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Safety & Health

Presentation: Draft AFSS Framework Document, 3rd Edition

Presentation by Dr. George Graber


DR. GRABER: Thank you, Paul. Thank you, Bernadette.

As you know from the look at the -- from the podium sheet, you will recognize the fact that I have retired. Someone came up to me and -- yesterday and asked when I was going to retire, and I told them, “Last August.” And I guess that was a little bit of a surprise. I tried to get someone else to do this presentation, but nobody else would volunteer, so --


Anyhow, today what I want to do is sort of break this up into three segments. The first segment will just take a few minutes to go through -- I am just going to cover some of the major issues that have occurred over the last 12 months or so, and there has been a lot of activity unfortunately in some food safety issues, but also some activities on the part of Congress and the part of the Agency and Departments.

Then what we will do is we will go through and talk about the Framework Document itself, cover some of the major changes, and also go through the components and the gaps, each of the gaps within each component. And then at the end, we will take comments and questions.

As Mr. Bachman mentioned, we will take a break at some time. I refused all the coffee and all the water and all the tea that he tried to give me, but we will take a break probably somewhere around 10:15. I will get Paul to keep tabs on the time.

One thing I should mention. If you go to the -- go to our website, the Animal Feed Safety System website, you will notice that the 3rd Draft, this is sort of the 3rd iteration of the same document. For some reason that we are not quite sure what happened, there have been several hiccups in putting that document up on the Web, and so some of the materials got moved from one section to another section and it took a couple of us to -- including somebody in the audience -- to identify these problems. So you will notice when you go to the website, you will see that there is -- it was posted at 3 different times. The one that is up there now was corrected as of yesterday.


Okay, the major events that I mentioned on the -- just mentioned -- the Melamine, obviously the Melamine pet food incident, it doesn’t seem like anybody who gets up here and talks about food safety gets away without saying something about Melamine.

But then, we have also had the food additive Food and Drug Administration Amendments Act of 2007, the Food Protection Plan. We had Dr. Acheson yesterday at the pet food meeting give a short presentation on that particular plan. We have also had a -- this Administration have an Interagency Food Import Strategy Plan. And then, lastly, a document -- a Memorandum of Agreement that Dr. McChesney mentioned yesterday.

If you look at the -- in your packet, there is a sheet that has the links to all of these documents, so if you are anxious to go home and read those documents, you can find the links inside the docket. Okay.


As Dr. Dunham just mentioned, everyone has got greater expectations today. The Melamine incident has certainly caused people to look more carefully and more closely at feed and food safety. On the left-hand side, we have got sort of the industry side, the feed manufacturers, people who are raising and selling meat, milk and eggs. And we have the packers, slaughterhouses. And on the right-hand side, we have got consumers, both domestic and international, we have got regulatory agencies again, both domestic and international, and of course the U.S. Congress is still interested in food safety and with the prospects of additional Congressional activity even occurring in 2008 and 2009. So there is all kinds of activity there.


The pet food and Melamine incident, the outcomes from that -- certainly, there were -- this was a serious issue. We had many dogs and cats become sick and die. The Agency does not have a count on that. The Agency’s goal at the time the incident was unfolding was to try to find out what the problem -- what the cause of the problem was and then take action to get the products off the market.

It certainly was front-page national news. Most of the newspapers in the country were carrying it. The -- you couldn’t turn on the nightly news and there was always -- seemed to be an article on the pet food incident as well.

Certainly, massive economic fallout for the companies that were involved. There have been -- certainly the industry has changed. It has become a lot more focused in looking at ingredients that they are certainly importing now from other countries. We have had Congressional interest which, as I mentioned, has led to legislation, the FDAA, and also which mandated not only new regulations but enhanced programs, and we heard about that yesterday.


The Food and Drug Administration Amendments Act -- I am probably going to start saying “FDAA” pretty soon, and hopefully people will understand what I am talking about. Anyhow, Title X, the food safety section of this particular Act, required by regulation within a two-year period, which is September of 2009, that regulations be written covering ingredient standards, ingredient definition standards, processing standards, labeling standards covering -- focusing on nutritional ingredient information. And then pointed out specifically, we are supposed to do this in consultation with AAFCO and with others, including the organizations that were listed in the Act, which were the pet food manufacturers, animal health associations, and veterinary/medical associations.

There is a docket that has been established, and hopefully people will be submitting comments to that docket.


There were other provisions, as I mentioned, besides the regulations. There were program effects. Again, we heard about this yesterday -- I won’t spend much time on it -- but within a year FDA is supposed to establish a pet food early warning surveillance and notification system. The idea is to identify adulterated product and get it off the market and then certainly notify the veterinary community and others to insure that the problem that is unfolding is brought under control.


Then we also heard about the “reportable” food, the registry that the Agency is required to establish.

