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Transcript: FDA Public Hearing on Ensuring the Safety of Imported Foods and Animal Feed: Comparability of Food Safety Systems and Import Practices of Foreign Countries

Thursday, March 31, 2011


CAMILLE BREWER:  Good morning.  I have 9 o'clock so let's get started. 

My name is Camille Brewer and I will be the presiding officer for this Part 15 Hearing.  I'd like to welcome you and some of you to welcome you once again.

Today we're going to be looking at best import practices.  You'll learn about an activity that FDA is about to initiate to obtain information from trading partners on their best import practices.  We want to learn what works very well and what could be improved upon. 

So we'll spend the morning talking about those practices.  And later in the morning, we'll be talking about capacity building, how capacity building lends itself to better imports and safer imports.

A Part 15 Hearing is a formal hearing in which FDA has the opportunity to learn from stakeholders.  We're sitting in the chair with senior leaders from FDA and we'll have the opportunity to ask questions of the panelists.

Dr. Steve Solomon is the Chair of the FDA inquiry team and he's joined by Dr. Murray Lumpkin, Commander Dominic Veneziano, Mary Stanley from FSIS, Dr. Katherine Bond from our Office of International Programs and Dr. Julie Moss.

They're joined by some senior advisors from FDA and they're in the first row.  They are Dr. Michael Wehr, Ms. Charlotte Christin and we're expecting at least two attorneys to join us.  So when they come I will introduce them as well. 

I neglected to introduce Dr. Merton Smith from CVM who's also on the Inquiry Panel today. 

So I have a number of housekeeping items.  We do have media in the room.  Could you, please, raise your hands so we know who you are? 

(Persons comply.)

CAMILLE BREWER:  Okay.  If you are media, I want to introduce Sebastian Cianci and Stephanie Yao, and they're in the back of the room.  Please see them if you have any questions.

There will be the opportunity for public comment at the end of the program today.  And if you have not signed up, please see Ms. Juanita Yates.  Raise your hand, Juanita, at break so you can sign up. 

Other housekeeping, there are restrooms, go to the top of the stairs; they're to your right. 

We have two hospitality rooms, one for our partners from foreign embassies and members of other Federal agencies and other foreign regulatory agencies.  If you have luggage you can leave your luggage in one of the hospitality rooms and they're both up the stairs and to your left. 

So with that let's get started.

And our first speaker today is Dr. Murray or Mac Lumpkin.  Welcome, Mac.

MURRAY LUMPKIN:  Thank you, Camille.  And let me also on behalf of Commissioner Hamburg and all of us at FDA send our very sincere welcome to all of you for coming, and particularly, as Camille said, for those of you hardy souls who have made it now three days in a row.  It's nice to have you with us.  I'm sure you've had your fill of FDA and will be quite glad to get back to your e-mails and your real lives tomorrow.

I do again want to express a very special word of welcome and thanks to our guests who have come from overseas to be a part of the panels that we've had these past three days.  As those of you who have been with us know, we could not have done these panels without them.  They are clearly a source of a tremendous amount of knowledge and experience that we had hoped to gain from them.  And I think what we've gained in the past two days has shown that our hopes have been far exceeded in what we've been able to gain and learn from them.  And I know today is going to be the same.

As Camille said, today really is a Part 15 Hearing where our focus is to again continue to see how we can learn from the experience of our respected counterpart colleagues.  I think we all know, we've talked about how the products that we are interested in have a global pedigree and how they are part of a global enterprise. 

I think we're also learning more and more that the regulatory enterprise is a global enterprise and that we're all who are involved in that, part of not only looking at things through our own national lens but looking at them through the wider global lens.  And what we can learn from our respected counterparts is really a great deal in what we're trying to do today. 

Part of that learning is to really try to identify what have been best practices that they've been able to institute when it comes to two major challenges or two major mandates that we have within the new safety legislation.  One of those, as Camille pointed out, is the best practices as they relate to imports.  And we're very interested in hearing about policies, about programs, about individual practices that happen in various parts around the world. 

Some of the things that I think we would be delighted to hear about and that we'll be asking questions about really get into the details of certification programs:  What they mean; how you do them; how you authenticate certificates; how do you work around the issues of counterfeiting when it comes to certificates; the issue of transshipments, how we handle transshipments; what they mean, what they don't mean; what they add to product safety, what they detract from product safety; how you handle differences and standards. 

We talked a great deal yesterday about what it means to have an equivalent or to have a comparable system, but what about within that system when you have individual standards for a product that are different; how do you handle those; what does that mean in reality when It comes to the border.

And one of the things, as you've heard over the last two days that we do struggle with a great deal is trying to identify metrics that will allow us to measure the effectiveness of these practices as we go forward.  So any ideas that people have on metrics and ones that they have used in the past that have been helpful in trying to assess the effectiveness of best import practices are things that we're particularly keen on hearing.

The other side, the other issue today is this issue of capacity building.  And capacity building means many things to many people.  We probably have as many definitions of capacity building as there are people in this room.  And we're going to talk in a few minutes about the definition, or at least the context in which the new legislation speaks to capacity building and some of the mandates, some of the challenges that they present to us as we go forward with trying to build a better food safety system for the United States. 

When you start talking about capacity building, what does it mean in the context of bilateral relationships, multilateral relationships, interfacing with the private sector, both NGOs and private businesses and other multinational organizations?  How do we leverage what other people are doing so that we're not being duplicative?  And not only what other people are doing within the sense of true agencies and organizations who are missioned for development, but leveraging the activities of our counterpart regulatory authorities so that indeed we are not being duplicative and wasteful of our resources.

And once again, this big issue of metrics continues to come up.  And the idea of if we're going to engage in these activities, how do we assess whether indeed having done something actually leaves a footprint someplace in the world?  If we think we're building capacity, what does that mean?  And if you were to go back a year later, would you be able to tell that your efforts had made any difference? 

And not only difference in the sense of does something exist, did you actually leave a footprint, but what is the impact of that footprint on the public health of the United States which is where we are focused and the public health of other parts of the world where these capacity building efforts are underway.

For those of you that were with us on Wednesday you saw this slide and I put this up to kind of bring these issues into context because even though we've talked about a lot of the changes that happened under this law, one of the major changes that did not happen was a fundamental change in the mission of the FDA.  We are still, as we have always been, a focused public health domestic agency.  That is where our mission is, that is what we're funded to focus on, that is what we're held accountable for doing.  We are not missioned and clearly we are not funded as a trade promotion or as a foreign development agency.  

But when you start talking about import practices, when you start talking about capacity building, this begins to blur a little bit.   And one of the things that we're quite interested in hearing peoples' opinions on is how we do this because this is something that we are struggling with. 

Clearly, not everyone seems to understand that we were not given a new mission, we were not given a new mandate to go forth and create little FDAs around the world.  When you look at our staff of around 12,000 people, if you add up everybody, whether it's the people at the border, whether it's my staff, whether it's the international affairs staff here at CFSAN; those of us who spend our entire day and evening focusing on international issues for FDA, it probably comes to around 450 FTE out of the entire 12,000 that are here. 

As all of you know, even though we got a new law, we got no new resources, so there are no new dollars, as it were, for capacity building kinds of undertakings or for any of the other things that we are mandated to do.  And so part of our challenge is how do we leverage, how do we do what people expect us to do but do it in a way that we use the meager international resources that we have, in a way that we leverage what our counterpart agencies are doing, what development agencies are doing, again, so that we can actually leave a footprint and hopefully accomplish the domestic mission that we have.  And hopefully that we can do it in a way that it's a win-win for all of us that are involved, because as you'll see again and as I mentioned on Wednesday, when you read the mandates in the legislation, people could interpret them in a very self-centered kind of self-absorbed way that what they're talking about and we'll show them here in a few minutes is these activities are done for the purpose of helping to assure that the U.S. food supply is indeed safer. 

And so the issue is, that's fine, that's what our mission is, but how in the global context do we integrate that in to the larger development, to the larger import practice and schemes around the world in a way that it is a win-win, not only for us here in our country, but for people in other parts of the world.

So let's look at some of these sections here for just a minute.  There are two sections that I just wanted to point out.  There are many, many parts of the new legislation that have components that have a very large impact on what we do internationally.  But I just want to highlight two.

The first is Section 305, which is for lack of a better term, the capacity building section of this act.  And it says that, “The Secretary shall not later than two years of the date of the enactment of this Act, develop a comprehensive plan to expand the technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries from which foods are exported to the United States.” 

So this is where you begin to see the specific context in which Congress gave us this mandate to look at our activities for capacity building. 

But it's interesting when you look further into the Act the kinds of things that Congress put under this umbrella of capacity building some people might argue are not really the traditional kinds of capacity building things.  And you have to read into them the idea that one does capacity building in order to accomplish some of the things that are listed up there.

For example, in number one, doing arrangements, doing capacity building, working with foreign counterpart agencies so that they can be responsible or more responsible or more effective in ensuring the safety of foods that are exported from their countries. 

That we work on issues of securing electronic data-sharing, that we work on ways of using each others inspection reports to make our own regulatory decisions in ways that continue to protect at the same level or even at a higher level but at the same time are not being duplicative and wasteful of resources, and allowing us to use the resources we do have for the higher risk questions or going into places where others are not going.

Making sure that people overseas who want to send their products to the United States indeed understand what our standards are and what our expectations are.  How can we use organizations such as Codex and other initiatives in a more effective way for utilizing our resources there so that other countries with whom we trade and who wish to send their products to the United States will be aware of and able to use these internationally agreed standards.

The other section I wanted to point out was the one that indeed put into law that we shall establish foreign offices overseas.  And I bring this one in not to talk about the foreign offices because we did that on Wednesday, but again to say that one of the ideas behind the foreign offices in the Act, was to provide assistance to the appropriate governmental entities of countries who indeed are shipping products to the United States.  Again, putting it into context why indeed Congress has asked us to be involved in these kinds of activities. 

Now, one of the things that Camille asked me to do after kind of setting the context for the discussions today is also to give you a little bit of a background and a little bit of a foundation in the things that we are already doing in these areas.  We clearly are not starting from ground zero on this.  There's been a long history in our Agency in our interaction with our counterpart agencies around the world with a lot of capacity building kinds of activities in the broad sense of the word. 

And what we want to learn today is from this foundation, what do people think we need to refine, what do we need to re-look at, what do we need to do new, what can we learn to do better from what other people are doing in other parts of the world? 

But, again, the whole idea is this idea of leveraging resources.  It is not that we have new resources to do this, and depending on the budget that we ultimately end up getting, one could argue that we might even have less resources to do this than we've had in the past, which simply means that we have to do what we're doing better and we have to do it in a more leveraged way with our counterparts around the world. 

Now, I just put up here, and I know that, at least I understand from Camille, that the slide sets are going to be made available to all of you, so just know that you will get all of this because you're going to see on some slides coming up a lot of information that I just wanted you to have for background.  But what I was trying to do here was just to give you an idea of kind of the broad scope and the breadth of the kinds of international work, the kinds of engagements we've had over the past decade.  And what has been interesting and what has been the real change in many ways is seeing our international work going from what it was ten years ago where most people in our Agency thought of it as discretionary work, as kind of work that we did when we could.  And you see this paradigm shift from it being discretionary to now it being recognized as an integral part of how we do our business. 

And that shift from discretionary to integral has been really the -- one of the major contextual elements of the kinds of work that we've been doing historically.

Historically, over the past five years, ten years, we have been engaging in many different ways.  We engage bilaterally; we'll talk about some of those in a few minutes.  We've been engaging multilaterally with international organizations, with various harmonization initiatives, and much more recently with the advent of product-specific regulatory alliances that I'll speak to you about in a couple of minutes. 

And also, more recently also with the private sector as we've gone out to try to see what the private sector is doing and how we might be able to appropriately leverage with NGOs and other elements of the private sector who are engaged in these kinds of activities.

Bilaterally, most of our work in the past has been looking at topic specific workshops, meeting with various delegations, doing various training both here and overseas.  We've had temporary staff secondments with many of our counterpart agencies around the world.  We have confidentiality arrangements that I'll talk about in a second that allow us now really to have daily exchanges in really high numbers of very, very critical information with our confidential counterparts around the world and probably the epitome of this is the embedded officials that we have from the EU who now are permanently embedded with us at FDA from both the European Medicines Agency and the European Food Safety Authority and also the people from FDA that we have embedded in London and in Parma at those two agencies.

When we talk about collaboration we have a long history of agreements of various kinds.  We have over 100 bilateral agreements at this point in time.  All of these are on our website.  So if you're ever up late at night and want to read bilateral agreements you can go there and see them. 

We also have confidentiality commitments with over 20 countries.  We have it also with Director General Sanco in the European Commission; we have them with the European Medicines Agency and the European Food Safety Authority.  We have it with EDQM, which is for -- the best way of thinking about it is the European USP, and we have it with the drugs on the biologics side of the World Health Organization.

These confidentiality arrangements and most of the other bilateral arrangements are really tools for information exchange and to allow us to do other affirmative kinds of collaborations. 

These are the list of the countries where we have confidentiality commitments with our counterpart agencies.  These are not country-to-country agreements, these are agency-to-agency agreements so when you think about the various products that we are responsible for at the FDA generally in these countries our counterpart agencies are the ones with whom we have up to this point in time developed our confidentiality commitments.

What these do is provide us under our regulations with a legal framework that allows us to disclose to them and allows them to disclose to us otherwise non-public information, which could include commercial confidential information, pre-decisional information, investigative or compliance information, but U.S. law does not allow us at this time to use these as a way to -- to share trade secret information even in the -- even when we do have a confidentiality arrangement. 

These do not require us to exchange anything but they give us a legal framework to allow us to do so if we wish to do so or if one of our counterpart agencies wishes to do so. 

