DEPARTMENT OF HEALTH AND HUMAN SERVICES

> FOOD AND DRUG ADMINISTRATION
>
> CENTER FOR VETERINARY MEDICINE
>
> ANIMAL FEED SAFETY SYSTEM
>
> PUBLIC MEETING
>
> Tuesday, September 23, 2003
>
> 1:00 p.m.
>
> Hyatt Dulles International Airport
>
> Herndon, Virginia
>
> [C O N T E N T S]{.underline}
>
> [PAGE]{.underline}
>
> Dr. George Graber, CVM, Moderator 3
>
> Dr. Clifford Johnson, CVM, Comments 5
>
> Dr. Stephen Sundlof, CVM, Opening Remarks 8
>
> Tim Costigan, Prince Agri Products, 19
>
> Ingredient Manufacturer, Minerals
>
> Dave Harlan, Excel, Ingredient Manufacturer, 49
>
> rendering Company
>
> Joe Garber, Wenger Feeds, Feed Manufacturer 65
>
> Mike Merkel, Doane Pet Care, Pet Food 85
>
> Company
>
> Mike Davidson, California Department of 104
>
> Food and Agriculture - State Feed Safety
>
> Regulatory Program
>
> Dr. Richard Wood, Food Animal Concerns 153
>
> Trust, Consumer Perspective
>
> [P]{.underline} [R]{.underline} [O]{.underline} [C]{.underline}
> [E]{.underline} [E]{.underline} [D]{.underline} [I]{.underline}
> [N]{.underline} [G]{.underline} [S]{.underline}
>
> DR. GRABER: I think we\'re going to get started. My name is George
> Graber. I\'m with the Center for Veterinary Medicine. We\'ve got a
> full schedule today so we need to try to keep on time. I\'ve got the
> first five minutes so off we go.
>
> If you open up your packet to the agenda, I just want to go over a
> couple of quick items on here. The reception tonight is going to be
> out here near the bar from 6 to 8 p.m. instead of 6 to 7. Then
> tomorrow morning from 7 to 8 a.m. there will be a continental
> breakfast available outside the meeting rooms here and that\'s not
> written down on the agenda.
>
> In your packet there are some bios for the speakers. We will not be
> going through any formal introduction of speakers so if you need to
> find out something about them just read the article from the podium.
> We also have a CVM Update, the Federal Register notice that announced
> the meeting, as well as a list of all the registrants as of probably
> 6:00 last night, so that\'s on the right-hand side of your packet.
>
> On the left-hand side is some information about the break-out sessions
> that Gloria Dunnavan is going to talk about later this afternoon but
> each of you are assigned to a break-out session and that particular
> break-out session, you should have a list of the people who have been
> randomly selected to be in that group.
>
> A couple of other items. There is a transcriber here. This is a
> government public meeting. We will be taking down what\'s said from
> the podium through today. Tomorrow, the break-out sessions, the
> transcriber will not be taking down those comments, but then tomorrow
> when we come back at 11:00 for reports of the break-out sessions the
> transcriber will be here.
>
> If anyone has a wireless apparatus please put it on remote. Otherwise
> that little person\--you know you go to those movies and you see that
> person being jack-knifed out of their seat? We\'ve got somebody who\'s
> going to fill those shoes.
>
> One other thing. Sometime today there will be an announcement that\'s
> going to be put up on the back of the room at the table to my left in
> the back here. It\'s an announcement of a one-day meeting being
> sponsored by the CDC, Centers for Disease Control and Prevention, to
> be held sometime in January in Atlanta and it\'s going to be on
> bacterial contamination of animal feed and food-borne illness, so
> there will be some brochures on that today.
>
> Okay, the first speaker coming up here for the next five minutes will
> be Clifford Johnson. Dr. Johnson is my boss. He\'s the director of the
> center, director of the Office of Surveillance and Compliance.
>
> DR. JOHNSON: Thanks, George. George has given me five minutes but
> he\'s told me what to say, also.
>
> It\'s certainly a pleasure to be here. We\'ve been looking forward to
> this day, the team that originally worked this issue as it formed as a
> concept within CVM, and we decided to explore this opportunity in
> light of food security and some of the other things that are occurring
> today. So this concept was explored by a wonderful team of people that
> we have within CVM and I\'ll give you their names in a few seconds. So
> here we are today now to get comments on the concept as we envision
> it.
>
> I guess the participants are up there and you see we have a
> cross-section of industry here, people from various walks of life
> within the industry. We have participants from the federal government,
> states, academia, foreign governments, consumers and press, so we\'ve
> got a really great group of people here today and some good speakers
> to give the kind of information that we\'re seeking.
>
> The animal feed safety team was composed of a number of people, some
> from CVM, some from the Office of Regulatory Affairs, some from the
> Office of Counsel, so we\'ve had a lot of people that have come
> together and all the people that are on this team or that gave input
> to this team are necessarily listed here because our team members, in
> turn, talked to people on the phone, by letter, and so forth, so there
> are many, many others who have contributed to this concept that
> they\'ve put together for the animal feed safety team. We thought we
> would just list the primary members that met on a regular basis. I met
> with them from time to time and I was just amazed by the enthusiasm
> that they brought to this team and how sincere they were about this
> whole thing. So it really turned out to be a great effort and we hope
> that what we learn here today will contribute to making that even
> better.
>
> Let me just mention something about our speakers today since George
> has said we\'re not going to necessarily formally introduce them all.
> Our speakers are Dennis Byrne from the Herr Angus Farm, who will cover
> quality control procedures used on the farm; Tim Costigan, Prince Agri
> Products, who will describe the steps used by his firm to ensure safe
> mineral products. Mike Davidson, a feed control official with the
> California Department of Food and Agriculture, will describe what his
> state is doing with their feed safety program. Joe Garber, no
> relationship to George, I\'m told, Wenger Feed, will describe the
> quality assurance program at his feedmill. Dave Harlan of Excel, who
> represents a rendering company and has started a HACCP program. Mike
> Merkel, Doane Pet Care, who will give us insight about the procedures
> used by his company, and also Dr. Richard Wood of the Food Animal
> Concerns Trust to present a consumer perspective. So we\'ve got a good
> group of speakers here and I look forward, as I\'m sure many of you
> do, to hearing what they all have to say.
>
> First we have to listen to my boss that I\'m proud to introduce, the
> director of the Center for Veterinary Medicine, Dr. Stephen Sundlof.
>
> DR. SUNDLOF: Thank you, Cliff. I want to welcome everybody. It\'s
> great to see the room is absolutely filled, standing room only.
> That\'s great. It just shows what an important issue this is and how
> wide an impact it has on this community.
>
> First of all, let me just say that I have enjoyed thoroughly working
> with this industry, with the feeds industry, and that includes the
> renderers and the mineral supplements and everybody else. It\'s just
> been a real pleasure for me over the years that I\'ve been in this
> position and that\'s why I look forward to seeing everybody here
> today. We really want to bring everyone in at the very beginning to
> capture all the good ideas that are out there and make sure that we
> hear all of the issues that people have.
>
> So today we\'re going to be talking about the Animal Feed Safety
> System and I don\'t know how to pronounce the acronym so I\'ll
> pronounce it some way and you can change it later. But the whole
> purpose of this is to develop a more comprehensive system for the
> whole feed cycle from\--actually, not on the farm but from the time it
> becomes a component of feed all the way up to the point where it\'s
> fed and to have a system in place that will be a preventive system in
> nature, that will be risk-based, and that will be flexible enough such
> that there\'s a lot of room for\--as long as we try and achieve the
> same goal, how we get to that goal can be very flexible.
>
> We certainly at CVM appreciate the time that people have taken to come
> here. It is a busy time of the year now that we\'re into the fall
> again and again we do welcome that. We want to welcome all of the
> comments and we have some break-out sessions later this afternoon and
> tomorrow that we really want to get people\'s input, so I want to
> personally encourage you to provide as much input to us as possible.
> It won\'t stop with this meeting. There will be many other
> opportunities to provide additional input on this endeavor but we do
> want to begin collecting some of the ideas about what this Animal Feed
> Safety System should look like.
>
> Well, how did we get started on this initiative? I\'ve been in this
> job now nearly 10 years and when I came into it I had no idea of all
> the various issues surrounding animal feeds and it\'s really been
> fascinating for me just to be here at this time when all these
> different issues are presented. And I want to say that the U.S. feed
> system has really been remarkable when you compare it to some of the
> other countries\' feed systems and the problem that they have as a
> result of that.
>
> Well, feed safety is important to all of us in this room. We\'ve all
> heard about a lot of the issues, BSE being obviously the most
> prominent in recent times, but other things such as PCBs and dioxin
> continue to come up now and then and dioxin is currently a hot topic.
> Salmonella issues that we\'ve been dealing with for many years.
> Micotoxins, which have also been with us for a long period of time,
> but there\'s always new issues that are coming up, as we found out
> last year in Europe when they found hormones that came from a
> pharmaceutical firm in animal feeds. It was unintentionally introduced
> into animal feeds.
>
> So there\'s always going to be different issues that will come up and
> we\'ll have to deal with those as the regulators of feed safety.
> Currently we\'ve tended to deal with these issues one issue at a time,
> so we deal with the dioxin issue or we deal with the BSE issue or we
> deal with the Salmonella issue without really taking the broader look
> at do we have a good overall system in place that is not as sensitive
> to the individual problems but would have more preventive effect on
> any problems, either anticipated or unanticipated, in animal feed that
> might come up.
>
> Our current system tends to focus on end product sampling rather than
> putting in place a preventive program, so we want to talk about how a
> preventive program might look. And we\'re very encouraged by a lot of
> the efforts that have already taken place within the various
> industries. You know, the feed manufacturers are putting in place
> various feed safety programs that are on a voluntary basis right now
> and again we want to take the best parts of those efforts and try and
> combine those into our final Animal Feed Safety System.
>
> This program that we\'re going to be talking about in the next couple
> of days also fits in very well with the Commissioner of the FDA\'s
> strategic plan, which he announced on August 20. One of Dr.
> McClellan\'s highest priorities, one of the five goal areas under the
> strategic plan, calls for FDA to provide high-quality, cost-effective
> oversight of industry manufacturing processing and distribution in
> order to reduce risk and that pretty much captures the intent of
> having a comprehensive Animal Feed Safety System.
>
> Another goal within the strategic plan is to assure the safety of the
> U.S. Food and cosmetic supply to protect consumers at the least cost
> for the public. So again the food safety mission of the FDA certainly
> comes through with our feed safety initiative.
>
> Again I\'m very proud to be part of a system that has had such a
> historically good record of safety. We\'ve had little problems that
> come up here and there over the years, some anticipated, some
> unanticipated, most of them unanticipated, but clearly when you look
> at other countries and especially when you look at Europe and the
> problems that they\'ve encountered as the direct result of their feed
> safety systems, it gives me a great sense of pride again to be part of
> the U.S. system and that\'s due almost entirely to everybody in this
> room.
>
> But now we have a new threat and the new threat is bioterrorism and
> our efforts to mount a counterterrorism effort as it applies to animal
> feeds and I think this is going to be an area that is going to receive
> a lot more attention in the future. That is actually looking at
> agricultural bioterrorism on a national basis, getting the agencies
> who are responsible for food safety and animal safety together with
> Homeland Security to develop a comprehensive system to mitigate
> against agricultural terrorism and feed safety is going to have to be
> an integral part of that, so this is the right time to be having these
> conversations.
>
> And because the U.S. must maintain its world leadership in feed safety
> because the food markets are international now, we also have to look
> across the borders to our trading partners and because we are a net
> exporter of feed components, make sure that our system will be
> sufficiently robust to satisfy the needs of our trading partners.
> We\'d like to see the U.S. continue to be the world leader in feed
> safety.
>
> So the Animal Feed Safety System could be considered as a logical and
> appropriate mechanism for all of these goals that I\'ve just talked
> about but what about the time lines? We\'ve decided that we want to
> make sure that there\'s sufficient time to put in place the best
> system that we can. On the other hand, we don\'t want to sit around
> waiting and we want to make sure that this initiative has a lot of
> emphasis behind it. So we\'ve projected that we want to be completed
> with this task by 2006. That may seem like a long time but with a
> system as complicated as the animal feed system, there are going to be
> lots of issues that we\'re going to need to study and have in place
> and make sure that we get a lot of input from a lot of different
> people in order to make it the best program it can possibly be.
>
> We\'ll need to keep a steady pace. In about three years, which would
> be 2006, we will have to complete a significant amount of work,
> including developing the whole concept of the Animal Feed Safety
> System, developing our regulatory approach, and if needed, proposing
> regulations. Hopefully we won\'t have to propose any new regulations
> but if there are certain areas that we just don\'t have the authority
> to regulate now and we think as a group that this is important, then
> regulations may be necessary and we would try and have those out for
> comment by 2007.
>
> We want our Animal Feed Safety System to be a risk-based system. I
> think everybody agrees with that. Any plan that FDA endorses will
> certainly have to be risk-based. Our regulatory attention must focus
> on areas that offer the most significant animal health and public
> health impact and are of the greatest risk. The plan will also be
> designed to deal with the risks we know and again the risks that we
> don\'t know. And it needs to be comprehensive. That means it needs to
> not only include feed mills but everybody in the chain. So the
> suppliers and manufacturers of supplements for animal feeds, the
> transportation that hauls feeds, everybody in that chain needs to be
> under the plan.
>
> It must minimize the risk to animals themselves from physical,
> chemical and biological hazards and it also must minimize the risk to
> humans from the same types of hazards.
>
> The components of the plan will be, like other plans that we have, it
> will obviously involve some form of recordkeeping and it will involve
> some development of standard operating procedures but, at the same
> time, we want the system to be very flexible. We want to have
> established goals but a lot of flexibility in achieving those goals.
>
> The feed industry has developed already, as I mentioned earlier, a
> number of innovative programs and as these programs have shown to be
> effective and in line with the goals of the Animal Feed Safety System,
> we\'ll consider making them part of the AFSS plan. AFCO we know,
> because we\'re participating with AFCO, we will also consider AFCO\'s
> process control program for the feed industry. Whatever system we
> develop will rely heavily on our state counterparts to make this
> program work, so we\'re very happy and enjoy working with the states
> and with AFCO and we\'ll consider their process control program in
> developing the Animal Feed Safety System.
>
> Again I want to thank the speakers and I don\'t need to introduce them
> now because Cliff Johnson just did, so you know who everybody is here.
> After the speakers this afternoon\--so the speakers will all present
> and then we\'ll ask for comment and we\'ll be dividing up into
> break-up groups, break-out groups, to answer some questions, specific
> questions that have been developed by CVM\'s AFSS team. The questions
> are designed to help provide us with information and advice about what
> an Animal Feed Safety System should look like. And Glo Dunnavan will
> give you more information about that later on today.
>
> Keep in mind that the feedback that you provide is absolutely critical
> to making this system work. We will probably have numerous other
> opportunities to meet but even in the absence of meetings, your
> comments are always welcome. We want to hear from you. We\'ll try and
> keep everybody up to date and present on our website, so I encourage
> all folks to check in on occasion with our website.
>
> And with that, I wish you a very productive meeting and thank you all
> very much again.
>
> \[Applause.\]
>
> DR. GRABER: Right on time. Very good.
>
> Next on the program is Tim Costigan. He\'s the manager of quality and
> analytical services for Prince Agri. Tim?
>
> MR. COSTIGAN: I think the easy part is probably giving a presentation
> this afternoon. The hard part is probably going to take place in the
> break-out sessions. One of the difficulties that all the speakers are
> going to be presented with today is taking something that they could
> probably talk about for about two weeks and condensing that to 20
> minutes. So if we go a little bit fast, kind of bear with us.