Here, it is -- we are only talking about where there is a reasonable probability of causing adverse events both in humans and in animals. CVM is -- this particular document is really being developed by the Center for Food Safety and Applied Nutrition and CVM has got its part dealing with reportable animal foods. This has to be done in a year, so that is September of this year, 2008, and as yesterday was mentioned by Mr. Young, Kim Young, that there is a guidance document that is due out sometime next month, so I suspect that, again, that is something that the Center for Food Safety and Applied Nutrition is working on now.


Then yesterday we heard again from Dr. Acheson, talking about the Food Protection Plan. It was announced in November of last year. It is a robust plan covering food and feed product throughout its complete cycle from development to consumption. It is a sort of a new framework to get work done.

As Dr. Acheson mentioned yesterday, there is -- it seems to be -- of the three subject -- three core elements, prevention is one that is going to get the greatest attention. It is the one that generally in the food area, as opposed to the drug area, there hasn’t been -- there has been limited input on the regulatory side, so that is going to change. It does require a great deal of cooperation among everybody who is involved in the food cycle, food and feed cycle, not only the, you know, the government agencies but also industry, academia, consumers and Congress. If one segment is silent on this particular issue, then the plan is not going to be as successful as it should be, so everybody needs to participate.


So here are the three core elements that -- for the Food Protection Plan. Prevention -- sort of build it in from the start. It is a risk-based approach. The idea here is the -- to promote increased corporate responsibility, to identify vulnerabilities and assess the risks, and expand the understanding and use of effective mitigation measures.

In the intervention area, the focus is going to be on inspections and sampling, again based on risk. Enhance risk-based surveillance and also to improve signals that could be used to identify contamination incidents as they are unfolding.

Then in the response area, clearly the issue here is to improve the immediate response. People have to know about these issues. We have to know about them. The firms involved need to know about them. The consumers need to know about them. The medical side of the scheme need to know about them as well. So there is really an important part for risk communication to all involved.


The cross-cutting principles for the Food Protection Plan -- when we talk about food, we are talking about both human food and animal feed which traces the way food is defined in the Federal Food and Drug Cosmetic Act.

It talks about focusing on risk over a food product’s life cycle from production to consumption.

It targets resources to achieve the maximum risk reduction, addresses both food safety and food defense, contamination of food and feed, and the idea is to use science and modern technology systems to improve the capability of all involved.


Now, the Food Protection Plan is part of a strategy that also includes the Import Safety Action Plan which was a plan that was developed through activities by 12 Federal Departments and Agencies. It was led by the Secretary of Health and Human Services, Mike Leavitt.

This also was released in November of 2007, has 14 broad recommendations and 40 specific action steps. This covers not only food and feed but covers a whole slug of products that are imported into this country. But by and large, the presentation, the recommendations, the way it is focused, it does mirror specifically the outline and direction that is in the Food Protection Plan.


Now, the import plan has six building blocks. They -- the first one here, Advancing a Common Vision, is really for Agencies involved, the Departments involved. Policies and procedures need to be reviewed and modified if necessary to insure that all the Federal Departments and Agencies are working on the same plane, they are working together to insure whatever products that their separate Agencies are responsible for, that they are safe.

There is also an increase in accountability for the industry, all those involved in the production, distribution and sale of imported products, and the Agencies involved in enforcement activities need to be ready, willing and able to take action against those firms and products that are not meeting the standards that they are required to.

They need to be focusing, again, on risks over the life cycle, as we talked about before.

The building of interoperable systems is an interesting one. It is easier said than done. I am glad that the telephone was invented in -- by Graham Bell a long, long time ago. I think we would have had a hard time trying to get everyone to build the same type of telephone today if we were doing it, so --

Focusing on a culture of collaboration, as Dr. Dunham mentioned. The -- this is highly important. I think if you look at the Melamine incident, in a way you could probably go back if you are an historian, and I am not, but if you go back to food production in this country, I suspect that there were many incidents in the early part of the 20th century where food adulteration, economic adulteration, occurred, probably a lot more then obviously than today. I think it is a culture issue as much as it is anything else. People know better today. But it is -- to me, it is not surprising what we are seeing with developing countries having these types of issues where there is economic adulteration. Unfortunately, in the case of Melamine, it resulted in animal deaths, and in the case of Heparin, we are talking about human tragedy.

Also, the promoting of technology, innovation and new science is an important thing. Innovative screening techniques are needed to handle the large volumes of materials that are coming into this country.

The last item is the historic event, the signing of the Memorandum of Agreement -- that is “MOA” -- between the U.S. and China on food and feed safety. We are going to have enhanced registration and certification requirements. There is supposed to be greater information sharing, faster access to production facilities, so that we can, if need be, go in and do an inspection. I think the time we got to the -- finally got around to looking at the facilities that were involved in the Melamine incident, they no longer existed there. I think there was a fence around them, supposedly, and -- but there was nothing inside the fence. So hopefully that is going to be corrected. We are going to have offices. FDA is going to be establishing offices in China, and we will have a small work force operating out of Beijing and I suspect -- I think one or two other cities.

Then there also needs -- there is also going to be greater regulatory cooperation standards and shared standards between the two countries.