We have very specific initiatives that come from these confidentiality agreements and it depends on the country, it depends on the issue, the importance of the issue, the level of capability, the history of our interactions, the willingness to do it, the level of confidence that's been built over the years and really we have to answer the question as in all of these things, is the juice worth the squeeze of the resource that you put into this?

And I just gave you some examples here of like the active pharmaceutical ingredient initiative we have with the Australians and the Europeans, the GCP initiative we have with our European colleagues and a medical device initiative we have with our Mexican colleagues. 

On the multilateral side, just to give you an idea of the host of multilateral organizations with whom we interact and have interacted, the WHO is obviously one of our major ones, both on the food side of the house with INFOSAN and the food work that they do but also on the vaccine side of the house and other on the medical product side.

The Asia Pacific Economic Cooperation, which you'll be hearing more about today, is an organization that we have begun using much more, particularly on the food side of our house for training.  And I hope you'll find the talks about that interesting as you will hear this the year that the United States is the host nation for APEC and the food safety component of APEC is one of the major focuses that we have, that the United States is putting on the calendar this year. 

We also work with the Pan American Health Organization, with OIE, both on training and using their good resources, their imprimador and their connections in many parts of the world to train on international standards such as with OIE.  You'll hear in a few minutes about a collaborative agreement we have with them to use the VICH agreed standards and using OIE as a mechanism for that training.

You're going to be hearing later today about FAO so I will not spend time talking about the relations that we have there, but, again, clearly in the foods world that's one of our major ones.

Again, I just listed ones here.  The one I wanted to highlight for you today are the last two.  One just is -- just to give you an idea of where you see a lot of things going and that we're very interested in working, this is one on the medical products side of the house, but it's an initiative under the East African community where they're looking at regulatory harmonization that involves WHO, the Gates Foundation, the British Aid Foundation, the World Bank, and many of us on the regulatory side working together as a capacity building effort within the East African community.

And I know we've got Bill and others that are going to be talking today about the Quads work in the food side of our house that we do multilaterally with Australia, Canada and New Zealand.

One new thing that I want to just mention to you because this is new to us, we just started this last year.  We made a decision to use some of the money that we had been given to stand up the -- the foreign offices and to be engaged much more in foreign initiatives to work out cooperative agreements with some of the multilateral organizations. 

And Dr. Katherine Bond is going to be talking to you about some of these that she'll -- that I'll just highlight.  She'll go into depth a little bit more about what they are, on the ones that primarily are focused on foods. 

But just to give you an idea, these are cooperative agreements that we signed in the past 12 months with WHO on surveillance for falsified and substandard medicines.  One that we've got with PAHO on building a regional information hub for regulatory activities, and then we've got a series here that you'll see a little bit -- that you'll hear more from Katherine that I talked about on the Global Food-borne Infections Network work with WHO, the Integrated Food Safety Information Platform to Facilitate Data Sharing with WHO and the one I mentioned a few minutes ago with -- that should be OIE that deal with regulatory capacity strengthening and trying to get many, many more countries to adopt the VICH International Standards in the world of animal drugs. 

Some other things you will hear from Katherine about include various contracts that we've gone out with to also help us learn more what is going out there and to get more ideas on how we can do what we need to do here in a better way.  We have contracts that are looking at the global supply chains and formulating strategies to address various weaknesses, both on the medical products side of our house and the food side of our house, looking at the fundamentals of regulatory systems around the world and where we as FDA might be able to fulfill certain niches that might be ones that are unique to us as a regulatory agency that we might really want to focus the efforts that we have to make the biggest difference and leave the biggest footprint.

And this whole idea of leveraging, we've got one of our colleagues here from USAID.  We are beginning to have a much more interactive relationship with USAID.  This is a very small first step that we have looking at pharmacovigilance in Africa for certain antiretroviral products.  But I think you see here the beginnings of the thought processes and the relationships and the legal frameworks to allow us to work with our people -- with multilateral organizations much more than we have historically.

I just want to mention the harmonization initiatives.  Again, something that we have been doing for many years here, we've been a part, as you've heard and as all of you know, with Codex.  But it's not just Codex.  On the medical products side of our house we also have harmonization efforts that we've been a part of for the past ten to fifteen years. 

What I did want to mention is more of a new thing that is beginning to develop and that is this idea of specific -- product-specific regulatory alliances where regulators from various countries who are focusing on one particular product area are beginning to come together and form these regulatory alliances to allow us to talk with each other, to share information, to share best practices, to use each other as peers, both at a strategic level and at a senior executive level and at a technical level.

We have the summit of heads of medicines regulatory agencies, which started about six years ago, the Medicines Regulatory Forum, we have it in cosmetics, we have it in pediatric medicines, in vaccines and combination products, in medical devices.  We're beginning to look at one for tobacco on good manufacturing inspectorates around the world and the Quads that you all are well aware of. 

This is just to give you a picture.  This was the Medical Products Heads of Agency Meeting.  You see Dr. Hamburg there in the center.  This was just to show you one of the groups that -- of these regulator alliances that are coming into being.

So to finish, I mean, as we looked over the  last ten to fifteen years, what we've learned is that we are part of a global enterprise, that it's not only our products that are part of a global enterprise but the regulatory enterprise also has a global pedigree we are a cog in that wheel but it's a cog that's part of a wheel, it's not the entire wheel by any means. 

That none of us has the financial, human or scientific resources to do all that our parliaments or people ask and expect of us.  We cannot meet our missions by only looking within our own borders.  We've learned, I think, that no nation or no regional authority has a monopoly on good science or good regulatory practices, they are our peers, we have much to learn from them and we're happy to share our experiences and hope that they find them helpful. 

The sum of our parts as regulatory authorities, it's clearly superior to their individual value.  And as I said at the beginning, regulatory cooperation is no longer discretionary.  We might have been able to make that argument ten, fifteen years ago, but the shift has occurred and continues to occur, that if we're going to be an effective 21st Century medicinal and food products regulatory authority, we have to be part of the global community that exists and that is the reality of the 21st Century.

In other words, the regulatory cooperation has to be part of our standing operating procedures, it is no longer discretionary, it is an integral part of what we do.

So the question is:  How do we do it better?  What are the best practices for doing so?  And that's what we hope to learn more today. 

So I am looking forward to hearing what our colleagues here have to say, to hear the questions that we get to ask and the answers from them and also hearing what you all have to say at the public session.  So if you've got ideas on best practices within the world of import controls and in the world of capacity building and the broad definition of capacity building, we're looking forward to hearing from you.

Again, thank you very, very much for coming.  And I hope this helps set the scene for the rest of the day.  Thank you very much.


CAMILLE BREWER:  Thank you, Mac. 

We're going to move right into the first panel.  The biographies are in your information packets.  We won't be reading those today. 

We're going to start with Dr. Julie Moss and she'll give us an update on our best practices activity. 

We'll move next to GAO. Anne Johnsonis going to talk about the study that was done a couple years ago on import safety. 

Renata Clarke is here from Rome from the FAO and she'll discuss her mature food safety system study. 

We'll move right into sharing country experiences, Australia first, Simon Smalley; New Zealand, Bill Jolly; Canada, Mary Ann Green and the EU Carlos Alvarez.  And, Carlos, you won't have to follow Bill Jolly. 

JULIE MOSS:  Good morning, everyone.  It's a pleasure to be here today with you all.

I'd like to take just a few moments to share a study that we're doing with regards to import best practices.  I'll just take a few minutes before we really get into the meat of this panel discussion this morning. 

The study that we have -- are looking into is to reiterate what Camille said earlier, is to really looking and learning about the import best practices of other countries.  Sometimes when we get too close to an issue we just can't see the obvious.  And so this is our opportunity to step back and learn some opportunities, learn some lessons learned from our trading partners. 

So the true reason for doing this is simply just that, for a learning opportunity for us and to really possibly consider some of the options that other countries are doing into our import programs.

What we did is we let two contracts, which we started in 2009, and we're doing this in two phases.  The first one was to develop the survey or the instrument and to pilot it so that we can validate the instrument.  And second is to actually conduct the survey.

For Phase I for the pilot phase, we started this and did this through 2009 and 2010, where we had a contractor that we were working with as well as some subject matter experts.  And these subject matter experts were recently senior level officials that retired from the Center for Food Safety and Applied Nutrition.  And I'll call them out because some of them are in the audience today:  Lou Carson, Bob Lake, Cathy Carnevale, Faye Feldstein as well. 

And we developed a survey instrument with the contractor and with the subject matter experts with eight specific categories that you'll see on the screen in front of you today.  This is to be used as an interview guide for a conversation with our trading partners about their import best practices.   

And just to give you a flavor of what the interview guide that we've developed, I'm just going to read one question for you.  The intent is for these conversations to be very informal, to provide open-ended questions so that we can just get as much feedback and learn as much as we can from our trading partners.

Under the inspection programs, one of the questions is:  Do you have a system in place to prioritize surveillance activities such as product sampling and testing, inspections at the border and facility inspections of the exporting country?  If so, what method is used to determine inspection priorities?

So you can see that they're very open-ended questions to open a dialogue to have a nice discussion.

Also, within the pilot program or the pilot phase, we -- once we developed a questionnaire we wanted to validate it so we brought in a social scientist to help so that we know that we were asking the right questions so that we could get the feedback that we were truly looking for.  And we validated it with the U.S. respondents here in the U.S. both from FDA and USDA.

All right.  Now we're going to get into the full study actually beginning right now.  We have a contractor that we have let, that's going to utilize the validated survey.  We're bringing in the same subject matter experts to help facilitate these discussions and dialogues with our trading partners.  We have gone through a country selection and determined the process and timeline of how we want to conduct this and I'll share that in the next two slides. 

What I really want to emphasize is that the -- again, the point is for information gathering. We're not going to provide -- do any judgments or evaluations on the information that we're learning.  It's really to see and to learn from what our trading partners are doing to identify trends that are possibly out there that we may not be aware of at the moment. 

So in terms of selecting the countries, we really just looked at a common sense approach.  And I'm going to go through these four steps that we looked into in terms of considering the countries that we wanted to do for this particular study:

Countries with whom we share a border, have significant trade with and historic strong relationship.

Secondly, countries that represent a range of economies and a variety of import practices. 

Countries where FDA has international offices.  And I will say there's a two-pronged approach there; one is logistically to have their support for when we conduct these discussions and secondly, is to utilize the relationships that they have built since being in countries for the past couple of years. 

And the fourth item is to align with or utilize the countries that were included in the FAO's Mature Food Safety System Study, which Renata will explain shortly to you. 

The U.S. was a participant in that particular study and we thought it would be a nice opportunity to build from that particular study as well to get a clearer picture.  So we did try to select a country or two that also participated in that particular study. 

The countries that we have selected thus far are:  Canada, Ireland, Netherlands, Mexico, Chile, Israel, South Africa, New Zealand, Australia and Japan, based on the previous slide and the commonsense approach.  Now, this is not necessarily set in stone and we welcome ideas and other options at the table now too. 

We have invited Japan but more than likely, they have other priorities going on so that may not come to fruition after all but our thoughts are with them.

Some of the countries as well may be conducted via DVC discussions rather than in-country visits.  We're thinking of Canada, Australia, and New Zealand possibly to have the conversation over DVC as well just to save on the budget side of things too. 

In terms of timeline and process, the invitation letters to participate with us went out on March 16th, just very recently.  Today is the public meeting to share with you what our thoughts are with regards to the study to provide transparency on what we're doing and really to ask for your input and suggestions. 

In terms of from this point forward in the timeline, it's a very tight timeline.  We have to finish this by September, the end of the fiscal year.  So the next immediate steps is for the contractor and the subject matter experts to do some homework and background research on the various import practices of these countries so that when they go to do the actual conversation and dialogue that we will have as much information as possible and to really structure the conversation to focus on the areas where we're missing some information or we'd like some clarity.

We would like to do physical country visits for most of the countries that we have selected and then once these conversations are done the subject matter experts and the contractors will then write it down in a report, have another dialogue or some e-mail exchanges with the country representatives that participated to make sure that we got the information correct and develop the final report with them. 

And then we do intend to post the report in some -- in some fashion whether it be on the web or some other similar way. 

So, thank you.  In short, that is what we intend to do in the very near future right now, and I look forward to hearing from our panel members about the work and the import practices that they are going to share with us. 

So thank you very much.


ANNE JOHNSON:  Good morning and thanks to FDA for allowing us to contribute to this discussion today. 

For those of you who are not familiar with GAO, let me just spend a moment to describe what we do.  We're the Government Accountability Office and our job is to help Congress ensure the government is operating effectively.  Among other things, we audit Agency operations and we report on how well government programs and policies are functioning.  And in some cases, we provide more general descriptive reports on topics that are of interest to the Congress.

I'm going to talk today about a report that we issued in 2008 on how foreign countries ensure the safety of imported foods.  We started the report in 2007 at the request of Senator Richard Durbin and Congresswoman Rosa DeLauro.  And they were interested in learning about best practices in some of these countries and how they ensure the safety of imported food.  And, in particular, these -- some of these countries had reorganized their food safety systems a couple years ago and they were interested in knowing something about the results of those reorganizations.

So our specific objectives were to find out how six countries, Canada, Germany, Ireland, Japan, the Netherlands and the United Kingdom as well as the European Union ensure the safety of imported foods. 

We also asked about what kinds of information technology systems these countries used to track food entering into the country and to what extent have these countries assessed the effectiveness of their food safety systems, particularly after the reorganization.  And what are these countries' most pressing food safety concerns looking forward into the future? 

So our methodology, just a few brief words on this, we reviewed Agency documents, strategy documents, annual reports, brochures, performance reports, guidance documents and so forth.  We met with a number of Agency officials in all these countries and in Brussels for the EU and we also spoke to representatives of industry and consumer organizations in each of these countries. 

