In helping us in our work groups tomorrow and in the future as we develop these systems of ID, what kind of information, proposals, plan or direction do you need from the industry in evaluating ID systems that meet your regulatory needs -- individually in your agencies and in terms of USDA as a whole or whatever it may be? I ask that of each of you.

I think that is less complicated for us than it is other agencies. For APHIS - - if we meet the needs of - - what we previously said was, as for identification, when we met the attributes of good identification, that is good enough for us. If we moved to electronic identification, we can do that easily, but we need to meet the needs of other agencies. If we find some other external identification that meets the attributes that I discussed, we can slip into those easily if we’ve got something that works better, a bar coded eartag vs. the type of eartag we used to know or bangle tag, we find that we are pretty flexible in that respect. It needs to be permanent. We’ve got any number of things we can work with the industry; you come up with some reasonable proposal, presentations, we will work with you for that. I think we are very flexible and I think that is easy for us.

Are we going to have to identify what point we can begin, or are you going to do that for us?

No, I think that at this point, what is going to meet the needs of the industry. We have discussed for the last four or five years that I have been involved, where do we go back and where is the identification place? Does it go back to the owner, is it after market and if so, who pays for it. ..our regulations as you well know, at APHIS, fall into place in interstate commerce. There is a lot that happens intrastate that we would not cover in our regulations, so there are some issues that, at this point, wouldn’t reach us. A lot of things can get done before it would fall into our realm of regulations. I, particularly at APHIS, would like to see a system developed that is going to be most effective with the other regulatory agencies and industry. As to that on the farm where we have 1.2 million producers putting in identification, I can’t answer to that. I don’t think we are going to put in a regulation that would require that. There are regulations that require that animals that move in interstate commerce be identified, so what seems to be accommodating that? What is going to work on the producer level? Will they want to identify their animals? Where there are small producers can it be done at the market and if so, that is a possibility.

Do some of the other panelists want to comment on that question?

I think from the standpoint of our agency, we would agree totally with APHIS that the system of identification that you have is effective for the industry is going to clearly ...one of the concerns that we would have is how identification is going to be recorded and tracked and that can not impose a system that creates such a record keeping burden on the industry and particularly the marketing and meat packing industry that it is impossible to maintain a system. I believe that the plans and the concepts that you come forward with need to address the question of how identification is going to be maintained, how much it can be tracked in the system, and what kind of record keeping systems will be required to maintain it. The type of identification system that you have will likely have a direct impact and a direct burden on the system.

A. Bert Mitchell, U.S. Food and Drug Administration

From the standpoint of FDA and the Center for Veterinary Medicine, our role is to protect public and animal health and no one has said we should not be doing that in this case. We need a mechanism. I said this morning that we might not, in the end, regulate these products as food additives, but we need enough information to assure ourselves that they are safe. Or that they can be removed from animals at slaughter with a high degree of assurance. We need some basis for concluding that these products are safe. I think that at this point, perhaps the regulatory hurdle, the height of it, is inhibiting to these manufacturers who are generally unaccustomed to dealing with FDA and that there might be a role, this is a positive statement out of this, there might be role for some organization to represent collectively the manufacturers of implantable animal electronic identification products so that information can be taken from FDA in a non confrontational way and delivered back to manufacturers in general.

The position of FSIS is very similar. We are quite concerned over the type of device. Probably the carcass ... Primarily we are looking at special compatible production of information generating devices that can give us accurate information as far as that which we need to know. We are also concerned about some of the other areas, toxicity is one.

A. Paul Mead, Centers for Disease Control & Prevention

The CDC isn’t really a regulatory agency and some have likened it to how much to evaluate in the system. I think from our perspective, a system that works would be ideal. I think the one emphasis would be on having a system that extends as far as possible and is as universal as possible obviously would...our interest.

Nancy Robinson, Livestock Marketing Association

I might mention in regard to that, there is some discussion in the industry that we do not necessarily need to go back to the farm of origin if we already have animals in the feedlot or as part of their production .., but at least we do want to go as far back as possible is better. Absolutely, I think that is where maybe our interests diverge at least on the surface a little bit from the industry’s. We feel that we don’t know really what is going on and that stopping at the feedlot may be enough but it may not be. If we can get some hamburger meat and figure out which feed lot it came from, to figure out where that cow came from, I think we stand a far better chance of tracking new animal pathogens through that process. I think there are very good segments of this continuum as far as tracing animals, figuring out which animal came from where, it is really being able to go the full distance because again, we are ---into that and we don’t know what happened upstream but we would like to be able to go as far upstream as necessary and predicting that in advance and saying where that end point is, we can’t do it. We don’t know. I think I say it is the difference between us and industry on the surface but I think underneath it is really in industry’s best view to be able, both for human pathogens and that involves animal pathogens, to be able to go back as far as possible to trace it back ideally to shortly after birth if at all possible or conceivable. I realize that is a tall order but that would be the ideal system. Certainly from our standpoint, but I think ultimately from the industry’s standpoint.

I would like to direct this question to Dr. Luchsinger. I would like to have you elaborate a little bit on what role we as producers play and what role you as government play as we work toward developing this program. And, also, I would like to hear you say that you have personnel to dedicate to carry out a proposal if we get that far and you already mentioned that you are facing cutbacks on people..