As Dr. McChesney mentioned yesterday, this implementation of the Agreement, it is going to start with several animal feed products, pet foods and treats, and also with some ingredients such as the wheat gluten, wheat flour, and stuff like that, so it is a start.


Okay, so that is sort of the background. The one thing that is -- it is important is that a number of these items, a number of these activities, all have a component dealing with animal feed. Animal feed is part of them. It is part of the animal -- as part of the Food Protection Plan. It is part of the import strategy. It is an integral part of the MOA with -- between China and U.S. And, fortunately, or I guess fortunately we have actually had a head start since we have started working on this program since 2003, so we are sort of a little bit ahead of the curve, although it doesn’t take long to fall behind the curve, so we need to be moving more quickly on some of the items that we will be talking about this morning.


It is the new title for the program. We have always had an animal feed safety program in FDA and CVM -- we have just given it a new title to sort of -- you know, sort of a catchy type of thing to insure that people recognize that there is work going on in this particular area.

The -- in your packet, there is a list of the Team members, the current Team members. It is on the left-hand side. You will note that the work force on this. for this Committee, is around 20 people. The Team that has been working on this particular project, the majority of them are from the Center for Veterinary Medicine. We also have representation from the Office of Regional Affairs within FDA, the Office of the Commissioner, and we have always had participation by state feed control offices, at least 2 -- sometimes we drop down to 1, but we have always had state participation, and it is critical to have that component part of this activity.

Anyhow, the framework doc is sort of the thing that we use to guide our work. It sort of keeps us from wandering. It is sort of a road map, so to speak. But it also is a document that started out with, well, what are the processes that we are using today within FDA? And one thing I stress -- I am going to use the word “we” sometimes. That is we, the FDA. I am an employee, but not in my former capacity but as a consultant, so when I talk about we, I am talking about FDA -- it is not necessarily just me or --


As Dr. Dunham mentioned, the first draft of the Framework Document came out in February of 2005, and we used it for a meeting in April of that year. We updated the document and put it out in December of 2006 -- that was the 2nd Draft -- and now the 3rd Draft, or the 3rd Edition, we put out in April.

Each time I -- you know, the document is -- from our perspective, has improved. And, you know, we got comments, we got feedback, and that was very helpful.


So what are the major changes between the Draft that was out in December of 2006 and the document that we are working off today? And we really -- there are just a couple of what I will call major changes. One is we have added one component, and we will talk about that. That is Component D, which is reporting of unsafe feed. And we have added three new gaps. So, before we had 11 gaps. Now we are up to 14 gaps. We have given ourselves more work to do. The truth of the matter is, these three gaps really came about because of FDAA, so in reality these gaps were mandated to us by Congress.

So these gaps -- one gap is in Component A, one gap is in D, which is the new component, and one gap is in F. And we will go through these this morning.

The other thing is we have also moved some gaps so that a gap might have been in Gap D last time -- or Gap D, which was not Gap D now. It is -- I mean, it is -- it could have been in E or F and now it has been moved to a different gap. So there has been some moving of a couple of the gaps.

But probably the most -- the thing that we did to improve the readability of the document was to try to work on each of these gaps to make sure that they actually appeared as a gap and that the way we were going to address the gaps appeared as a fix. So that is probably -- these are the biggest changes between the 2nd Draft and the 3rd Draft.


Okay, and as people have said already, the purpose of the -- and scope of the Animal Feed Safety System is to protect -- protection of animal and human health. It covers the entire spectrum of FDA activities. I think that we did have -- I might say that there is probably one activity that -- major activity that is not at this point included within the Animal Feed Safety System, and that is the actual approval process for clearing drugs to be used in animal feeds. So that is really caught under a separate part of the Agency’s program activity, and so the statement about “covers the entire spectrum of activities associated with animal feed,” that would be one that is really one that is not included, at this point.

Again, we will be talking about oversight of labeling, production, distribution and administration of all feed at all stages. It includes -- we will be addressing all commercial and noncommercial feed establishments and all feeders. So it is the concept of production through consumption.


It consists of both regulatory and what we call, you know, mandatory, and voluntary components. We are trying to improve the risk-based component for the Animal Feed Safety System, and we will talk about some of that this afternoon and we will give some specific examples and -- covering both inspections as well as contaminants.

Then we are also -- important is the feed hazard evaluation by all feed manufacturers to insure unacceptable risk to animal and human health is controlled. So this is probably a little bit of a twist. There is going to be an onus on people who are making, distributing, producing and distributing feed to insure they control their hazards.


So the 11 Operating Principles -- you know, one thing you can do is if you want to follow some of the language, it is in the Framework Document which is -- a copy is in your packet. We are going to go -- just list through -- just go through these 11 Operating Principles. I forget what page it is on -- I think it may be Page 2 or 3 of the document.

MS. : 3.
MS. : 2.