We also contacted the supreme audit organizations of all these countries and those -- the supreme audit organizations are GAOs sister organizations, the agencies that conduct audits of their own country's organizations.  In particular, we asked if they had assessed the effectiveness of the reorganized food safety systems in their countries.

Just a couple more caveats.  As I've pointed out, these countries are all different from the U.S. in organization and structure.  So not everything that works in these countries would necessarily be applicable in the United States.  And we did not independently audit these countries.  We have no authority to audit any countries besides the United -- Federal agencies of the United States.  Therefore, we know how these programs work on paper but we did not audit them to independently be able to tell you how they work in practice.  And we have not updated the report since we issued it in 2008.

I'm going to also draw today on another report that we issued in 2009 in which we looked at U.S. import safety practices, but we also had a section in there where we referred again to practices in the European Union.  So I'm actually drawing from two reports here. 

In general, we found that public opinion regarding food safety measures in all the countries we talked to had improved after they had reorganization -- reorganized.  And industry and stakeholder groups also believed that the reorganization and consolidation of the food safety systems have been beneficial. 

And, in particular, I'm going to describe some of the insights that we -- the specific insights that we gain from our study.  We found that all of these countries use a farm to table approach that covers all aspects of the food safety system for both domestic and imported food.  The emphasis in all these countries is on prevention of problems throughout the food chain. 

In the EU, for example, they have regulations covering feed and how animals are treated on the farm, transportation requirements and through the processing and sale of the finished food products. 

These countries also make producers responsible for food safety and that's enshrined in the legislation in both the EU and Japan and Canada as well.  The EU has an integrated set of legislation beginning with the general food law of 2002, but -- and that provides the general framework for food safety.  But national agencies in each country are responsible for overseeing the food safety in each country -- my apologies for that distraction. 

And then the Food and Veterinary Office based in Grange, Ireland verifies the compliance of these -- of these implementation of regulations by each country.  And they also verify the compliance with the -- with import regulations.

A representative of the European meat industry told us that farmers and producers can no longer hide behind inspectors.  However, that's not to say that there are no inspections conducted.  All these countries conduct inspections of imported food and, in fact, Japan told us that they did -- in 2006, they inspected 11 percent of food products. 

These countries also separate risk assessment and risk management and they created in some cases special new organizations to -- for scientific assessment of risks and then other agencies managed the -- managed the oversight of food safety and that's to prevent any conflict or perceived conflict of interest. 

All these countries conduct risk-based inspections of food.  In the European Union all products of animal origin are considered high risk.  That includes meat, milk, honey and other products and so they must -- all such imports must go through special borders -- border inspection posts.  There's 300 of them within the EU.   

And there's a -- there are some very specific instructions that they must follow including pre-notification.  There's a 100 percent documentary check of all products of animal origin, 100 percent identity check and then certain percentage of each category of food is physically checked at the border.

And, unlike the U.S., the European Union does not require borders to -- importers to post a monetary bond that can be liquidated in case of a problem.  According to EU officials, violating food safety legislation is a crime so a bond is not necessary. 

Products of non-animal origin can enter at any port but they must -- they must meet the EU's safety requirements. 

We found that some countries have specific bilateral organizations -- bilateral agreements.  Japan in particular had an agreement with China whereby Chinese inspectors would be trained to oversee that the growing process of spinach, which is a high-risk food in Japan, and they would inspect it at three points throughout the process and then they would inspect it again on leaving the country.  And once the spinach arrives in Japan, Japanese inspectors would likely inspect it again. 

With regard to information technology systems, the European Union requires trace back, one step forward, and one step backward.  That is, all importers must know their suppliers and where their products are going.  Mandatory trace back allows governments to track questionable food products to minimize harm to public health. 

One of the important systems they use is called the Rapid Alert System for Food and Feed managed by D.G. Sanco in Brussels.  And this system notifies all EU members in case of a problem.  And this system is connected to TRACES, which is the Trade Control and Export System, which they use to track all products of animal origin coming into the country.  And the advantage of this system is that they can quickly alert all of the ports that there's a problem import.  And then also it obviously eliminates the problem of port shopping because they will all know where -- all the ports will be aware of a problematic import.

Canada, Japan and the EU also have mandatory animal identification programs for certain types of livestock.  We found that none of the countries had formally assessed their reorganized food safety system, but they do assess aspects of it and they report on certain indicators such as the number of inspections, enforcement actions and recalls.

The supreme audit agencies, our sister organizations, have not conducted any formal system-wide assessments, but they have looked at certain aspects of it.  For example, the National Audit Office in the United Kingdom conducted an audit in 2003 of the Food Standards Agency to assess the extent to which they had improved -- met their goal of improving public confidence.

As I mentioned before, the Food and Veterinary Organization in Ireland audits how member organizations implement their inspections and how they -- how well they're overseeing regulations at the port and so forth. 

Some agencies have conducted self-assessments.  For example, the Canadian Food Inspection Agency has conducted a self-audit as has the Food Standards Agency in the United Kingdom. 

And then other -- other bodies have conducted assessments of certain aspects of the food safety system.  For example, Health Canada audited the Canadian Food Inspection Agency, several programs there and the United Kingdom has audited how well the country responded to a problem they had a few years ago with  Sudan 1 dye that got into -- that got into the country.

Emerging issues in these countries include climate change, their concern about new pathogens such as the vibrio virus that can be found in oysters.   Demographic changes; more older people in the society means that there's more susceptibility to food borne illness.  New technologies such as nano technology and genetically modified foods and then the fact that consolidation of the food industry means that the smaller number of corporations involved means that the impact of recalls will be greater. 

Thank you.


RENATA CLARKE:  Good morning.  I'm Renata Clarke from the Food and Agriculture Organization of the U.N.  I'm from the group that's responsible largely for capacity development of the system in developing countries of their systems of food control.

It takes a lot to have an effective system of food control and there are many FAO/WHO publications that outline the basic elements of food control, but giving guidance to countries on how they should actually go about developing the capacities of their institutions and services at national and sub-national levels to ensure that those elements are actually in place, is a whole lot harder.

About six or seven years ago, we were developing FAO guidelines for helping countries to assess their food safety capacity building needs.  And in the course of developing that publication, we had panels of technical -- technical panels of food control experts from around the world reviewing the draft, giving ideas for strengthening the guidelines and there were several of those technical experts that said it would be very useful if you could develop some kind of rough benchmarks.  Benchmarks that would allow developing countries to understand more or less where they stood in relation to, for example, the capacity of their analytical services or inspection services or the efficiency of their services compared to with what is standard efficiency in countries where the food control systems have been demonstrated to function well.

Now, we agreed it would be a good idea if we could provide those benchmarks but the data wasn't there.  So we all agreed to put that idea to the side and we would think about it later. 

Well, later came in 2009 when our group was asked by -- to participate in an organization-wide exercise to estimate the investment needs in a number of investment areas.  We were involved in the food control area.  So to estimate the investment needs for a number of developing countries with an object to feeding the World by 2050. 

So, of course, we were completely unprepared for this and we figured that we would -- the only way we could think of of developing these estimates would be on the basis of benchmarks.  So we thought okay, we would do something very quickly for that immediate exercise but, of course, we were more interested in having the basis of something that we could see how we could further develop to serve the purpose that we, six years earlier, had thought would be useful and that is just giving developing countries a kind of a reference point, a benchmark, to understand where they stood.

But very hurriedly in 2009, we put together a questionnaire with the idea to gather data from a number of countries with mature systems of food control to understand what their resource base was, what their investments were. 

We actually approached quite a few agencies, a few countries I should say, about 15 countries.  And despite a lot of begging and pleading and constant reminders, roughly a year later we had answers from just six countries. 

We appreciate the effort of this.  The questionnaire had about 40 questions so it did take a lot of time and effort on the part of the respondents and we are very grateful to those six countries who did take the time for no other reason but to help capacity development activities all over the world. 

There are some problems with the data and some of the problems are our fault.  In our rush to get out the questionnaire, perhaps we could have formulated the questions a little bit differently.  There are things we know we should do better in the next round of collecting better information. 

The way some countries gave data it was some times difficult to understand exactly how the resources were used in the different elements of food control.  So with all of these issues, I'd like to underline that anything that's coming out so far is very, very preliminary. 

Something I should mention is that, of course, we understand that the appropriate level of investment depends very much on the characteristics of the country.  So in selecting the countries that we were asking, we chose countries with different characteristics in terms of size, population, contribution of agriculture to GDP import, production, agricultural production, to give us an idea of, okay, how we could -- we weren't sure what we would be able to do with this data but we said let's just dive in and see how we can relate the data we get to the various variables that we thought should affect the investment in food control.

In the end, as I told you, we got so few data from so few countries that we had to re-dimension our analysis.  Very quickly, and remembering that this is very preliminary, there were some -- the trends that came out are outlined on the screen now, but the total expenditure for the countries, these countries with mature systems of food control, varied quite substantially between roughly six to $40 per head population.

There was one developing country that we, in our capacity development work, we came across that had been investing substantially in the last five to eight years.  So just to understand how -- where that country fit in the scheme, we also included -- we asked them to fill out the questionnaire and we, for your -- just for a point of comparison, that country, the expenditure was roughly $1 per head.

Remembering what I said, the starting point of this exercise would be the need for us to participate immediately in this investment assessment project.  And just between parenthesis, even though a lot of the data from the other developing countries that were surveyed was very incomplete, you can see that the spending in many of the developing countries is, of course, well below.  It's a few cents ahead. 

The total food control staff varied considerably from between 50 and 300 per million head population.  Here the developing country that we had as a separate reference was at about 40 per million head, which is interesting even though the total expenditure is significantly lower, the actual number of staff with costs corrected for price parity adjustment.  So even with those costs and the salaries and so on adjusted for, the cost of investment in food control overall is significantly different even though the number is staff is roughly comparable.  We saw that the total inspection staff accounted for approximately one-third of total food control staff.

Now, I'm really pushing it since the point of this meeting was looking at import, I just pulled out this statistic but without understanding some of the other variables, it's relatively meaningless that the ratio of imported to domestic food inspectors ranged between 10 to 40 percent.  And there was a wide variation in the number of -- in the amount of sampling and testing done in different countries. 

Of course, without having more data and being able to relate it to other aspects of how the system is set up, it's hard to make a judgment on what some of these figures mean.

The questionnaire also collected information on enforcement actions but it's very difficult to extract any wisdom from this because of how these were reported.  There was no -- enforcement actions can be highly variable from a warning to a fine, to court case.  And there was no indication of what the enforcement actions reported were and how to evaluate the widely varying numbers that were reported. 

Very importantly, there was either very variable reporting on IT expenditure and on training, the emphasis on training rather than non-regulatory approaches to approving food control rather than just on the, as some of our respondents said, the control and command aspect of food control.  And it's very important for us to have an understanding of how different countries balance between the regulatory, the enforcement part and the support to the various value chain operators to improve their practices.  And at this stage, we're not able -- we're not able to say.

We didn't have nearly as much data as we would have liked to have, but we have enough to know we would like to get more.  Some of the data we received had certain discrepancies and we have to go back to some of our data providers to try to understand better how the data could be desegregated to understand really what it means in terms of what is -- what is a balanced investment or in terms of having an effective system of food control.

So we have revised our questionnaire and we are going to go back to the countries that participated as well as some of the countries that we asked but did not participate to see if we can get -- if we can get further information and use this. 

The point I'd like to emphasize is that this exercise is not about judging country systems of food control.  Our objective, as I said, is to be helping countries understand where they are in terms of -- in relation to countries that are performing much better in food control as a means of encouraging them or enabling them to plan better for their investments in their own food control system development. 

So the purpose of this exercise is sort of harvesting knowledge and experience from those countries whose systems have evolved into something that works much more efficiently and putting that at the disposition of the countries who are now trying to establish and improve their systems. 

Thank you.


SIMON SMALLEY:  Clearly, Australia isn't quite as good a friend of the U.S. as we thought we were. 

(Comment made due to speaker having had computer problems created laughter.)

SIMON SMALLEY:  If I might just start firstly by giving the apologies of Greg Reed, my colleague from Australia who you had invited along to this.  He was grateful for that invitation but unfortunately domestic matters are uppermost in his mind at the moment.

I'm just going to give a little bit of background on Australia, talk about our food safety standards arrangements, our imported food inspection scheme, the sampling rights that we have under that, some practical matters related to that scheme and then a scheme that we have called Food Import Compliance Agreements that we have got arranged with our importers.

So Australia is roughly the same size as mainland U.S.  We have a Federal parliamentary system of government and we have six states and two territories.  The territories are kind of like D.C. in that sense.  I'll just refer to them all as states.  None of those is New Zealand.


SIMON SMALLEY:  However, we are very cooperative with our colleagues across the Tasman and we have a common Australia and New Zealand food standards code.  And it deals with the issues that are covered there in the dark points, which for the sake of brevity, I won't read to you. 

And the Code also has requirements for identification and tracing of food to facilitate market recalls.

There's an independent statutory authority which is Food Standards Australia New Zealand, which is the statutory authority that maintains the Code, develops food standards and does so in consultation with a range of the stakeholders. 

So we have in the imported food inspection scheme which is controlled under our Federal Imported Food Control Act.  Under that Act, the Ministry for Agriculture and our Australian Quarantine Inspection Service, which I'll call AQIS, inspects and tests imported foods on the basis of a risk assessment that is done by FSANZ, that Food Standard Australia New Zealand Organization.

Under this legislation, importers are responsible for meeting Australia's food safety standards and our food safety laws. 

As I said, FSANZ determines the risks of foods to public health and safety using food safety risk assessment processes.  They categorize foods as either a risk category if it has the potential to pose a medium to high risk to public health and foods that are not judged to be a risk are called surveillance foods. 

And FSANZ advises AQIS of the risk category and that then determines the frequency with which foods will be inspected and the appropriate testing regimes for those foods.