I think the experience of the federal government, the recent election and many other things is the same to us. The driving force for this effort has got to come from industry. We at APHIS are not going to be able to be the driving force of animal identification with the number of animals that are produced by the producers in this country. I very clearly see that industry is going to have to, hopefully that is what is demonstrated here, pick up this baton and clearly take that challenge on. In our organization, we have some infrastructure and we have some responsibility where our regulations lie to support that, to support industry, to help facilitate that. What congress is going to appropriate us in funds, I can make no guarantees as you well know, but certainly, historically, they have supported our program, our infrastructure then that is converted into support for this, actual number of people, some of those things, you know I can’t make that. But we are there, we have some responsibility and we have that interest and obviously we are going to do everything we can to assist in that effort but I think truly the creativeness, the involvement is going to fall back on industry.

This question is for Dr. Mitchell. If an electronic ID device were implanted into the connective tissue of the anus of an animal and subsequently removed during the slaughtering process, would this be an acceptable means of identification for the FDA?

I think so, it has the prospect of being acceptable. Depending on how close to the anal ring and the assurance that could be provided and that the technique would result in it going in the rendered materials as opposed to any possibility of becoming a direct additive to human consumption.

And also to Dr. Luchsinger, from what you are saying, are you also very interested in finding an implantable type ID device ?

Our position is that we need something highly efficient and effective and if that becomes the most effective identification device, it would meet our needs. There are other things that we have been using over the years. If this, in fact, is going to be something that is going to increase that effectiveness and efficiency, then we would certainly be willing to support that.

I think efficiency is one thing. I am kind of looking at the area of permanency more than anything else. I mean, anything that is on the outside or affixed in any way can always be removed to some degree very easily. Something that is implantable is a little bit different and I think that is one thing that all of you say, that we need something a little more permanent and that kind of lends itself to implants.

I do not disagree with that at all.

I was wondering if any of the regulatory agencies represented have been in contact with AIM, Association of Identification Manufacturers? They are the industry association and there is a RFID committee for animal tagging specifically, you know working with the manufacturers, trying to create consensus there. Have any of the agencies contacted this organization?

I don’t know about this organization and it sounds like an ideal sort of umbrella organization that could deal at arms length basis with the Center for Veterinary Medicine on some of these standards and go back and talk to individual members.

They are already in contact with the AVMA over this small animal, companion animal tagging standard which are making tremendous progress so they are based in Pittsburgh and I think they would be a good resource for you.

Our agency has been working in cooperation with APHIS on interagency preharvest work and we have been holding open meetings for various groups that are interested in sitting down and not only talking with regulators but also giving us an education too. It has been very useful and I certainly offer an invitation to any ...

A question for Dr. Mitchell. Your comments were aimed primarily toward injectable identification units but I think that there is quite a lot of interest in having ID at some other location or attached some other way rather than injected. For example, as we heard a minute ago, in the anal area. The rumen is another possibility and the question I have for you is, does FDA’s jurisdiction go, or extend over those type of devices where they would not go into the human food chain? The second part of that is would it be a necessity that those animals that had those devices inside be identified someway so that they would be visually marked?

The answer to your first question is yes, the food in the Federal Food, Drug and Cosmetic Act as defined in the statue, says food for man or animal. So rendered meat and bone meal derived from animals falls under the provision if the Food, Drug and Cosmetic Act. Should an animal have a visible marker indicating that it has been implanted? I don’t see that as a necessity. I did remark in my prepared statement that it has a possibility of sort of being a good idea. It is like the sticker that you put on the outside of a house indicating that it has been electronically secured, the windows are marked some way. That indication of that level of security has a deterrent factor in itself from theft. And I think as you might hear from some of the speakers later in this program, people who are working animals need the visual identification system. Herefords can look all pretty much the same or certain Angus can and they need some external number or identification as well as the internal marker.

It is kind of a broad question and probably doesn’t have an answer to it, but being the regulatory panel that they have up here and they say what we can do in the industry and what we can’t, they say that it is up to us to put something together and then for them to shoot it down I guess. Anyway, my question is do we have a definition, a 21st century definition of animal identification? I have heard bits and pieces and Dr. Mitchell has mentioned this a little bit. It has to be permanent, it has to be so and so...do regulatory agencies at that level have a 21st century definition of animal identification? Then, if we do, then I think we can progress with these other things and work out these steps.

I think the questioner was probably accurate, it probably doesn’t have an answer. That would be a good challenge for this group if it is not on your panel tomorrow, maybe you should take that on as part of your discussions today and tomorrow. What is this group suggesting as a 21st century definition of animal identification? I would certainly welcome your suggestions.

Q. Jim Hodges, American Meat Institute

The current regulations with APHIS and the recovery of ID tags or devices on the slaughter floor is fairly prescriptive. If the packer has alternate methods for animal identification how will the agency treat that or would they be acceptable? For instance, is some of our packers are collecting eartags from beef animals that indicate a feeder lot number they are all the same. They serve no useful purpose for animal ID when the packer has an alternate system for letting through electronic identification on the shackles or whatever. How is the agency going to treat those kinds of systems and the reason I am asking the question is this is both an FSIS and APHIS question.

Relating to an FSIS point of view, I don’t think we have any problem as long as it is effective in meeting the needs of the basic system. I think we can take a look..

Jim, I think the only thing that I would add, with our current external identification devices, primarily relating to tuberculosis, brucellosis, pseudorabies, we do ask and like to have those collected because the color, the shape, something about that device can make it unique and can be helpful in a traceback. If we go to a system where we have something that is an absolute unique numbering or identification system that would get us that same level of efficiency or back to that most recent premises, that would do. Just a number or whatever that identification would do. But with our current external system, then we do ask for those devices because they, in themselves, can be unique. Does that help?