DR. GRABER: 2 and 3, okay, thank you. So the production, distribution and use of safe animal feed is the responsibility of the feed manufacturers, feed establishments. This is -- you know, a lot of this stuff that is up here is not earth-shaking. It is understood. But it is also -- it is a good idea to go over it occasionally just to keep things straight.

The establishing of the rules to insure that -- and guidance, and to conducting oversight is the responsibility of government agencies, state and Federal. Oversight is also a responsibility of the industry.

Rules and guidance provide flexibility. That is sort of a them of the Animal Feed Safety System. The idea is to insure that we are not overly prescriptive and that existing programs that have been developed and utilized for many years will continue.

Pretty -- a fairly critical element is that cooperation will continue among Federal and state regulatory agencies. FDA and CVM in particular in the states have feed control offices, have had a tremendous relationship over the years with individual states and through the Association of American Feed Control Officials and we anticipate that this will continue.

We are not in the business of trying to replace state programs by developing a greater Federal presence, but what we are trying to do is focus more of everyone’s programs on issues dealing with safety and less in the areas of economics. But that -- but the Agency will continue to support programs dealing with economics because in fact we have these types of programs as well. But in terms of risk, they are obviously going to come up a little bit lower on the scale.


(Technical difficulty) --- which are -- feed through pesticides which are regulated by EPA and vaccines that are added to animal feed which are regulated by United States Department of Agriculture.

For the most part, we have regulations in place to deal with the safety of food additives and color additives, GRAS substances and those new animal drugs that are permitted to be used in animal feed.

But we also use procedures that are not covered by regulations. For example, we have a voluntary consultation process that we have been using for I think it must be 5 or 6 years now for reviewing information about biotech plants before they go on the market. So it is a voluntary consultation process that the biotech industry has been using, as far as I know, without exception.

We also -- FDA also participates in the AAFCO feed ingredient process for modifying ingredients or for adding new ingredients into the AAFCO official publication, so --


So, the gap. The gap that the group came -- the Team developed was that our regulations -- we are often asked for a complete list of ingredients and additives that can be used in animal feed, and the fact of the matter is that FDA’s regulations are not complete in this area. And if you look at the definitions -- if you look at the GRAS definition in the Code of Federal Regulations, Title XXI, it specifically states that the GRAS regulations are not complete.

So it is sort of an issue. People continue to ask us. We don’t really have an answer in terms of a Federal location or a location in the Federal Regulations and we don’t have a separate listing ourselves that we use informally. But what we have been using over the years is the AAFCO official publication, the definitions that exist in there, and that is generally where we refer people to.

But, as you know, the FDAA mandate was that we write regulations for feed ingredient standards and definitions, and that we have till September of 2009 to complete that task. Fairly formidable task.

At one point, the Team was going to develop a compliance -- “CPG” is a Compliance Policy Guide which would develop -- which would explain the relationship between FDA and AAFCO and would establish a policy whereby we would sort of officially recognize the ingredients that appear in the official publication. But because of the mandate from Congress, we have sort of put that on hold, and we are just going to wait to see what the regulations look like and then decide at some point whether we need to write guidance. It is very likely we will still need to write guidance for that regulation, but we will just have to wait and see what that guidance will need to look like.

But in the meantime we have signed a Memorandum of Understanding between FDA and AAFCO. It was signed I think in August of 2007 and is -- I think runs for 5 years, at which point it can be renewed. And what this MOU does is it describes the processes by which FDA and AAFCO -- what their roles would be, respective roles would be, in reviewing materials that have been submitted to AAFCO, again to either add a new definition or to modify an existing feed definition.

The last item here is the GRAS Notification Rule, and I -- there is a former friend that I don’t see in the audience anymore, but she is tired of asking me about when the GRAS Notification Rule -- I -- nobody else has taken up after her leaving, retiring, I guess, but they are still working on finalizing this Rule. It just keeps on falling further and further behind in terms of priorities.

We know the Center for Food Safety and Applied Nutrition is utilizing the GRAS notification concept. CVM is not, and it has no intention of doing that until the Rule is published as a final Rule. When that will be -- I could use the Federal “soon,” but that is old hat now, and --

But even though we don’t have -- the CVM doesn’t have the GRAS Notification Rule, the AAFCO definition process certainly is one that is quite useful, and so they are really -- from the perspective of the Agency, FDA, it certainly -- the GRAS Notification Rule, if it comes about, okay, but it is probably -- in the long run, it is really not that necessary in the feed area. At least, that is my perspective.


I think what we are going to do, Paul, is take a break here.


DR. GRABER: It is 10 after. I am going to go through the rest of these components and then we will have a question and answer period. Want we come back, what, at 10:30?

MR. BACHMAN: 10:30.

DR. GRABER: Okay. At which time I will --(Whereupon, a break was taken from 10:12 to 10:37 a.m.)

MR. BACHMAN: Could I have your attention, please? We would like to begin, or reconvene. Thank you. If you all could grab a chair, Dr. Graber would like to reconvene, get this on, so you can ask some questions.


Okay. Component B is limits for feed contaminant, on Page -- this is on Pages 4 to 6 in the Framework Document.