Under the imported food inspection scheme, imported foods are inspected against a selection of those food standards and are also tested for a number of contaminants including pesticides, antibiotics, natural toxicants, food additives and microbiological and metal contaminants. 

Going to the sampling rates that we have for the different risk foods, all consignments of risk foods are referred to AQIS by our Customs Agency, and you can see here a tiered approach to the way that risk foods are sampled.  And then also for surveillance foods, which are at a much lower level of sampling rate.

I'm going to skip quickly because I've just been given the five-minute warning.  So, Bill, all the old jokes are out. 

Some practical matters under the imported food inspection scheme, AQIS is a full cost recovery operation where there is private benefit identified.  And so for inspections there is full cost recovery. 

We have IT systems that are linked from customs into AQIS for the sampling selection.  And the customs brokers identify who is the importer and for risk products they also have to identify who is the producer so that if there is a failure in the system, then we can target the producer and the country.  Otherwise, for surveillance foods, we do not target in particular the country or the producer.  It's a pure random sampling basis.

We have a system of having formal regulatory recognition and audit of imported foods safety management systems by AQIS and we have six of these agreements in place already.  And this enables importers who qualify for the system to be exempted from the imported food inspection scheme altogether, whether they are bringing in risk products or surveillance products.  So we are looking purely at their systems to make sure that they are adequate.

That is done also on a cost recovery basis so they pay for their applications for maintenance of the scheme and also for our twice yearly audits of the systems.

Just a couple of key points to finish on.  Australia's imported food safety system is a risk-based system.  We see that as a strength and it enables us to focus our attention where it is needed.

And those compliance agreements that I spoke of very briefly are also a very useful tool for us.  They're good for the industry and they're good for AQIS in understanding better the business of those importers and the food safety processes that they have.  And it also gives AQIS a systems perspective rather than a point in time assessment or a test of a consignment.  We think those are strengths in our system. 

I'll leave it there and we'll take questions later.


BILL JOLLY:  Okay.  With the recently short time I'll skip a few slides too I think but I'll leave them on the record.

A couple of quick things following on from Simon, FSANZ, Food Standards Australia New Zealand, we -- it is a trans-Tasman authority.  It does a lot wider range of things for Australia than it does for New Zealand but we are working cooperatively with it in a number of fashions.

Okay.  So New Zealand's a long way from other countries, no land borders, makes things a lot easier, limited number of sea and air points, tight by security controls, all the advantages we have. 

A couple of reality checks, you cannot regulate beyond the borders.  You can't stop export, and so the import, you know, you are operating a screening system to some extent.  And accordingly, unless you tie in with your customs, you don't know what you don't know.  And so we're very conscious that import systems really are sort of a third -- I'm sorry a tertiary system whereby the first screening is always done by customs and regulated by security agencies. 

And melamine showed us that you need a system that which can potentially target any food.  So what is a risk food today may be different tomorrow when you have a crisis type situation. 

I tried not to put too many funnies in today.  I only put one. 

We did an import review.  Our current program started in 1997.  There's been significant changes since then and like every country, we're constantly reviewing and we're in the process of doing a major one.  So I'm going to talk about the new system which we're putting in place.

It was all about getting more cost-effective, more targeted and to have a better impact.  Obviously, we've heard this from the last couple of days, reduced reliance of testing on the border, improve the scientific basis in targeting and to strengthen the responsibility and focus on importers to make sure that they import safe and suitable food. 

As I say, coordination with the border inspection agencies, most countries this is very fragmented.  Now when you start looking at the concept of trade single window and coordination of inspection there's potential for other agencies to do a lot of work for you.  When you come through the border in an airport and you get screened by officials they're actually working on behalf of a number of agencies and we stand to look at that concept to food control as well.

Under the TTMRA, Trans-Tasman Mutual Recognition Agreement, we effectively have a mutual recognition of each other's food safety system, so there's a relatively free flow of food between New Zealand and Australia.  And that was one of the concept behind FSANZ.  And we've been working cooperatively to share risk criteria. 

So what do we know?  Inspection is the lowest form of quality control.  Prevention is better than the testing.  It's better that someone else does it.  And it's better if it's done offshore. 

Key concepts:  It's risk-based, it's safe, the primary obligation on the importer who is the seller.  The requirements of risk be managed pre-border, integration with other border activities, integrated with domestic regulatory approach. 

We have this concept of virtual border.  Effectively the foods move beyond the border but before you often to get the chance to even have a look at them and beyond customs' sort of controls. 

Key components:  Information capture.  As I say, you need to potentially capture all of imports of food.  And then you have multiple levels of refinement so you can ask those questions.   Australia has a particularly good system here. 

Registration of importers allows you to communicate with them, allows you to hold them accountable.  It also means that you can actually suspend them, remove them, and use them as a point of leverage. 

Duties and obligations of importers:  This is a key component of our system now.  They have to notify imports of import consignments, they have to keep records.  They have to take due diligence as far as show us how the food is safe and we've seen that under the FSMA Act coming into play and under -- previously under the AQIS final rule and traceability, one forward, one back. 

Categorization of foods and food country combinations is a trigger for intensification of requirements and responsibilities. 

Key components of powers, ability to restrict and impose additional requirements by food type, by country or a combination of country and food type and/or a combination of company and food type.  And, again, it's -- we've understood that it's not just the food that can cause you the risk, the source can be equally important.

Ability to enter into pre-clearance agreements.  And Mac talked to us about this this morning, and/or recognize MOUs or other agreements.  We're encouraging doing this so a high regulatory interest food become a -- can become a low regulatory interest food by coming from a country which we have an agreement with.

Ability to verify:  Importers, brokers, foreign countries, and, again, from an audit basis. 

Ability to sample:  Monitoring surveillance is obviously important.  Holding, tracing, recalling, destroying, ability to cost recover.  And part of that cost recover is especially -- not just for specific activities but to recover a fee that allows you to actually fund some of your more socialized or generic activities. 

A couple of complex diagrams, which I won't go into any extent but they're just for the record really.  The categorization determines whether it's a high-risk food or a low risk food.  We then look at the risk management options in the profiling, whether it can be managed or it's not managed and then that can change it back into a -- it can change a high-risk interest food into a low risk interest food or it can change a low regulation interest food into a high-risk food.

And then we have a lot of risk management tools on the right-hand side there.  So obviously mutual recognition with Australia.  Recognized equivalence, we have a lot of those with the EU, some with the U.S. 

Confidence in specific parts of an exporting country regulatory environment and we've done that for shellfish, bivalve molluscan shellfish with a number of countries. 

We've got the ability to recognize private standards and it's something that the FDA, of course, is looking at. 

And then we also have the -- look at the importers, what sort of quality systems they have.  Obviously, sampling testing and a few others. 

Clearance and data capture say customs is key.  All foods come through customs.  You need to work with their data capture and then look at how you can refine that. 

Import obligations.  Registration is key for us so that we can identify them, so we can audit them, so we can impose generic requirements which is basically due diligence, keeping records, you know, checking whether the qualifications of their suppliers, et cetera.  And we can also impose additional requirements.  So part of the due diligence, if we identify a food which has a high regulatory interest, and we've done some of these lately, Cassava chips as being one, which -- associated with cyanicides (ph).  So we've actually told the importers that they need to actually take a much greater interest in these, potentially get some analyses done or get their suppliers to provide some analytical results. 

With the higher nutritious foods we're introducing a lot of pre-clearance agreements.  So, in other words, this is a positive list.  You can't trade unless you come from a country which we have done an assessment.  Bivalve molluscan shellfish is a classic example there.  And in the U.S. and the EU, of course, most animal products.

So I think I'll leave it there.  And otherwise, we'll have far too many slides for discussion. 

Oh, last one, sorry, is with the regulatory model you saw yesterday.  We pose the same regulatory model on imports and it's basically regulated CFSAN standards.  We have verification of those standards both from an inspection point of view and an audit point of view but the ultimate accountability is on the importers and they work seamlessly with the domestic market and the controls on the domestic market. 

Thank you.


MARY ANN GREEN:  Thank you and I think I have the easier job following Bill today than yesterday.  He only got -- by time constraints he got to put one joke in so I'm much happier. 

Some of the things that I'm going to say are going to have been repeated or mentioned already.  Again, what I'm trying to come from is providing a Canadian perspective on imported food safety and trying to contextualize it and bring it into an assessment of how are the tools and what are the systems rather than focusing on specific aspects of Canada's food system.

As everybody has mentioned before, we are just exploding in terms of the number of products coming in, the number of trading partners.  But the key mandate of the imported food programs is to provide assurance that imported foods meets Canadian requirements and that has to be kept in mind at all times.

The other two principles are that importers are responsible for products that they import and they have to assure those products meet requirements and governments are responsible for oversight. 

We also have to look at efficient use of resources but also risk-based and evidence-based.  We talk about risk-based a lot.  The other comment is you have to have the evidence to prove it as well.

You use a variety of tools.  There isn't just one tool, you have to look and match and mix up as to get the right tool to get the deal with the right program.  Your tools are used to assess both the compliance of products, the compliance of importers, but also to monitor the effectiveness of the import program.   We talked -- we heard earlier about the need to be able to respond rapidly, but your program has to be in continuous improvement and to do that you have to be prepared constantly to say is what I'm doing effective?  Am I doing it right but am I doing the right thing?

The approaches in general can either be country based, in other words, where you're looking at the food control system within the exporting country that has been mentioned previously and a number of tools exist for that.  It can be importer-based where the importer is required to have adequate controls and this can include importer licensing, product testing and certification.

It can also include border controls, the in-country food safety controls, whether it's monitoring an intervention at the border or even when the country comes -- sorry, the product comes across the border into an importer warehouse.

Critical to this is it's not mutually exclusive.  We have to look at the full range of options so that you can use the most effective tool for the most effective result that you're looking for.  But you have to have three critical issues.  You need to know what is coming in as Bill has mentioned, and others.  What products enters, where they enter and who's responsible for them. 

You have to have some idea of who's bringing them in in terms of the importer controls, both licensing importers and setting conditions, and whole concepts of environmental scanning of evidence-base of understanding the information gathering international collaboration and border blitzes.  

Starting off with import notifications, there's a basic requirement of knowing what is coming into the country.  Some of the areas in Canada we've looked at is having an importer notification, not border, not customs, holding the importer responsible to tell us what, the food safety organization, what is coming in.

In some cases, this -- in our meat programs, this has resulted in pre-import notifications.  There needs to be some criteria around this because if you're also including pre-notification for inspection, you need to assess to make sure that they're actually telling you not just the good products but also all the random ones as well.

In fish program, the notification is on import and the product moves through the border and goes to the importer warehouse.  They cannot move that product until it's released by an inspector.  And so we, within the surveillance and the random processes, you have all the product coming in, you have 100 percent available for inspection and then an inspection.  An inspector will make a decision.

Critical to this is the program design, that the product is available for inspection for the inspector to make a decision based on that design.  You can target the high-risk commodities, you can target importers with a history of non-compliance as long as the product remains available for that decision. 

And, of course, there needs to be some random monitoring of products in terms of assessing compliance trends and your program effectiveness.  You are assuming that the product coming in that has -- has to meet compliance because the importer is responsible for bringing in compliant product.      And also assess and enhance those controls. 

And one of the importer controls that is used in Canada is called the Importer Quality Management License.  Everybody in fish has to be -- all importers it's mandatory and in the fish program must be licensed.  Under the -- importers that choose to be quality management licensed, they must develop and submit a written plan, and we have set out reference standards for such licensors that include what are the responsibility of the holder, a product sourcing plan, product safety assessments and management verification and maintenance of that plan and record and document controls.  It's all on the website of CFIA.

The conditions may include and so QMPI have decided to go this way, where they will enter into an agreement, often a single source where they have the supplier quality arrangement that supplements their QMPI reference standards.  And under the -- we have developed a guidance for those importers that would like to deal with such supplier quality assurances to give guidance on what is the process for determining their suitability, what's the process for maintaining records and what's the process for verifying implementation.  The government then maintains an annual audit against these plans to assure that the importers can maintain their license.

Environmental scanning is also a very key part because of the responsive nature.  You have to be able to gear up and respond.  Food borne illnesses can -- or outbreaks can happen in many foreign countries.  If you have good cooperation and collaboration you can get that very quickly.  There may be other things that break through trends and you have to look at what your documents and your evidence is saying. 

There is, of course, as I said, the possibility of notification of issues of concerns, clarifications of how different countries are bringing new strategies, whether it's increased sampling.  Where countries are working overseas, they may be dealing with enhanced inspection.  How are we working together to deal with emerging issues. 

And then one of the other areas that's important in terms of being able to move forward are continuing border blitzes and lookouts so that you can target areas that you think are emerging and see whether or not you actually have concerns, because often when you start out you may think you have something but there isn't any evidence.  And the evidence then should either confirm you have a concern and you would move into a longer term strategy or say there isn't a concern there.

So you've really got to look at an import program as both Australia and New Zealand have said previously, that uses a number of approaches, looks at what is the most appropriate approach and what's the most appropriate tool or a mixture of those to assure the food safety.

The key success factors are having the appropriate information, using the most appropriate tool and working with industry to assure that they have the most appropriate tools in place. 

Thank you.


CARLOS ALVAREZ ANTOLINEZ:  Good morning and thank you to FDA for having me again. 

And so what I wanted to present to you today, it's another view of the control systems for imported foods in the EU.  We -- I'm afraid I will have to repeat a little what Anne Johnson has already explained and hopefully I will not be saying something very different or else it could be worse. 

Let me just start by saying that the EU is the largest importer of food and feed.  Traditionally, we have -- we import those commodities, which are not produced in the EU as tea, coffee, spices and fruits, probably some types of fruits.  And also commodities where our production is short compared to our demand -- to the demand, typically, fish and animal feed.  So these will be probably the main commodities.

Overall, I think we can say that we have a harmonized free space controlled system and that our system is in full compliance with international standards. 