>
> One of the things we were asked to do is explain a little bit about
> our companies. Prince Agri Products, along with a number of other
> manufacturers, produce trace mineral premixes for the animal feed
> industry and they also supply straight ingredients. So our company
> takes various mineral products and sells those as straights, like
> copper sulphate calcium carbonate, calcium phosphate, those types of
> minerals. Also specialty products\--some of the flavoring or the
> palletants, as they\'re called, a number of other products that go
> into the animal feed industry. They then take those products, blend
> those together, and make trace mineral premixes.
>
> Now at Prince we maintain over 3,000 different trace mineral premix
> formulations, which are all custom designed by our customers. The way
> we put those together is really indicated by the slide. What we have
> is ingredients that we bring in in bulk. We\'ll bring in full
> truckloads of those products, put those in bulk tanks, and then those
> are metered onto a load cell.
>
> Secondly, we may add those from minibins. We\'ll bring in super-sacks
> of product, put those into these smaller bins, minor quantities of
> those may be added. We have bag break. In some cases you\'re adding
> 150 pounds, 175 pounds. You actually take that from bagged product,
> 50-pound bags of product. Then down right over the mixer is what we
> call a hand delivery system where we\'re taking the micro
> ingredients\--these are the ingredients that are added as less than 50
> pounds\--and those are put directly into the mixer in order to make
> sure that those do, in fact, get into that mix, that they\'re not lost
> in transition.
>
> The load cells are hooked to a computer system. The computer system
> then controls the addition of each of those ingredients and records
> that. Along with that, we also do\--and I\'ll get into that in a
> little more detail\--we also do some checking of those numbers as they
> go through and process a batch. That material is then blended in a
> mixing system and then transported up to a packing tank. From the
> packing tank it can be put into bulk truck again, into super-sacks or
> into 50-pound bags. So that\'s kind of an overview of the premix
> system.
>
> Some of the other things that we\'re somewhat concerned about is
> controlled formulations. When a customer sends a formulation to our
> headquarters we then put that into our systems. What we send down to
> the plants are the actual working copies of that and the mix regards
> are controlled documents so that we know that those are up to date,
> they\'re current, and when any changes are made those are replaced.
>
> The computer-controlled ingredient addition helps us in ensuring that
> we do get the proper quantity in there but there is a secondary check
> of each of those numbers as they go through and they do mark the mix
> record manually to ensure that the read-out on the scale does come to
> the desired quantity.
>
> Then there are electronic scale records that help us trace back to
> each batch. So there\'s really a three-check system. One of the things
> that we try to incorporate into our systems is that each important
> aspect is checked at least three times, three independent checks or
> three ways of checking the same thing. That redundancy gives you a lot
> better assurance that the product is going to be as desired.
>
> One of the main ingredients, and I think you\'ll see this through any
> of the risk assessment programs, is that you have to take the risk on
> early in the process. You can\'t inspect the quality into the product
> at the end of that. So one of the main problems that we have and one
> of the main issues that we have to address is our in-coming raw
> materials. Same with the feedmill, same with the companies who are
> delivering that feed to their animals.
>
> So in our case the raw materials and the specifications are based upon
> a number of things. Number one is the process. We buy products from
> mining processes, we buy them from chemical processes, et cetera. We
> have to understand the process in order to know the weak points in
> that process. When you understand the weak points in the process you
> know what to check on an on-going basis to assure that the material is
> up to quality, is up to snuff.
>
> The second thing you have to really look at is the end use. Our
> company provides minerals to the animal feed industry. Our sister
> company provides them to a lot of other industries. So in looking at
> the final use of the product, you decide what\'s the most important to
> be checked upon, what\'s important to the customer, what affects this
> product? The specification has to be related to both of those things.
> You have to write a specification that ensures that your supplier
> hasn\'t changed something or something has moved in his process. You
> also have to be sure that it\'s proper for your customer\'s use and
> knowing the hazards for your customer becomes key.
>
> Inbound ingredients are sampled and retained in our plants for one
> year, so if there is an issue that comes up we can go back and pull
> actual samples from each shipment that\'s brought in. We have
> scheduled chemical and physical analysis. You don\'t need to do the
> same analytical work on every product that\'s brought into the plant.
> A load of calcium carbonate that\'s used as a diluent certainly has
> less effect upon the quality of that finished product and the use than
> a load of zinc oxide, which may contain heavy metals or other things
> of that nature.
>
> So sampling is done on inbound materials again based on experience but
> by lot, by shipment, and by month, as well, so that testing is done,
> that data is reviewed from a QC function, and then the product
> released or in some cases actually used prior to release there.
>
> Complete analysis is done annually. That\'s one of the things that we
> try to do. You try to address all the known issues. You try to learn
> about issues that you weren\'t previously aware of. So a complete
> analysis for us gets quite lengthy and I\'ll explain that in a little
> bit. Actually, the next slide will go into some of that.
>
> To give you an example, one of the products that we purchase is zinc
> oxide. Now in order to understand exactly how to approach that zinc
> oxide that we produce, it\'s primarily made by the Wales kiln process.
> In the Wales kiln process you take a zinc-bearing ore, you heat that
> up to a fairly high temperature. You actually cook off the zinc.
> You\'re volatilizing the zinc to a zinc fume. That zinc fume is then
> captured, oxidized, and you create zinc oxide. Unfortunately, there\'s
> some byproduct to that. There\'s also some lead and some arsenic that
> come over with that zinc. Now the lead and the arsenic is certainly
> detrimental to animal feed so you want to make sure that that\'s
> removed.
>
> The second part of that process is to heat that product up again to a
> lower temperature where only the zinc is volatilized, so one of the
> checks that we have in place on inbound product is to make sure that
> the zinc concentration is correct because that\'s what our customer
> formulates to. That\'s what he\'s after. We want to make sure that he
> gets what he\'s after.
>
> But secondly, you have to take a look at the process and the known
> hazards and in this case lead, cadmium and arsenic are three elements
> that we analyze on the inbound product and monitor on a close basis
> because we know that a failure in his process could result in product
> that\'s detrimental.
>
> In the case of annual reviews, we talk about known hazards. You also
> have to look for things you don\'t know to be present. One of the
> things we do is the analysis of the ones listed above, of course, but
> annually we\'ll pull a sample, have that tested for dioxin. That\'s
> one of the more recent known hazards.
>
> We also do a scan for 70 trace elements. Now a scan for 70 trace
> elements, it\'s a semi-quantitative scan and it gives you numbers that
> you then can compare to the previous year\'s results just to make sure
> that the process isn\'t drifting, some new or introduced or some other
> contaminant present that you hadn\'t expected.
>
> Going back to the production process, it\'s kind of difficult when
> you\'re producing trace mineral premixes, especially custom trace
> mineral premixes, when you produce three tons of this one, five tons
> of that one, seven tons of that one, and then it takes three to five
> days in some cases to get all the analytical work back. So we have to
> put in real-time QC checks. Part of that real-time QC check is to pull
> a sample of the product you\'re producing, every fifth back through
> there, and you lay that on a piece of paper and then compare that to
> the actual what we call a standard from a previous run. What you\'re
> looking at is not just the color. You\'re looking for the various
> ingredients that are present. You can easily pick out magnesium oxide,
> copper sulphate, ferrous sulphate. A lot of the ingredients of various
> oxides you can see in that batch.
>
> So an appearance check is something that the operator can look at as
> he\'s bagging the product to assure that there\'s consistency within a
> batch and then from batch to batch.
>
> We look at batch yields. If you formulate to 2,000 pounds, you expect
> to get 2,000 pounds. It seems pretty common sense. But if there\'s a
> problem with a contamination or flush left within the system, that\'s
> where you\'re going to catch it.
>
> The next thing that we look at is periodic analysis. For periodic
> analysis we have various reasons to analyze samples. I\'ll go through
> those a little bit later but we are analyzing batches periodically, we
> do use that data to evaluate both the process, the raw materials, and
> to report data to customers, as required by them.
>
> The magnet inspection. If we look at other concerns that we have
> within our system, magnet inspection is one of those. One of the
> foreign materials that we\'re worried about is scrap metal coming in
> or if we have a break in a piece of production equipment, some of that
> metal getting through the system. So a magnet inspection just to
> remove the contaminants is one thing but we also document that so we
> can understand what contamination is taking place and if there\'s more
> today than there was previously and if we need to go back and look at
> some of the raw materials.
>
> The inventory reconciliation is used if we come up with a problem
> putting a batch together, we have a yield that\'s not expected, and we
> need to try and investigate what happened there. We can go back and
> check our raw material inventories to see if those are all in line, as
> well as doing the analytical work on that.
>
> One of the things that you\'re asked to do is keep a lot of records.
> If you\'re going to go back and investigate a situation you need good
> records in order to complete that investigation. It\'s one thing to
> have an incident within a plant; it\'s another thing to take
> corrective and preventative action to make sure that those things
> don\'t continue to occur.
>
> So some of the records that we put in place, we have custom
> formulations. As I said, there\'s over 3,000 of those. The tags and
> the preprinted bags are controlled by our formulations department.
> Only the current copy is issued to the actual plants producing the
> products. Any historical copies are kept in the office and away from
> the production facilities so that we know that only the current
> documentation or the current packaging is being used.
>
> We have mix records on every batch that we put together. The mix
> record tells the plant what to put into each batch and then they use
> that to confirm that those additions were made. Scale records,
> electronic scale records are attached to those mix records to verify
> the weights and to give us a way to trace back to exactly what was
> ordered, what was added to the mixer, and in what sequence.
>
> The receiving records, when we talk about shipping and receiving, the
> receiving records, any product coming in is sampled, records are
> filled out as to what lot numbers are received, et cetera. Same with
> shipping records. We have records of material going out and the load
> sheets reflect lot numbers and then the weights of each of those
> products that are shipped. So when you\'re talking about traceability,
> we try to help our customers by recording lot numbers that we ship to
> them. If there is a recall, at least we have some way to help them
> trace that back.
>
> Sales records are present there if we want to go back and look at when
> a product was shipped, what carrier moved that material, et cetera.
> All that information is available.
>
> Analytical records are available for any of the products that we
> analyze and within our laboratory we\'re running over probably 50,000
> mineral assays a year. All that information is available and can be
> traced, again back by item number and lot number.
>
> Then audit records. We do audits out in the plant. We do QC audits in
> the plant. There\'s a whole list of audits that I\'ll go through but
> those records are maintained and used for reference.
>
> If we look at traceability, it\'s one of the issues that especially
> for feed safety becomes a concern. When you run into a hazard, number
> one, you can inform your customers. If you discover that hazard and
> that product has been used, you have to have a way to know who to
> contact and who\'s been involved in that. Secondly, if the problem is
> discovered downstream, you need a way to trace that back through your
> system. So traceability becomes fairly important.
>
> On ingredients, resale ingredients\--we\'ll break those down a little
> bit. On resale ingredients, we actually track by the supplier\'s lot
> number. So if we bring a product in, a pallet of 50-pound bags, and we
> ship that out, we record that supplier lot number.
>
> On consumed macro and trace ingredients, we actually track those by
> shipment. When a shipment comes in we don\'t record every single lot
> number within that shipment. We do, however, sample across that group
> and apply our own lot number to that material.
>
> For consumed microingredients, we\'re actually tracking that by the
> supplier\'s lot number. So I talked about the ones that we dump
> directly in the mixer\--those are used less than 50 pounds at a
> time\--we have the lot number of each one of those and the reason is
> that one lot number of that may be used over several days of
> production or several weeks of production. So the volume involved in a
> recall would be quite large, so we do specify the lot number on each
> of those.
>
> On that last point, the final product on our finished product, we do
> apply lot numbers to all of those. The lot numbers tell us what plant
> or location manufactured that, the actual day of the year, the year,
> and then the batch or the ton produced that day.
>
> On traceability, on biosecurity, number of steps that we put in place.
> This has been since the 9/11 incident that we felt were helpful in
> containing some of the biosecurity issues. One is that visitors that
> are on premises must sign in and sign out and a visitor tag is issued.
> It\'s a way for us to more easily identify the visitors in the plants.
> Most of our plants are fairly small, everyone knows all the other
> employees, so when they see someone that doesn\'t belong, it certainly
> gives them an idea of how to react or what to do.
>
> The second thing is that any visitors that are on the premises must be
> accompanied by a Prince person so we\'re able to keep track of them,
> make sure what their activities are.
>
> Employees, we check background before hiring now. We do a little more
> thorough job of that. Also training of employees on procedures, which
> is key. It\'s nice to put procedures in place but when it comes to the
> biosecurity, unless they thoroughly understand what their position is,
> how they\'re supposed to act and what they\'re supposed to do when
> circumstances arise, it really does not help you very much.
>
> Materials. In order to control both inbound and outbound materials,
> we\'ve started sealing all of our loads so everything inbound and
> outbound has a seal on it. The customers know what the seal is.
> They\'re numbered by our paperwork that accompanies it and the only
> thing that\'s left really not covered in that situation are LTL
> shipments, less than truckload shipments. In that case the truck is
> opened and accessed a number of times en route.
>
> Inspection of trailers and then review of paperwork becomes a little
> bit of a necessity there. A lot of the companies that we deal with
> we\'re buying product on pretty much a continuous basis. There\'s
> trucks that are scheduled in and we have agreements with the truckers
> on what products they should or should not be transferring in that
> equipment.
>
> Contamination concerns for us really encompass the three levels, which
> most of you will\--chemical, microbial and biological and physical.
> For us, the chemical is the big one. Toxic elements, such as lead
> cadmium, arsenic, mercury, can be present in some of these
> ingredients. By understanding how your suppliers produce the product
> and what the liability is there, you can certainly keep a handle on
> that.
>
> Cross-contamination or incomplete blending become an issue. Some of
> the elements that we add to a trace mineral premix, for instance, the
> selenium is very toxic. It\'s needed in very small amounts but you can
> put a thimbleful into a premix and that\'s all you\'re adding. So by
> keeping track of those and keeping track of any issues related to
> cross-contamination or incomplete mixing become another concern of
> ours.
>
> There are a few concerns with organic materials. In this case
> pesticides and lubricants can be of concern and those are really the
> only things coming into our system of a biological nature. The nice
> thing about handling most of the minerals is that the microbial and
> aflatoxin, that type of stuff, are not a concern. Those kinds of
> things do not grow very well in most of the products that we handle.
>
> Physical contaminants can be primarily explained or primarily
> represented by metal and glass. In the case of metal we actually have
> magnets through the production system to pull any of that material
> out. In the case of glass, we limit the exposure of glass in the
> facilities by covering any light fixtures, et cetera. We also do not
> allow people to take glass containers out into the plant. So we\'re
> minimizing the risk of contamination by keeping that material
> separated from the production areas.
>
> So far as controlled documents, one of the other things that you have
> to do is if you\'re going to perform consistently day to day you have
> to have documentation that\'s out there, that\'s understood, and
> that\'s used. In our case part of our company is registered to the ISO
> standard. Prince Agri Products is not but they borrow a lot of things
> from that. I think one of the things you\'ll hear from a number of
> companies is that there\'s not one system that\'s complete, that has
> all of the aspects you need, but there are a lot of systems that have
> good pieces and we borrow from those.
>
> In the case of document control, a lot of our procedures are set up in
> an ISO format. We have document and data control, three procedures.
> Purchasing, we have five procedures. Product identification and
> traceability, two procedures. Process control, 18. Inspection and
> testing, 17. Control of inspections, measuring and test equipment,
> five. Inspection of test status, three. Control of nonconforming
> product, one. Corrective and preventative action, two. Handling,
> storage, packaging, preservation, delivery, three. Control of quality
> records, one, and training, one.