FDA uses several regulatory approaches for controlling the limits of contaminants in animal feeds, things such as guidance limits, action levels, tolerances, and regulatory limits, and these are applied usually to contaminants that have been added -- are added to feed, as opposed to things that are inherent in the feed. Under that scenario, usually some sort of tolerance might be established in terms of how much of an ingredient can be used.

The procedures that we use for establishing these types of limits -- the regulatory limits -- are in Appendix 3, which is on Page 14 of the Framework Document.

Now, this particular component deals with contaminants only, not with feed hazards per se, not all feed hazards, and I know it took me a while to understand the difference between the two.


But here are the definitions and there also -- there is a section in the Framework Document that also has the definitions of things like feed hazard and feed contaminant.

But a feed hazard is a biological, chemical or physical agent in, or a condition of, feed with the potential to cause an adverse health effect in humans or animals. So it is an agent that is in the feed or a condition of the feed.

A feed contaminant, on the other hand, is all potentially toxic or deleterious biological, chemical or physical hazards inadvertently present in animal feed.

So, in reality, the way this is defined, feed contaminants are a sub-set of feed hazards. So, feed contaminants are feed hazards, but not all feed hazards are feed contaminants.


Okay, the gap that was one of the two gaps that was identified with limits for feed contaminants is on the basis that not all feed contaminants carry the same level of risk. So what we are looking for is some systematic way of considering the various contaminants that might exist in animal feed.

We have held the last two Public Meetings -- the 3rd and 4th Public Meetings. We were talking about developing this risk-ranking model, and we discussed within that model the two components of risk which deal with health consequence scoring and exposure scoring. And this afternoon, you are going to hear a little bit more about that particular model and you are also going to hear -- you are going to hopefully get a little bit better insight into how we are utilizing these particular scores and arriving at a rank of risks for the various -- for some of the various contaminants.

Now, these risks are relative risks as opposed to absolute, and this particular model, just to remind everyone, that what we are building is really for internal use for the Agency to allow it to decide how best to utilize resources.


Now, the second gap is actually -- is one of the gaps that has been completed, but it is something that came out of one of our previous earlier meetings, one of the earlier meetings.

We were advised that it would be really of value to all involved, the Agency as well as the industry, if there were methods available, practical and regulatory methods available, when we announce some sort of regulatory limit for a contaminant whether -- again, whether it is a tolerance or an action level or guidance. And so we didn’t have a written process by which we would insure that limits -- that we would go about developing methods.

So, right now we have developed a CVM policy and procedure document and the number is there for it and the link to it is in the Framework Document. It is on Page 6 of the Framework Document, so you can read this particular policy and procedure that was developed, but essentially is when the Agency decides that it is going to establish a limit for a particular compound or modify -- it could even be modifying an existing limit, making it lower, for example, which would necessitate maybe improved methodology -- what would happen is the Director of the Office of Surveillance and Compliance in CVM would convene an analytical chemistry panel and they would do some research, look for methods that are available in the literature, and then develop a plan to have a method developed in time when the limit was put into place.

So all of that is in place now, and it has been in place for a while, and, of course, we haven’t needed it because we haven’t established a limit recently, but at some point we may get to a point where we need to utilize this particular policy and procedure.


Anyhow, the next component is process control for production of feed ingredients and mixed feed, and this is on Pages, I think, 6 and 7, of your document. Process control is a systematic approach designed to insure feed safety through the identification and use of appropriate controls during the manufacturing, packaging, storage and distribution of feed and mixed feed.

Feed process control entails measures seeking to prevent or eliminate or reduce risks to an acceptable level in terms of animal and human health. And currently, within the Code of Federal Regulations we have cGMP regulations that exist for B and C medicated feeds and also for Type A medicated articles.


But we don’t have any process or any regulations in place that deal with all aspects of feed that are associated with feed. So, for example, non-medicated feed and feed ingredients -- at this point, there are no regulations per se that deal with these particular segments of the industry.

As we announced in the 2nd Framework Document which as out in December of 2006, that we have begun writing regulations, what we call “process control standards,” that cover the production, storage and distribution of all animal feed.

They don’t cover the use of the feed at the farm level, but they cover -- they will cover the production -- like I say, the production, storage and distribution of feed at commercial feed establishments and what I will call noncommercial feed establishments -- mixer feeders.

We still have a lot to do to get this thing moving. We think the impetus from the FDAA is going to assist in moving this particular document along.

We have completed the codified portion of this regulation and we are now working on the preamble for the regulation, and we are hoping to get -- like I said, we are hoping that the activity within the Agency that is under the FDAA as well as the Food Protection Plan, that these particular entities


So what will our process control regulations provide? And if you look at Appendix 5 in the document, which is, I think, on Page 15, there are 9 reasons listed here -- I don’t have them all listed here on the screen. These are the -- what we think the process control regulations will -- are needed or will accomplish. Hopefully, you know, it is going to broaden the coverage to all feeds and ingredients.