I mentioned already yesterday a little about our legal framework so we have our general food law, which is telling us these general principles are what imported food has to comply with our requirements so equivalent requirements, or in the case of agreements, we take the standards of the requirements established in the agreements.

Very importantly, this Regulation 882 on 2004, this is the key piece of legislation when it comes to control of imports.  It covers more than imports.  It covers all kinds of physical controls but there is everything related to the control of imported food or feed in the EU is regulated there.

There is, of course, secondary legislation, which establishes the requirements for particular types of foods or feeds, commodities in general.  We have bilateral agreements as we mentioned, that's the other way.  And as we will see, we -- and it's -- already Anne mentioned, there is a clear distinction between animal origin and non-animal origin. 

I mentioned yesterday and repeat today, that when it comes to work is being required, our legislation in the form of regulations gives sometimes some room for maneuver for member states of other countries to -- how to achieve the standards.

Food of non -- sorry, food of animal origin, so if we go quickly through the requirements, we have a set of requirements which concern hygiene.  They're established in Regulation 852, general -- there are some general requirements which apply, in fact, to all types of food and they are mentioned there briefly.  And this includes, of course, procedures based on health and principles.  And then there are specific requirements for particular types of products.

All of this is covered in our Regulation 853 where you have a long list of our nexus with requirements for meat or for feed, et cetera. 

There are, of course, other types of health requirements, contaminants, residues, hormones, all of these, et cetera.  There may be, for particular commodities, some specific requirements and there are also animal welfare requirements in the case of meat, but this concern only is slaughtering conditions.

Now, our legislation requires that importers are -- they have the obligation, they have to make sure that what they import is in compliance with our legislation.  They have to make sure that the product comes from a country, which is already listed or approved, that it comes from an establishment which is also listed and also it contains health or identification mark, health certificate, it's available for control at the border inspection post and comply with animal health requirements.

And the same -- I mean, this obligation is from the importers.  They are primarily responsible for this.  Then you have the competent authorities and they have to make sure that they have provided adequate guarantees as regards to their official controls, their list of establishments and certification requirements.

So in practical terms, what happens is that any consignment of animal products, food of animal origin has to be presented at one of these designated border inspection ports.  There are 300 as mentioned earlier, and they have to go through veterinary checks, 100 percent of identity on documentary checks.  And then physical checks we may or may not include the laboratory test, vary, and they are establishing legislation from 20 to 50 percent depending on the commodities. 

Other requirements:  Prior notice of arrival, health certificates, as mentioned earlier, only coming from approved countries, regions and establishments and at the same time, other controls can take place at the entry.

There are a number of commodities, currently nine, from nine countries, which are under the -- under what we call safe governances.  They have been identified as having particular risk and as a result, they have to go -- they are under a more strict system.  So they need to be accompanied by pre-export testing, so they have to be tested before export.  They have to be accompanied by certificate saying that about particular hazards, which in most cases, is residues of identified drugs.  Tests have been carried on that positively in the sense of the results are satisfactory and they will be tested again.  So, a very -- relatively heavy or strict system for the animal origin.

Now, when we move to food of known animal origin the requirements, we have general requirements, we have health specific requirements, non-health requirements.  But I think this is no different from any other country.  So and this affect only particular group of products, which may carry some bad pathogens or pests if you would.

In terms of procedures as has already been said, the importer is responsible.  There is no certification, there is no pre-notification.  The controls are carried out by member states.  And they can enter by any point, there is no particular points.  And they have to be carried out on the basis of risk but it is left to the member states to decide their priorities on the basis of their -- the information they have.

I'm not talking about plant health requirements.  I don't think it is particularly relevant here. 

Now, what is new and probably this is after your study of 2008, is we have identified a number of problems which we consider that are -- well, they require an increased level of controls.  So we are speaking here about the 21 combinations of commodities and country products.  You have a list -- well, you have some examples there what kind of products.  And for these ones we require prior notification that they have to use a -- what we call a commodity entry document and they are -- they have to enter through designated points of entry.  This is something that is probably -- I mean, there is a regulation and it is published and it is reviewed every -- every -- I mean, four times per year. 

So the large majority of food of plant origin there is a very -- a relatively super system and then you have a number of commodities which are subject to a more restricted system.

And then we have, of course, similarly to what we said about the safeguard measures in the case of animal products, the same applies to a number of products related to -- particularly the risk of aflatoxins.  These are considered safeguard measures and in these cases, we need health certificates.  This was not the case for the previous category.  And also, we need the results of analysis.

Very briefly, we have spoken about controls take place at the level of entry.  Now, there is -- the oversight activity of the Commission which is -- which takes the form of FVO audits, so this is the Food and Veterinary Office.  We have or we used to have -- well, I mean, because I used to be there.  They are all overseeing what's happening in member states.  So our task is to make sure that member states carry out the controls properly and in a harmonized and consistent manner.  But we also conduct inspections in member states.  Inspections, remember, all these in member states can take place -- the purpose can be either per a listing in the case of animal products or more generally just to verify compliance over equivalence.  The frequency is determined by risks, and, of course, in the case of bilateral agreements this is also taken into account.

The animal reports -- there are all these acronyms there which refer to bodies or tools that we consider that are important when it comes to looking at the effectiveness of our systems.  I don't think I have time to go through this.

I just wanted to say that -- I mean, currently the Commission is reflecting about our system.  We think that we have a very robust system and we think that we can improve.  So we are saying it is risk and evidence-based but it is very complex.  You may not get this from my presentation today, but actually, when you go more in-depth, it is complex.

So we think that there is a need for streamlining the system.  There is a need to improve consistency and efficiency and also in the area of assessment of risk we are considering legislative improvements, reviewing this main piece of legislation and controls.  There will be some improvements or changes because there is new legislation being prepared on animal health and plant health and we also think that there is a need to work on this electronic system which follows or tracks all the consignments of live animals and animal products. 

It has to be expanded.  It is already accessed by third countries; some of the third countries.  It could be expanded to others.  A certification could be incorporated.  We think we can improve RASFF, the Rapid Alert System for Food, which is the first one, and the second one which is for plant health.

And, in general, and as other speakers, we have the pressure to use -- to optimize the use of resources and in this respect, we think that we need to coordinate more and better both inside and abroad.

Thank you very much.


CAMILLE BREWER:  I'd like to thank all the panelists and I'd like you to come forward to the table and if the inquiry team could assemble, please.

I turn it over to you, Dr. Solomon.

STEVE SOLOMON:  Well, thank you so much.  That was a tremendous amount of information and we're very grateful for it. 

Let me see if I can ask a question that's going to combine several things that have been teed up in the discussions. 

When we -- I haven't gone through a word count of the Food Safety Modernization Act of how many times risk-based is in there, but it's in there a lot.  And in every one of your presentations you used the risk-based systems and some of you tried to describe the basis for those risk-based systems.  And, clearly, every country has an opportunity and has people in place and processes in place for making those determinations. 

I guess the question from a globalization prospective: are there opportunities, either leveraging opportunities or greater opportunities that we should explore when trying to reach greater harmonization and consensus on those risk-based approaches?          

Clearly folks have all come to agreement here that we didn't -- we talked yesterday that there weren't kind of the ultimate public health metrics to look at and clearly, we had discussions about the systems-based approach that everyone's taking, but are there greater opportunities that we should be looking at for trying to better assess what these risk-based approaches should be because we sometimes run into issues about what are -- some would view as technical violations, others being as more risk-based violations. 

So I'd be interested in your thought on the issue on risk-based approaches and harmonization. 

MARY ANN GREEN:  There can be and there could be but, again, it comes back to some of the discussions we had yesterday on how you're looking at risk with regard to country, commodity and importer combinations. 

One of the areas that we have found significant non-compliance in is with labeling.  Is that a technical violation?  Is that a risk?  And much of the labeling violations run because we have particular laws for Canada that's called bilingual.  In Europe they're probably multilingual.  But is that a product?  Is that a risk in the product -- inherent in the product or is it something that has to be addressed within Canada?

So while harmonization is a laudable goal and there is, as Australia and New Zealand have said, some options for trying to manage harmonization with regard to product risk assessment, the combination of what the inherent risk of the product is, the controls put in place by the producer, the controls put in place by the country and then the import conditions, all make it a very challenging to say this is a global risk. 

I think in a lot of specific programs that are closely aligned, you may have a better ability to do something like that. 

BILL JOLLY:  It is a different -- a difficult question.  We've been working with our colleagues from Australia recently just to agree some risk categorization, risk assessment categorization criteria.  And that's the first process and then out of that process then we have all these risk management options we can choose and that's a sovereign activity. 

One of the things which we have looked at is that there's very few risk management options that you have and so, you know, the -- it's important to look at that inherent risk for them to see what is in place which will let you reduce that so that what is the residual risk is important and not get caught up in the hazard game.  Because there's 10,000 hazards but there's -- you know, most of them can be controlled to a reasonable level and there's a very limited number of risk management options.

So it is a hard one.  We're actually looking to the U.S. for some leadership here.  We also look to the EU as being two of the largest parties in the World.

MR. ANTONLINEZ:  From my side, I would like to say a couple of things.  On the one hand, we have maybe -- I wouldn't say they're advanced, but the way that our system works is that we have -- when it comes to risk assessment we have an independent agency.  So we have a TS advisor between risk assessment and risk management.  That's -- I think that this helps others to try to establish, to help the risk assessment.

Second, I think that to some extent, risk is already incorporated into our legislation so they have to -- we have identified animal products as high risk  problems of risk commodities.  And we also have identified within the non-animal, certain groups of combinations of foods and origin have a higher risk than the usual and that as a result, our legislation has already adopted this.

So having said that, I mean, our legislation at the same time did some room for maneuver, as I said, controls carried out by member states on the consignments have to be carried out when it comes to physical checks, I think we need to make a difference there. 

But on the other hand, legislation speaks of the risk of the food but at the same time the history of compliance of similar or the origin of the problem controls Canada by the importers so there is a whole set of criteria to be considered in addition to the risks themselves.

But as I said in my presentation, we think -- we are not -- we don't think that our system cannot be improved in this area and that's why this is an area where we think that we need improvement.  So, again, we are very open to discussing these problems. 

MS. BOND:  Thank you all for your presentations.  Many of you referred to ongoing efforts at continuous improvement or monitoring the performance of your systems and I wondered if you could elaborate a bit on whether you have a core set of indicators to do that or systems in place, which are used to evaluate particular elements of the system. 

Thank you.

BILL JOLLY:  That's an easy one.  No.

Slightly different answer though, what we are doing is we're running two programs, an annual monitoring program which looks at efficacy, what is getting through and then we're running a separate program which is a scanning list which is much more reactive.  And so, when we have an issue highlighted, it might come from something that Mac sends me through the confidentiality agreement or something that comes up through the Rapid Alerts through Europe.  We'll go for an intensive period of monitoring and all those -- those -- that characteristic just to see whether that risk is -- whether that sort of hesitant consequent risk is coming through the country. 

MARY ANN GREEN:  Again, it's one of those things that needs continuous improvement and it would be lovely to find one metric that said, yes, this is how you're going to continually improve, but as you're moving through the development of IT systems and we heard about rolling out Predict and we've heard about others, you learn that if you continually monitor the evidence coming out of those systems, assessing them against your program standards, you can better direct where you're going.  But it's a learning process. 

In some cases where you got a clear standard and, you know, in our -- in one of the cases I mentioned in terms of import licenses, getting a link into the border that says no license, no entry, period.  Through an IT system has been extremely useful, but it's little increments, not a huge review that says, you know, this is the metric we're going to improve on.  It's taking every element and saying how do we do it better?  What is the evidence showing us?  Are we over-reacting?  Doing too many inspections, too little, too few, putting not enough borders and the little incremental things that will tell us what we're doing? 

BILL JOLLY:  Can I just have a supplementary?  We've done a couple of the economic analyses that -- and, again, it's been an absence of evidence rather than the evidence of absence to some extent.  But they fail to identify a real problem with imports and it's part of the problem to actually justify to the politicians to increase your regulatory powers. 

One of the few that we have identified as directly impacting on public is noroviruses in oysters as an example.  And so that's one where we have taken steps.  But we just don't have the evidence that imports are causing a lot of risk.  There's a lot of rhetoric out there that, you know, all imports are bad, et cetera.  But when you actually start looking for the evidence and putting that across all your domestic food safety issues, it's hard to come by sort of a differential evidence. 

MR. ANTOLINEZ:  Actually, I wanted to concur with Bill on this point.  I think that -- the EU is the largest importer of food and animal feed products.  But it still -- when you compare this with domestic production -- with domestic consumption, it's little. 

So in the same way if you look at statistics about incidents, outbreaks, problems, again, there are -- and I think it's the same here, a large majority of the problems are caused by domestic products.

So I agree, there's a little of over-enthusiasm of the problems of imports.

Now, how is that done?  And to your question, yes, it's very challenging.  I think I said already yesterday that measuring the effectiveness of your control which is our requirement of our legislation, not probably with respect of imports, but in general, it is a very challenging topic and subject.  I don't think we are there yet.  I think that different member states and, again, it's because they are obliged by our legislation to have the system procedures to measure the effectiveness but in most cases what we have is just about processes. 

So I don't think that members that have already been able to identify what with inspection,  although in some cases they are trying to do so.  Otherwise, from our perspective commission we have this Food and Veterinary Office to carry out our inspections.  And, again, we inspect -- in terms of the number of inspections or audits that we conduct, I would say probably 70 percent is about inspections in member states, maybe 75 percent and only the rest in third countries, which is, by the way, our -- this is part of the control system as well. 

But part of the inspections that we do in the member states is about how the controls of imports actually taking place.  So if you combine the two things, obviously, there is a -- it's a significant level of insight from the level of the Commission over the authorities of member states.

