|
|
MR. SCHWALM: We had hoped that Dr. John Kvenberg would be available to provide a closing summary of the workshop, but, in his absence, let Art and I say a few things in terms of what we've gotten out of this.
The first thing is that when we put this conference together, we knew that this was not going to be one of those workshops where FDA had all the answers and we were going to present the answers to you. Sometimes government has the tendency to wait until it has the answers before it begins communicating with it constituency. This is obviously not the approach FDA is applying here, and the purpose of this conference was not to communicate answers.
Instead, I think that we all, including myself, will go away from the workshop with an increased awareness of the problems surrounding the safety of apple cider. We understand where we're at right now, what are some of the issues and the questions, and where we need to be going. I also hope that you share with me the understanding this will not be an easy process.
There is a concern about the apple cider industry, and an effort is being made to preserve the fresh portion of the industry. There is also a concern about small processors in the apple cider industry, and an effort is being made to address their unique needs. On the other hand, apple cider is a food product, and there are important public health issues involved. We also have, as NFPA has pointed out to us, a larger segment of the industry that thermally processes apple juice. If there is a problem with one firm anywhere in the industry, that problem affects everybody else. So, it's not an easy situation, and there are several different issues involved.
I think that another important understanding that I will take away from this workshop is a confirmation that prerequisite programs and sanitation are a vital component. Poor sanitation has been the source of the problems when there have been outbreaks. If nothing else, the industry and regulators must try to improve sanitation. Perhaps this is the best thing that we can do right now in terms of reducing the risk. Hopefully, we all have a renewed commitment to do work, at a minimum, towards these types of improvements.
In conclusion, I'm really happy and very pleased, that we had such good representation at the workshop. We will remember the challenge that Jim Cranney gave us in terms of going out to the industry. Hopefully we will be able to bring a summary of this meeting together from the materials that have been presented, and maybe update these materials; and to make sure that this information gets out. However, if FDA can not do this, we have given you each a procedures manual. We invite you to go back and make copies of it, talk to your local people, and distribute it to your industry. Don't just rely upon FDA being able to get out to these local meetings. I don't know if that is going to be possible. So please be our advocates in terms of giving the information out the best that you can.
DR. MILLER: One of the lectures I give has to do with the subject of emerging pathogens. That whole lecture can be boiled down to the fact that we have an idea but do not necessarily know where these pathogens are coming from. We have all been eating ever since we all emerged from the primordial soup. What has changed to suddenly make people sick?
The apple cider industry presents a classic example of the problem with emerging pathogens. We have an industry who, as John Kvenberg said yesterday, has been providing a food beverage since before this nation was a nation, and here it is in the '90s and we're suddenly concerned about its safety. What has changed?
We know that the pathogens have changed. In fact, we could probably say that the first E. coli O157:H7 outbreak that we're aware of occurred back around 1980 in apple cider. Have the sanitation practices of the industry, changed? Well, we know that there has been some consolidation of firms, but we still have an awful lot of small cider processors. Surveys have shown that sanitation conditions probably have changed little.
To boil this all down, what we are saying is that we are not certain exactly how things have changed or what has changed or how much, but the fact is that we do have people who are getting ill as a result of this product. And the bottom line from the FDA perspective is public health.
We called this meeting for the purpose of exploring new and promising technologies, and I think we have heard about a number of these technologies. We still have an enormous number of questions on where the technologies need to be applied, are they efficacious, and how and where they should be applied.
We tried to add some perspective to these issues this morning by talking about hazards in the context of risk assessment and risk analysis. This seems to be the direction in which the agency is moving since we know that the research can't provide all the answers as fast as possible. In my estimation risk assessment allows us to stay ahead of the research, as we heard this morning, because it allows us to come up with the "what if" scenarios. By coming up with the "what if" scenarios, we can then develop hypotheses that can be tested. Thus, I think it's a very valuable tool.
Finally, as a result of these risk assessments, there is always the need for more research. I think better than many other meetings that I have been through, we have identified where the research needs are. And I think we have, at least in my mind, come up with a road map of how we need to proceed.
Thank you very much for coming, and everybody have a safe trip home.
