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MR. SCHWALM: The object of today's presentations is to wrap things up, and to talk about what our future needs, issues, and concerns. There have been a number of people at the workshop who have talked about " really needing to do this and really needing to do that." The next session is a panel of FDA/CFSAN managers who will provide an opportunity to get on the table concerns, issues, and directions as to where we want to go.
The panel consists of Dr. John Kvenberg who is the head of CFSAN's HACCP effort, and Dr. Bob Buchanan, who is CFSAN's science advisor and research coordinator. We also have Mr. Joe Bacca, who is our new Director of the Office of Field Programs and is very much involved in the interaction between our food safety programs in the Center and the field. The objective is to have an open discussion between the workshop participants and the panel.
DR. BUCHANAN: Let me begin by cautioning that since we are in the process of developing the final form of the juice HACCP regulation, there are certain restrictions on what we're allowed to talk about in public during that process. In particular, what we can't do is in any way talk to you about what will be in the final regulation.
MR. SANFORD: Sanford from Tennessee. I've worked with FDA for quite some number of years and have nothing but the highest regard and respect for a lot of the individuals I've worked with. I'm in the field, and I'm a mill grading officer. I'm one of those guys who is trying to make apple juice like milk. I get accused of this every day. All I'm trying to do is make it safe. I was asked to assess it, okay?
I want to address some issues, and really I'm just expressing some thoughts and issues. I work with some of the best academicians that I've ever worked with here at the University of Tennessee. They've worked with me. We've worked hand-in-hand with these folks.
Pasteurization -- we have some of the top experts in fluid, beverage, continuous flow pasteurization within 300 yards of this building here in Washington D.C. Sure, they are experts in milk pasteurization, but some, if not all, of the components are going to be the same. As of this morning at 8 o'clock, they have never been contacted for any assistance in evaluating apple cider pasteurization equipment.
I have people that I deal with in my state that are being sold, as I expressed yesterday, junk by equipment companies and the cider processors are told that it's pasteurization equipment. I have nothing to stand on when I inspect this equipment. I can handle a vat pasteurizer, I can handle continuous flow, high temperature/short time, high heat, aseptic, UHT, any of those, work with them, understand them.
But I can not get someone from FDA to tell me what pasteurization requirements should be applied to apple juice. I have yet to see that. So that's one area that we really need to leap tall buildings in a single bound. And, again, there are FDA people readily available who have the required knowledge, whether it's all of the components or merely part of the components. I know because they trained me.
Sanitation inspections -- this is another area that I'm running into great difficulty, and it's not only with State inspectors, it's also with FDA investigators, and no disrespect intended. These people's wagons are full. They may do a blood bank today, they may do a cosmetic manufacturer tomorrow, and they may do a food processor the next day.
I'm asked to do a public health safety assessment of an apple juice processor. I go in, and I come out with three sheets of significant public health safety concerns. I'll just go over a few common findings.
We talked about steam in process, but no one has addressed the issue of safe steam. I find steam that may be killing the organisms, but it may also be applying toxic chemicals from the descaler to the steam. We find cooling water in direct contact with product from cooling towers that's unprotected. We weren't told about Salmonella.
So I go in and I document this, and then I find out that FDA investigators have been there just previous, and their comments, and I've got copies of this, "No objectionable violations were found." I really have a problem with that. These people, they've not been properly trained. This is a very, very significant problem. These are my two concerns.
MR. BACCA: Can you give us, provide the examples that you've provided here and give me some list or something, and I'll take it up with ORA.
MR. SANFORD: Absolutely.
MR. BACCA: If we can provide training, we certainly will. And I think if we're missing some obvious GMP problems that you're aware of, then we have to start looking for those things.
MR. SANFORD: I have taken it up with the district person there who has been fully cooperative. I have actually been asked to put on some training, and have done that, with some of the investigators. I have full support at the top, but in between there's some insult factors, because at no time--there's a law written somewhere -- at no time can a State official train an FDA inspector to do anything, if you know what I'm saying. And we need to move beyond that, we need to move forward.
MR. BACCA: In response to your other comment, I think we are moving toward specialization, where food people do food work. While food people do food work, the food people may not necessarily do only apple juice, but we generally try and keep them focused in one area. And hopefully by doing more of that we can better address your concerns.
There's a limit to the number of people. That's our big limiting factor, and especially if we're going to be doing inspections out of our resident offices. If they're not near a big city or a district office, it creates a problem. But I'll certainly take those concerns up with ORA management and see what we can do.
DR. BUCHANAN: Yes, and I do want to add that most cider producers did not think of themselves as food processors. Most of them feel that they were agricultural activities. But I want to make it very clear is that as far as FDA is concerned, these are food processing operations, and as such fall under the Good Manufacturing Practices that are required of any food processing operation, and so they will be inspected on that basis.