It is -- we can’t predict that we -- you know, we are hopeful that it will prevent contaminations, but, you know, you -- I don’t think there is any foolproof system, and I don’t think we are in that particular mode to think that there won’t be future contaminations, but hopefully process control regulations will assist in this area. Hopefully, it will also reduce the number of feed recalls that occur which are both a drain on everyone involved -- the industry as well as government agencies.

We think that it will assist -- has the potential to assist with insuring there is no trade disruption. An important component of confidence in the food supply is in terms of meat, milk and eggs is that there is confidence that the feed supply is also safe.

We are looking for -- hopefully, this will provide for uniform coverage. We won’t have -- at the Federal level, we won’t have some states that are enforcing some sort of regulations and other states aren’t. It will also, hopefully, help the FDA focus its limited resources.


Now, in terms of writing these -- in terms of writing the regulations, these are sort of points of consideration that we used in doing this. We know that there is a wide diversity in the types of operation that exist today, both commercial and on the farm.

It was also important to us to insure there was -- that again, as I said before, that it is -- that our rules are not overly prescriptive, that there is sufficient flexibility to allow the different types of operations to meet the rules without, you know, not having one particular set of regulations that fits everyone. So, the idea was to build flexibility into them.

There are obviously some minimum standards, baseline standards, that are in the regulation.

We have also introduced the concept of a risk evaluation component that the feed industry would need to review to determine where the risks are and what steps they are going to take to control them.

There is certainly the aspect of accountability, which I mentioned, with the import plan. This also applies in the case of feed establishments -- the axiom of “it is not written down, it didn’t happen.”


I think those are the -- and we are moving to the areas of consideration, and, you know, none of this should probably come as a surprise. These types of areas are ones that exist currently in the GMPs for medicated feeds, for example.

So we have got materials entering establishment, we are considering what happens to materials that come into a facility, what happens when the ingredients are mixed together or whatever additives are used in making either an ingredient or a mixed feed.

So it is a processing, a manufacturing aspect, storage and packaging, labeling -- critical area.


We have also included areas -- included sections on testing and traceability and importing of ingredients and mixed feeds.

So, in reality what we are looking at is sort of a GMP-type regulation with a -- what I call with a twist. It has got a risk component associated with most of the areas of consideration, so that is why it is GMPs with risk incorporated into most of the areas.


Okay, the -- that is our gap. That is Gap C1.

Gap C2, as you know, it has probably been over, or close to, 10 years since the Agency responded -- gave an interim response to a citizen petition that was seeking the replacement of the dual set of GMPs for medicated feeds, the idea of creating a single set.

The Agency thought that this had merit and indicated that it was proceeding in writing -- combining the existing GMP regulations into a single set.

But this thing got held up. There were sort of a number of challenges that -- as the concept was put through the Agency, there were challenges that were put back on CVM’s shoulders.

For example, the cost of creating this single set of regulations as well as the public health importance -- where would -- by changing this, what improvements in public health would occur? -- and we just haven’t been able to focus on these, to overcome these particular challenges.

The thing is still in a “hold” status. We need to make a decision fairly soon about how we are going to address this particular activity. So, anyhow, that is sort of a status report on Gap C2.


Gap D is the new gap -- I’m sorry. Component D is the new component, reporting of unsafe feed.

The compliance programs that FDA has and the states have for collecting -- you know, picking up samples and analyzing them, feed samples, and analyzing them is -- you know, provides some useful data about unsafe feeds but it is -- but it really isn’t a fairly -- it is not really a very significant amount of information. States actually do a lot more work in this area than FDA does.

But these is surveillance that is going on in other areas. The feed industry does its own testing. Occasionally, animal producers will have feeds tested either by themselves or through -- say, through a diagnostic lab. Individual veterinarians occasionally do work. Academia, even occasionally the public, will get involved in analyzing, or having feed analyzed. So, these particular sources can be an additional -- can provide additional information to the Agency about potentially unsafe feeds.


So, the -- there are two gaps now in Component D. And the first one is there where the Agency needs to be more proactive with regard to learning about informing the public about unsafe feed situations. And this is sort of almost language that exists in the Food Protection Plan, and it is also a mandate that came out of the FDAA legislation, the development of an early warning and surveillance system and reportable food registries.

So these are the two activities that I talked about previously and you heard about yesterday, are really the fix in terms of being -- finding out about food contaminations, feed contamination incidents, and then taking steps to inform the public and others who are involved -- who potentially could be involved in feed contamination problems.


Gap D2 was actually one of those gaps. It is now in -- under Component D. It was in -- under the regulatory oversight component in the previous version of the Framework Document. So its placement there is new, but like I said, it is not new to the Team. This is one of those where we did do a little bit of rewriting to make it clear what it is we were trying to -- what the problem was and how we were going about fixing it.