SIMON SMALLEY:  If I can just make two points.  Firstly, in respect to our program, we do have continuous monitoring of the system and reporting on a six-monthly basis the web-based reports that you can access in relation to where breaches are occurring in relation to the inspections that are being undertaken on a risk basis. 

And, secondly, by virtue of having a separate risk setting statutory authority versus the management and inspection resources, you have that necessary kind of regulatory tension within your system as well that I think is helpful for us.

COMMANDER VENEZIANO:  Dominic Veneziano.  First of all, I want to thank you all for the presentations.  I think they were extremely helpful to us to listen to them all. 

You all talked about the adequacies and pretty much the import systems or the import controls and the testing that's done is to validate your systems or your import programs.  What I didn't hear and maybe each of you can talk about is the enforcement actions taken as a result of violative issues.  So if you find something positive for salmonella per se, do you have -- do you destroy all products?  Do you allow things to be exported?  And what happens to future shipments associated with them?

MARY ANN GREEN:  Somebody's got to start.

Products that are -- come into Canada, again, if they're violative, they're not allowed for sale.  If they can be brought -- conditioned to be brought into sale -- into compliance, and, again, the concept is being -- meeting our requirements.  And, again, a lot of them are labeling.  A lot of them are able to be complied -- to be treated and brought into compliance, then they're allowed for sale.

If they are in a process that you cannot bring them into compliance, they will either be destroyed or returned to the exporter.  We have no authority to prevent a -- or in a majority of cases, we have no authority to prevent a return to exporter.  There is some legislation where there's a high risk.  We will prevent it.  And in those instances, we will be actually talking -- we actually look for documentation and then we would be talking to the competent authority of the returning country.

But most of the times, if you've actually got a health problem, the importer will just destroy it on the request of the government.  But we will take action and where we find that an importer has not provided enough information or control there are also recalls taken in place and we will prosecute as well.  So there's a full range of enforcement actions.

BILL JOLLY:  This one's easy for us, because by the time it's presented to us or that evidence is found, it's in the system, it's within the country and our law says you cannot sell if the product doesn't comply with the law and that includes export.  And so if it doesn't comply with our law, they can't do anything with it other than destroy it.

And having said that, if it can be reconditioned, then we allow that and again, we've got to differentiate between sort of technical non-compliance versus food safety risks and, you know, there's a big difference there.  And so labeling issues you could potentially re-export or recondition.  But if it's a threat to public health, it ain't going nowhere.

SIMON SMALLEY:  For us, because we have that two-category system, risk foods are on a test and hold basis so they don't actually get into commerce.  That said, 83 percent of our failures are failures for labeling in the most recent report that I was able to access.

 But consignments of risk foods that fail inspection cannot be imported so they're either brought into compliance or they're re-exported or they're destroyed.  For surveillance foods it's not a test and hold basis, it's a test and release basis but, again, because the laws do not allow sale of unsafe foods we can have our state governments be able to stop those at point of sale as well.

And for us, what happens at least to the importer and the producer is that the inspection rates go back up.  For risk foods it goes up to 100 percent again and then they have to pass a series of barriers in terms of the inspection rates which I think are highlighted in my presentation. 

MR. ANTONLINEZ:  And I think it's -- it's similar in our case.  Our legislation provides for cases where the consignment does not comply with our requirements, so it would have to.  It certainly cannot enter.  It can be destroyed in cases of high risk.  It depends on -- there are a whole point -- whole possible actions.  Of course, again, it is better controlling -- quite better control.  It's mostly in the case of animal products because the frequency of testing is high. 

The other aspect which is important is once you have identified -- because as soon as you have a result which is negative, this has to be communicated.  So you use the -- our rapid alert system so everybody, all the authorities know at all the entry points and so the authorities know about this type of product.

As a result, you know, this is having been rejected or destroyed, there will be an increased level of controls for a certain period.  This is establishing for a period -- something that will be.  For this particular commodity coming from this particular OEG, I'm not speaking badly about the establishing, but in the case of animal products, then you have to be testing and say food testing for a number of -- for a number of consignments.  It's -- it will be found on a significant numbers of consignments.

MR. SOLOMON:  Just as a -- I think we have time for one or two more questions.  If folks would speak into the microphones so everyone can hear we'd appreciate it.

Dr. Lumpkin.

MURRAY LUMPKIN:  Thank you all again.  I have a fairly quick question and it's more on the administrative side and I think Simon spoke to it probably in the most depth.

Two questions.  Number one, do you require registration of importers, and if you do, do you charge a fee for that?   And, secondly, at your border do you have a comprehensive fee for engaging in a border activity with a particular product or do you have more of a la carte approach where you would charge a certain fee if you do a physical exam, another fee if you do a laboratory exam, another fee if you have to destroy or if you have to return a product?

BILL JOLLY:  I can start on this one.  The current system is restricted by the legislation we're at but where we're moving into is, yes, there will be a registration fee.  Yes, it is mandatory.  And, but it's really just to cover that process of registration.

Fees for inspection, yes, there is a consignment based fee and it is a la carte depending on what's required.  What we are trying to do though is where we're doing a socialized type of activity such as monitoring or surveillance screening if you like, is to charge an increment above on all imports so that we can cover those costs.  But our -- the intention is for the whole of the system to be cost recovered. 

SIMON SMALLEY:  I'll collar up a little bit from what I said.  Actually, sorry, Mac, but I'm not really sure whether we do have any fee for registration but we do indeed have a registration.  I wouldn't have thought we did would be my guess.

But at the border we do charge full fee to service bases but it's done on service basis with a quarter hourly charge rate.  So it doesn't really matter what kind of thing is going on.  But then in terms of laboratory testing the laboratory testing is done at the choice of laboratories by the importer of our listed accredited laboratories for various activities and they charge directly so it's out of our hands.

MARY ANN GREEN:  Canada functions under multiple laws for imports.  So we have different process under the multiple laws.  So the conditions are set out in the regs.  However, we are moving to extend licensing for importers more broadly to all importers under the various regs, different timeframes for getting there because Parliament works in strange and wonderful ways.  But it is moving.                

Again, and under those regulations, different industry have asked and looked and supported for different cost recovery under different fees.  So, for example, the fish inspection have asked, the industry asked for a fee per kilogram imported.  They were getting very concerned about the cost per inspection analysis so they actually went to a much lower fee but on an import per kilogram.

The QM -- our quality management importers pay a fee for their license but then they actually provide the inspections through accredited labs on their dime.  So it's a mixture of processes, again, using a tool that works for the right industry.

Cost recovery, yes, we're moving cost recovery on a number of fronts.  But we have a requirement under our law that all cost recovery be consulted with the industry and they have to support it which poses, of course, a different approach in terms of how you move things forward and the analytical support for moving that forward. 

MR. ANTOLINEZ:  Under the EU system, our legislative requests all food business operators and this is including importers to be registered with the competent, national competent authorities.  There is no requirement for fees.  And as we have the checks carried out, import -- the principle of the EU legislation is that national authorities can charge for these activities on a recovery basis, but there is no -- there is no specifics in our legislation about that.  But that's the principle and it has to be respected.  So they cannot charge more that what is actually the cost of the tests of the check system.

MR. SOLOMON:  I think we've run out of time.  Let me thank the panel for your information and our questions. 


CAMILLE BREWER:  I want to thank both the panelists and the inquiry team.  We have just a short list of public testifiers today so I'm confident that we're going to end on time.  So I'd like to give you a 15-minute Blackberry break and I'll see you back here at 11:25.

Thank you. 


CAMILLE BREWER:  All right, let's get started for the second panel.  And this panel is addressing Supporting Safe Imports: Capacity Building. 

First we'll have a very short update from Dr. Kathleen Bond on some of the FDA activities, then we'll move directly into an APEC-PTIN update by Peggy Rochette.  Renata Clarke, Dr. Clarke will be back with us again to share some FAO perspectives.  Mr. John Lamb will talk about some of the issues and challenges with respect to donor organizations.  We have Dr. Marcus Sanchez-Plata from the Inter-American Institute for Cooperation in Agriculture.  And finally, we're going to end with again, Carlos Alvarez Antolinez.

We'll go to questions and then we'll end the morning session with testimony from stakeholders.  So thank you.

Dr. Bond.

KATHERINE BOND:  Good morning everybody and thank you to Camille and others for the opportunity to speak to you today.  Yesterday we heard from Deputy Commissioner Mike Taylor a couple of points that I think will carry through today and Dr. Lumpkin has also referred to.  The first is under FSMA, that we're looking to push prevention offshore.  And the second is that we're looking for ways to leverage resources and to cooperate further.  We heard quite a bit about how those principles apply in the areas of comparability yesterday, today we'll be looking at those same principles in terms of capacity building.

Dr. Lumpkin teed up quite a bit of information this morning about FSMA and about how the FDA has engaged, over a long period of time, in various aspects of regulatory cooperation.  So what I would like to do this morning is just to give you some thoughts about how we're going about this with respect to the Plan Section 305 and to set the context for the rest of the panel.

So as just to recap where capacity building falls within FSMA, Title 3, Section 305 requires within two years the development of a comprehensive plan to expand the technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries from which foods are exported to the United States.  We have Title 3, Section 308 which requires the FDA to establish offices abroad to provide assistance to regulatory counterparts with respect to food safety.  And another section that wasn't mentioned this morning, but that's related, is Section 303(b) which refers to the requirements for assessing foreign food safety systems, which will inform a range of tools and approaches under The Act including capacity building in the discussions over the last couple of days have further fleshed those out.

And again in the Section 305 outlines the elements of the capacity building plan as follows.  The plan will include, as appropriate, recommendations for bilateral and multilateral arrangements and agreements, including provisions to ensure responsibility of exporting countries to ensure the safety of food; provisions for secure electronic data sharing; provisions for mutual recognition of inspection reports; training of foreign governments and food producers on U.S. requirements for safe food; recommendations on whether and how to harmonize requirements under the Codex Alimentarius; and provisions for the multilateral acceptance of laboratory methods and testing and detection techniques.

So I would like to outline for you, very briefly, how the FDA -- what the FDA is doing so far to meet these requirements, in terms of three areas.  First, consultation with stakeholders.  The second is the FDA International Capacity Building work group under Imports for FSMA Implementation.  And the third refers to a number of the efforts that Dr. Lumpkin laid out this morning with respect to global landscaping needs assessment in partnerships.

So, first in terms of consultation, the plan states that we shall consult with stakeholders, including U.S. agencies, foreign governments, food industry, NGOs representing consumers and others.  This consultation is carried through a number of our efforts and over the past year, under the auspices of One Mission, One Program, described yesterday by Roberta Wagner. We have consulted extensively with our U.S. government counterparts on their capacity development efforts with a very particular focus on metrics and evaluation to better understand how they frame and design their efforts and what metrics and approaches to evaluation they use to determine their impact.

This morning's panel really represents key stakeholders who possess a wealth of expertise with multilateral organizations, regional entities, public and private partnerships, development banks, donor organizations and we look forward to your inputs with respect to some of the principles that I'll lay out now.

The working group under One Mission, One Program Imports Core Group, which was established about a year ago, really was a time to take stock of what FDA has been doing over the years and to think about it more strategically, recognizing the challenges going forward.  Julie Moss and I co-lead this group which is now under the implementation plan and it's represented by members across the Foods Program including CFSAN, CVM, ORA as well as OIP and the Office of Planning and Policy.

So the work group really started by reviewing frameworks, numerous studies and reports and trying to develop common terms and definitions. And I won't try to claim that anybody has any singular final definition of capacity building, but really to try to lay out the continuum of efforts, all the way from basic infrastructure development to very, very specific targeted technical assistance.

And then we tried to also look across what the agency has been doing over time and where our resources and efforts have been focused, to identify new approaches, potentially also with the foreign offices now in existence and to lay out some key principles.  And Dr. Lumpkin did mention that FDA is not a development agency, but we certainly do believe that we have something to learn from the work of development agencies and some of the principles, particularly with respect to being more proactive, risk-based as we heard this morning, with an emphasis on prevention, looking for opportunities that will leave a longstanding, sustainable impact, accountability and ownership, all of which are principles under the Paris Declaration for Accountability Development Assistance, those that actually address gaps clearly identified in country systems that respond to their needs and approaches as opposed to assuming the gaps and responding as we thought -- think we should.  And then we discussed quite a lot already, the past couple of days, about the need to link our capacity building efforts to public health outcomes and better performance measures. 

We have a number of other important considerations, the fiscal realities laid out this morning I think are something that we're all aware of, how do we do more with less, how do we get the best bang for our buck.  Partnerships are essential in terms of leveraging resources and expertise and developing the kinds of cooperative and collaborative efforts that were described earlier.

We're looking and quite interested in looking further at the potential for regional approaches, recognizing the opportunities there with economies of scale, efficiencies and harmonization.  And clearly now with foreign offices, utilizing those to our maximum advantage.

I also want to briefly go into some discussion of several of our landscaping and needs assessment efforts that Dr. Lumpkin referred to earlier.  The first is one that the CFSAN and ICB has initiated with respect to program design.  And that is recognizing the importance of a program that lays out an entire spectrum of work in import safety with clearly defined health goals and very specific measurable steps to get there.  This is what we will refer to as an imports framework and program design.  And we've worked across the imports team to begin to develop this and are fleshing this out further so that we can anchor the work that we do in capacity building to that broader imports framework.

The second is a study that we've commissioned by the Institutes of Medicine, Strengthening Core Elements of Regulatory Systems in Developing Countries.  And this study will also involve considerable consultation with our foreign counterpart regulatory authorities as well as industry in countries that are strong producers as well as exporters to the United States.  And from this to garner recommendations in terms not only of the role that FDA can play in addressing key gaps, but also how to engage other partners, development banks, bilateral agencies, the development sector, et cetera.