>
> What\'s important is that you take a look at the things that you
> expect people to do day to day, you document those and that they fully
> understand how to react to those.
>
> Looking at audits, one of the things that we found and I think most of
> you people will find when you look at your production systems, et
> cetera, is that the best way to make sure that the procedures are
> followed and that things are happening the way you expect is to have
> someone review them frequently. To go out and do a yearly or a
> quarterly QC audit does not have the effect of an every-day audit. The
> same with regulatory. To go out once a year and do a regulatory audit
> is a good thing to do but you don\'t know what they\'re doing in
> between that unless there are some records or some verification of
> that.
>
> What we do is monthly safety audits and that\'s a cross-functional
> group that does walk-throughs of the plant. They go out and they look
> for various hazards. They review some of the legislation that\'s
> coming up. They\'re more or less conscious of what the safety aspects
> are within the plant. We\'re speaking here more along the lines of the
> OSHA safety rules but also anything that would affect the safety with
> the manufacturing process and contamination there.
>
> Weekly sanitation audits to make sure that areas are kept clean, that
> clutter is kept to a minimum, that things are put away, that the
> process system is in order.
>
> Periodic procedural audits. We have a number of procedures listed
> there. You do need to go back and review those and make sure that
> those are being followed correctly and that there is supporting
> documentation and that there\'s independent evidence out within the
> facility that things are being done. In other words, to give you one
> example, sampling of inbound materials. How do you know that samples
> are done? You look for the samples in the sample retention area. Also
> go out into the warehouse, take a look at the packages. If you don\'t
> find packages that have been opened and sampled, then chances are this
> is not being done. So that objective evidence is a good part of that
> audit.
>
> The quality unit does a couple of areas that we really focus on. One
> of them is the annual comprehensive audit, and that encompasses all of
> the areas that we\'re interested in kind of reviewing. It takes a look
> at the sanitation within the plant. It takes a look at process
> systems. It takes a look at statistical studies that were done. We
> take a look at the performance and the recording documentation of
> procedures that are followed. We take a look at safety records. We
> take a look at management policies, et cetera. So that whole thing is
> reviewed once a year.
>
> The comparison of one year to the next, there is a point system
> associated with that, but it shows the plant which area they\'re
> strong in, which areas they\'re weak in.
>
> Now one of the things that\'s really been helpful for us is to share
> that across the number of production facilities. By doing that, you
> find one area that\'s maybe suffering on one facility; another
> facility is very strong in that. They\'re able to talk to them and
> then develop procedures and put those into place, which are much more
> effective or really address the products more efficiently.
>
> And the annual formulations audit. For us it\'s very key to be taking
> care of our customers\' needs and our customers\' needs are for custom
> formulations. Everybody has their formula put together so they get
> maximum performance out of their system. The formulations audit, we
> actually send the formulations team from our corporate headquarters to
> each of the locations. They go through every single file that\'s there
> to make sure that the revision they\'re using is the current revision
> and is up to date.
>
> Some of the statistical techniques that we have in place is we do a
> yearly mix plant error assessment. For us, these are key to
> improvement. The things that we\'re looking at is the amount of raw
> material variation in the product coming in the door. We take a look
> at the variation associated with the material introduction into the
> system. We take a look at mixing and segregation error and sampling an
> analytical error.
>
> So if we take our final product going out the door and you measure
> those things, those are all the major portions of the error that\'s
> associated with that finished product. In the case of doing these
> evaluations, you can then focus efforts and product improvement
> efforts upon those individually. In some cases the raw material
> variation may be the highest. In other cases you may have a production
> system that is not ideally suited to introduce zinc oxide, which may
> not flow quite as well as ferrous sulphate into a system. You can make
> improvements to that production system. You can make improvements to
> your raw material supply, et cetera, in order to limit that amount of
> variation.
>
> Mixing and segregation is important to monitor in our business. We\'re
> in the business of putting together homogeneous mixtures. Now if we
> analyze just samples out of the mixer, we\'re kind of taking a short
> picture of that. You really want to analyze the product in the
> finished package that the customer\'s receiving. So we\'re doing a
> mixing system evaluation. We sample that finished product, we measure
> that variation. That variation is due to all three of those
> things\--raw material variation, ingredient addition error, and then
> also mixing and segregation.
>
> And when you\'re taking a look at the whole system, analytical error
> does play a part. It\'s nice to know that you have excessive variation
> in one component or another but if you\'re going to truly address
> that, you need to know whether it\'s an analytical issue or not, so
> that certainly becomes a focus, as well as our error assessments.
>
> Semi-annual mixing studies are performed or whenever we make major
> changes to a mixing system, perhaps replacing paddles or if we have a
> new portion of the system put in place or maintenance done on that.
>
> And quarterly bag weight studies. One of the other aspects we\'ve
> identified is a lot of our customers take a 50-pound bag and dump that
> into a batch of feed, so they\'re relying on us to put 50 pounds into
> that bag and we do statistical studies to assure that our packaging
> equipment is working effectively and that they are within the range
> that\'s expected.
>
> Analytical work. We have a number of ingredients that we\'re bringing
> in. We really focus on those ingredients. We have scheduled sample
> submission at the plants based upon a number of things. One is
> supplier history and the amount of data. If you work closely with a
> supplier, a number of our suppliers we\'ve worked with for in excess
> of 30 years. When you work with a company that long, they understand
> your needs, you understand their needs. When you exchange data you
> become much more familiar with each other and you can relax some of
> those requirements.
>
> Ingredient variation and previous concerns. If you have problems with
> a particular source or a particular supplier or if there\'s been a new
> hazard that has been identified, then you need to address those and
> the way that you address those is you increase the testing on those
> particular products.
>
> Then the last thing is a complete yearly analysis, which we already
> spoke about.
>
> Premixes, we test on samples. Whether safety or quality concerns, we
> may be testing every single batch. Selenium premixes are one of those
> cases. In the case of selenium, it\'s a very toxic substance. We bring
> in a product that\'s 45,000 parts per million. We then blend that down
> to something in the 1,000 to 10,000 parts per million range. We then
> blend that down another time into the lower part per million ranges,
> which go out to the feed companies.
>
> So for us, to do that tiered blending is a very important QC effort in
> order to make sure that we do get good distribution and that there are
> no issues with toxicity. Any of those concentrated mixes are analyzed
> per batch, so we do have a very good idea of what\'s going on with
> those and keep track of those.
>
> Single batches are analyzed each day. One of the aspects that we have
> is if you know your raw materials are good, you\'re watching your raw
> materials, you know that your process is functioning correctly, the
> finished product should be good, so our efforts are then placed on
> monitoring that. Now if I do a mixer study once a year, I know that on
> that day it worked. Well, how do I know that it works every other day
> in between? So the idea of taking a single production batch and
> analyzing that, not only for tag guarantees but for all the other
> elements that are present.
>
> In our case we have 17 elements that we monitor. Those 17 elements
> incorporate all of the raw materials that we bring into our plants. So
> we may not notice that there was a little bit of di-cal contamination
> in a load of limestone through just the analysis on calcium. However,
> when you see a peak on phosphorus where it\'s not expected, then you
> know that perhaps something\'s going on and you need to go out and
> take a look. If it\'s a raw material addition, maybe it\'s a
> malfunction in the mixing system, those types of issues.
>
> The last thing I have is any type of production issues. When you do
> come up with a yield that\'s incorrect, then you do want to go back
> and investigate that and we do the analysis on those.
>
> The last thing I want to talk about is overall quality program. You
> want to apply the portions of existing programs that really fit your
> needs. In our case, biological is one of the lower level concerns
> because there\'s just not a lot of exposure. There\'s not a lot of
> things that can happen to the trace minerals. They\'re not friendly to
> the growth of microbials, et cetera.
>
> So in our case we borrow from a number of different areas; HACCP is
> one. The risk assessment with HACCP is very good. In ISO, the control
> of documented procedures and just the overall control of documentation
> and training become very good.
>
> With GMPs, hygiene, traceability, contaminations, those issues
> certainly need to be addressed and GMPs help you do that.
>
> The focus needs to be preventative measures. In our case ingredient
> quality is certainly kind of up-front on the list of issues. Process
> evaluations is very high on there. You need to make sure that things
> are performing correctly in the process.
>
> Then you want to do confirmatory testing. Confirmatory testing assures
> that the entire process is working correctly and that things haven\'t
> gone awry.
>
> That pretty much wraps it up. Thank you for your time.
>
> \[Applause.\]
>
> DR. GRABER: Thank you, Tim.
>
> Next on the program is Dave Harlan. He\'s the by-products manager,
> marketing manager for Taylor Beef, Cargill Meat Solutions.
>
> MR. HARLAN: Good afternoon, everyone. I\'m going to talk about more of
> the rendering role, where rendering fits into the bigger picture of
> food animal production. You can see rendered co-products used, raw
> materials from the meat processing industry and from on farms and
> produce animal feed ingredients that are used for the manufacture of
> animal feed that is fed on the farm and also in pet foods. So it plays
> a very critical role in this whole entire cycle.
>
> Typical fed cattle plant. These are the large plants that process
> young cattle, mostly out West. You see the red side is the processing
> of these animals into edible beef products. These facilities tend to
> have what\'s called an edible rendering process, which is the taking
> of fat and bones and producing edible tallow and bone for gelatin
> purposes.
>
> Off of the dressing floor there\'s a by-product called offal, which
> goes to inedible rendering for the production of beefmeal and beef
> tallow, and we also raw blood that is processed into bloodmeal.
>
> At Taylor Packing we don\'t have the edible rendering portion of it so
> our approach is a little bit different. Our dressing floor offal and
> fat, bone and fat, are transported over to our rendering facility, get
> mixed together and then ground in a raw state. They then enter a
> continuous cooking process at one end, move through that process where
> the moisture is evaporated and come out the other end and hit a screen
> that basically splits that slurry into a liquid and solid fraction.
> The solid fraction ends up becoming the beefmeal. This solid goes to
> pressers which squeeze any residual fat out. You can see the bottom
> line. That fat goes over to the liquid side. The beefmeal is then in
> our process cooled, ground and screened, put into storage, and then
> eventually goes to our load-out and protein blending plants.
>
> The liquids coming off the screen go over to a centrifuge, which takes
> some impurities out, some solid participate matter out of the tallow.
> That tallow then goes to a tank. In our process we filter it and any
> solids here go back to the right-hand side of the screen into the meat
> and bonemeal.
>
> In trying to develop a comprehensive animal feed program at Taylor
> Packing we want to use many tools. These are some of the tools in our
> toolbox. It starts out with philosophy and commitment of the owners
> and the workers. We look at the raw material source and the
> specifications on that raw material. We use HACCP, hazard analysis and
> critical control points, GMPs, employee training, transportation
> policies and third-party audits. I\'ll be going into each one of these
> in a little more detail.
>
> This is where it\'s going to get a little difficult. We\'re a little
> animated here.
>
> First of all, you have to have a preventive mindset. We\'re very
> proactive instead of reactive. We believe in continuous improvement.
> And you truly need commitment from the entire team, from the
> leadership on down through production employees.
>
> Our raw material specifications. We source 100 percent of our raw
> material from our own in-house beef packing plant. That\'s consisting
> predominantly of about 70 percent culled dairy cows and the rest fed
> cow. A hundred percent of this material is from animals that have
> passed veterinary inspection conducted by the USDA FSIS veterinarian.
>
> We also have programs in place where the packing plant employees are
> trained and are aware of potential risks that they could cause or
> introduce into the raw materials.
>
> And the last point is we actually have a process where in our
> specifications where CNS materials, namely brain and spinal cord, are
> removed at the packing plant and do not enter our system.
>
> If you could put all seven up, just a quick review of the HACCP seven
> principles. I\'ll be going into a little more detail on one example at
> Taylor Packing. But first, in HACCP you assess your hazard. You
> determine the points at which you can control, potentially control a
> hazard. You establish limits or critical control points. You then
> monitor those critical control points. You develop corrective action
> plans in case something goes astray or gets out of the tolerance that
> you\'ve set up. You have to keep records on this, obviously. Then you
> need a verification process where the point is you\'re verifying the
> effectiveness of the HACCP program.
>
> The potential hazards in HACCP could be split into three classes\--the
> biological, chemical and physical. When we analyzed our potential
> hazards, this is what we came up with at Taylor. We have
> microbiological hazards in a raw material. We have the potential to
> have insect infestation in the finished product. There\'s the TSEs,
> which are BSE. Chemical hazards such as pesticides, PBCs, dioxins. And
> then lubricants and oils from our packing plant, which could also
> inadvertently make it into the product stream. Then also the physical
> hazards, such as metal and plastic.
>
> This is an example of one of our HACCP programs specifically geared
> around microbiological controls and the pasteurization step that our
> cooking process affords. When we first assess the hazard we know that
> a raw material contains potential pathogens. We determined that our
> critical control points for these hazards would be the cooker
> discharge temperature, the raw material grind, the processing rate.
> And then we established critical limits for these CCPs, basically that
> for temperature it\'s a minimum of 270 degree Fahrenheit, for a grind
> it\'s a minimum of a 30-millimeter anvil gap on the prebreaker. This
> is the point at which we grind the raw material. The gap in that
> equipment cannot go over 30 millimeters. The CCP for rate is a maximum
> of 36,000 pounds per hour going through the cooker.
>
> The procedures we use to monitor these critical control points. For
> temperature, it\'s a continuous monitoring by using a certified
> thermocouple. The grinding, that actual equipment is inspected several
> times each shift and then weekly we actually go in and measure the
> anvil gaps to see how close we\'re getting to the 30 millimeters. The
> rate is also tracked by computer.
>
> Corrective action plans. This is if your critical control point
> control limit gets outside of the acceptable tolerance. For
> temperature, if we went under 270 degrees Fahrenheit an alarm would go
> off notifying the operator and what\'s great about our system is that
> we actually set it up so the computer would shut off the discharge
> from the cooker, so it\'s a corrective action plan that\'s built into
> the system.
>
> For grind, if we during visual inspection of that prebreaker see that
> something is broken, we have to shut down and repair it. Then also I
> mentioned weekly we are looking at the spacing of the anvil gaps. When
> it\'s approaching 30 millimeters we decide to rebuild that.
>
> Rate is simply if the rate starts going over 36,000 pounds an hour we
> take it back down.
>
> For recordkeeping, both the temperature and rate are tracked on the
> computer and if there\'s any alarms that go off, they\'re also tracked
> in a separate alarm log. For grind, this is documented by operations
> and maintenance logs.
>
> Then next, verification. As I mentioned, you\'re verifying that the
> process, that the HACCP program is effective. We use, for
> microbiological risk, clostridium perfingins as an indicator organism.
> What our approach is is we are getting a kill of clostridium
> perfingins, we are getting all the other pathogens that could be
> inherently in our raw material.
>
> We do this testing at 15-day intervals, the idea there being you start
> out on a Monday, it\'s two weeks and a day later, you\'re on Tuesday.
> We also rotate through each shift as we move through these samples and
> that way by the end of the year we\'ve had a sample come from every
> shift of every day, as a verification.
>
> The screen that she\'s pulling up is the actual real-time screen that
> the operators are looking at and you can see down at the bottom
> there\'s five different temperatures. The one all the way to the left
> is our discharge temperature. So this is an example of how the
> operators can actually watch the temperature profile.
>
> This screen is from our data collection computer that tracks this
> data. It\'s actually our physical records. We\'re not writing these
> down. It\'s all computerized with good back-up. You can see there\'s
> five lines here. The blue at the top is the discharge temperature.
