rely on correct packaging and correct labeling to make sure that we are not contaminating or getting an allergen product out to the consumer.

We are going to spend well over a million dollars in the next 12 months on assuring that we have systems in place, sophisticated electronic computerized systems to make sure we have correct packaging.

But I want to make sure it is understood and considered, that if there is going to be some way to measure at the plant level, it is understood we can't do that.

There are no other -- other than for peanuts, one ELISA test of the eight major allergens, and the four that we're considering, we're very, very limited in what we do.

If we get burdened down by an excess of regulation, then we won't be able to do what we can do to try to minimize allergens.

So next point was also -- Jim with the fresh cut produce industry. Ingredients to us are massive. So for us, what happens -- we have two people that we employ that do nothing but travel in North America, particularly the Central Valley, up in Washington State, Central America, Mexico, South America, to do nothing but look at, particularly, ingredients from the time the season comes in, at the field level, on what is going to be happening and how that product -- those products are taken from the ground, or the trees and put into some kind of packaging container to be transferred to us.

That's the point we want to make. How that is done is very critical. And if the HACCP program is going to make that successful, the emphasis from our perspective is that good GMP policies do need to be followed from where the product is produced to where it is first-line packaged.

First-line packaging means it goes from some kind of sanitizing method and some kind of sanitary packaging developed. Emphasis for industry needs to be at that point.

I wanted to make sure that at least that was -- that was at least brought out in the discussion point.

Again, Laura's consideration getting on large batch sizes today. But from a very large organizational situation, we have found statistically -- and I will be sending some broad information also in comment on this -- that -- that we have facilities that have 25 major production lines.

We will have on an individual line on one day maybe make 10 product changes. That -- those are -- each change or each production is a lot.

Our goal and they've -- they've burdened us in quality assurance to try to minimize the amount of changeovers that we have.

We have found that we get labeling/packaging errors, formulation mistakes and massive ingredient mistakes by the large number of changeovers that we are required to do to fulfill our customer needs.

With that in mind, there needs to be, you know, consideration that broad statements about minimizing -- minimizing batch sizes needs to be taken into consideration, that there could be some significant problems associated with that too.

And, finally, equipment design. Being a large organization, we take great pains to align ourselves with the AAA. I hope that if, indeed, no piece of equipment comes into our operation that is not AAA or AAA-equivalent, or we work and spend hundreds of thousands of dollars to work with that vendor to get that piece of equipment qualified by AAA, I would hope if the standard is going to be made by FDA, there is no conflict that goes against what AAA and USDA is trying to say about equipment design, because they're very specific, very detailed, rules and regulations that industry does comply to. And I hope there will be no conflict in that area.

DR. ZINK: Thank you. Can I ask about a couple of points. Currently in the Good Manufacturing Practices there is nothing in there about allergens.

The agency has always had a requirement that a product be accurately labeled. So when someone has an undeclared allergen, certainly they've violated labeling regulations.

But if you image that you're writing a corporate policy or requirement, how would you address, in a GMP context, allergen control?

MR. EARP: We're doing it right now. We've got three different teams with various different aspects that are working with different phases of this question.

And with that in mind, we have found that we can't do it by testing. There is nothing out there that allows us to do that. We have to focus on making sure the right product gets into the right container.

We're spending large sums of money for two-D coding and camera vision equipment right now at the end of our production lines in various processes. Computerized systems that makes sure the right mix gets to the right line.

DR. ZINK: If you were a small business, could you do that with manual checks and check-off sheets?

MR. EARP: Yes. But the focus has to be, in my opinion, on labeling and packaging because there is minimal, if not none, opportunity for us to detect for the allergens.

DR. ZINK: Do you think there would be some value in having some requirement that a processor verify that the right product is being matched up with the right package?

MR. EARP: I think if put into the right context, yes.

I think if put into the right context, this would drive a variety of people like the Charm Science Companies or other major companies to try to develop accurate testing devices with which we could determine this.