The third is a global landscape of training programs.  And this is really an effort to identify where in the world we have strong institutions and programs that can respond to the needs of developing countries in the core capacities for regulatory systems that are required.  And from that landscape, a database that will allow ongoing use to do a number of things, anywhere from identify specific needs and requests or respond to requests to a broad global overview of what the gaps are in these areas and where, collectively, we can move toward addressing them.

Dr. Lumpkin also laid out a number of cooperative agreements that we have engaged in with multilateral organizations such as the World Health Organization, The Organization for Animal Health.  These are, in a way, a kind of consolidation efforts that have been involved a number of scientist exchange that now allow for more strategic direction.  For example, the development of a plan for an integrated food safety platform, which we're working with WHO on, as well as other member states.  This is really helping us to identify what information and systems exist already, what information and systems are being used by risk managers, risk assessors, other decision makers, where the needs lie, developing a number of scenarios in order to be able to really get some more granular level input in terms of what additional systems or integrated systems would be most useful.

The other is AGISAR, which is an effort among a number of scientists from FDA as well as with WHO and members states to look at training and laboratory analytical methods for antimicrobial resistance and the Organization for Animal Health through which we're working to try to do some synthesis of assessments that have already been done with respect to veterinary health requirements and VICH in particular as well as the potential for lab training programs and regional training on VICH.

So this is really a summary of where we are now, how all of these efforts, in as much as they engage with and consult with and inform, will contribute to the development of this plan.

I look forward to hearing from the rest of the panel.  Thank you. (applause)

MS. ROCHETTE:  Thank you.  I'm Peggy Rochette from the Grocery Manufacturers Association and I'm extremely pleased to have the opportunity to be here with you today to talk a little bit about capacity building.  And I was specifically asked to talk about a GMA initiative within the APEC countries, which is called The Partnership Training Institute Network for Food Safety, PTIN for short.

I think most of you, I see a lot of friends in the audience here, so I think most of you are quite familiar with who GMA represents.  Just a couple of things I want to emphasize and that is that GMA companies are extremely dependent upon a safe, efficient and reliable global supply chain.  And I also want to emphasize that GMA, along with the Australia Food and Grocery Council are two, the two industry representatives on the steering group for the Partnership Training Institute Network.

This is an old graphic that -- GMA graphic that some of you may recall from 2007, the Four Pillars to Food Safety, a Commitment to Consumers.  And this graphic predates the food safety modernization act.  It predates the PTIN in APEC.  But it followed on to a series of very extensive, expensive food safety recalls, food safety incidents, not only imported -- related to imported food, but also related to domestic food.  And as a result of those numerous food safety incidents there was a serious adverse impact upon the confidence of U.S. consumers in the food safety supply.  And that was particularly targeted at imported foods, whether equitably or not, it was targeted at imported foods.

That third pillar there is capacity building with a foreign focus.  And the GMA ask in capacity building with a foreign focus was to expand the capacity of foreign governments to prevent and detect threats to the food supply, to expand FDA training in science outreach and to expand FDA access to foreign facilities and data and to expand efforts internationally to harmonize standards.  But at the same time, the GMA companies realized that it's the companies that are ultimately responsible for the safety of the food supply and that there was a real need for capacity building and that all stakeholders have a responsibility in that capacity building. 

The GMA companies recognized there was a real need to restore consumer trust in food safety and frankly in GMA brands.  The capacity building, although critical, the governments really didn't have the resources to do it alone.  They recognized the need to increase vigilance within their supply chains, both domestically and overseas, and they also recognized that they had some resources that they could offer to that capacity building, both in terms of scientific and technical expertise, but also in international presence, both in terms of the multinational companies that are located internationally, but also in their experience with international food operational practices and their experience with trade.

We also noted that a very important training block for the GMA companies were those 21 countries that bordered the Pacific Ocean, the 21 APEC economics who are -- account for 40 1/2 percent of the world population and nearly half of global food production.  Sixty percent of U.S. egg exports go to the APEC countries.  Sixty percent -- and if you count fish and forestry, 65 percent of the imports that go in to the U.S. food supply, those ingredients, are APEC countries.  And our top five source countries are all APEC countries.

We also had an opportunity, in 2007 because the APEC economic leadership called for a need to develop a more robust approach to strengthening food and consumer product safety standards using scientific risk based approaches and without creating unnecessary impediments to trade.  They endorsed, under the umbrella of a food safety cooperation forum, the Partnership Training Institute Network, with the challenge of understanding and applying risk-based practices in a way that ensures long term sustainability through a public/private partnership.

Well, many of those APEC countries are a real mix of the most developed countries and a lot of countries that have a limited infrastructure and a need for capacity building.  But those same APEC countries with that limited infrastructure are very good sources for food ingredients.  And those APEC countries are also interested in meeting the demands of the market and improving their economies.

The PTIN provides a tripartite structure, academics, industry and governments.  Our opportunity to share good practices and promote science-based decision making and generic training programs that can provide consistent messaging, these generic training programs are intended to be sustainable and easily accessible globally.

Now, I just want to -- the next slides will show you some synergies between what we're doing within the Food Safety Modernization Act and what we've already been doing within the PTIN.  The mission of the Food Safety Cooperation Forum is transparent information sharing and communication, harmonizing food standards with international standards and enhancing the skills and human resources to enable the development of food safety regulatory systems.  The primary goals of the PTIN are to create a network for food safety institutes and trainers in the APEC region that are focused on food safety, to build on existing  relationships within APEC, specifically among the food safety regulators, and to include academia and industry and to develop and implement food safety capacity building activities that support the use of international standards. 

The PTIN identified four priority areas:  Supply chain management, food incident management, risk analysis and lab capacity.  Now you've seen this slide twice already this morning and perhaps more, but these are some of the elements within Section 305.  And if you look at some of the elements within Section 305 you'll see there are a number of synergies to what we're trying to do within APEC. 

Let's look at them together.  The mandate in the Act, foreign supplier verification programs, preventative programs, an enhanced tracking of food.  What we've done under priority number one, within the PTIN, is a supply chain management workshop, just this last November, producing the first two modules on aquaculture and HACCP.  The Food Safety Mandate contains risk-based preventative controls, risk-based inspections, risk determinations in several areas.  And our first program was in Singapore in August, 2010, on risk analysis.  The Food Safety Mandate, the Food Safety Modernization Act Mandate, mandatory food recall, preventative programs, food defense and improved surveillance. 

And our PTIN priority number three on incident management includes a workshop in Big Sky, which we are presently preparing for in May of 2011 along with several other food safety programs that were mentioned by Dr. Lumpkin.  Philippines also did a workshop in May of 2010 on recall.

Priority number four, the Food Safety Modernization Mandate, capacity building, multilateral acceptance of methods and detection techniques, accreditation of labs, domestic and foreign and to build laboratory networks with agreed methods.  We are -- our program funding for 2011 will initiate the fourth training program area in lab capacity.  We have program funding for a program in September, 2011.

Just to close out, going forward we will be -- we're building and replicating training modules.  They'll be available beginning in May, after Big Sky, through a website.  This is globally accessible, not limited to the APEC countries.  We'll have to identify more sustainable funding.  We'll be building out the network of trainers and users and continue to assess the specific capacity building needs and we've started -- we'll be starting this next month an assessment program specifically related to lab capacity.

So, in a way you know, this could be a model for going forward and leveraging some of the resources within -- to help accomplish some of the goals of the Food Safety Modernization Act.  Of course we do want to build the skill sets, ultimately, of suppliers and improve global understanding of international best practices.  We want to enhance the efficiency of rules for global commerce, the capacity for less developed countries to export products and thereby improve their economies as well as the safety of the domestic food supply.

RENATA CLARKE:  Good morning again.  This time I'm talking about the work that FAO does on food safety capacity development. 

Just before I start looking at specific areas of work, I think it's useful to put things in perspective.  This is a graphic that shows how FAO's funding is used for its various strategic objectives.  The little one, "D" refers to the strategic objective for improved safety and quality of foods at all stages of the food chain.  So, ignore the purple line, look at the green.  The green represents the funding that's assigned from FAO's fixed budget is the dark green, the light green is the funding that we're able to attract from external sources to carry out work.

So in the general scheme of things, the resources available for FAO's work on improving food safety and quality is limited.  Furthermore, some of that, in "D" -- our work is not entirely capacity building. You heard a lot about the Codex Alimentarius Commission, the Secretariat for the Codex is hosted by FAO and a lot of that funding, the most part of that funding goes for the running of the Codex Secretariat, goes for developing scientific advice in support of the development of science-based standards and the rest relates to capacity development work that we do around the world.

So, fortunately the world isn't waiting only for FAO to build capacity in food safety, there are many players.  This is good, because there's a lot to do.  It's less good when we don't get our acts together and maybe the resultant of a lot of fragmented efforts perhaps doesn't go as far as it might go if we worked a little bit more closely together.  So it's been encouraging to hear everyone talking about the need to partner.  We also feel very strongly that need.  So there is an awareness of the need to work better together.

And before I paint a catastrophic picture I should emphasize that there are already many initiatives for working better together at country level.  There are a number -- there are development frameworks to which countries ascribe, there are also donor groups and partnerships at national level for coordinating the implementation.  On an international level there's the Standards and Trade Development Facility which is -- in which World Bank, FAO, WHO, OIE are the major -- WTO are the major partnership.  And for the moment I think it's a U.S. chair of the STDF.  And one of the major goals of the STDF is to facilitate better coordination at the international level for capacity development work.

Before I fly, ten minutes goes very quickly, I just want to stop here for a minute to remind us all that capacity development, if it's going to be sustainable, has to occur at several levels.  Training people, the individual level, is important but you won't get very far unless there's institution building as well as an appropriate strengthening of the overall systems framework, the policies, the legislation to support food control.

There was a -- our governing bodies are having -- are insisting on a lot of reviews and assessments of FAO's impact. And one of the recent reviews was on capacity development activities in Africa.  It was very -- it identified a number of areas where we could improve, but notably among the positive things that it said was that the capacity development work in food safety, animal health and plant health areas, there is a good blend of activities focused at the three levels and good indications of sustainable impact.

Shifting back to the capacity development work in food safety, there are three major areas in which we work.  The first area relates to policy, institutional and legal frameworks, working with countries to update and upgrade their -- those frameworks, working with countries to improve the capacities to design and implement official programs of control, and within that area we do training on risk analysis, strengthening inspection services, analytical services and food safety emergency response.  And finally, developing the capacities of the value chain operators to follow good practice, to avoid the problems that arise in the first place.

Very quickly, I've already gotten my first sign, here I want to emphasize this is where we think we need to improve the most.  A lot of the problems that we've done, at technical level, very successful, but in the end the sustainability is very often limited by the fact that the decision makers, the ones who decide where money goes, often don't support or allocate the resources necessary.  So we realize we do have to spend a lot more time putting information together in a way that the policymakers can understand much better the impact or the reasons for investing in food control.  And we are proceeding, in the next biennium with developing a methodology for better use of evidence in decision making for food control.

I spoke earlier about our guidelines for assessing capacity building needs in food safety.  After the last five years of using that, we have fairly good ideas of how it could be improved to give a better assessment of food control systems.  And a lot of what we heard yesterday and earlier today relates to how confident can we be in other country's systems.  A very good assessment tool, I think is -- would be something that's very useful for all of us.

FAO has a legal development law service, I think it's the only UN agency that does.  So there's a lot of accumulated wisdom about legal frameworks and legal issues in relation to food safety control.  So here again is where we know, at FAO, we need to put a little bit more emphasis so that we can get strengthened commitment at national level for building a sound base for food control.

Okay, in designing and implementing better food control programs, there's been a lot of training done and a lot of training being planned by many people on risk analysis.  Again, it's an area where perhaps we haven't seen as much impact as we would like to see.  And I'm not just talking about our work, but in general.   

In some countries, the more emerging countries, networks have been established for sharing data, generating data and actually there are clear signs of countries using data to make risk-based contacts and to be able to communicate better with trading partners. 

We are currently working with WHO on the development of a risk analysis tool kit.  As a starting point we've taken four common questions or four common situations, I should say, where developing countries should be applying their knowledge of risks much better to make decisions on their systems.  Here I have to say that very often the comment we get from developing countries is, "Yes, risk analysis is a very exciting concept, but it's very -- it's too sophisticated for us."  This is a sign of failure, because if countries think it's too sophisticated for them it means we haven't made them understand how it should be used and how it is very relevant to them.  So we are working on developing training materials, basically to help them understand what do you mean by a risk-based food control system.  How do you establish risk categories or how -- what are the ways in which you could go about establishing risk categories for your inspection systems and setting national standards.

There have been a number of food inspection manuals that we've developed in the past.  We are currently working on updating the FAO guidance manual on import inspection and I look forward to following up with some of you about the lessons learned most recently, so that we can make sure that the guidance that we give to countries is indeed the most updated.

At the bottom there you see an online tool that's been developed as a byproduct of one of the joint committees on microbiological risk assessment coming out of the work of JEMRA.  They have recognized the need to provide very concrete guidance to countries on microbiological sampling.  So we've got very good feedback from this, from member countries and we are developing training materials to support that sampling tool.

Emergency response and incidence reporting, FAO participates in the FAO - WHO INFOSAN Network and possibly more importantly, the in-country work on developing emergency response capacity will actually strengthen those INFOSAN focal points.  So they're able not only to manage emergencies, food safety emergencies better in the country, but they're able to participate much more effectively in that global information system.  So the world benefits from more reliable and rapid communication when required.

Supply chain management, again as you will have already heard this morning, there's a lot going on.  FAO training does emphasize the explicit linkages with the Codex texts and the implementation of Codex texts.  Given the scope of FAO's mandate in animal production, crop production, fisheries, we're able to provide a very integrated approach to addressing food safety management at all stages of the chain.  We are -- we realize and we are working more closely with national institutions, national universities to be the vehicle by which these training goes on after our initial input.

