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U.S. Department of Health and Human Services

Animal & Veterinary

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Safety & Health

Open Discussion

Paul Bachman, Moderator

MR. BACHMAN: That is why we have contracts! Yes, is there anyone at this particular time that -- we have like 15 minutes or so before the scheduled break for lunch. If anybody would like to make a comment or ask a clarification question, there are microphones on this aisle and over here.

(No response)

DR. LITTLE: Dan Little with DairyNet, Brookings, South Dakota.

My question has to do with the -- talking about feed manufacture and mixing. And in my experience and investigating feed adulterations, it seems as though the most common challenge that we are seeing at the farm level is lack of control of feed -- it would be distribution as it comes into automated mills, goes into a bin that no one looks in, and the wrong product is in there and so it results in a feed mixing error. And the other issue is a feed mixing error of overdose of products that then become toxic to various species.

I am wondering, as we go through this whole process, are you specifically looking at some of those common on-farm things that -- and of the list of stakeholders that you have listed there, one group that I see is left off is insurance companies carrying liability coverage for these errors. I think they are quite interested in what you are doing.

DR. GRABER: I am not sure there was -- you know, if there is any need to respond to that, but I would certainly think that whatever regulations we write that in terms of inspector being out on the facility, whether it is a commercial feed facility or an on-the-farm mixer/feeder, that they are going to check these types of records and look to see where the problems arise and where they might arise, and -- but that is a good point, that is an interesting point, and perhaps it is something we should even consider for guidance because we do -- we are going to need to write guidance probably for our process control regulations as well. And then thank you for your point about the insurance companies, yes. Paul?

MR. GOTTULA: Yes, Brad Gottula with Quality Liquid Feeds and National Grain and Feed Association. I just had a couple questions, or maybe looking for some clarification, and perhaps -- maybe we won’t get those today but did wanted to raise just a couple of questions.

One is, just going back a couple of years to some of the original or initial meetings on AFSS, I believe in the April ’05 meeting that took place in Omaha, one of my colleagues with National Grain and Feed or not necessarily with National Grain and Feed but on our committee, Greg Sherwood, who is not here today, raised the whole issue which is still being discussed and listed out in the document of contaminant versus adulterant.

My question is: Wouldn’t the term “adulterant” be a better and more consistent term with FDA’s authority and some of the other documents and legislative bills that are coming out or that are in the process both in Congress and with FDA and with AAFCO? So that would be a question that we would like to pose at this point.

DR. GRABER: Thanks for the question, Brad. We will take that question back to the Team and, you know, obviously we want the people that are going to speak this afternoon to voice their opinion on that, as well as all the Team members representing various areas within the Center. So, appreciate that, and we will take that under consideration. You have another?

MR. GOTTULA: Yes, just got a couple more. One is -- the next question would be in regards to process control regulations.

You know, quite a bit of work has been done by AAFCO and particularly their Feed Manufacturing Committee on the non-medicated feed GMPs over the last several years. And my question is: Will this be utilized in some fashion, or what role do you see this playing as FDA puts together process control regulations for all manufacturers?

MR. BACHMAN: I wouldn’t touch that -- no! George touched on it this morning in his presentation, and I think that is probably the best answer we have at this time, is that with a Federal regulation we would seek to have more uniform application of that regulation across the states, whereas if, you know, AAFCO does adopt a process control regulation, each state then in turn needs to adopt that within their own state jurisdiction, and you have the variability of how many states will adopt it and variability also what form it will be in once adopted and the application of that once it is adopted to various degrees.

We think that the situation is a critical nature, that, you know, requires a more uniform approach to it.

MR. GOTTULA: Yes, and I guess, just as a follow-up, I guess what I am suggesting is that there has been a lot of work done and I would hope that some of that work and some of that language maybe could be used as a template for whatever FDA is going to come up with here as they go down the road on that.

MR. BACHMAN: Yes, and the Team continues to have input from two state representatives, and we are -- you know, we are talking to the states, the AAFCO people that make up the AAFCO, and, you know, many people from -- several people, I should say, from CVM serve on that AAFCO feed manufacturing committee.

So we are in tune with what is -- to some degree, we are in tune with what is happening there as it processes through their system as well as taking into consideration what we learn from the states from the day-to-day activities and what they see facing them in this particular realm of regulation.

MR. GOTTULA: Okay. Last thing I just wanted to bring up -- when we are talking about risk-based inspections and that gap that was identified, my question would be: As a manufacturer that we rely on outside carriers a lot for bringing in ingredients and sometimes even hauling our own product along with having our own fleet, but my question is really, what is being considered by FDA to step up, change or implement transportation inspections when risk is identified because at this point in time the inspection process that takes place quite frankly doesn’t touch on that too much?

MR. BACHMAN: Thanks for that, Brad. You know, we have a degree of understanding in that, and as George pointed out on one of his slides, one of the considerations in development of the process control standards was transportation. I mean, it still is transportation.

So we have learned over the years from these meetings, these Public Animal Feed Safety Public Meetings, the input that individuals such as yourself and others here in the crowd have brought to our attention, the transportation issues, and we --- from that and we have attempted to address that within the means available to us, within the statutory means available to us and the authorities available to us.

MR. GOTTULA: Thanks for your response on that, and we probably will have some other comments that we will put in writing and submit, so --

MR. BACHMAN: Thanks, Brad.

DR. GRABER: You know -- this is George Graber, for the transcriber. I am trying to look for -- I thought there was something in the Framework Document. It has been -- that dealt with the transportation issue, dealt with the fact that there is a law that was passed in 1990, Sanitary Food Transportation Act, that the Department of Transportation never enacted regulations.