It would -- anything that could drive them to do that -- it is money driven. If they don't have any impetus to do that, they won't do it.

Right now it is in our court to make sure we don't have any issues. It would be nice if we had help along the way from technical industry to help to support that cost.

If it could be written appropriately to drive organizations to do that, it would actually help industry.

DR. ZINK: Okay. I have one other question. You know, years ago USDA used to require that any equipment used in their plant had to be approved by them. There was a venerable gentleman, Mr. Roy Oyster at USDA that was the approver of equipment, now retired. And they no longer are in that business.

And what do you see? Is there a value in maybe trying to expand third-party approval of sanitary design for food processors?

AAA has historically dealt with the milk-related industry. There is nothing for, for example, for pasta makers, for example.

Is there value in that?

MR. EARP: Right now AAA -- I've been directly associated with AAA committees and their efforts.

AAA is attempting right now -- what they've done, they've had their first class of what they considered in the last year, trained to be advisors to all industry to look at pieces of equipment and act in -- as their agents to be able to assess and evaluate pieces of equipment.

There are 18 people that went through that first class and are certified by AAA to be able to make assessments associated with whether or not a piece of equipment is sanitary and are -- will meet the function of whomever -- of what AAA would recognize for that particular function it should be.

If it -- and those particular -- as a matter of fact, we keep one on contract right now that we deal with, so we don't have to continually wait for AAA, which their time is very limited.

All I would say in that vain, if an organization could just simply look up the AAA website and contact them, get a list of those people who are certified to do that, it would greatly help their industry in trying to come closer to what good food safety considerations are.

I'm not an advocate for AAA, I just know I spent a lot of time dealing with their equipment.

DR. ZINK: Okay. All right.

MR. EARP: Thank you.

DR. ZINK: Would anyone else like to make a comment?

MS. GIRAND: I was hoping to ask that question of the audience, because I've been going to these meetings for about seven years and I have seen and even read a lot of the materials industry puts out, and I say that respectfully, about educating producers, processors, et cetera, on food safety.

And I have to say there are a lot of materials, and they seem to be quite good, given the context of English.

I would like to understand from industry how industry expects government to -- I'll say educate the people who -- or the processors who ignore the education that industry puts out and ignore the information that government puts out. Because processors do exist -- they don't come to these meetings, but they do exist -- but ignore both government and industry efforts to educate them to be safe.

I'm pleased when I hear that HACCP has created over 100 percent increase in five years in a particular area, but when I hear it is in the 50 percent range, that is wonderful. What about the other 40 plus percent? What are they doing and where are they and does government even know where they are?

So I'd really appreciate it if anybody cares to stand up, and I promise I won't say anything else. If anybody has any comments about what can be done about the bottom 40 percent as opposed to the top 60.

DR. ZINK: Kevin Gillies.

MR. GILLIES: This is a very good question and a frustrating one, I think, for a certain segment of the industry because, as I say, we might not be here having this discussion if 100 percent of the food-producing industry was following what we think is full compliance.

Our problem with -- with -- I think money is the industry's problem with an approach that takes a more proactive approach as being in the food manufacturers -- more of a policing function.

Really, our problem with that is based on USDA's experience because they have this direct plan for oversight function, and they have a lot of premarketing function that is not currently inside the FDA amendment.

We don't see that particular activity as a great deal more effective. It is a great -- it is a problem. There is no doubt about it.

I'm as disturbed as you are when I hear a good 50 percent where people are in compliance, or at least knowledgeable. I think it is one of the great issues.

I don't think this can be solved by rewriting GMP along the same philosophical lines that we have today. I think we have an example of an attempt when we're trying to rewrite or write the dietary supplement of GMPs, where we're trying to make a hybrid document that has quality demands, a little bit -- not so much a policing function but more muscle to that document.

I think you can see that that document today is not satisfying. I think the need that you expressed: How can we do it?

As a particular industry -- and I'll get off this -- voicing my frustration as you have.