> There\'s a start-up period which you\'re not discharging and then a
> shutdown period to the right, but this is the temperature profile in
> that cooker over the course of the entire day, so we can see from
> this, looking at the statistics at the bottom, that at no point in
> time did our discharge temperature go under the control limit of 270.
>
> When we look at GMPs, we view these more as housekeeping issues and
> general recordkeeping. Our pest control program falls under this.
> These are issues that deal with facility design or redesign and
> repair. Our sanitation program fits into a GMP from our standpoint.
> Then we also have start-up and shutdown procedures.
>
> An example of a GMP would be to prevent Salmonella recontamination of
> the finished product. We know we\'re getting a complete kill of
> Salmonella during the cooking process. It\'s potential recontamination
> after the fact.
>
> Our approach is modeled after the animal protein producers industry or
> APPI approach, which has been adopted by over 99 percent of the
> rendering industry. Basically we break our facility down into separate
> processing zones. We have a raw material zone, a cooking zone, a
> cooling zone for the cracks, storage areas, grinding areas, and
> protein blending areas.
>
> And the APPI program or these GMPs are built around work habits and
> policies. One example of that would be that hand tools, things like
> shovels and brooms, are dedicated to one specific zone. They\'re not
> to be carried from a raw material area to a processing area.
>
> We have start-up procedures, reprocessing of product spills. If meat
> and bonemeal were to somehow come out of an auger and hit the floor
> you don\'t just shovel that up and throw it back in the same auger.
> That material has to go back and be reprocessing with the raw
> materials again.
>
> We have dry cleaning of finished product areas. Again you don\'t want
> to introduce water for Salmonella growth. And we have many sanitation
> practices that really go after the targeted hot spots. These are areas
> where both moisture, time and temperature would exist to grow
> Salmonella.
>
> We look at facility design and also the equipment maintenance.
>
> The effectiveness of this Salmonella reduction or recontamination
> prevention program is done by finished product testing for Salmonella
> on a routine basis.
>
> Now the point here with the GMPs is there\'s no one critical control
> point, like in HACCP. There is no one specific kill step for
> Salmonella that we can put a silver bullet in and say at this point,
> under these conditions, we will prevent recontamination. However,
> I\'ll throw one caveat to that. A few years back the FDA CCM approved
> the use of formaldehyde as a terminal disinfectant and if we were to
> use formaldehyde as a feed additive to disinfect our animal proteins,
> I would personally consider that a critical control point.
>
> We go into employee training in our approach with modules that are
> specific to HACCP, GMPs, and standard operating practices. New hires
> always start their job at an entry trainee position and we actually
> give them individualized training over several months. To advance in
> their career development they have to get specific training to the
> next job they want to move into and we actually\--it\'s kind of like a
> masters defense\--they have to pass both a written and verbal defense
> showing that they understand the requirements of that job.
>
> All employees go to quarterly quality training meetings and if we were
> ever to have a feed safety problem, we would bring the entire team
> together. The great thing about our facility is it\'s a very small
> group, so there\'s a lot of good communication going on there.
>
> In our transportation policy, our shippers, our trucking
> companies\--everything\'s shipped by truck\--has signed off and
> certified that they\'re in compliance. Our trucks are only to haul
> agricultural commodities. We ask our suppliers and they have agreed to
> this, to ensure that their trucks when they arrive at facility are
> clean, that there\'s no residual or carry-over from the previous load.
> Our operators, prior to loading that truck, go through a visual
> inspection looking for carry-over and there\'s I don\'t want to say
> zero tolerance but we don\'t want any residue of whatever ingredient
> was in that truck from a prior load. We don\'t want it there.
>
> We also look at is the tarp acceptable? Is there any damage to the
> truck? Basically asking ourselves the question: is the integrity of
> our product going to be maintained during transportation to the
> customer? Very important.
>
> Now we manufacture products that are termed prohibited feed
> ingredients, meaning that they should not be fed back to ruminant
> animals. And one of the issues that we\'ve had is when we ship this in
> a truck, as soon as it leaves our facility we kind of lose control. We
> were concerned about trucks delivering our product to a facility, to a
> feedmill, say, and then not cleaning out after that and then going up
> and picking up soybean meal and hauling it to a feedmill that makes
> dairy feed.
>
> So we included a provision in our certification for our trucking
> companies that they would agree to clean the truck after delivering
> any of our products. We actually put a strip of paper\--actually it\'s
> florescent orange\--on each bill of lading that reminds the driver
> that they\'re required by law to clean the truck after delivering this
> product. It\'s just one more reminder not required by the FDA\--feed
> raw on BSE\--but it\'s something we thought would be appropriate.
>
> Personally I feel that clean trucks and rail cars are very important,
> that this inspection prior to loading for any feed ingredient relay
> should be mandatory. It\'s just a good practice. There\'s other
> potential hazards that could be there. I just think it\'s a very good
> common sense approach to look in the truck\--is it clean? Is there
> anything there that could cross-contaminate the product?
>
> We rely heavily on third-party audits, more geared toward the feed
> role for preventing the amplification of BSE. The first certification
> that was conducted a few years ago was through APPI, actually
> conducted by Cook and Thurber, a prominent third-party auditor, and
> they found very high compliance within the rendering industry. That
> was backed up by FDA inspections and then earlier this year that
> program was discontinued.
>
> So we decided we want to do something, have an additional
> certification, especially because we have a protein blending plant, so
> we recently became certified under the Facilities Certification
> Institute or FCI. The requirements for this program are based upon the
> FDA rule but have some little extra requirements that you must comply
> with to be in the program. It requires ingredient supplier and
> transport certifications from your trucking and rail companies.
>
> In our case, where we commingle beefmeal with other ingredients that
> can go to ruminant feed in the same facility, we demonstrated the
> adequacy of our flushing and separation procedures using tracers. And
> then I should also mention that you have to do this certification on
> an annual basis, so you can\'t just do it and then hold it up for the
> next five years and say we passed.
>
> So on that I\'d like to thank everyone for listening to me today and a
> special thanks to our folks back in Wyalusing for keeping the place
> running while I\'m gone. Thank you.
>
> \[Applause.\]
>
> DR. GRABER: Brother Joe is coming up. Joe is with Wenger\'s Feedmill
> in Pennsylvania. You notice there\'s a little bit of a Pennsylvania
> connection here. John Brightsman runs a good program up in that state.
>
> Anyhow, Joe Garber.
>
> MR. GARBER: Thank you. Good afternoon. I am all that stands between
> you and the break so treat me well and I will get you out on time.
>
> As a brief introduction to who we are, Wenger\'s Feedmill, we are a
> manufacturer of bulk poultry and swine diets. Everything that we
> manufacture is delivered via bulk loads direct to bulk bins on the
> farm. We are a family-owned and -operated company founded by Mel
> Wenger in 1944, headquartered in Rheems, Pennsylvania, which Dr.
> Graber just mentioned is just north of here. And we\'re operating six
> mills\--five in Pennsylvania, one in Maryland. The five in
> Pennsylvania are actually federally licensed medicated feedmills but
> we operate all six under the same standards. Corporately we see no
> reason why anyone would ever want to operate a medicated or a
> nonmedicated mill under different standards.
>
> We provide nutritional, analytical and research services, in addition
> to feed manufacturing, and do some pullet growing and egg marketing in
> case anyone needs any pullets or eggs.
>
> Brief overview. I\'m going to take a few minutes to go through our
> current quality assurance program, kind of a where-we-came-from, a
> brief moment on HACCP, what it\'s good for and why we did it, kind of
> a what-we-just-did, and then the next step, the Wenger system, which
> is where we\'re going as a company in terms of looking at quality
> assurance and food safety.
>
> That\'s not straight, in case anybody wondered. That was just me in
> the middle of the might making it crooked.
>
> Our quality assurance programs are customer-driven. We look at
> everything that we do and we have a demanding core of customers. And,
> as you\'ll see as we go through this, you\'ll note that a lot of
> things are obviously for some customers who have some incredible
> demands.
>
> Our quality assurance program starts at product design and labeling,
> which is near and dear to me. I started in feed formulation. If we
> don\'t have a feed that both contains legal and appropriate
> ingredients, if we can\'t create a legal and appropriate label for
> that feed, really we don\'t need to go any farther.
>
> So our quality assurance program starts by taking all the ingredient
> analysis that we receive from our mills, generating our nutrient
> matrix, and looking at creating diets which are appropriate and will
> meet the needs of our customers.
>
> The second and actually one of the most important parts of our quality
> assurance program actually goes into ingredient selection and those
> three words\--approved supplier list\--are an incredibly important
> part of our quality assurance program and are valuable to a feed
> manufacturer.
>
> In our company our approved supplier\'s list is maintained by
> technical services and formulation, not by purchasing. Purchasing
> needs to buy ingredients from the vendors that are chosen, that have
> proven to us that they can deliver safe and consistent ingredients, as
> are required by the formulas, not as are mandated by what is the most
> appropriate and most cost-effective for that week.
>
> We place a lot of emphasis on our suppliers\--folks like the Taylors
> and the Princes. As you saw with the two previous presentations, their
> quality assurance programs are really the foundation on which we need
> to build ours because that\'s a crucial part of what we do.
>
> Then production scheduling, which actually begins at our operations
> with order entry. We relay can\'t schedule production until we get an
> order for something to manufacture. Our customers call their orders
> in. In our order entry software we actually have checks and balances.
> If you are a producer and you call in and you have laying chickens and
> you try to order a swine finishing diet the computer will not let it
> go through. It needs to be a species for which you are on record as a
> customer as having. If you try to order any additives, we have the
> additives coded and obviously we have all medications coded. If
> someone wants to add a medication at the time of the sales order
> entry, those medications need to be appropriate for that species. They
> also need to be within the weights and the clearances that are allowed
> for that medication for that species. So we do have a lot of checks
> and balances.
>
> At production scheduling that specific order is assigned a work order
> number, which the rest of the world would call a lot number. J.D.
> Edwards calls it a work order number, so that\'s what we call it. And
> that number then tracks that load all the way through the system,
> through manufacturing all the way out to invoicing and any other
> samples we need to take.
>
> Flushing and sequencing is a very important part of what we do. Being
> a manufacturer of only poultry and swine diets, we have a little bit
> of an easier time in terms of BSE regulations. We\'re not
> manufacturing any ruminant diets or any of the diets where prohibited
> proteins are an issue but we do need to be very concerned about
> flushing and sequencing, especially due to medications anti-toxic
> ingredients, if we look at minerals, but primarily our flushing and
> sequencing is based around customer requirements.
>
> We have a lot of customers who are involved in niche markets. Some
> don\'t want animal protein. Some want all vegetable oil. Some don\'t
> want bakery by-product. Some want this, some don\'t want that, and
> they\'re just as interested that there\'s no carry-over of those, in
> their mind, undesirable, unmarketable ingredients as we are with
> carry-over, commingling or cross-contamination with medicated feed
> additives. So a lot of our production scheduling is really based
> around customer-driven requests and processes.
>
> Involved in manufacturing, which is a large encompassing word which
> takes everything from our plants where they maintain cleaning books
> and records. If you don\'t write down when you swept the floor you
> didn\'t sweep the floor and you\'re going to get in trouble for not
> sweeping it this shift. So we require records of all our cleaning and
> housekeeping procedures of our employees. We also maintain records and
> policies for bin rotation, bin cleaning, making sure that our
> facilities have the product move through and we\'re operating just
> like the rest of the world, on a first-in, first-out-type basis.
>
> We\'re keeping medication records. We\'re keeping batch records. And,
> of course, all these records\--medications, batching\--then are also
> tied back to that work order number, which was generated when the
> customer called that order in and we have that for complete
> traceability through the system.
>
> In addition, preventative maintenance. Our maintenance guys don\'t get
> enough credit for what they do for our quality assurance procedures.
> Keeping our equipment running, keeping our scales calibrated, keeping
> our meters calibrated, just keeping everything functioning to the
> highest level that they can do it is an important part of everything
> we do.
>
> Then, of course, we have delivery. Everything is going out
> in\--actually, about 95 percent of our feed we manufacture is going
> out in a Wenger-owned and employee-driven bulk feed truck in which
> there\'s a whole other set of flushing and sequencing. One of our
> primary concerns then, as we get to delivery, we get into biosecurity.
> As Wenger policy, we will not drop-ship feed. It doesn\'t matter if
> you get three tons of feed on a 28-ton truck or 28 tons, we\'re going
> to bring one truck to you and that truck\'s going to come back to our
> facility then. We will not drop-ship or go between different farms
> because of the density of the livestock that we work with.
>
> And actually, all of our delivery vehicles have an on-board
> disinfectant unit where we carry about a 25-gallon tank of
> disinfectant. Underneath each of the undercarriage of all the wheels
> there are wide band spray nozzles. Going on and off of every one of
> our customers\' properties the drivers are required to activate that
> spray system and coat the undercarriage with a disinfectant solution
> to just do everything we can to eliminate any possible vectors for
> disease.
>
> That\'s no different than anything anyone else does in the feed
> manufacturing facility. At Wenger\'s we\'re proud to be part of an
> industry that is proactive. I kind of enjoyed Dr. Sundlof\'s word
> stumble where he said break-up sessions. You know, one of the exciting
> things about a group like this and a meeting like this is really the
> feed industry and the center and states and all the groups have done a
> great job of never breaking up and the fact that we\'re together and
> talking about these things is what makes it great.
>
> HACCP. My introduction was what\'s it good for? Something a few years
> ago we probably would have had a difficult time answering. From our
> perspective and what we think HACCP is good for and why we chose to do
> it is it\'s really a comprehensive risk analysis focussed with a
> pinpoint accuracy on potential human food-related illness risk
> factors.
>
> So what we did is we took our production process all the way from
> formulation, ingredient purchasing. We invited a cross-functional team
> at our company. We had sales, financial, human resources,
> manufacturing, purchasing, technical services, quality assurance. We
> got everybody together and we spent about 150 hours in a room\--not
> all at the same time\--and we went through the entire process and
> asked ourselves in everything we do is there anything that we\'re
> involved in, whether it\'s an ingredient, whether it\'s a chemical,
> biological or physical contamination, that could cause a human
> food-related problem? And we looked at HACCP and have taken the
> corporate philosophy to keep HACCP separate from the rest of our
> quality assurance programs because our quality assurance really has
> been primarily based on looking at animal safety, looking at the
> things that we can do not to get those flocks, those herds, those
> groups ill and sick because that\'s an economical obviously advantage
> for us.
>
> We\'ve taken a look at HACCP and done a lot of things and basically
> we\'ve created a formal system for identifying risks and tracking
> these nonconformances, these things that\--we at Wenger\'s define a
> nonconformance. We made the assumption that our customers expect us to
> do everything correctly. Correctly means legally and that our quality
> assurance procedures are covering all the barriers to give them the
> best product that we can.
>
> So in our definition, a nonconformance is anything that we\'ve done
> that\'s going to violate what the customer expects us to do or has
> asked us to do. And any time that that happens, we expect our
> employees to fill out a nonconformance report.
>
> One barrier we came to was typically nonconformances are human error.
> There are occasional mechanical errors but they\'re often human error.
> We had a large educational curve to overcome because it\'s really
> tough to get people to tattle on themselves. You know, I did this
> wrong. Okay, please hand that in now. And we had to really work on our
> employees to make sure that they were aware that the reason we wanted
> to know those things is because we wanted to look at it from a systems
> approach. We wanted to look at what we\'re doing realistically and
> what we need to change from a systems approach to make sure that
> we\'re not putting any human consumers at risk from a product that we
> may have manufactured or created.