But bottom line is we get medicated feed adverse event information only from licensed -- FDA-licensed mills, and I think right now we are down to about 1100, somewhere between 1,000 and I think 1100 licensed mills. And these mills are only required to submit information that deals -- to the Agency that only deals with the making of those feeds that required the license. So if they are making medicated feeds that didn’t require the license, they don’t have to submit that information to the Agency. And then also, all the other feed manufacturers are not required to submit any information about feed that they are making, medicated or non-medicated.

So the fix to this was -- actually had begun quite a while ago, almost -- I think it was something like 17 years ago, they started working on rewriting the records and reports regulation. And while it was completed for animal drugs, it never got completed for medicated feed, and so we are working on developing the plan to re-propose that particular regulation. And so we are going to essentially start over, start the process over again, and in part because it has been 17 years and also because we are thinking that we want to expand who needs the report under this regulation, covering those areas that the current regulation does not cover.


Okay, Component E again was Component D in the previous version. We are talking here about regulatory oversight, and this is on Pages 8, 9 and 10 on the Framework Document.

The primary purpose of an inspection is to determine in establishments or products degree of compliance with FDA regulations. An inspection can occur simply as a review of labeling. It could be at a mill site just looking at the labeling, or you can be looking at its manufacturing facility to insure compliance with some aspect of the regulations.

Under the more expansive Animal Feed Safety System, regulatory agencies would probably find themselves in a worse situation than they are now in terms of being able to inspect all the facilities and being able to do it in a timely manner and addressing obligations that came about as a result of Congressional action.

So we are looking at a, you know, a risk-based, science-based approach to improve the Agency’s ability to deal with which probably would be daunting numbers. When you compare the current situation today, then if you add additional facilities as a result of having more firms subject to routine inspections or some sort of inspections, it even becomes a really difficult -- it will become more difficult for the Agency. So the idea, of course, is to try to do this on a risk-based approach.


But, anyhow, the three gaps that were identified in this particular regulatory oversight component are: We are not doing these inspections in a timely manner, we are not giving attention to all segments of the industry, and up until recent times, we had not really been thinking too much about feed defense.


So the first gap is the one about timely inspections. Even under today’s standards, we are probably talking about an inventory too large for current available inspection resources, and even when we work with the states by the contracts or other arrangements, it helps but it doesn’t necessarily get us to covering all the facilities that are -- we have identified needing -- that we want to inspect.

So we are in a process of developing a risk-based procedure for -- using a risk-based approach for deciding on inspections. You are going to hear a little bit about this the first presentation this afternoon. Barry Hooberman is going to talk, give you an overview of where we are on this particular process.

There was a statistics professor at University of Illinois who told me that the time something gets into print, it is probably wrong. So yesterday we were looking down at these slides, and it is even in the document, and it turns out that this last bullet isn’t exactly correct -- they have actually implemented the risk-based inspection prioritization for both licensed medicated feeds as well as for BSE inspection. So -- but you will hear a little bit about that this afternoon. You won’t get an in depth discussion of the criteria that we are using, but you will get an overview, you will get some idea about some of the criteria that they are looking at.

One thing that the Agency did come out with recently that probably could help in this particular area, and that is the idea of using third party inspection certification. There was a Federal Register Notice that I think appeared sometime this year seeking -- it was sort of a -- like an advance notice of proposed rule-making. It dealt with third party inspections of food and feed establishments and it was just essentially seeking information. So the docket closes on that particular item I think on the 19th of May, so --


One of the other gaps is Gap E2, is that inspections of some industry sectors that are required by statute, such as medicated feeds, and other sectors aren’t even on the radar screen in terms of the statute. The industry certainly has diversified over the years. We are seeing a lot more on farm feed manufacturing. But there are segments, like we have mentioned here. Transportation is one where we have not had a great deal of coverage.

So one of the things we need to do is factor in these other segments -- importing, transportation, storage -- and start considering these particular segments in terms of: Where really are the risks? And if these segments do create risks or at least appear to rise higher in the risk scale, then we need to be prepared to address that.


The third gap, E3, is the one dealing with feed defense. You know, I think at some point down the road this will all be integrated completely and you won’t even be talking about separately, but at this point they are separate. There is a food safety work and then there is food defense work. It is not only within FDA, but it is that way with USDA and it is -- and of course Homeland Security, that is really their main bailiwick, is deliberate contamination.

Anyhow, the CVM has a counter-terrorism coordinator that works closely with these particularly organizations and with industry establishing, you know, establishing lines of communication with them.

We have also been participating in vulnerability assessments that have been using the CARVER-plus-shock tool. The link for that tool is on Page 10 of the Framework Document if you are interested in taking a look at it.

Unfortunately, the findings for these vulnerability assessments are sort of confidential, so only the firms that were involved in these particular assessments -- and there has been one of a feed mill, there has been one of a feed yard, and there has been one of a grain elevator -- at some point in time we think that information should become more commonly known so people can get a feel for where are the issues that might -- you know, that might be open for contamination, deliberate contamination.