Industry associations, many of them -- and as Jim mentioned the fresh cut produce association -- the enzyme manufacturers worldwide also have associations that have developed guidelines for production, guidelines for safe handling of product, et cetera, and have an internal policing function.

Frankly, I think where you have those types of associations that is more effective than anything else because you have a peer pressure to do that, outside a mandate to actually have an internal policing function for the manufacturer.

Thanks.

DR. ZINK: What about mandatory education programs for anybody that is going to be in the food business? Is that --

MR. GILLIES: Certainly you can conceive of that, how that might be implemented and how you might actually determine whether or not someone was thereby qualified to be in the food business, raises a lot of issues I think.

But, clearly, there -- there are ways -- and I didn't bring this up earlier. I'm actually quite a proponent, if we are going to rewrite the GMP or at least improve it, we start to codify some of the things that are in practice, HACCP programs, perhaps some benchmark objectives from those HACCP programs, et cetera. Again --

DR. ZINK: That's what we're interested in. We're interesting in hearing about -- I'll call them state of the art things that everybody is doing or should be doing for Good Manufacturing Practices that we can broadly apply across all the foods we regulate.

We're very interested in that.

MR. GILLIES: Absolutely. And I certainly -- especially things so well established as HACCP because it has been such a benefit to the industry from the standpoint of reduction, obviously, of hazards, but also as a means to focus the business on the total quality approach inside the business.

But that's been extremely effective without being, as you noted, without being a mandated program in most industries.

DR. ZINK: I should say there has been difficulty with the terms "GMPs" and "HACCP."

And when this one began and the other end, even if you look at some of our regulations, the seafood HACCP, while we call it a HACCP regulation, there is a lot of GMP elements in it.

The juice HACCP regulation is perhaps more purely HACCP. But I guess the current thinking is you really can't have one without the other. That you have to have Good Manufacturing Practices that may deal with things and ways different than we do process controls.

So the term that we have begun using around the agency is "universal preventative controls." By universal, I mean something we can apply to all foods by preventative -- we would really like to see --

If we look, there really hasn't been a reduction over the years in the number of recalls. We would like to see these measures significantly contribute to a reduction in recalls, to a reduction in food-borne illness.

And by controls, we mean things that are documentable, verifiable, measurable, but may not be quantitative. They may be subjective in some cases, but nonetheless, things that a processor could do that are demonstrably in place and happy.

MR. GILLIES: Quick question and then I'll sit down.

In that vein, do you see a drive to emphasize particular risk areas -- do you see a drive to do that inside this GMP modernization, or do you see more of the approach that Jim was recommending, that we maintain the GMPs as the guidelines they are, but then take a specific, perhaps rule-making approach, based upon observed and quantifiable risk?

Going back to the ready-to-eat foods example.

DR. ZINK: There are probably some specific foods and processes where the specific rule-making approach that Jim mentioned would be the way to go.

We hadn't been thinking outside 21 CFR Part 110 right now.

Yes, I think we do want to make these things focused on food safety risks more strongly. Some of the comments we've gotten from other meetings have said go ahead and say in the regulation what risks you're addressing with this control. And I'm not sure we know how to do it yet or thought about it.

But also I want to say, we're not going to make it just totally food safety. We recognize that the GMPs have something to do with wholesomeness, foreign objects, things that don't necessarily in and of themselves lead to a safety hazard, but just filth.

We're not going to ignore that. Filth and wholesomeness are still something we want to address.

But I think to better focus resources on outcomes, making them more strongly tied to food safety, risk is an interest.

MR. GILLIES: Would you say, philosophically, would you say within the agency the feeling is that the more risk-based targeted approach rather than something like the GMPs to approach those specific risks?

DR. ZINK: I think we see a lot of problems that are -- would have been prevented had there been GMP-type controls in place.

I think we think that a lot of food-borne illness could be prevented by either implementation of better GMP-type controls. I mean, you're looking at a lot of problems we've had.