MR. SANFORD: One additional question, if I may. Do all product contact surfaces, in your opinion, from the crusher on where we actually have juice, have to be safe?
DR. KVENBERG: Yes. We would go to our existing regulations under GMPs, under Part 110, referring to food contact surface information, and that's pretty clear. We should be focusing on the cleanability aspects. It's clearly something that's known, and how to do it.
DR. MATTHYS: Is there a reason we did not cover Part 110 requirements here at this particular session. There isn't even a copy of 110 in the documents here, and that should have been provided to the participants. It's a requirement that we all having to meet.
DR. MILLER: This meeting was designed to talk about mitigation strategies. It was the assumption that basic sanitation things are being done right. The question is, what can we do to provide even better food safety controls?
DR. CRASSWELLER: Rob Crassweller, Penn State University. The big question when I go back is going to be, what happens if a local grower produces 5,000 or even less than 5,000 gallons and he keeps it all within a two-county region? What jurisdiction does FDA have over that individual as far as Federal rules and regulations on safety? Can you come in and shut him down?
DR. KVENBERG: This goes to the legal question of what is FDA's jurisdiction, and I don't think we're prepared to answer the discussion on this particular issue at this point in time. As a general rule, the Food, Drug and Cosmetic Act gives FDA the authority to regulate interstate commerce, and there's a policy that we apply to determine when the requirements of the FD&C Act are applicable. We are just not prepared to talk about that in the context of juice because we're in the middle of rulemaking, and this is one of the issues that Dr. Buchanan warned you that we really couldn't comment on this, but I know that is a sensitive issue. I think it's quite valuable that you bring up this issue at this workshop as a concern.
DR. HIRST: I have a question concerning the proposed HACCP rule. It sounds like there will be some kind of HACCP rule in some form. What time frame do you have in mind? When will it be finalized?
DR. KVENBERG: I can't predict exactly. We have a proposed rule and we are currently reviewing the comments and addressing the issue in response to the comments that we have received. We are actively in that process now. I can't give you a time frame for when the rule will become final.
I might explain the process it has to go through once it is out of the Center. First it has to go through the department level at the Food and Drug Administration, through the Department of Health and Human Services, and then on through to the Office of Management and Budget. That's how rules are made. It's following the normal course, as other regulations do.
DR. BUCHANAN: To follow the process further, once it clears the Office of Management and Budget and it is signed by the President, then I believe there's a 30-day period during which we can not implement the rule in order to give Congress the opportunity to look at it.
DR. KVENBERG: Then, not to make it more complicated, there will be an effective date of the rule that will provide for its implementation. So it wouldn't be effective immediately. Further, we stated in the proposed rule that we would stagger the effective dates for large, small, and very small businesses. This would, again, stretch out the time frame for full enforcement implementation, if and when the rule becomes final.
DR. HIRST: So, I'd be pretty safe in assuming there's not likely to be a HACCP rule to cover us for this coming cider season.
DR. KVENBERG: That's what I'm saying, yes. That is a logical extension of what I said.
MR. TAYLOR: Kirk Taylor, El Dorado. One of the backbones of a HACCP program is identifying critical points and establishing critical limits. Do we have enough scientific information to establish these points and limits for the cider industry?
DR. BUCHANAN: I think that part of the last talk provided some thinking on how you would go about identifying where your critical control points are. And remember, a critical control point is not only where the hazard occurs, but it's the step that you have identified for controlling that hazard. And there are different options for controlling hazards. That's the purpose of this conference. Different controls and critical limits are being explored by different people.
So, it's hard to give a single answer, but what we are looking for in any HACCP program is the degree of control that will be achieved. This will require that the control steps that are needed have been identified, and that these controls are being applied. So, yes, you're going to have to have critical control points.
MS. HUMES: Lorraine Humes, FDA. There is a seafood HACCP hazards guide published. How specific is that, in comparing it to what might come out for the apple industry, as far as control points?
DR. KVENBERG: Your specific question is, are we going to have a hazard guide on juice products? My answer to that is yes. That is, in my opinion, we need to have a processors' guide in order to provide information as to likely hazards and information on corresponding controls for juice. When and how we accomplish this has not been decided.
DR. BUCHANAN: One of the commitments FDA has made under the Food Safety Initiative is not only to do research, do risk assessment, et cetera, but to make sure that the knowledge that's generated and the information that's needed by everybody is disseminated to them in a form that's useful. So we have a very active program now, and a very good team to put together the information and get it out by different means to the people that need it.
DR. SAPERS: Gerry Sapers, USDA. One of our preliminary conclusions concerns the possibility that apples might be contaminated internally. If this is the case, it would be necessary to intervene with controls applied to the juice, which presumably means some form of pasteurization. Have you considered the implications of this with regard to fresh cut or fresh market apples? That is, is there a significant risk of internalization of E. coli or other pathogens? It seems to me that hazards could be present in apples intended for other purposes as well as cider.