>
> It\'s been really valuable for us in identifying weak spots in our
> system. I mentioned the curve of getting folks to \"tattle\" on
> themselves when they\'ve created a nonconformance. At 3:00 in the
> morning when you get the phone call and \"The turn head didn\'t work
> and we put three tons of this in that bin\" and I always have to end
> the phone call with, \"You\'re going to write the paperwork, right?\"
> They always say, \"Yeah, I\'m going to write the paperwork.\"
>
> Folks have discovered that that paperwork has come to the office,
> we\'ve started to collect and track those issues and we\'ve made
> improvements. In a lot of cases we\'ve made a lot of great
> improvements that have made our mill operators\' lives easy and have
> given them the opportunity to have a voice of things that they saw
> happening that they thought, well, just no one really cares. Now they
> have an avenue to report those things to us.
>
> One of the major weak spots that we\'ve identified and have been
> unable to fix as we\'ve looked at human food safety is the issue of
> transportation, specifically transportation of raw ingredients to our
> facilities and even more specifically, looking basically at
> commodities. In Pennsylvania we need to be constantly vigilant.
> Demolition waste backhaulers, which is illegal but it still happens
> and we\'re aware that that happens. Coal country. We need to be aware
> that we don\'t have folks back-hauling coal. Coal is a wonderful thing
> but it\'s not real great in a feedmill and we don\'t want it.
>
> And one of our things that we need to work on as a company and have to
> really struggle with is how can we get those who are transporting
> ingredients to us to go to the next level to give us the assurances
> that the products they\'re bringing us have not been contaminated
> either by something that was in the truck beforehand and/or by
> something being added during transportation.
>
> Last but not least, the quote, \"Where are we going?\" The Wenger
> system is a name that was created late one afternoon and we\'ve
> decided to take a look at all the things we\'ve worked on in the past
> and create one comprehensive management system, a framework for
> basically managing all of our not just quality, but all of our
> environmental and safety aspects in one holistic systems approach.
>
> I hate to get Covey on us but we really need to truly be proactive
> versus reactive in the things that we do. We\'ve looked to taking
> these five aspects. Our regulatory, which is our GMPs, which is a lot
> of what our quality assurance system is based on. Quality, which
> we\'re working off the ISO 9000 standard and seeking certification in.
> And we\'ve found that we really honestly can\'t separate quality from
> environmental, occupational health and safety, and human food safety.
> We really need to look at these all as one piece.
>
> When we make a mistake in the mill, that\'s a quality problem. If that
> feed needs to be disposed of, we\'ve now contributed to the solid
> waste stream. Now we have an environmental problem. When we have to
> handle things more than once, we create the potential risk for
> employees being involved in equipment. That\'s an occupational health
> and safety issue.
>
> So we wanted to look at all these together and create one holistic
> system. I don\'t want to get all ISO on everybody because ISO\'s not
> necessary for everybody but it is what we\'re looking at. Really it\'s
> fairly simple and it\'s really made sense to us as we\'ve gone forward
> where we\'ve traditionally been regulatory-driven, we want to do
> things just to kind of stay out of trouble and then if customers ask
> us, we do more because we obviously don\'t want to get in trouble with
> our customers.
>
> We want to be beyond that. We want to be beyond our customers. We want
> to say to our customers, \"We already did that.\" We want to say to
> the folks who regulate us, \"That\'s fine; we did that already.\" We
> want to move forward. We want quality and environmental and
> occupational health and safety to be a strategic business unit. We
> want these things to add to our bottom line because we think they\'re
> important to our business as we move forward.
>
> As a wrap-up here, these are the reasons that we\'ve looked at
> implementing a management system which is no different than why we\'ve
> implemented quality assurance systems but we\'re trying to take that
> one step further.
>
> Improved compliance, which should make a significant portion of this
> crowd happy. Reduction in liability and risk. Our insurers are very
> interested in that. We live in a world of litigation and we have no
> desire to be involved in that. A system for prioritizing resources.
> Like the rest of the world, we live in a world of diminishing margins
> and resources. We need to be able to put the dollar where it\'s going
> to do the most good.
>
> We want to decrease costs. We want to have a market advantage. We want
> to be able to say to our customers, \"This is the things we\'re
> doing.\" We want to be a step ahead of them and give them the ability
> to market us to their customers. We want our customers\' customers to
> be proud of who makes their chicken feed. We want them to be able to
> go to Manhattan, where they sell chicken in a butcher shop, and to be
> able to throw that butcher in a car and we want them to be able to
> come and visit a feedmill and enjoy it and appreciate and be aware
> that the feed that fed the chicken that was processed and is on ice in
> their facility, they can be proud to sell that, also.
>
> Pressure from interested parties, whether that be regulatory and/or in
> our case it\'s mostly economical, from our customers. And obviously
> continual improvement. If we don\'t have our eyes on continual
> improvement, we\'ve really lost focus on what we\'re doing.
>
> You don\'t need to see that. That\'s what we\'re working on. Everybody
> knows the continual improvement model\--around and around and around.
>
> Just as two last slides, what it\'s taken to get us this far, looking
> at creating the Wenger system and integrated ISO system, we required a
> gap analysis. We both had a gap analysis from a commercial consultant,
> in addition to we had a gap analysis done for us by\--we actually got
> a grant from the state and they came in and helped us look at our
> programs.
>
> We need to have a top management overview. If the individual at the
> top doesn\'t believe it, live it, and push for it, you\'re all wasting
> your time, I think. We all know that in any organization, that we need
> to have quality zealots at the top.
>
> We developed a policy. We did aspects and hazards analysis. Just like
> we did on HACCP with food where we needed to look at every single
> aspect, we went back and did all that again for occupational health
> and safety and environmental concerns.
>
> Lots of training with the policy. We developed a manual with all the
> different levels of documents. We have actually put an RFP out for
> registrars, convened a steering committee which is kind of our
> midlevel managers to champion the cause. We just finished on Friday,
> last Friday, interviewing registrars and we\'re going to make a
> decision on that probably Monday. And from this point we\'re going to
> complete our documentation, be involved in aggressive training and
> education, get a preaudit, and our goal is to have an audit and be
> certified in ISO 9001:2000, 14,000 and have a letter of compliance for
> the BSI 18,000 occupational health and safety standard, and have a
> letter that we\'re satisfying the seven principles of HACCP by March
> of 2004.
>
> So that\'s the schedule of where Wenger Feeds is looking at quality
> and trying to protect both animal and human food safety and our
> customers. That\'s it.
>
> \[Applause.\]
>
> DR. GRABER: I don\'t want to put pressure on our next four speakers
> but you\'ll have to admit that the speakers so far have been giving us
> some excellent information about the processes that are occurring at
> their particular companies.
>
> Okay, as Joe indicated when he started, we\'re at the break. We\'ve
> got 20 minutes. Please be back here at 10 minutes of 3.
>
> \[Recess.\]
>
> DR. GRABER: Okay, we\'re going to get started. Please sit down.
>
> The next speaker is Mike Merkel. Mike is the director of research and
> development with Doane Care, Pet Care. Okay, let\'s go. Mike?
>
> MR. MERKEL: Thank you, George.
>
> Good afternoon. Everybody\'s all refreshed from break, I can see, and
> ready to go for the rest of the day.
>
> I appreciate the opportunity to be here today to share an overview of
> how one pet food company, Doane Pet Care, the firm I work for, manages
> food safety for dogs and cats. You\'re probably wondering, well, what
> does that have to do with animal feed safety? Hopefully there\'s a lot
> of things that you\'ll see that are common in our system that may be
> beneficial for the programs that you have.
>
> A little bit about Doane Pet Care. We are the largest private label
> manufacturer of dry dog food, dry cat food and treats in the United
> States. We sell to over 600 customers, many of whom are in this room
> and most of the top pet food retailers in the U.S. We have 19 dry
> extrusion plants, five bakeries that make dog biscuits, and two
> intermediate moisture pet food treat plants here in the United States.
> We also have six plants in Europe.
>
> At Doane Pet Care our mission is to be the trusted partner of choice
> for our customers\' brands. You\'ll rarely see Doane Pet Care\'s name
> on any packages but you will see many recognizable customers\' brands
> and we\'re entrusted with that responsibility. Consequently, to assure
> that all of the pet foods that we manufacture and distribute are safe
> and wholesome for the pets that consume them, we have our means, which
> is the pet food quality assurance system or PFSS, as we refer to it.
>
> Our pet food safety system is a risk-based preventative system. It
> begins with a detailed analysis of every pet food processing system at
> each of our plants and that\'s important because the system has to be
> unique for the needs of each of the processing requirements.
>
> This analysis is actually conducted by a team of plant and corporate
> employees and managers who are knowledgeable of each system and who
> are trained in HACCP methods. Illustrated is part of a HACCP flow
> chart from one of our dry extrusion pet food plants. Our typical
> extrusion process consists of receiving bulk ingredients, both by rail
> and by truck, storing those bulk ingredients in bins, taking those
> ingredients and accurately weighing them out according to the formulas
> that are issued and controlled by our nutritionist in order to make
> certain that we meet the specific customer\'s recipes or formulas.
>
> We then thoroughly mix all of those batched ingredients to assure that
> we have uniform distribution of all the nutrients for dogs and cats.
> We then take that batch and we finely grind it into small uniform
> particle sizes. The reason that\'s important is we want to have
> efficient hydration and absorption of water and heat in that mixture
> during thermal processing.
>
> In the preconditioner we add hot water and other liquids and uniformly
> disperse that into the mixture. We apply steam, thermal energy and
> mechanical energy, friction, in the extruder in order to destroy
> microorganisms under high pressure and temperature in order to
> inactivate the enzymes so the food is stable and to gelatinize starch
> to give it the functional aspects of the product.
>
> The cooked extrudate is then formed into desirable shapes and expanded
> to give us a good texture that\'s palatable by the dog and cat. Next,
> the cooked wet extrudate is exposed to heated air in a dryer in order
> to remove the excess moisture in order to render the product stable
> with the water activity. Dried extrudate is then run through a coater
> where we uniformly apply fat and other palletants in order to deliver
> the energy and the taste to the product. We then cool that product to
> ambient temperature so that it\'s stable for packaging.
>
> You\'ll notice on this HACCP flow chart that it also includes things
> like rework, how we handle bulk liquids, and how we handle preprocess
> ingredients. So it\'s a comprehensive look at all the potential risks
> on the ingredients and the processes that we work with.
>
> The next step in our pet food safety system is identifying what the
> potential pet food safety hazards are and assessing all of the
> processing and product risks. We identified and implemented critical
> control points in the process with specific accountabilities and
> identified corrective measures that have to be taken in the event
> those things are identified. It\'s especially important to make
> certain that all the employees who are involved in the food safety
> system are trained in the process control measures.
>
> We require mandatory documentation of all those critical control
> points in our process, including regular supervisory review and
> sign-off to assure that they\'re being consistently maintained. In
> addition, the documentation is reviewed during corporate and
> independent pet food safety system audits.
>
> We validate that our prevention system is effective through several
> means. One, by rigorous testing of our finished products, we carefully
> monitor our 800 number system, which gives us great feedback from
> consumers, and regular review by the team of how well the system is
> working and modifications to keep it contemporary.
>
> It\'s a well established fact that no one can inspect quality into a
> product. Consequently, we strive to build food safety into our designs
> for buildings, which our in-house engineering services group, by the
> way, builds and constructs most of our plants in order to make sure
> they\'re pest-proof, that they\'re easy to clean, and that they\'re
> secure, our grounds so that they are free from pest harborages and are
> also secured, and our food processing equipment, which once again we
> build the majority of, that is safe, easy to clean and sanitary.
>
> We also want to make sure that the packaging that we use is
> tamper-resistant and that it prevents post-process recontamination of
> the product. But most importantly, it\'s the people, making sure
> they\'re trained and that they\'re fully engaged in the pet food
> safety system.
>
> The eight key components of our pet food safety system are ingredient
> integrity, a comprehensive quality manual that applies to all of our
> facilities, sanitation and microbiological control program, integrated
> pest management, controls of foreign materials, lot traceability,
> validation of the food safety system\'s effectiveness by audits, and
> continuous improvement of the food safety system.
>
> Our quality manual provides uniform policies, standards and procedures
> for every one of our facilities and also for our distribution
> facilities. It\'s ISO 9000-based, even though we\'re not ISO
> 9000-certified, and it includes all of the quality system elements
> that are applicable to pet food. The quality manual is regularly
> updated by a standing team of plant and corporate personnel and our
> quality assurance manual is a controlled and audited document in order
> to assure that it\'s uniform and accurately deployed through all the
> facilities.
>
> Ingredient integrity is where our recipe safety really begins. You\'ve
> heard from a number of ingredient suppliers and all the comprehensive
> measures that they go through and that\'s very important to us.
> Everybody knows you absolutely have to start with safe ingredients if
> you want to end up with a safe finished product and no amount of
> processing or inspection can totally eliminate the adverse effect or
> impact of poor quality ingredients.
>
> We\'ve found that the most effective way to assure ingredient
> integrity is to move our quality system upstream. Consequently, we
> concentrate the majority of our quality assurance time and effort on
> our vendor assurance program. We certify that our vendors\' quality
> assurance programs are adequate for our needs and the reason for that
> is that\'s the critical point at which the safety of the ingredients
> can be most effectively controlled.
>
> This is a joint program at DPC between our quality assurance group and
> our purchasing group and we\'ve actually dedicated a senior ingredient
> specialist to provide management focus and priority to this critical
> program. This team of purchasing and quality folks conducts extensive
> on-site inspections of our vendors\' processing plants and their
> warehouses, as well as auditing their processing and their testing
> records. All of our ingredient specifications include specific pet
> food safety requirements that our vendors have contractually agreed to
> meet.
>
> Now upon receipt, we subject all of our bulk ingredient shipments,
> like corn, wheat midlings, wheat flour, rice and animal by-product
> meals, to probe-sampling and analysis prior to acceptance on loading
> in our plants. We also test all our bulk ingredients with a scanning
> infrared analyzer and that\'s mainly done for proximate analysis, not
> food safety, but one of the interesting unanticipated and novel
> benefits we\'ve seen is that the scanning NIR that we use also signals
> whether or not there\'s something potentially wrong with the
> ingredient, the possibility of some mixing with other ingredients that
> might not show up with the naked eye. This is known as an H value, an
> elevated H value.
>
> We have a one-strike-and-you\'re-out policy for high-risk issues like
> micotoxins. This means that if a supplier has just one load testing
> out of compliance for micotoxins that they\'re disqualified. And all
> of our facilities are equipped for on-site quantification of
> micotoxins, like aflatoxin and DON, more commonly referred to as
> vomitoxin. All of our wheat product loads are tested for vomitoxin and
> all of our corn and rice products are tested for aflatoxin prior to
> unloading.
>
> Now pictured on the left side of this slide is the quantitative ELISA
> reader and central data management reporting system that we have in
> all of our plants. In addition, on the right you\'ll see that we\'re
> picturing our automated florametric analyzer, which we have in our
> corporate laboratory, as well as a number of our larger plants in
> order to confirm and quantify the micotoxins.
>
> All of our plants are empowered to reject any load that does not meet
> our specifications and if the rejection is for high-risk
> nonconformance like micotoxins, then they would have to go through the
> entire vendor certification process to requalify.
>
> An often overlooked aspect of ingredient integrity is the transport
> vehicle itself. Consequently, we\'ve incorporated vehicle inspection
> as the very first and perhaps most important part in our
> ingredients-receiving process. Before any truck or rail car can be
> received onto our sites we carefully check the load documentation to
> ensure that it\'s an improved ingredient from an approved vendor
> processing facility and as amazing as it may seem, we have had loads
> show up that we didn\'t order that weren\'t from approved facilities.