If you go back to what Rachel said. A lot of workers not following established procedure, a lot of it. A lot of it is just -- allergen recalls were almost always a failure to either match the correct product up with the correct label.

And there is nothing in our regulations that would alert a processor to the need to do what seemingly should be obvious. Another part of it is simply a failure to adequately clean.

We've seen many recalls where someone has a demonstrable lack of knowledge about sanitizers and detergents and how to use them to clean a piece of equipment to make sure it is ready to go for the next product and to prevent allergen cross-contamination.

There is a lot of lack of knowledge out there.

MR. GILLIES: Thank you.

DR. ZINK: Okay.

MS. DE VLIEGER: I just wanted to clear up some percentages here. I don't want anybody to go away thinking that only 50 percent of the seafood industry is in compliance with the GMPs.

Rolled into that 54 percent figure is also their compliance with sanitation monitoring and record keeping. And so because in seafood HACCP they took eight key areas out of the GMPs that related to food safety and made monitoring and record keeping mandatory, when we do inspections we inspect for sanitary monitoring, record keeping and the additional GMPs that wouldn't be within those eight elements.

So in that 50 percent figure, probably the higher figure is because a firm wasn't in compliance with some sanitation monitoring record keeping, more than GMPs.

In fact, statistics where there was no significant GMPs violations for all firms inspected -- this is just in the seafood area, so I can't -- this data doesn't speak to other foods.

But at the beginning, it was at 48 percent, now it's 70 percent for GMP issues in the seafood industry.

So, again, I don't want you to go away thinking only 50 percent of the industry; in fact, the figures where there were cited deviations and the corrective actions were taken, that was done in 92 percent of those types of situations.

MS. GIRAND: I would argue that 92 percent is still somewhat on the low side, given that 8 percent, almost one-tenth of the producers are still having problems.

We have statistics like this. We had a meeting in Washington, DC, at the end of June and a professor from Cornell had done a study of this is good agricultural practices, and found only 30 percent of farmers in that particular survey in New York were following good agricultural practices, and knew what they were.

And we have similar level compliance with OSHA issues in California on the farm, where we have statistics of between 50 to 70 percent compliance.

So compliance is a significant issue. And I found it always wonderful to hear about the great things a lot of processors are doing to make sure their products are safe.

But I don't think it is sufficient for industry to stand back and say we've educated everybody we find when everyone knows their companies are out of compliance.

DR. TROXELL: My name is Terry Troxell. I'm a director of plant and dairy foods at the Center.

I wanted to go back to the point David was talking about -- David Moore was talking about the CEO versus the food safety manager.

I think -- what can we do to resize -- modify the GMPs so that they're -- we either support the culture of food safety throughout the industry or, you know, make them more enforceable so that when that culture isn't there, we can deal with problems better.

The -- a great food scientist once taught me -- I think his name was Don Zink -- that you really need -- I mean, really major essence of the whole problem is that food safety has to be part of the culture from the top down, and has to be part of the, you know, performance and reward system of a company. And it can't just be, you know, lip service to it.

So if there is disconnect between the people who are trying to do the job and trying to comply with the essence of a general GMP, and a CEO says I'm not making money, then there is a problem.

Now, we recognize that -- that there are major companies, many, many major companies, have food safety as, you know, one of their highest priority objectives. Of course, they're interested in making money too. But they have it as one of their objectives because, one, they're morally responsible; and two, because they need to protect their brands if they have problems than -- then they're basically doing it as part to protect the business.

But what could we do in modifying the GMPs to -- to stimulate the -- the culture of food safety and to assure that -- that we -- we have a better tool here to promote that?

Maybe it is not possible through them, but I think it is worth asking.

DR. ZINK: Go ahead and take the microphone there. David Moore, right?

MR. MOORE: I'll speak up from the production floor again.

