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U.S. Department of Health and Human Services

Animal & Veterinary

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Public Comment Period

DR. STERNER: Okay. Good. We will ask that speakers who -- will identify themselves who come and wish to make comments about this portion of the deliberations, identify themselves and their organization. You will have three minutes. Jim will signal you when you have 30 seconds left. And we expect you to bring it to a close at that time. So with that, we are open for public comments. Richard.

DR. WOOD: Thank you. This way I get to catch my airplane. I am Richard Wood. I am the Executive Director of FACT, Food Animal Concerns Trust. We work on food safety issues related to meat, milk and eggs. We also have a model layer operation where we -- since 1991, we have had Salmonella enteritidis controls in place on our farms and market the eggs on the east coast and in the midwest.

According to a presentation we heard yesterday, I think it was Dr. Long, he indicated, and others have, as well, that science is but one of six inputs that are considered in a risk management decision making process, public values, economic factors and so on.

So my comments come from this broader perspective that must be considered in a risk management decision. Regarding the risk standard, the way that I think we would approach this is that since the goal of risk management as defined by the risk assessment is the reasonable certainty of no harm, and since this particular risk assessment that we have been presented with has demonstrated that there is potential harm to at least 5,000 persons, then we believe that mitigating steps must be put in place immediately.

To look at this as a risk assessment model, what I am trying to say is that you give us data that shows that there is potential risk to X number of people, 5,000 or whatever. Then we want a response. We want to see some risk mitigating steps put in place and, in fact, would support a moratorium on the future use of fluoroquinolones in treating poultry as an optimum mitigating step.

Does the FDA have the power to take that step Well, it is my understanding that removing a product from the market can be a lengthy legal process that may take up to six years. And in raising this issue with them, I am told that it is highly likely though that if the FDA is seen to have its ducks in line, I think someone has said earlier today, and the elephant is going down the hill, to use another image, that perhaps there would be cooperation on the industry side to respond to any mitigating steps that the FDA had arrived at.

And yet the recent experience with FSIS with the Texas plant suggests that good will may not always abound. And so to meet its obligations under this risk assessment, the FDA should pursue statutory changes that will give it full enforcement powers.

At a minimum, we would call on immediate steps to be taken to reduce resistance coming from poultry. And I thought that in this two-day workshop, that there would be a greater emphasis placed on discussing actual mitigating steps that would relate to this model.

And we have heard some of those. Yesterday, on-farm interventions were suggested by one speaker. Dr. Cray suggested processing contaminated flocks first. Dr. Angulo was offering some steps that the industry might take. But as a consumer organization, we believe and ask that there be mitigating steps taken immediately or as soon as possible.

What is the appropriate population on which to base the standard Well, yesterday Dr. Bell indicated that fluoroquinolone use may soon be appropriate for children which according to another chart that we saw yesterday from Dr. Smith may -- is the largest population infected by Campylobacter. As a group such as ours, concerned about public health, children, the immunocompromised and the elderly, the high risk populations are the appropriate populations for us to consider in mitigation steps.

What is the appropriate legal standard Well, we are not equipped to answer that question. But I would like to affirm that the risk management plan and the threshold setting should be established through a public process as we are going through today with public notice, public comments, public meetings and formal agency action.

As the risk assessment is a valued process partially due to its transparency, so, too, must its risk management be. Thank you.

DR. STERNER: Thank you. Further public comments Dr. Sundberg.

DR. SUNDBERG: I am Paul Sundberg. I am a veterinarian with the National Pork Producers Council. And perhaps I could start with just a comment to expand a little bit on Richard Wood just said. One of the things about the whole process of this issue is the two-day workshop that would help give some input into the process. And the whole process is what we are really concerned about right now.

We would like to make sure that we have adequate opportunity for input. And that includes perhaps a suggestion of a real workshop type of format that we could work off of for the coming meetings. So we've got examples of veterinary feed directive. We've got examples of HACCP process. We have got a number of examples that offer stakeholder input.

And it really comes down then to stakeholder communication. Communication from FDA CVM to the stakeholders here is one thing. And I think offering that kind of input and that type of process would very much help.

Dr. Lieberman made the comment that she was questioning what is the impact going to be. And if we would have -- we would use the transparent and open words. But if we would have a format that we could offer discussion and real input, we might feel that we have more of an impact into the process. So that comes under communication with the stakeholders.