Well, that got transferred to FDA and USDA, and so -- it covers food, and food means feed, so CFSAN -- the Center for Food Safety and Applied Nutrition -- has the lead on this, and so at some point we are probably going to see regulations being crafted to deal with transportation, so --

DR. WOOD: I have -- I am Richard Wood. I am with FACT, but I am a concerned --- consumer group that focuses on the safety of meat, milk and eggs. And we have been present at most of these meetings that have been here with the development of the feed safety system and really appreciate the openness and transparency and the discussion that has happened as this scheme is being put together.

So my question has to do with: How is that transparent function going to happen from here on out? I mean, now that we are close to having the scheme, and once that is in place, how will emerging and new and missed risks be incorporated into the system? How will on-farm practices that were just identified that, you know, may or may not have been considered and may be seen as risk be incorporated into the process once this scheme is in place? And where will there be opportunity for public input? That is a global question, but, I mean, it is a --

DR. GRABER: Well, that is a -- since I don’t work for the Agency other than as a contractor, I could probably just give you how I think it should play out, and that is I think basically this particular document should just continue to evolve, and as things are -- work gets done, I think it should be publicized and made available.

You know, when we do -- well, obviously, when you go through the rule-making process, it involves all the -- you know, all the stakeholders who wish to be involved because it is a public activity. You get input onto -- into any regulation you are writing.

We are also writing -- if we are writing guidance documents, they are usually put out in draft form, and so there is always an opportunity for comment on those as well.

I can’t say that we are going to continue to have these types of meetings in the future for the Animal Feed Safety System. They do take -- there is -- you know, it is like any other meeting.

I am not saying that this one is special, but I am saying like any other meeting, there is an awful lot of work that goes involved in preparing for a session, and at some point maybe we need to be spending more time getting some of these gaps completed and done and moving on with some of that work.

So I can’t say we will continue to have public meetings. But I have been a proponent of these types of meeting. I think they are -- at least from my perspective, I think it is has been useful not only in terms of getting comments but in preparing for these types of meetings, you start realizing that you have got to present the information and you start looking at it a little bit more closely and become a little bit more careful about what it is you think you are going to do.

So it is -- so to me it is a useful process. I can’t say that the Agency is going to continue to do it, though, but --

Dave, Dr. Acheson, was talking about, you know, transparency the other day. I think they are -- the Agency is really committed to transparency. How that plays out, I can’t tell you, but does that help?

MR. GORDON: Hi. I am Randy Gordon with National Grain and Feed Association. We are to thank you again for the Public Meeting and again the transparency that Dr. Wood referenced and the progress in issuing the new Framework Draft.

George, I think one of the questions that I have, in terms of issuing the process control regulatory proposal, one, do you have a time frame that you are looking at for doing that?

Second, in assisting ingredient manufacturers, feed manufacturers, and others who will be affected by that, you have obviously referenced the risk assessment process that has gone on internally within FDA to use your risk-ranking mathematical model to evaluate risks, but that is going to be held kind of internally, but what kind of way do you see educating the industry in terms of what hazards are the most appropriate for different kinds of feeds being manufactured or different kinds of ingredients? And where are the proper intervention steps to address those hazards as part of a process control regulatory approach, rather than holding that information internally?

I think we all have quality assurance programs that we have in place that try to do that right now, but what kind of way would the Agency have to make that kind of information available so that it could be addressed in process control compliance, or in terms of the approach that companies use in developing those?

DR. GRABER: Well, one of the things, you know, we have talked about internally and we know we have to do, and that is we are going to need to write guidance. And to a large extent, the guidance that we prepare is not going to be -- it may be in language that we are familiar with, but in reality, a lot of the stuff is going to come from what exists already in terms of information that comes from academia -- you know, say, extension information comes from an extension agent’s -- it could be from quality assurance programs that already exist.

I mean, it is all going to be based -- to a large extent, it is going to be based on limits that we already have established or are recognizing. But we know we are going to have to put out some guidance in this area.

MR. BACHMAN: And just to touch on that a little bit more, Randy, in regard to the educational component, one of the things the -- or the things that the educational work group is working on is doing some outreach and reaching out to stakeholder groups, you know, whether it be particular specie groups or the manufacturing industry, in trying to partner and leveraging with those groups in a future development of some of those training materials and avenues for getting the information in regard to this whole Framework and the future of the Framework and putting it into place, you know.

So we are anticipating, you know, additional outreach and cooperation with various organizations in getting the word out and, you know -- of course, any documents that we put out will be put out generally for review first and comment.

It is a good point and one we have taken into consideration and one you have again brought to our attention that we need to continue on.

MR. LITTLE: But you can talk about education and all of the things about getting information out, but, specifically, will the risk-rating model be available to companies to do their own self-assessment against your regulations?

DR. GRABER: I don’t -- you know, right now we are developing this model for internal use. I don’t -- you know, it certainly would be available for anyone who wants to use it. But keep in mind it is a relative -- it is comparing -- you know, it is comparing Contaminant A versus Contaminant B versus Contaminant C for our use in terms of allocating resources.

We may decide as an Agency to look at Contaminants A and Contaminants B for, say, doing some research or for conducting a surveillance program next year. But as a feed manufacturer, as a feeder, you may be interested in all of those contaminants, not just A and B. You may be interested in A, B and C.

So you need to be a little careful about the model, about its application, because it is a relative thing as opposed to an absolute risk. And then you also have got to deal with the fact -- and Dr. Hooberman will talk about it this afternoon, and others, about the paucity of data that exist, so --

MR. BACHMAN: Okay. We are a little past the scheduled time for the lunch break.

If anyone has a hot issue at this time, you know, we have a couple minutes, but it cuts into your lunch break. If not, please be back here at 1:00 p.m.

(No response)

We will start with the afternoon portion of this Public Meeting this afternoon.

(Whereupon, a lunch break was taken at 11:42 a.m.)