Clarity of regulation, just something we bumped up against quite a bit in the wine industry, in particular. You have a class of ownership that is frequently coming from finance, from business, from fields that provide them with the means to own a winery --

DR. ZINK: Entertainment industry.

MR. MOORE: -- and those of us who work in the wine industry, coming from a background of food science, manufacturing, other technical training.

And if I don't know who is regulating what I do or how because it is under -- maybe it is nebulous whose umbrella it comes under or where I find that regulation or how that regulation gets communicating to the people who are in charge of enforcing it, I'm already at a disadvantage to explain it to my boss and justify the case.

Next, if I try to speak to, for example, statistical process control, and my boss never took statistics, or why we need to get out of using chlorine because it is having this affect on the health of our water processing plant, something like that, there was a time, apparently, when you had a very simple list of things you had to own as part of your winery operation to become licensed.

You had to own an instrument for measuring the alcohol content for taxation. You had to own an instrument for determining what is called volatile acidity spoilage, an indication of spoilage.

When you apply for your bond and your license to operate a winery, you have to demonstrate you owned those things. You didn't have to demonstrate you knew how to use them, but you had to own them.

When my boss bought the winery, presumably that would have been an opportunity for government to say, by the way, here is your list of basic fundamental requirements.

Apparently, for a number of years, due to poor previous management our winery operated without anybody on staff who understood you had to be licensed to apply pesticides and report your use of pesticides.

I take that one personally because I'm the guy that applies those pesticides.

When regulated industries go through the process of setting up shop, that gives an opportunity for that to be made clear, and the clearer it is, the easier it is to make -- convey that to the people both on the shop floor and the people signing the checks.

DR. ZINK: As Terry said, we often have these philosophical discussions. We really do.

I think one afternoon we discussed, in a fairly large group, you can -- in most states you can't manage a fast food restaurant unless you've been through an approved food safety course. But, of course, you can be the CEO of the largest food processor without ever taking a food safety course.

And some thought it was very funny that we should ever entertain the idea that CEOs would have to have mandatory training.

Someone, I think the economist, said, well, image what an hour of their time would cost.

Is that a completely ridiculous idea? Would that help foster a culture of appreciation for food safety that helps us?

Anyone want to tackle that one?

MR. HORWATH: Mike Horwath. H-O-R-W-A-T-H.

I'm with Meritech, Inc. We produce the hand washes that Frank talked about.

I cross numerous boundaries in industry, from pharmaceuticals to dairy plants to meat plants to produce plants, you name it, where hand washing is used. I deal with quality assurance people on a daily basis.

I would have to say there is probably not one that I run into that doesn't see the advantage to a validation to their hand washing program that our equipment offers.

The biggest obstacle we run into is management above the quality assurance. We can't spend the money. They don't recognize the importance of validating the people washing their hands prior to hand washing. But yet if you can get in and see the management level and convince them and prove to them how this works, most generally they will buy off on it.

But we do have a lot of management that still considers a $400 hand sink with a faucet adequate, even though, if you go into restaurants, plants, producers, you will see those hand sinks with mops, buckets and pails in them, and there is no way to validate whether their employees are washing hands.

If you can't get management to buy into that, you can't get them to buy into the food safety program of the hand washing. I'll limit it to just the hand washing side.

But management needs to be trained on the importance of GMPs, even if it is so far to go that you have to put in the GMPs that you must validate or verify the workers are washing their hands.

DR. ZINK: How far up does that training have to go?

MR. HORWATH: I would say the owner or CEO.

MS. GIRAND: May I add one?

I think FDA undercuts its own position by trivializing food safety with cartoon characters and such, and it doesn't seem like a serious issue for CEOs.

DR. ZINK: Like the fight back?

Frank Tabares.

MR. TABARES: But getting to see the corporate culture to buy in.

One thing I think that the GMP or FDA can do to further, you know, the vested interest of the CEOs is making them responsible for what's inside their GMP.