Another opportunity is communication. And the stakeholders -- when I am talking about stakeholders here is these that are at the meeting. We know what the issue is. We know what is going on.

Another real opportunity here is to take advantage of Dr. Hueston's eloquent comments and also other comments that have called for communication -- outreach communication if you will, risk communication. As I think Dr. Hueston said, saying that the process is done isn't enough as far as communication goes. The real challenge is going to be to be able to communicate what has happened, why it has happened, what the next steps are. And that also then to be effective should include all the stakeholders into that process.

Finally, one comment and I think the risk communication, the very importance of that is to maintain consumer confidence in the products we have. Without that, as I think it was said before, you will hear numbers and you will say risk and that is all it is going to take. But in order to communicate clearly the real risk and really the process, that will help maintain consumer confidence in the food supply.

Finally, adding NPPC's congratulations to the chorus of congratulations that have come in bringing forth the risk assessment certainly is in order. One of the things that we are concerned about is that we have only, as everybody else, have had just a few days to take a look at it.

And that is very important that CVM remain open to input in this process. We will be submitting written comments, further written comments that will give specifics on the risk assessment. Thanks.

DR. STERNER: Thank you. You get an extra ten seconds for compliments, by the way.


DR. PRETNICK: Steve Pretnick with the National Chicken Council. We would also like to congratulate CVM for going through this risk model development. We do have a number of concerns, however, with some of the assumptions that were made, as well as the scope of the model. And we will address those in writing in detail.

I would also like to add that we, too, support a workshop. We feel that some of the concerns that we have with the model could have been addressed if there were an opportunity for the industry to have a dialogue with CVM. We could have worked out some of what we think may be erroneous assumptions.

But, anyway, we, too, would like to be a part of this process. And we think it would benefit all the stakeholders if we could have such a workshop and move forward.

DR. STERNER: Thank you. Dr. Berkram.

DR. BERKRAM: I am Tom Berkram, Executive Director of the American Association of Swine Practitioners. And first of all, I would like to make a bit of a correction, with the permission of my esteemed colleague from North Carolina, about poultry when he was listing the different commodities.

I am sure it was an oversight, but he forgot to put pork on that list. So I would just include that right now.

DR. WAGES: I apologize.

DR. BERKRAM: Apology accepted.

DR. STERNER: The other white meat.

DR. BERKRAM: Right. Now, at the risk of turning this into a love fest., I would commend Steve and his staff for doing this risk assessment. We think that it is a good first cut. And that is a quote from a statistician that we have engaged to review this risk assessment. Given the short period of time though, we haven't done a complete review.

And in the preliminary review, we have discovered some areas that we feel will need to be clarified, modified and corrected. And we will be offering complete comments in writing at a later date.

Just as the risk assessment is a good first cut, we feel that this should just be the first step in the ongoing discussion of this particular issue. And I would echo the comments from a number of the people already that although we recognize the value of this format being a lecture format for a meeting.

For transfer of information and knowledge, we think that a really substantive and interactive workshop would certainly advance everybody's feelings about this, to feel more comfortable with the risk assessment and the stakeholders having that input.

Lastly, we would urge the FDA to continue to recognize the complexity of this issue. Although I can now describe this risk assessment as a very simple mathematical model, although I often question that, that really belies -- that description belies the fact that this is still a very complex issue. And we would certainly not want to see simplistic mitigation tactics or strategies imposed on an industry -- on the animal agriculture industry without some consideration being given to all the consequences, intended as well as unintended. Thank you.

DR. STERNER: Thank you. Any other comments It is about that time per day. I have seen many post-prandial insulin surges here and some eyelids being stared at from the rear side. It probably would be good to stand up and recirculate static blood for about five minutes. And then -- please, Dr. Sundlof.

DR. SUNDLOF: Yes, I just -- I made a terrible oversight yesterday in not recognizing one individual who was more or less responsible for the creation of the risk assessment and that was Peggy Miller who has left CVM for bigger and better things. And for some reason, when she walked out the door, she kind of checked out of my memory.


But I think it is very appropriate to make sure that Peggy Miller does get recognized for having the vision to put this whole thing together.

DR. STERNER: So we have a five-minute break here. And then Dr. Thompson will start.

(Whereupon, a brief recess was taken.)