> So it\'s very important that we check that documentation.
>
> We also check then to confirm that acceptable flushing procedures were
> used and documented and also what was transported in the vehicle prior
> to hauling the ingredients that we received. Obviously that\'s to
> prevent cross-contamination. We then conduct a thorough inspection of
> the vehicle itself for signs of carry-over or other signs of
> unacceptable conditions.
>
> One simple but very important pre-unloading procedure that we\'ve put
> in place is pictured in this slide and it\'s again quite simple. We
> put a large catch pan under each rail car and truck hopper bottom and
> a sample\'s collected and tested. Only if the bottom samples that are
> collected and the probe samples which are analyzed separately all test
> okay will the load be accepted in. We\'ve found that this sampling
> method is a very reliable means of verifying the vehicle\'s
> cleanliness and assuring that there hasn\'t been any ingredient
> carry-over.
>
> Sanitation and microbiological control is the next key component of
> our pet food safety system. We employ master cleaning schedules and
> sanitation standard operating procedures that are specific for each
> plant and specific for each type of processing equipment. The
> sanitation and the microbiological control procedures are conducted at
> the plant level by quality assurance personnel. These procedures
> include the design and the maintenance of the plants and controlled
> movement of employees, plant materials, and equipment. It includes
> predelivery testing and supplier certification of sensitive
> ingredients, like palletants, for example, which we apply after our
> thermal process, and this is necessary, of course, to assure that
> they\'re free from pathogens like Salmonella.
>
> In addition, we conduct routine microbiological sampling of
> plant-specific production sites, environmental areas, and finished
> products to detect any potential risk. These samples are analyzed in
> our technical services laboratory, which has extensive microbiological
> testing capabilities, including pertinent pathogens. The laboratory
> also provides, most importantly, training at all of our plants for the
> on-site testing done at the plants and also additional technical
> support for problem-solving.
>
> Pictured here are two of our microbiology technicians examining and
> preparing XLD plates for presumptive Salmonella testing.
>
> Integrated pest management is also an important part of our pet food
> sanitation and food safety program. The two components of our
> integrated pest management program are first, a master pest control
> schedule that is specific for each plant, including mechanical
> exclusion of pests from all buildings. We rely mostly on
> nonpesticide-based control measures like insecticutors, pheromone
> traps and rodent traps, and controlled limited usage of approved
> pesticides targeted for specific localized infestations that didn\'t
> respond to the nonpesticide-based controls.
>
> The second component of our IPM program includes the use of nationally
> contracted pest control firms and their affiliates for facility
> personnel training in integrated pest management, automated tracking
> and reporting of any pest activity at each plant, as well as
> electronically documenting all plant pest control services and
> pesticide applications. Any fumigation of ingredient bins or
> processing areas, if required, is conducted by these licensed
> contractors.
>
> Foreign material prevention is the next component of our pet food
> safety system. It begins at the ingredient level at our vendors. We
> require the vendors to inspect their process, including the transport
> vehicles and trailers, for foreign material. We include transport
> vehicles and trailers in our audits at those vendors. We use magnets
> to detect and remove ferrous metal during unloading and at key
> transfer points in the process. We audit and inspect the carriers and
> warehouses, including packaging materials stored there. We conduct
> daily in-process inspection at each plant of the physical building and
> the equipment, including magnets at key transfers and metal detection
> at packaging.
>
> Pictured is an in-line metal detector typical of our plants, which is
> coupled with an air-activated rejection diverter in the event any
> positive sample is detected that can be diverted from the line. This
> happens to be at one of our dog biscuit bakeries.
>
> Good preventative maintenance procedures are essential to prevent
> equipment breakdown and deterioration. It\'s equally imperative to
> have good standard operating procedures for maintenance repairs or
> replacements to assure that all the tools and the parts are accounted
> for and that any work areas are thoroughly cleaned prior to resumption
> of processing.
>
> As I mentioned, we have an 800 number system that enables us to
> efficiently evaluate potential consumer concerns and this includes
> acquiring production lot information and samples for analysis and
> plant notification. If we do detect potentially nonconforming
> materials in our process we have a clearly defined hold system to
> identify, isolate, document and to prevent the use or distribution of
> those materials.
>
> Another critical component of our pet food safety system is lot
> traceability. Needless to say, the ability to trace a potentially
> contaminated material lot to the finished product code dates
> manufactured using that ingredient lot and the distribution of those
> finished products to end customers is very essential.
>
> Our pet food safety system includes the following procedures to
> establish and maintain a chain of custody for our ingredients and
> finished products. It starts at the ingredient level where we require
> and record the lot number on bagged ingredients. This is obviously
> important for stock rotation, as well. We also have mandatory storage
> bin designation requirements for the bulk receiving paperwork so we
> know where every ingredient lot was placed.
>
> We have mandatory origin information, as mentioned, that\'s required
> on all bulk receiving paperwork to validate that materials are only
> coming from approved processing plants. And we have mandatory batching
> and ingredient usage records that are critical to link ingredient lots
> with specific finished product lots.
>
> At the finished product level, all of our packages have legible code
> dates which designates the plant, the line, the date and time
> packaged. We conduct hourly checks of those code dates to assure that
> they\'re legible and correct.
>
> We also conduct unannounced mock trace and retrieval testing at all of
> our plants. Now this is conducted and graded by our quality systems
> manager both for speed and for accuracy. Interestingly, this score
> counts toward the plant performance objectives. That means it hits the
> plant manager\'s bottom line. And we firmly believe that pet food
> safety performance must be put in the value system of all management
> and employees at our facilities alike to truly become the way of work
> life.
>
> The final component of our pet food safety system is comprehensive
> auditing and continuous improvement. An annual internal GMP food
> safety audit is conducted at all the plants. These are performed by
> trained auditors who were formally quality assurance coordinators at
> each our plants. Consequently, they\'re very familiar with the
> plants\' ingredients, processing systems, and procedures.
>
> We also have annual external GMP food safety audits that are conducted
> at all of our plants and they\'re performed by nationally recognized
> independent food safety experts. Both these internal and external
> scores count towards the plant\'s performance objectives.
>
> Lastly, many of our customers conduct quality audits and these are
> performed by trained customer representatives or by industry
> professionals which our customers have hired on their behalf and
> ultimately all of these audits ultimately determine business awards.
>
> We also conduct continuing education at all of our plants for the
> employee population to make certain they\'re aware of critical issues
> new and emerging in things like restricted use protein product control
> procedures, the Public Health Security and Bioterrorism Preparedness
> Act.
>
> And lastly, the pet food safety system must be flexible, it must be
> cost-effective, and it must be appropriate for each specific
> application. It must also take into account technological limitations
> and resource constraints in order to be practical and self-sustaining.
>
> In conclusion, we do all these things at DPC for the beneficiaries,
> the dogs and cats. Thank you.
>
> \[Applause.\]
>
> DR. GRABER: Okay, next on the program is Mike, another Mike, Mike
> Davidson from California Department of Food and Agriculture.
>
> MR. DAVIDSON: Well, it\'s a pleasure to be here. I am from California.
> Arnold says to say hi to everybody and encourages you all to go see
> \"Terminator 3.\"
>
> Anyway, I\'m with the California Department of Food and Agriculture,
> the Agricultural Commodities and Regulatory Services Branch.
>
> In the fall of 2002 we decided that we could do more to promote feed
> quality assurance in California so the concept of the safe animal feed
> education program was brought about. This was presented to our Feed
> Inspection Advisory Board, which is made up of industry people and a
> public member to advice the secretary of agriculture on feed safety
> activity, feed inspection activities.
>
> It was also presented to the board of directors for the California
> Grain and Feed Association in early 2003. They liked the idea and so
> this is what we presented. It was to provide education and outreach
> materials for feed safety and feed quality assurance training,
> maintain a web site with feed safety and feed quality assurance
> information with regulatory requirements and multiple links, and to
> continue the voluntary feed quality assurance inspections that we\'ve
> been performing in the last few years.
>
> I guess one of the questions that could be asked is why have a SAFE
> program? That could be asked by somebody like Richard Sellers, for
> example. The reason is that we felt the first legislative charge in
> the California commercial feed law is as follows: enable the feed and
> feeding industry, with the aid of the state, to ensure every way
> possible a clean and wholesome supply of meat, milk and eggs for the
> benefit of the consumer.
>
> There is more livestock feed produced in California than any other
> state and therefore we must continue as a leader in the area of feed
> safety. Promoting feed quality assurance is the most effective way of
> preventing unsafe adulteration of commercial feed. As even Dr. Sundlof
> and many others have indicated, the end product sampling and testing
> is not going to prevent a problem; you\'re just going to find it. You
> don\'t want livestock to be telling you that you have a problem, or
> pets.
>
> SAFE is not a new effort. It is the utilization of resources in a more
> proactive approach to take feed safety and quality assurance programs
> to the next level.
>
> Okay, basically a three-pronged approach, the first being education
> and outreach materials. SAFE, in cooperation with the California Grain
> and Feed Association, will provide feed quality assurance training
> programs for commercial feed manufacturers. This would be feedmill
> staff and SAFE and the CGFA will produce a feed quality assurance
> training manual, including CDs and video cassettes, for firms to
> provide on-site training.
>
> Imagine a partnership between an industry group and a feed regulatory
> program. It kind of sounds like a lyric from a John Lennon song.
>
> The SAFE program will provide feed quality assurance training for
> on-farm feed manufacturers. This first set of trainings are especially
> designed for personnel on dairies that purchase commodities and mix
> their own feed. The first quality assurance training for on-farm feed
> manufacturers is scheduled for next week, September 30. There are two
> more trainings scheduled for the spring of next year. We hope the SAFE
> program will be a source of continuous education for purchasers of
> commercial feed ingredients.
>
> The web site we hope to be a clearinghouse for feed safety information
> and approved feed ingredients, federal and state regulatory
> requirements, with example labels posted on the web site. We also have
> SAFE program updates with a list of available classes, training
> materials, and research information.
>
> The last component is the voluntary feed quality assurance
> inspections. They will continue to be performed at feedmills
> throughout the state. The inspections are not designed to focus only
> on current good manufacturing practices. These inspections advance
> feed safety into all areas of commercial feed manufacturing, not just
> medicated feeds.
>
> The California commercial feed quality assurance program checklist was
> developed several years ago by special investigators working in the
> field. This truly was a grassroots thing that came out of people that
> were in feedmills every week. It\'s been revised at least six times,
> adding items such as a biosecurity section.
>
> AFCO members and industry advisors have worked for a couple of years
> to develop a checklist for feed safety inspections, also. The AFCO
> checklist for best management practices guidance document for
> manufacturing, packaging and distributing animal feeds and feed
> ingredients\--if you get through the name you\'ve got half the
> inspection done\--has 93 inspection items and it is posted on the web
> site listed on the screen. The California commercial feed quality
> assurance program checklist has 123 inspection items and it\'s posted
> on our web site, as well.
>
> I received a copy of the Canadian Food Inspection Agency commercial
> feedmill inspection. It\'s 52 pages. I couldn\'t find it on the web
> site but Inspection.gc.ca is their web site address.
>
> Going on with the feed quality assurance checklist, I feel that these
> checklists are tools for feed safety inspections. They\'re a feed
> safety outline from which U.S. FDA regulations could be developed. We
> feel that this fosters practical, effective and realistic regulations
> based on actual manufacturing and distribution practices.
>
> State and USDA investigators and industry quality assurance personnel
> could perform inspections and provide input on the strengths and
> weaknesses of a proposed U.S. FDA checklist. Next month we plan to
> have an inspection team use the AFCO checklist, along with the
> California checklist, to identify strengths and weaknesses of each.
>
> I think that if regulations are developed through a grassroots
> approach such as this, I think you can have the possibility of a great
> outcome. This is something that\'s going to take a lot of thought and
> effort and will be met with a great deal of opposition.
>
> In conclusion, I hear a lot of industry people stating that every
> change in the laws or regulations cost money. I had the privilege of
> attending an AFIA feed safety symposium and I was taught that a truly
> effective feed quality assurance makes you money in the long run
> because recalls and complaint adjustments are very expensive. The key
> is that any new regulations need to be effective, practical and
> realistic for commercial feed.
>
> Thank you for having me.
>
> \[Applause.\]
>
> DR. GRABER: Okay, next on the program is Dennis Byrne, also a
> Pennsylvania connection. You\'re getting the drift here? Dennis is
> with the Herr Angus Farms Division of Herr Foods.
>
> MR. BYRNE: Thank you, George. I appreciate you all having me here. For
> those of you who don\'t know it, this is extremely scary for an old
> farm boy. I didn\'t think I was that old but I\'m starting to feel
> older all the time. I\'m left-handed, so obviously I have to come in
> from a different way than everybody else.
>
> Oh, I thought control-alt-delete just took one slide out. We might
> have a problem here. Well, it\'s getting better. I wasn\'t sleeping
> much. I mean this really is scary and I didn\'t know what I was going
> to do. Fortunately, the good Lord reminded me that this event isn\'t
> all that big. He sent me a dear young lady to visit with me Thursday
> and Friday. Her name is Isabel and I realize that this isn\'t a big
> deal, at least not down on the home farm. We\'ve been pretty busy and
> the nights have been fairly short since then but I was sleeping quite
> a bit better when I did get to bed. Something about 3:30 this morning
> just kind of reminded me of Isabel all over again and back up I was.
>
> So I\'m glad to be here. I mention of Jim Hogue. You can wave a hand
> or something. Jim came with me from Pennsylvania. Jim is a
> nutritionist with Agri Basics. Agri Basics Group does a lot of work
> with us at the farm. They\'ve been with us for a little over 18 years
> and I feel real empty without their input, so Jim helped me a lot and
> I appreciate that. Thank you, Jim.
>
> The other really neat thing is I told my wife since I was picking up
> Jim, it\'s kind of on the way for the carpool this morning. There\'s
> five kids that ride together in the carpool so we get to rotate once a
> week and my wife has Tuesdays. I said, \"Well, I can drive the kids
> for you.\" So I picked up the kids at the carpool spot and we\'re
> going down the road and my daughter Sharon\'s in ninth grade. She
> says, \"Look, Pops is in a suit and it doesn\'t have carhard on it.\"
> \[Laughter.\] The kids wanted to know what that was all about, so I
> didn\'t tell them too much.
>
> The other thing I really appreciate is Ellis Island. Daddy came over
> in 1922 as a very small child and somehow or another when Mom was
> trying to get him and her through immigration they took the O off, so
> now I get to be at the top of the speaker list. I\'m taking this home
> and bragging about it, all because they took the O off of O\'Byrne.
>
> I\'ll talk a little bit about Herr Angus Farm and we\'ll move through
> these, I think, fairly quickly. Herr Angus Farm is a division of Herr
> Foods. For those of you who are in the Mid-Atlantic region, hopefully
> you know about Herr\'s Potato Chips and hopefully you\'re a steady
> customer. If you\'re not, I grant amnesty and forgiveness; just start
> buying our product.
>
> Nottingham, if you were to draw a straight line from Philadelphia to
> Baltimore, which isn\'t there, sits exactly between the two. We\'re
> one mile above the Maryland border.
>
> Jim Herr is the founder. Jim is still alive. He\'s a great, great
> friend of mine, mentor, a farm boy at heart. He\'s 79 today. He\'s
> still quite active in a lot of things but the day-to-day plant
> operations he leaves up to the second and third generation. The
> company\'s been around for 57 years, makes all kinds of products. From
> where I\'m at you can\'t tell anything but all kinds of potato chips,
> corn chips, pretzels, popcorn, all kinds of salty snacks. About 375
> ingredients are either manufactured or resold through the Herr\'s
> name.