Quaker made that decision back in 1988 or '89, I don't remember which year, where they actually have the corporate GMP policy, and the first page is a letter signed off by the CEO stating he's responsible for making sure each of their facilities meet the general interpretations.

And that at the individual facility location, their corporate structure policy was the plant manager, bottom line, he is responsible to fully understand -- maybe not to do the testing -- but to really understand what was required in the GMPs and the reason for them. And he was ultimately responsible to -- for any failures in that, you know.

So because of that, general corporate philosophy, they got their plant managers, CEOs, all the executives to bind -- because they are signing a document with their name, yes, I am responsible, so, you know.

Plant manager so-and-so is in charge of this facility. He understands all his guidelines and signing off saying I understand these and the importance of these, and I'm responsible to make sure they get enforced.

He's hiring dedicated, you know, quality people and using the information, you know.

Something along those lines with a little bit of a, you know -- tying the GMP and failures of it to the higher levels, not actually training them, but making them responsible to at least have a working understanding of it, may be one way to help enforce that a bit.

DR. ZINK: Okay. Thank you.

If there are no more questions, I will wrap the meeting up.

I want to tell everybody that we've carefully captured every remark and presentation made here today, and everything is going to be considered by our working group as we move forward here.

We've heard everything from no significant changes are needed to changes are needed. We have heard that raw materials should be tested and that raw materials shouldn't be tested.

I'll say, where there are differences of opinion, the most helpful thing to us is if you can include case studies, quantitative information and data.

If it is your view, for example, that raw material testing can be effective perhaps through example, you can show how that can be effectively applied, given likely contamination rates that exist in the world and the test methodology and the times to tackle it.

If you conversely -- if you feel they're not effective, perhaps you can show by example, and get into the record details that support that position. In other words, I'm saying that differences of opinion are fine, but ultimately we have to work with data and examples.

We've heard a lot about training, the importance of training in some understandable form for every worker regardless of their cultural heritage or language skills.

We've heard about the need to include food allergen controls in the GMPs. We have heard that it's important for us to issue guidance, and we certainly recognize that guidance is a vehicle that we could use to more fully explain than we could in a regulation what is necessary to comply.

We have heard that the HACCP concept should be incorporated in to the CGMPs. We've heard HACCP should be maintained voluntary.

Many commenters have said that it is important to maintain the flexibility of the GMPs, that this is both a strength as well as a weakness.

We have heard that addressing lot sizes, making lot sizes smaller, presumably for smaller units of control. We've heard opinions to the contrary.

Again, I go back to my remark about the quantitative or qualitative impacts of those sorts of things.

We've heard that we should not mandate SSOPs, and some have felt that we should mandate SSOPs.

Some have felt that SSOPs, without records of compliance, would not be as meaningful as they would with records.

We have heard that gloves for food contact are not necessary, and may be detrimental.

We have heard that there may be value in being more specific about water quality. And I even have to admit that statements about "adequate water supply," that certainly does sound vague, but we're also challenged by the fact that water in food is used for many, many different things, from the water quality you might use to drip irrigate crops could very well be different from the water you might use to wash a ready-to-eat produce item. And perhaps that is something that can be dealt with better through guidance.

We've heard that we should use other rule-making to address specific food risks. We have heard about -- at this meeting it is kind of unique in that we've heard more about ways to foster a culture of compliance or understanding of food safety and quality.

We have heard about the importance of ensuring correct packaging, linking up with the correct product as an allergen control.

We've heard that errors occur more frequently during changeovers as a counter argument to frequently changing lines or small lot sizes.

We've heard of the possible use of third-party sanitary equipment design organizations as a mean of validating the sanitation of equipment. We heard quite a bit on education.

I'm sure there is a lot I haven't mentioned, but I have tried to capture everything that was said, but I would encourage all of you to submit written comments to the dockets listed in the federal register announcement.

As we said, there will be additional opportunity to comment on, and participate in, the GMP modernization effort as it evolves.

With that, I'll adjourn the meeting and thank everyone for attending.