DR. BUCHANAN: Let me answer your question. You have raised several different points that need to be addressed. One is that the basis for any of our guidance and for our regulation is sound science. If a specific commodity is known to have a specific problem, control of that hazard must be addressed in the development of any kind of guidance or regulation. As we consider the issues associated with juices, we know that apples and oranges are not the same, and that we must bring to bear the best science we have in looking at those differences.
Another point to emphasize is that the first part of HACCP is the hazard analysis, and that this is where you bring your best science to bear to identify the problem. The hazard analysis part is specifically designed to be on a plant-by-plant basis because we know that no two processing plants are the same. Every processor needs to be able to identify where they think their hazards are and then make sure that they have the appropriate controls to intervene at that point.
Right now, with the scientific knowledge that we have on potential internalization of bacteria and other microorganisms in apple products, we would have to work with the assumption that internalization of microorganism within the intact food is a reality or certainly within the realm of possibility.
MR. HAXTON: Bob Haxton, Iowa. You may have already answered this question, but let me ask it again anyway. Does the FDA regulation requiring warning labels for juice apply to manufacturers who are involved solely in intrastate commerce, and how do you define intrastate or interstate commerce? Are warning labels required when the manufacturer is only processing for sale at the mill store?
DR. KVENBERG: The question, as I understand it, goes to the labeling rule and how far does it reach. In essence does the rule apply to the retail unit and does it go right down to local distribution level? I'm not the legal expert on that rule, but it is my understanding that it does apply.
MR. TAYLOR: Mr. Kirt Talyor, California. In the proposed regulation there was some exemption for firms that produce less than 40,000 gallons. What type of exemption will be in the final rule?
DR. BUCHANAN: We have received numerous comments about that part of the proposal. We are actively reviewing those comments and evaluating whether to keep that, but beyond that, we can't really say.
MR. BUSH: Don Bush from Canada. What is the rationale behind the 5 log reduction? Why not six or seven?
DR. BUCHANAN: The rationale for the 5 D, which was articulated in the proposed regulation and which is being reevaluated, was based on the likely degree of contamination expected on fruit and in juice. The 5 D level resulted from the public meeting on juice that occurred almost two years ago. The information from the public meeting was then reviewed by the National Advisory Committee for Microbiological Criteria for Food (NACMCF) and they established the 5 D. Their recommendation was passed on to the Food and Drug Administration as a means of assuring safety while at the same time attempting to maintain the unpasteurized character of juices.
This is another subject in the proposed regulations that we received numerous comments on regarding both the extent of the reduction -- 3, 5, 7, 12, etcetera logs -- and also where you start that process of counting. That is now being deliberated by the agency in making the final rule.
MS. ZINN: I'm Leslie Zinn, Ardens Garden. We are a juice processor in Atlanta. My concern is that the large outbreak that spurred all of this rule making to take place involved some negligent manufacturing practices. Further, several of the outbreaks that occurred previous to that large outbreak also included some very poor manufacturing processes. Although it has come to light that juice can carry pathogens and it is a possibility that contaminated juice can make some people sick, the risk seems to be extremely low.
As a processor of fresh juice, we don't have a problem with complying with GMP's. But, I am very concerned with this most recent outbreak that just took place involving citrus, that we're going to be forced into pasteurizing. It's not a cost issue. It's an issue that this is the niche of the market that we serve and this is what our customers want, and I'm afraid that we're going to be denied that opportunity to provide a fresh product, period.
DR. KVENBERG: I totally understand your remarks and your concern regarding the current situation that is unfolding. This outbreak is under investigation so we just cannot comment on it or how it may affect the specific rulemaking process that we are undergoing at this time. I guess my only comment is, we hear your concerns.
MR. BACCA: And let me say something with respect to the outbreaks that have occurred. When we have conducted inspections, it has not been obvious what the failure was that led to the contamination. When we had found the cause and we have been absolutely sure that it was the cause, it has taken an awful lot of digging. So, in general, the problem is not something that's right out there in front of everybody to look at.
DR. BUCHANAN: I do want to correct one thing. While the one current outbreak being investigated is precipitating a large degree of activity, it was already well recognized here within FDA that there were concerns with unpasteurized juices. These concerns were actively being considered. It was not a single incident that led us to start this activity. There was a history of problems.
I also might note that we have done an extensive survey of the industry--I'm not sure if the results of that have been shared or talked about--that demonstrated a pattern of problems in a substantial portion of that industry. A report of this survey is available on FDA/CFSAN's website.
MR. SCHWALM: I want to thank the panel and the participants for their questions. These have been important questions that have come up during the workshop. Having CFSAN managers who are very actively involved with developing our policies and our positions here to listen and understand is an important part of this workshop.
