Welcome
by Dr. Bernadette Dunham
DR. DUNHAM: Thank you very much. Good morning, everybody. (Sets up slides.)
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It works -- fantastic! All right -- there we go. Welcome, everybody. I am delighted to be here, and welcome to another wonderful day in D.C. You have really brought some great weather. And many of you came from out of state, so I am delighted to see so many great faces. And again, your participation is something we value very, very, very much, and I can’t thank you enough for not only being here in person but also for the great input you have given us over the past few years that we have been developing this Animal Feed Safety System program. It really, really means an awful lot, and we want to thank you so much. And I am delighted that we have a 5th, and possibly now coming to a close, a finality, as we finally get this to be agreed upon, so your input today is very, very, very important.
As you know, this Animal Feed Safety System has been aimed at protecting human and animal health. That is to ensure that animal feed is safe. It is the linchpin in everything we have, not only for feed for animals and pets, but all the way up to our human consumption of foods.
The overall Animal Feed Safety System will cover all the Agency activities, based upon the pre-approval of additives for use in feed, establishing the limits on feed contaminants, providing education and training, conducting inspections, and taking enforcement for ensuring compliance within the Agency regulations.
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It also includes oversight of labeling, production, distribution and administration of all feed ingredients and mixed feeds for all stages of manufacture, distribution, and use, whether it be commercial or non-commercial establishments.
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We had the initial public meeting back in September, 2003, and at that time, the group collected information about rules and processes that are used by both the feed industry and by government regulators to enhance the feed safety system. At that time, everybody sat down and found there were a number of gaps, so the whole purpose now was: How could we strengthen the system? And from there, a first Framework Document was developed by the partnership that we have in this room and beyond, and we presented that in April, 2005. This took place in Omaha, Nebraska -- and again seeking public comment, which we received, and we thank you very much for that.
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Taking that, we then further developed, and had another Public Meeting, in 2006, and this time it was to look at the risk ranking method. And the Team presented a method to take a look at feed contaminants, and how could you put a risk-based approach to that?
They did this using a swine diet model to go through their examples, and this method would help determine both animal and human exposure scoring for chemicals and microbiological feed hazards.
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The overall risk-based approach, which is something everybody now is understanding is important that we use -- not only here but in many walks of life, it identifies the potential hazards, it characterizes the consequences of hazards, it characterizes the likely exposure, and it ranks the risks of hazards as compared with other hazards, to put a perspective together. Putting all this together is going to help us develop really the best possible feed safety program that we can have.
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I think everybody understands the importance of that.
Last year, we had the Melamine pet food contamination recall, and it really opened the eyes of everybody. I know it was devastating to lose so many pets, and we often make the analogy it is like having the canary in the minefield. And at that time, it was an eye-opener to think: Oh, my goodness -- where are all the ingredients coming from? And it indicated to us, and to everybody, the diversity, the complexity, of what you now take for granted on a substance that is going to become part of a food. And food now means food for animals, food for pets, food for people.
When this happened, then the awareness grew so much that you saw Congress get involved. We have had an opportunity for pieces of legislation to come down. We now have interactions even more so and a partnership that is growing in strength to try to find out, how can we do a better job every day to ensuring the food and feed that we have is in fact safe? Where are the ingredients coming from?
But it is very, very challenging, especially when you realize now, with hindsight, that what happened with Melamine occurred truly in a fraudulent manner. This was something that was done with an intention to falsify, in this case, the nitrogen level.
Well, we lost some pets, but then we have just seen this happen once again, and this time it has happened with Heparin, and we have lost human lives. And again, by the looks of everything, this again was fraudulent because your Hypersulfated Chondroitin Sulfate does not occur naturally. So this is putting a new light on how we work with not only industries, companies, now foreign governments, and where is everything coming from? How do we interact together to get our hands around this? And that means we have to have transparency, we have to develop trust, work partnerships together, so that everybody here internationally can always reach for something on a shelf in a store and never have to second-guess: Is this product safe?
So that is why we embrace the opportunity to sit down and work things out, and this is one very important phase of that, and that is to develop the feed safety program that we are talking about.
I think we also learned very quickly something industry has known, and that is: It is a very fast-paced system that we have. An ingredient can come in, it becomes part of a product, and that product is disseminated so quickly not only across the United States, but internationally. And we had the luxury of having things coming in internationally, which gives us a lot of variety, and that is great, but we also want to make sure everything we have is safe.
This contamination that we saw with Melamine, as I mentioned earlier, wasn’t just in pet food, but we also saw, and traced this, that it went and impacted potentially the food that was going to swine and poultry and fish feed. And from that, if we hadn’t had a chance to intervene, it could have gone further. And this impacts, again, the potential for human health.
So I think all of that has now a lot of lessons learned and truly has brought the best out of everybody. When crises happen, you see that, no matter what it is. Right now, we are experiencing that with the earthquakes in China, with the cyclones. This is the scenario of bringing the best scientists together to develop a program that will not only work here but potentially can work internationally. And I think, again, the value of that is unbelievable.
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So, today, with a lot of pride, we are now presenting our 3rd Draft, looking forward to an incredible dialogue with you all again, and part of this, as you know, is also in company what I mentioned earlier -- from Congress. We have had our FDA Amendments Act of 2007 trying to again address the issue of concern of how do we get these standards agreed upon? How do we embrace what I think is very important, and putting a risk-based approach together that can help us all address the compliance and the activities that we are going to be involved with.
So I really do appreciate, again, your input today and through the docket and over the past few years that you have all participated to develop this program, and I look forward to a very lively discussion.
There will be some good presentations all day long and I hope you enjoy yourself. And again, I want to sincerely thank you for coming today and making this a very successful program.
On that note, I get to turn the podium over to Dr. George Graber. Thank you very, very much.
MR. BACHMAN: Thank you, Dr. Dunham.
As Dr. Dunham has indicated, the next person on the agenda for this morning is Dr. George Graber. Dr. Graber will present the 3rd Draft of the Framework Document. If you should happen to have a burning question in regard to the information being presented that would help you understand or clarify what Dr. Graber is presenting, please feel free to ask that question at the time of the presentation. Otherwise, if you could, hold your comments or questions until after the presentation and we will have some dialogue at that time. Dr. Graber?
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