We have also been busy trying to help FDA’s Prior Notice Center, which is handling both food and feed and drugs and medical devices, et cetera, in terms of importing, trying to identify those feeds that potentially have the greatest potential for being deliberately contaminated and therefore reviewed before they enter the U.S. So we worked on criteria for that and they are utilizing -- the Prior Notice Center is now utilizing those criteria.


Okay, the Component F, the last component, is on Pages 10, 11 and 12 of the Framework Document. At one point we -- you know, actually we vacillated back and forth as to whether to take education and outreach and put it into each component because it is -- almost every component has some aspect of it that warrants education and outreach activities, but in the long run we decided that it was important enough to keep it separate and so we have a -- the last component being education and outreach, education training -- whatever word you want to use.

The idea is to insure that whenever modifications exist to the program that FDA and state personnel, regulatory staff, understand what the changes are and that the impacted parties understand what the changes are as well and that whatever implementation goes -- occurs that it is done in a timely and efficient manner.


So there are four gaps in here.


Component F, Gap 2, as they say here, it is probably something that is a constant, may not really be a true gap per se because you are always going to be confronted with the need to provide education and outreach just about on everything that we -- you know, that as a regulatory agency we develop.

So one thing we are trying to do is develop a plan. The plan right at this point in time is basically just a spreadsheet that lists all the components and then identifies all the various activities that fall -- that an agency such as FDA has done, might do, to insure that each of the components -- each of the fixes, each of the gaps, for example -- are understood by FDA and state personnel as well as the industry.

So we are still working on this. It is sort of -- progress is slow in this area because we are trying to spend most of our time trying to get the other issues completed because there is no reason for outreach and training until we get some of these other fixes completed.


Component F, Gap F2, is firms that submit a license for medicated feed mills need to have -- they are required by regulation to have a copy of the -- what we call the “generic label” for the feed that they are making, the B and C feeds. We call it a “Blue Bird” label. It is a term of our -- a term that has been around for as long as I have been with the Agency.

But these firms by regulation are required to have these B and C labels in their possession, and what we have defined in their possession to mean not only physically having it at the site but also being -- having access to it via the Internet.

So we are in the process -- the fix here is we are in the process of developing a Web-based system that would have the recently approved Blue Bird labels for each of the drugs, for each of the animal drugs, for both B and C feeds. We are getting support from the animal drug sponsors.

It has been a slow process. We hope to have a test model of this, or test of this, up by the end of June for people to take a look at and we will hopefully get some feedback on that.


The third gap is -- deals with activities on the farm for feeding -- for animal feeders. As I indicated prior, the process control regulations that were developed will only apply to those feeding operations where only the mixing -- or those feeding operations where they mix feed. So -- but we think that there is need for assessing and controlling feed hazards on those operations where the feeding part of the operation, whether it is a mixer feeder or without, you know, where they just buy their feed.

So we are in the process of developing some guidance in this area. We are pretty far along on this particular document. And so the idea here is to develop guidance to insure that maintaining, storing and feeding that occurs on the farm will not somehow result in adulteration either of the feed or the meat, milk or eggs.


The last gap is really one that deals with providing more useful information on pet food labels, more meaningful information. The -- you know, this is really mandated to a large extent by the FDAA.

We are requiring a regulation, again by September of 2009, and so that is work in progress, and hopefully the docket for this particular -- and the others as well will provide some useful information and assistance as we work through this -- through these FDAA regulations.


One thing I should mention. Somebody came up to me at the break -- we were chatting about FDAA. You know, FDAA gave us additional requirements to do, you know, like to write these regulations and to develop some program -- do some enhanced program work. But FDAA didn’t give us any additional authority, so the authority that the Agency is using for, for example, writing process control regulations, is the same authority that was utilized for writing HACCP regulations or anything dealing with -- on the food side.

So don’t think that we have got any additional authorities. There is no -- there was some changes in the prohibited act section but that dealt with -- Kim Young talked about it yesterday, but by and large you really don’t have any additional authority.


Okay, in conclusion, the Animal Feed Safety System project is an important component of the Agency Food Protection Plan. It really is the work dealing with feed that comes under this plan. It is also part of the import strategy plan, and, as I mentioned, also part of the MOA that exists with -- between China and the U.S.

This 3rd Edition, you have a copy of it. It is posted on our website. We have got a lot of work to do, as you heard today. We in reality have finished just a couple of items. We have still got a lot more work to do. Hopefully, things are -- the ball is starting to -- instead of going uphill, we are starting to roll downhill.

The docket is open. It is -- if you looked at the Federal Register Notice for the Animal -- for this meeting, there is a docket number for sending comments.

We are in the process -- the Agency is in the process of converting to a government-wide docket, and it is -- I think people have been running into difficulty submitting comments to the docket -- to the -- it is called http://www.regulations.gov/. And so if you do have comments and you are going to submit them that way, go ahead and do it, but I would recommend that you send a copy of your comments to Zoe Gill at fda.hhs.gov and she will insure that they get into the docket.

Okay, thank you, and I think we are going to move to the comment period, and Paul will take all the questions.


DR. GRABER: Provide all the answers.