>
> For those of you that can come visit us sometime, we definitely have
> the tastiest tour in all of Nottingham, Pennsylvania. I urge you to
> come, eat some hot chips. Contact me, as well, and I\'ll give you a
> little tour of our farm. If you can\'t do that you can find our
> virtual tour on the World Wide Web at Herrs.com. Also, during the
> holiday season you\'ll see our tremendous light display that we do
> every year there and you can take that tour on the web or you can come
> and do it personally yourselves.
>
> That gives a little background. Herr Angus Farm is very much tied in
> with Herr Foods. We sit on about 2,000 acres in Chester County. About
> half of that is woodland and wildlife area. The other half is
> productive ground. We have the ambition of processing about 1,500 to
> 1,600 quality Herr Angus beef per year. However, there are cattle that
> find out what a haven it is to be at Herr Angus, so you\'ll see some
> other breeds and colors appear every now and then.
>
> One of the key ingredients to what we do is by-product feeding. We
> feed potato peelings and also the steer party mix. And quality
> assurance at any given point of the day will reject popcorn, cheese
> curls, pretzels for some kind of reason that they think you won\'t
> like it so much, so they won\'t put it in the bag, so they\'ll send it
> to the farm. So that\'s one of the ingredients of our feed.
>
> We also run about 200 head of grass cattle every year. That\'s usually
> from about late March till November for us. We work those cattle two
> ways\--the old way and I\'m sorry about the Ap but being a Mennonite
> he was free; I had no choice, Mike. And sometimes we also use the
> four-wheeler. We also run about 120 brood cows, as well, and our own
> calves. Again you\'ll notice that some of the neighbors\' cows will
> just always come over because our grass is greener.
>
> Vision statement, when I thought about this meeting, was in order for
> a beef farmer to succeed he must provide the consumer with a product
> that is high quality. That means it better taste good and it better be
> nutritious, better be fresh. It has to be wholesome, and that\'s a lot
> about what we\'re talking about here. It\'s got to be safe.
>
> Convenient. Our consumer\'s a lot different than she used to be or he
> used to be. One of the great things about the grill is it has helped
> to increase the demand of beef. You\'ll see a lot of people buying
> grills and you won\'t see very many men say, \"Honey, won\'t you go
> out and get a chicken for me to cook on the grill.\" So I appreciate
> that. Buy more grills, buy more steaks. I\'m a happy man right now.
> And it\'s got to be reasonably priced.
>
> In order to continue that enterprise to go on and on, the beef farmer
> has to provide a product that\'s going to be that way every time. If
> you go to a restaurant and you get a bad steak, that\'s it. You\'re
> not going to order steak at that restaurant the next time and that\'s
> a bad deal. So we have to think about a consistent high quality eating
> experience every time.
>
> The second thing is I\'ve got to make money. If I\'m not making money
> producing this great high quality eating experience you have then
> forget it, I\'m not going to be around to produce it for you. And in
> order to achieve this goal what we\'ve found in the industry is we\'ve
> got to quick looking at being in the cattle business and we\'ve got to
> start looking at being in the beef business or in the meat business.
>
> There is a success story and this one started probably 10 or 12 years
> ago when NCBA did some quality audits and found out there were some
> problems in the beef on the shelf and the consumer was really getting
> messed up because we were using all kinds of names for beef that made
> it sound like it was high quality and it wasn\'t. So they started
> looking at what those quality defects were and began to work backward
> from the meat case to the producer to conception to improve that.
>
> The purpose of our beef quality assurance can really be summed up in
> that it\'s to protect the consumer\'s confidence in not only the
> safety of the product but also the quality of the product. What\'s new
> is that today the producer is accepting responsibility for that. That
> did not happen before.
>
> And the other nice thing about this program is that it does have
> independence from regulatory agencies. It\'s a proactive event.
>
> Okay, somebody was talking earlier and I forget who it was about
> quality and staying in business. Two little blips there that happened
> in the news that all of you will remember. The first one I won\'t
> mention Oprah\'s name but these things cost us a ton of money, a ton
> of money, and we can\'t continue to do that. So as things have
> progressed, producers are recognizing that we need to do everything we
> can to build that consumer confidence.
>
> Some of the advancements we\'ve made is we found that the top butt,
> which is one of the higher dollar cuts, used to have all kinds of
> lesions in it from injection sites. We\'ve changed that. The injection
> sites are all done in the neck. Those of you that buy neck meats, I\'m
> sorry, but most people I know like to buy sirloins and top rounds.
> We\'ve dropped from 22 percent to 3 percent.
>
> The choice and prime product today is hitting the shelves heavier all
> the time and the dollar spread that I\'m getting paid for a choice or
> prime product is much greater than the select, in the neighborhood of
> about \$15 a hundredweight right now.
>
> And bruising and some of those difficult things that you got from
> hauling and trucking cattle to the packing houses caused by horns,
> we\'ve alleviated that. We\'re either breeding pulled cattle now or
> we\'re dehorning calves young.
>
> Again all about more quality.
>
> Feedstuffs. You know, I\'ve listened to some really good speakers and
> I recognize we probably still have a long way to go here. As a
> farmer-feeder, I produce probably\--well, my situation might be a
> little different. About 30 percent of my products are by-products, so
> they\'re coming from the factory but all the rest of the product is
> coming from the farm. We grow our own forages, we grow our own grains,
> and the only thing I actually buy are some mineral
> mixes\--vitamins-mineral mix and a little bit of protein\--soybean
> meal, sometimes even some urea, so probably less than a pound of that
> material I\'m buying out of a 42-pound-per-head-per-day diet.
>
> One of the things I really have to watch is what herbicides and
> pesticides am I using on my crops before I make them into animal feed.
> And I need to know that because there\'s violative residue issues, as
> well as just a safety issue. I\'m the first customer and so\'s my
> family and then you guys are my second customer, so these things
> concern me.
>
> We want to be sure that all the feeds that we do have coming in are of
> quality. You know, I probably relax a little bit because I figure that
> Herr Foods is buying products that are for human feeds and they\'re
> much better standards than animal feeds, so whatever they send me I
> figure is pretty good.
>
> We have to watch for molds, micotoxins. Most of that\'s done by sight
> and smell; secondly, cattle preference. If you\'re going to give
> cattle some rotten feed they\'re not going to eat it. They\'re going
> to walk away from the bulk and my objective is to get them to eat as
> much as I possibly can every day. Forty-two pounds was enough last
> week, Jim, but next week I want them eating 43 pounds because if
> they\'re eating 43 they\'re gaining just a little bit more and I\'m
> putting more green in the pocket.
>
> BQA talks a lot about suspect feeds and what to do. Again, like I
> said, I don\'t buy very many so this isn\'t an issue for me but in the
> policy, suspect feeds are to be checked frequently and tested to see
> whether there\'s any aflatoxin or molds or something like that that we
> need to be concerned about.
>
> I had to ask Jim. This one I remember seeing but I couldn\'t think
> about it. He straightened me out. We need to justify the feed products
> that we\'re using. Why do I use the Herr party mix? And then verify
> that it is what I think it is. They\'re going to send it to the lab,
> test it, evaluate what\'s in it. Then I\'m going to monitor the
> results. He might tell me it\'s a great feed but if the cattle aren\'t
> gaining or performing well or not grading the way I want them to, I\'m
> going to say, \"Wait a minute. My monitored results say it isn\'t a
> great food; what\'s wrong here?\" So that\'s where we go.
>
> You know, some things are just real common sense. The only
> postgraduate degree I got was a food handler\'s permit. I like to eat.
> Sometimes I like to cook and sometimes I even like to cook for a lot
> of people and in our county you have to have a food handler\'s permit
> in order to serve other people, especially if you get a dollar for it.
>
> So that\'s something I wanted to do and that took a lot of time and I
> got awful scared about what food handlers can do. It\'s kind of a
> scary business\--you know, some of the things that can happen to us.
> But one thing I learned was that in most cases it\'s common sense that
> everybody forgets and that\'s what this is here. This is just one more
> example. All of us know that but you know, when you have a BQA meeting
> and you mention it, somebody\'s light bulb finally goes off and says,
> you know what? I\'ve got my cat food sitting down in the feed room,
> where I feed my cat, next to my cattle feed. Don\'t belong there
> anymore, does it? Or pesticides, fly sprays. You know you\'re going to
> spray flies down in the feed room. Well, where are you going to keep
> your fly spray? Not in the feed room anymore.
>
> So anyhow, it\'s just a thing. Use some common sense. Make sure we\'re
> not putting things around feeds that we shouldn\'t.
>
> Biosecurity is an issue we\'re all hearing a whole lot about in all
> kinds of areas of our life, unfortunately. This is one that we\'ve
> really been cautious about. Obviously the trouble that England had a
> few years ago with BSE scared us a lot and then immediately following
> that they had foot and mouth, which even scared us more because we
> know how that disease can transfer easily.
>
> One of the things our farm has done for years and years has been open
> for all kinds of tours for the kids in the local schools, the FFA
> chapters and that kind of thing and we kind of shut it down for a
> while. We like telling the good story that agriculture has and where
> the food comes from. It doesn\'t always come from the grocery store;
> sometimes it has an earlier start than that and we enjoy telling that.
> But we got pretty nervous when we were reading some of the things that
> were going on over there and we didn\'t want it to happen here.
>
> So we watch very carefully where our feet go and also where the trucks
> come from that bring us cattle or take cattle out. We want to know
> those kinds of things.
>
> This just talks a little bit about what the BQA policy requires for us
> when it comes to vaccinating our cattle, doing herd records, and that
> kind of thing. It\'s pretty involved and detailed. There\'s over 900
> producers in Pennsylvania that have signed onto this in the beef area
> and the dairy people are just starting to get pretty excited about it,
> too, so I expect that number to triple here shortly.
>
> Proper management enhances beef quality and product value. That says
> it all. I mean that\'s what we\'re doing. We\'re just trying to
> enhance and get better.
>
> One of the ways we can do that, a lot of people are worried about
> antibiotics, both injectables and fed. One of the ways we can avoid
> all of that is to keep animals healthy and that\'s what this slide
> talks about. We spend a lot of time thinking about how we can keep
> these animals healthy. Obviously with only 120 cows you know that I
> don\'t raise all of the 1,500 cattle that we market every year. I buy
> in a lot of cattle, so I\'ve got to talk back and back and back not
> only from the seedstock grower but also into the backgrounder and then
> to the people that are providing me the cattle. How are they handled?
> What vaccines have they had? What medications have they had? What can
> I do, Jim, when I first get those cattle to make sure that they\'re
> eating instead of getting sick? So those are things that we talk about
> all the time.
>
> Another area that I\'ve seen a lot of improvement in is just total
> cattle handling and that\'s something that\'s been taught a lot to us
> from BQA. There\'s a couple of specialists out there that are bovine
> psychologists. I say that sarcastically but it\'s unbelievable what
> they\'ve taught us. If you\'d see our facilities, see a lot of changes
> have happened. It\'s very animal-friendly. The cattle move now. We
> hardly ever have to use a whip or a prod because the way we\'ve
> changed things, the cattle just naturally want to go forward, so that
> works out really well for us.
>
> Would you eat what you produce? Doggone right I would and I invite you
> to come down and have a steak with me any time you\'re in the area;
> I\'ll cook. But it\'s got to start with that baby calf and it\'s going
> to go all the way through while that calf\'s on its momma to when
> it\'s weaned and going through some serious stress to the time it\'s
> in the feedlot on a pretty hot ration till it ends up at your shelf. I
> want you to enjoy that product and I\'m going to do everything I can
> to make it right for you.
>
> BQA is part of a changing philosophy. There\'s a lot of people
> wondering why is beef so good right now? I would say that the number
> one reason isn\'t the border up above; it\'s the people in this room.
> Beef is back because demand is back and people are really enjoying the
> product today. That\'s because it\'s taken us this many years to
> finally get a product that\'s a whole lot more consistent in the
> grocery shelf, that when Mr. or Mrs. Consumer goes in and buys it,
> they\'re confident that when they get it home they\'re going to enjoy
> it.
>
> I really believe that and I can back that up with some numbers because
> we continue week after week after week since the border closed in
> early June to kill more cattle than we did before. Go figure it out.
>
> Real quick, beef quality assurance. You go through the course, you get
> trained, you get certified, but it\'s on-going training. I think Mike
> talked about that. It\'s been on-going. We\'re learning all the time.
> A few years ago, you know, nobody had to worry about BSE. We didn\'t
> worry about meat and bonemeal and where it was but today we really
> worry about it.
>
> So it\'s recent and it\'s every two years and it\'s a matter of just
> reevaluating your program on your farm. What could you do a little bit
> better? All kinds of new information comes out, like I say, regularly.
>
> A technician or veterinarian from the Pennsylvania Department of
> Agriculture in our case will actually come out and visit your farm and
> go over your records, go over your feedlots or your cow calf herd or
> whatever and just kind of check to see what you\'re doing and how you
> might be able to do it better.
>
> Again we\'re looking at HACCP and I kind of talked about this already.
> It\'s putting all the sciences together so that that little baby calf
> becomes that. It\'s hard, you know. I live with them things but they
> do taste good and my objective is to take very, very good care of them
> every single day that they\'re alive and recognizing where they\'re
> going in the end, but they\'re going to have a good life when they\'re
> with me, anyhow.
>
> That says it all. Only the farmer can really prevent the defect while
> he\'s got these cattle. Don\'t pass the buck onto the next person.
>
> Questions I have raised and Jim has raised concerning this meeting and
> I don\'t know if these are questions we\'re going to break out to or
> not, George, if they\'re close to what you had, but I really didn\'t
> know what this was all about. Maybe you guys knew before you got here
> but I\'m kind of like, \"What is this about?\"
>
> But what\'s considered a threat to human health? I know I know that
> we\'re looking at at strategic feed safety program that will result
> back to human health. What level of any threatening contaminant can be
> accepted, if any? How often should ingredients be tested? That\'s a
> good question.
>
> If samples are retained, how long should they be held for? You know,
> it might be one thing in Dave\'s plant to hold some samples but it
> would be crazy at my place. Also, which sample? I mean I know you guys
> may beaucoups of samples but it\'s probably crazy for you, too. You
> know, I might make 12 or 14 batches of feed in a day so which one
> would I save? How would I save it?
>
> And if we are going to sample, who\'s going to pay for it? That\'s a
> big question that farmers would raise really quickly. It costs the
> same amount to run a sample whether you have 50 cows or whether
> you\'ve got a 30,000-head feedlot. That\'s going to be a question
> that\'s going to be an issue for a lot of farmers, especially the
> small feeder-farmer. We\'re putting a lot of them out of business with
> regulation, so we want to be careful how we do this.
>
> Feed and food safety are important to all of us, no doubt about it.
> The current BQA program has been widely accepted by cattlemen and I
> emphasize widely accepted. A lot of cattlemen are excited about it and
> it seems to be meeting at least a lot of our needs for safety and also
> I think we\'ve seen a big improvement in quality for the consumers. I
> think we\'ve worked well there.
>
> Recommendation that I would have would be that any mandates that come
> out of this would fit into that current BQA model, that it would be
> voluntary.
>
> Well, there you go. There\'s that Ap again. I\'m sorry, Mike. But at
> the end of a day, and that was pre-Isabel, I\'m pretty happy at where
> I\'m at. I really love what I do. I love what I provide. I love the
> company I work for. My family and I love the food that we get to eat
> and I feel like God\'s really made me a very lucky man to be a steward
> of as much as I am and I\'m very thankful for that and I go to bed
> pretty comfortable, unless I have a meeting like this the next day.
>
> Next slide gives a contact. If anybody wants to talk further or wants
> to contact me about anything, there it is. I left some manuals at the
> back. They were BQA manuals from Pennsylvania. I think I see all of
> them are off that table. They sent them to me and told me to get them
> out; if anybody wanted to look through them they could. If anybody
> would like to see that manual and didn\'t get a chance to, again
> contact me and I\'ll see to it that you get one through our Beef
> Council Association. Thank you.
>
> \[Applause.\]
>
> DR. GRABER: Okay, the last speaker before we take a break is Dr.
> Richard Wood, Food Animal Concerns Trust.
>
> DR. WOOD: Once again I am giving a presentation that our food safety
> program manager should be giving but he\'s in another meeting. The
> last time this happened he was off getting married in Italy. I told
> him never again but here I am and I\'m also a little frightened.
>
> I\'m actually coming at this from a completely different perspective
> than we\'ve been talking about for most of the day because I was asked
> to step back and take a little at these questions of risk and a
> comprehensive food safety system from a consumer perspective.
>
> Food Animal Concerns Trust advocates for better farming practices to
> improve the safety of meat, milk and eggs. As a consumer group we
> address a range of issues regulated by the Center for Veterinary
> Medicine, including a focus on several feed safety issues. FACT has
> worked over the years diligently with the federal regulatory agencies
> to develop an appropriate response to bovine spongiform encephalopathy
> since the mid-\'90s and our work on pathogens in feed began when the
> FDA was discussing a zero tolerance for Salmonella in feed. Recently
> we\'ve also explored specific feed safety issues that may impact human
> health.
>
> At FACT we\'ve just completed the Nest Eggs Project, which for 18
> years was a for-profit company that contracted with up to 14 egg farms
> in Pennsylvania, where everybody else is from, except our offices are
> in Illinois, and we supplied uncaged eggs for major grocery chains
> stretching from New York to Washington, D.C. and also earlier in the
> Midwest and our organization itself has about 30,000 supporters
> nationwide.
>
> During the past 10 years at the regulatory level the primary
> intervention point for addressing food safety was through processing
> controls. Many of us here sat around this huge table at the USDA in
> the mid-\'90s to craft a HACCP plan for slaughterhouses and processing
> plants. As important as this intervention is, its impact on food-borne
> disease is mixed. We have seen a decrease in the incidence of
> camplylobacter and listeria but for several other
> pathogens\--Salmonella and E. coli 157 being the most important\--we
> have not seen significant reductions in human disease since 1996. The
> USDA FSIS has reported recent declines in both these pathogens in its
> regulatory sampling program. Hopefully in the future we will see these
> reductions reflected in the incidence of human disease. In any case,
> slaughter and processing steps need to be combined with preharvest
> controls if we are to continue this downward trend.
>
> We\'re delighted that the FDA CVM has recognized the importance of
> feed in the food chain and is taking steps to develop a comprehensive
> feed safety system. I\'ve been asked, as I said earlier, to take a
> step back and identify feed safety risk from a consumer perspective.
> There are a few of us here in the room, some from groups, and all of
> us sit down at the dinner table.
>
> This means two things for this presentation, though, in this kind of a
> setting. First, the obvious. I am not a renderer, an ingredient
> manufacturer, a feedmill manager, a state or federal regulator or a
> producer. Actually, I do live on a farm when I\'m not working in
> Chicago at FACT and FACT has managed egg farms for nearly two decades.
> But still I\'m here today as a consumer. I come representing that part
> of our lives where we do sit down at the dinner table and want our
> plates to be filled with food that is safe.
>
> Second, I\'m here to identify and discuss priority risks related to
> animal feed and human health. Therefore I\'m going to work through a
> set of risks that we feel must be responded to in a comprehensive feed
> safety system. The FDA and/or the industry already have effective
> controls in place for many of these risks on what I will list and
> it\'s been delightful today to hear presentations from various groups
> that have understood the risks that are out there and are taking
> concrete steps to respond to those risks with controls.
>
> Still I want to identify those risks because as the feed safety system
> is constructed, everything must be on the plate. Just because it\'s
> working doesn\'t mean it should be ignored. Other risks I will
> identify do not have agricultural controls and will require tougher
> and more complete controls as far as FACT is concerned and I\'ll leave
> most of my comments to those issues.
>
> FACT recognizes that BSE has not been detected in domestic cattle in
> the United States and that only one infected cow was identified with
> BSE in Canada. FACT sees this as an indication that steps taken by the
> FDA and the feed industry have protected American consumers and the
> livestock industry. Still the occurrence of the mad cow across our
> border requires us to reexamine our BSE control programs so that
> consumers can continue to have confidence in what they eat.
>
> The U.S. system and that of Canada are practically identical, as you
> know. Millions of cattle have crossed back and forth across the border
> and also all during the period when the cow detected earlier this year
> was incubating the disease. Any comprehensive feed risk management
> system needs to acknowledge the possibility that there may be
> BSE-infected cattle in our national herd. Given this possibility, we
> need to strengthen our programs aimed at keeping the disease from
> spreading between cattle.
>
> This first risk is an area where we at FACT, as a consumer group,
> believe that more needs to be done. Additional steps are under
> consideration by the FDA. Here are two steps that the FDA should take.
>
> First, the FDA should close the loopholes that exist in the current
> feed ban. One loophole is the use of poultry litter in cattle feed, as
> we see it. Both cattle and poultry are raised in large numbers in
> several regions of the country and it is in those regions where
> poultry litter is likely to be used as a feed ingredient. It\'s in
> areas where they\'re not raising potato chips or popcorn or whatever
> the feed ingredient we heard was from the last speaker.
>
> Also, today there may be increased poultry litter recycling due to
> stronger regulations of livestock waste as an environmental pollutant.
> FACT does not have explicit data on this practice but in meetings with
> producers a couple of weeks ago I was told that cattle producers would
> rather not use poultry litter, even though it is used.
>
> The issue, of course, is that the protein that is passed through the
> digestive tract of chickens or spilled from the feeders is a ruminant
> by-product that can be a protein source for chicken feed. Poultry
> litter varies in the amount of crude protein from 13 to 31 percent,
> according to Cross in 1995. There is no evidence to suggest that the
> digestive tract of chickens will destroy prion proteins, which are not
> readily destroyed by low pH or digestive enzymes. Also, the practice
> of composting and drying litter would not destroy the prions if they
> were present.
>
> So poultry litter can also carry levels of Salmonella and
> camplabacter, important food-borne pathogens that are also not fully
> controlled by composting. FACT wants the practice of recycling poultry
> litter to end.
>
> Another loophole to close is requiring feedmills to establish
> dedicated equipment for handling prohibited materials unless there is
> a satisfactory method in place to ensure the effectiveness of steps
> taken to prevent cross-contamination. Dedicated facilities are the
> only way to ensure that cross-contamination does not occur, given the
> inability of the regulatory agencies to provide a daily presence at
> this facilities, as does the USDA at their inspected sites. Dedicated
> equipment is particularly important given the recent history in Europe
> where cross-contamination is implicated as a likely cause of many of
> the born-after-the-ban BSE cases. If dedicated equipment is not
> required, FDA needs to act to prohibit repeat violators of the rule
> from marketing feed intended for ruminants.
>
> Also, more effort needs to be placed on developing a test for
> prohibited proteins. If such a test were available, then the
> effectiveness of procedures to control cross-contamination could be
> evaluated. Unless mechanisms for testing for prohibited proteins is
> developed and incorporated into a monitoring system, FACT believes
> that dedicated facilities are necessary for an effective ban.
>
> Other possible loopholes in the ruminant feed ban that have been
> discussed more thoroughly in other forums are those of allowing plate
> waste to be used in ruminant feed and the impact of using automatic
> meat recovery systems. The USDA just responded a little more
> stringently to that, apparently. Consideration also needs to be given
> to the likelihood that some specified risk materials may need to be
> removed from the animal food chain altogether, and I think this is a
> step that Canada may take. An animal feed safety system needs to close
> the gaps in the BSE feed ban to protect American cattle and human
> health.
>
> A second step is that the feed ban must be fully enforced. I haven\'t
> checked since Hurricane Isabel but the FDA has not updated its
> compliance information since last year; at least not on its website.
> Maybe that project is done. But when reviewing the data that is
> available, renderer and federally regulated feedmill companies looked
> pretty good a year ago. Last year\'s GAO report, though, questioned
> the reliability of FDA\'s compliance statistics. Statistics aside, it
> is time for the FDA to move beyond education to enforcement.
>
> An equally serious compliance issue that many of you in this room may
> want to speak to at some point is the current ability of states to
> enforce the ban. I understand that AFCO and the feed industry are
> taking steps to change the state regulatory climate so that the entire
> BSE rule can be enforced by inspectors in every state. However, most
> states have serious budget deficits. It would be helpful to learn how
> the states are faring in these difficult economic times regarding the
> ban\'s enforcement and dealing with compliance and also to learn about
> the continued federal funding for monitoring BSE. BSE is an area of
> primary risk for consumers. We feel that further regulatory steps are
> needed.
>
> The role of pathogens in feed must also be reexamined in terms of
> their being a threat to human health. FACT has long maintained that if
> you want to reduce the risk of food-borne illness in humans, you
> control pathogens in animal feed. This is why for 17 of the 18 years
> of our Nest Eggs Project in Pennsylvania we cooked the feed for the
> layers on our farms and then periodically tested the feed for
> Salmonella.
>
> We all have devoted huge amounts of time and resources to developing
> and implementing controls for BSE in feed and more needs to be done.
> Still we have not had any BSE Creutzfeldt-Jakob-related deaths in the
> U.S. On the other hand, the CDC estimates that bacterial food-borne
> pathogens account for 5 million illnesses, 46,000 hospitalizations and
> more than 1,400 deaths each year in the U.S. While some of these
> illnesses and deaths are attributed to contamination, some are down
> the food line beyond the farm gate; animals are the primary reservoirs
> for these bacteria.
>
> Studies focussing on Salmonella have documented that animals can
> become infected when eating Salmonella-contaminated feed. Studies
> presented a couple of weeks ago on E. coli 0157 are still not
> conclusive at that point, although these studies do see contaminated
> feed as a contributing factor.
>
> An article published last fall in Clinical Infectious Disease, and I
> saw copies back there on the table from somebody, by John Crump and
> others from the Centers for Disease Control identifies three major
> steps to address animal feed safety out of a concern for food-borne
> illness. The first step is to establish surveillance of animal feed
> for microbial contamination, integrating that surveillance with the
> surveillance of food in humans. This step as I understand it is
> already under way.
>
> Second is to establish HACCP programs across the animal feed industry
> to minimize Salmonella. The reports provided at this meeting from the
> presenters we\'ve heard in the reports prior to me indicate that this
> step is already being incorporated into operations on many feedmills
> and other places.
>
> Third, implement a Salmonella negative standard for animal feed. The
> FDA announced this policy in 1991. A few years later when I began at
> FACT I remember the feed industry stating that zero tolerance was
> impossible and, in essence, what we were asking the feed industry to
> do was to lie. Today a Salmonella negative standard is a necessary
> risk management step to protect human health. I know that an industry
> group has questioned the data from the study that I just mentioned but
> the validity, to me, of these three steps stands on its own.
>
> In our view, the presence of resistant pathogens or resistant
> commensal bacteria also needs to be monitored in animal feed. Steps
> need to be developed to ensure that the highly virulent
> multi-drug-resistant disease strains, such as Salmonella DT-104 or
> Salmonella Newport, are not spread through feed.
>
> The undeclared, unintentional or inappropriate use of feed additives
> is another area of risk for human health. Drug residues are one such
> contaminant that can occur due to cross-contamination in feedmills.
> Medicated feeds left over in the equipment from one batch may
> contaminate the next batch of feed that is not medicated. Feedmills
> are required and what we\'ve heard this morning, do implement good
> manufacturing practices to reduce the risks of this type of
> contamination. Still, clearly more can be done. One study in Europe in
> 1998 found that 35 percent of the 250 medicated feeds tested had
> undeclared antimicrobials and of the 160 unmedicated feeds tested, 44
> percent contained antimicrobials.
>
> It\'s my understanding that we do a good job of controlling residues
> in the U.S. Still, this risk needs to be on the table as a
> comprehensive plan is put in place.
>
> An equally important unintentional consequence of a feed additive is
> when antibiotics are added to the feed to promote growth or to prevent
> disease. The routine use of antibiotics in this way results in
> resistant bacteria in the animal. The risk to human health is that if
> the food product is not thoroughly cooked these resistant bacteria may
> infect humans, resulting in antibiotics being less effective in the
> treatment of food-borne illness.
>
> In 1998 the American Veterinary Medical Association and other
> veterinary specialty groups, along with the FDA, developed a position
> on judicious antimicrobial use. This position identifies 10 steps that
> should be followed in treating sick animals through the therapeutic
> use of antimicrobials. No such prudent use protocol exists for
> nontherapeutic uses with animal feed. We believe that a feed safety
> system needs to address this risk.
>
> Regarding alternative additives, enzymes, antibodies, and so on, we do
> not know how many of these products will interact with the complex
> ecology of animal digestive tracts.
>
> Regarding other unintentional, undeclared contaminants, the feed
> industry has described its control programs for addressing dioxins.
> Still, the FDA should provide a clear benchmark for dioxin
> contamination levels. Heavy metals\--lead, mercury, and cadmium\--are
> metals of concern. Also, there is a real risk that toxins ingested in
> livestock feeds can be transmitted through animal products. The extent
> of this risk is unclear but these natural toxins are important because
> of their potential as carcinogens. Everything we\'ve heard today
> indicates that the industry understands this risk and have controls in
> place.
>
> As we\'ve heard in the earlier presentations, another way of
> organizing the human health risks is to determine which source
> materials are most problematic. For example, downer are already
> prohibited from being used in ruminant feeds and for good reason. The
> Harvard BSE risk assessment found that downer cattle are the ones more
> likely to carry BSE than healthy cattle at slaughter. Downers also
> carry a higher incidence of food-borne pathogens and illegal drug
> residues.
>
> The use of reclaimed industrial waste is a risk due to heavy metals,
> dioxins and PCB contamination. And the use of recycled animal waste is
> a risk, as discussed earlier, because of BSE residue and pathogen
> concerns.
>
> In summary, as we take these risk together and place their controls in
> one system there are several important components to a feed safety
> system from our perspective. First, the system should establish a mix
> of voluntary actions and regulations, as needed. Second, it should
> require that current feed-related policies be enforced. Third, the
> riskiest materials should have the greatest regulation.
>
> Fourth, it should provide an integrated surveillance system, beginning
> with the feed ingredient suppliers and continuing on to human health.
> The USDA and CDC should also be involved in developing this system.
>
> Fifth, the decision-making process should be transparent. The public
> must become fully informed of the risks they face and the responses
> being discussed. And sixth, we must recognize that a comprehensive
> animal feed safety system does not stop at the feed distributor\'s
> door. Thank you.
>
> \[Applause.\]
>
> DR. GRABER: Okay, the idea for the program this afternoon was really
> to inform us and to get us thinking about food safety systems and
> animal feed safety. So really the critical part of the program, as Dr.
> Sundlof talked, is going to start after the break. That\'s when Gloria
> Dunnavan will explain why you\'re all here and what you\'re going to
> do.
>
> \[Whereupon, at 4:15 p.m., the hearing recessed, to resume on
> Wednesday, September 24, 2003.\]
>
> \- - -