So, in conclusion, there's a lot of work being done, there is a lack of coherence and we all have to play our part in improving the total value of our efforts by working a little bit closer together, communicating a little bit more.  We are a small, but we're a strategic player in food safety capacity development.  We would like to play a better roll in that pooling of knowledge.  This is a bit of the role of the UN agencies, to pool the knowledge and the experience of different countries and make it available to the international community.  And finally, as I said, we do need, we recognize the need to influence decision makers better. 

Thank you.  (applause)

MR. LAMB:  Hello everyone.  Great pleasure to be here.  When I first heard about this event it was actually an early announcement and I remember thinking, "Wow, that sounds like an interesting event, lots of friends possibly and I'm certainly going to learn a lot."  And I am learning a lot.  But then when I got a call from Camille inviting me to actually speak I said, "Oh boy, now this is getting serious," because knowing who is in the audience and what you do and all that you accomplish, this is a problem because I am not technical, as you see from the biography.  And I'm certainly not a regulator and in fact the only time I ever worked for the U.S. Government is in the early '70s when I joined the Peace Corp.  So I was wondering what could I add in terms of value to this group.

If there's anything I can add in fact it's something I hadn't thought of until listening this morning and I think that's two things.  One, as the bio said, I've had intermittent involvement with food safety and number two, I'm not working in food safety.  So the fact of being intermittent and not be an expert in this field and not be my day job is in fact part of the value I'd like to add to you.  And the reason for that is the people in the international development community are not experts and they're not working on this day-to-day basis.  Yet it's been said correctly that a lot of interaction, a lot of alliances and so on are needed to leverage people's resources.  So, the people you need to work with to accomplish that are in fact people for whom this isn't a day job, who don't know the language, who are not -- don't have the experience you do, yet may have control over resources that you'd like to leverage.

I'm going to speak particularly from my experience with the World Bank and also long experience as a consultant with USAID.  But I've had experience recently with a lot of other organizations as well while I was three and half years at the World Bank, so I'll sort of allude to connections there.

But of course when we talk about partnerships in this field, it isn't only these organizations you see here and ones like it. It's also the public standards setting bodies, the three sisters, some of whom have been present here.  It's also entities like APEC and multilateral organizations with whom you are working or might work.  It's also bilateral donors, not just multilateral of which USAID is just one.  Even though the focus here is on raising the bar for imports into the U.S., USAID is only one of the possible partners in that regard.

It's about private standard bodies and certifiers and auditors, some of whom are present in the room and I gather spoke earlier.  And it's about a whole bunch of civil society organizations like GMA and others, as well as even entities that you might consider a surprise, like the Gates Foundation.  As I'm going to mention we're involved right now with a major aflatoxin push with the Gates Foundation.  So there are nontraditional actors.

So one of the challenges of leveraging resources is with whom do you work, what resources for what purpose and what's the transaction cost involved. 

Now why are international development agencies interested at all in the food safety?  Well, frankly the primary reason is it's bad for business and it's good for business.  It's good for business because compliance allows export-oriented projects in particular to do better, to prosper and it's bad for business because if they do it badly obviously the markets get blocked, automatic detention occurs and other disasters that affect the development objective.  And of course it's bad for the same reason for the people for whom we work, for whom an automatic detention can actually kill the entire business or the industry.  But of course we are an international development organization with humanitarian purposes, so we are concerned, as individuals, as development professionals, with what happens on a human level, we are concerned about it, I'd say on a day-to-day basis but of course as international organizations we have a fiduciary responsibility. 

So when you talk about risk analysis and risk management, if I ask the entire people working in the World Bank, which is now, I think, 17,000. what risk analysis means, I'd be surprised if ten could give you the same definition well.  The risk to the bank, to international development purposes is not risk primarily to human health and welfare.  That's a fiduciary risk that's in the background but not primary, on top of mind.  So our definition or our concern about risk analysis is quite different than yours and it has to be taken into account when you try to come up with partnerships. 

There are differences between what we do and why we do it and there's also similarities of course.  So, in this case you're looking at foreign culture.  Is this an opportunity or is it a problem from the prospective of food safety.  We would see it, in the international development field, as an opportunity.  You as regulators would probably see it as a problem, because you're concerned about all the things that could go wrong.

What have we done as international agencies?  An example would be the biggest single food safety project of the bank, $100 million signed in May of last year for Jilin Province, just one single province in China, which is the first and only time we've had a project that big in food safety.  The total amount of investment by the World Bank in the food safety area over a five years period never exceeded $150 million.  So -- I'm sorry, not -- yeah it was 150 over four or five years.  This is one single project of 100 million in one place.  Not likely to be repeated, but an example of what you can do when you concentrate.

One of the dilemmas is in the international field there are very few quote "food safety" projects.  There are value chain development projects, there are diversification projects, there are agricultural development projects.  Food safety is a part of all of them but it's not the core of any of them, typically.

What have we learned about capacity building?  Well one, that may not be obvious in these pictures which is the meal that I had last Monday while I was in South America and this is how it was prepared, at 4,000 meters, and that's the food that resulted from it. I thought of asking one of my colleagues on the team quietly, how do you say HACCP in Aymara and in fact he said, "I have no idea."  And I said, "Well, it's okay because I don't think we should say it anyway."

Food safety and agricultural health systems are often not up to best practices, but that's a practical need why we have to work in the area.  But it's also important because not doing it well affects economic and social development.  And it requires upgrading and that in turn requires capital.  And that's one of the functions that the World Bank in particular, but also regional development banks and so on can provide and should provide.  And that's where there's a partnership possible.  We don't have, in the international development field, the technical expertise that our FDA has.  You may not have access to or leverage of the resources that the World Bank has.  So one form of partnership is to partner technically and financially and work together.  And that's one of the things that is being actively discussed right now between the World Bank and FDA, but hasn't moved along as fast or as far as I would have liked.

It also requires technical support.  And we have some of that, in terms of how you do business in developing countries, but we don't have the level of technical support you have or technical knowledge you have. 

We do recognize that food safety matters.  We recognize that it has all kinds of implications.  And we do, in fact, have a lot of demand for work in this area, but it tends to be demand from people involved in value chains, supply chains who are trying to penetrate and hold markets.  We get relatively little demand from the Ministers of Finance of different countries, unless one of two things happens:  Either they're going to accede to the EU or they just signed on to the WTO or they have a major food safety problem with is blowing up and is going to cause them to lose their jobs.  So the immediate motivation for requesting money in food safety is different than what you would have thought it was.  It isn't the long term affects on public welfare.

Now we do try to improve the public welfare, but of course we see it quite differently.  For us, public welfare involves alleviation of hunger and poverty.  For an entity like FDA or in a developed country it might be alleviation of obesity, which is not a concern that we particularly share or worry about day-to-day. 

I don't have to remind you that food safety is your top of mind concern but it isn't for international.  There's a big difference too in perspective.  It's a bit like a donut.  You are within and focus on what happens in the U.S., speaking of the FDA people present, we do everything else.  We're concentrating on what's happening in the outside of the donut.  So the trick is how do we make the inside and outside come together into one whole.

We're also subject to host country priority setting based on the declarations, the Paris Declaration that was mentioned earlier.

There is a declining attention to international trade versus regional and internal commerce.  I did a lot of the initial work in this field promoting nontraditional ag exports and so on, which is how I get involved intermittently with food safety matters.  But the amount of attention going to international trade is declining and we're more concerned now about regional trade and internal commerce.

We tend to pursue economic opportunities rather than respond to hazards.  That's a fairly big difference in mindset.  We try to address the entire field of agri- food standards, not food safety alone, because we don't have the time, willingness or mandate to concentrate on one specific part of agri- food standards.

So when in ag development I was the agribusiness team leader for the bank for three and half years.  I was concerned not just about food safety but about this entire pyramid of agri- food standards.  We had a program for dealing with food standards that went far beyond food safety and didn't go deep enough into food safety as one would like.

We do do some of the same of the same tasks.  We promote, we advance knowledge, we respond to crisis, we build capacity, we monitor, we advise.  But of course, one big difference is some of the development agencies actually provide money and none of us regulates.  So we have similar, overlapping types of activities but with type huge differences.

Now I'd like to quickly run through the history as I saw it over the past 30 years in this field, again interacting intermittently with food safety.  In the 30 years, more or less or the phase one, although it wasn't called a phase at the time and only in retrospect would you even define it as a phase, we were concerned with basic -- supporting basic public infrastructure relating not just to food safety but the entire SPS field.  Later on, starting about in the middle of the '80s, when there was a push towards filling in seasonal windows in particular and moving into high value crops, we got more concerned with assuring compliance with the requirements of target markets. 

Third phase started about early '90, was building capacity for trade integration, particularly with feed trade agreements, preference agreements and so on.  1995 and this continues, it was tied to actually carrying out the disciplines acquired through membership in WTO.  And secondarily, for some cases, those that were acceding to the EU and wanted to be able to continue to that market.

Fifth phase, if you could call it a phase, was satisfying escalating private agri- food requirements.  Doing things like HACCP plans, obtaining fruit certification, dealing with multiple audits, the costs and time associated with them. 

Sixth phase was started about in 1990 with the increasing attention, first of all to pesticide residue issues, secondly with microbial issues such as e. Coli, vibrio, cyclosporine and so on.  And that phase is -- continues to this day of course, because the problem isn't solved.

Now there are some examples of USAID activity I'll just quickly mention.  Mostly it's technical assistance and training, often tied to specific value or supply chains of interest, often tied to target markets.  Not too much technical assistance from the USAID side in recent years to actual -- to governments, but the bank continues to do that when requested.  A lot of training on the USAID side in dealing inappropriate pesticide use and so on, increasing interest -- continuing interest I'd say in public/private partnerships, forming connections with associations with entities locally public and private who might provide training itself in GAP and so on, some attention to incident and crisis management, sometimes in combination with FDA and EPA. 

The bank's activity is somewhat similar but somewhat -- but hits a higher level.  Local public partnerships.  One was already mentioned, the Standard and Trade Development Facility which the World Bank put the seed money into, about $900,000, six or seven years ago.  The Trade Standards Practitioner Network.  What the bank called economic and sector work in food safety and other health -- agricultural health standards.  We did do a guide for assessing national lab improvement requirements.  We do ongoing analytical advisory assistance. 

And of course we have operational lending.  The bank lends $60 billion a year at the present rate.  Of that 4 to 6 billion -- well actually no, 6 to 8 billion is going into agriculture.  And so the challenge is how do you get some significant share of that to go into agricultural health and food safety and in the same way, how do you get the health activity in the bank to come through.

One of the challenges we had within the bank and this is true in USAID and all the donors, is stove piping between the health and agricultural activities.  And only recently, with the rise of interest in food security which straddles those areas, is it really possible to connect in a meaningful way, but it's still very nascent. 

Now the -- we do have a sense that this situation is changing.  One, that the evolution of old hazards, it appears the new one is still out stripping the risk mitigation capacity and we would like to make a contribution.  We're also concerned that this is a problem where the 85/15 rule, that 15 percent of the suppliers even in the more mature deals, are the ones that are causing the problem, whereas 85 percent are not.  So there's an issue there that hasn't been resolved.

We generally feel, from our experience, that the private sector has a tremendous amount of expertise which is not fully being tapped and we would like to do that.  But we also have the sense that that the private sector is not coming up with the kind of private resources that it should early enough in the game to deal with the moral hazard caused by the 15 percent situation.  Although the private sector, through GMA and others, is showing lots of interest and is working on things like APEC PTIN, the money that is needed, actually is needed at an earlier stage and with less -- and more in a precompetitive manner.

Our perception is that host country governments rarely approach this challenge proactively because the risks are latent and there are many other demands on their money.  So it's only in crisis or an opportunity of accession that they really pay attention.  That causes low demand for World Bank lending and regional development bank lending, even for USAID technical support. 

Now, what are some of the lessons learned in collaboration?  Obviously, as everybody said, it depends on close collaboration between everybody.  One issue is differentiation or divergence of approaches.  If FDA follows one approach and the EU follows another, that complicates our life in the developing side and the supply side.  So to the extent that the major markets can get their act together and share the way they're doing things, that makes it easier to respond on the supply side.

We hope and would urge that in fact the international agencies continue events like this but actually make it operational, in terms of having convergence of approaches.  The same principles you push for harmonization or at least equivalence and convergence when you're talking about specific standards that really are needed for the developing country point of view for the overall system.  

There's an unmet need and opportunity for coherent, consistent approaches that would lower costs.  There's too much fragmentation and duplication and every invention of the wheel.  Yet there's an ongoing need for customization as well, because of circumstances of who are your trading partners, what are the major markets, what are the commodity systems, all of that varies.  So you need a flexible approach which most towards divergence but is also flexible.  And it can't be just one off interventions.  They need to be continuous improvement and there should be a pathway to continuous improvement, which doesn't always exist.  Sometimes it's just yes or no.

And the efforts have to be sustainable over time in technical, financial and political terms.  In other words, you have to have political buy-in at the country level and the source country level to really make it stick.

What about financing it?  As I mentioned, we need expertise in the development community of the kind that FDA and some of your organizations have.  But you don't have the money.  We have the money, speaking for the World Bank and others, but we don't have the technical expertise.  So there should be a marriage there, but it hasn't happened yet.

The private sector, again, has waited too long to contribute its significant funding and is sort of waiting until we figure out a global approach to this which could take advantage of their expertise.  But they're still staying within their own supply and procurement systems when in fact the problem is usually now at this stage, at least for the major players, outside their particular supply and procurement systems.

We've learned a lot about private versus public standards.  Private standards, and I gather earlier in the week there was discussion on this specifically, they have increasing technical sophistication, organization on market power.  Yet there is, within the WTO's committee -- SPS committee - continued resistance that's a problem and in fact I think is blocking progress.

My view personally, I'm not speaking for the bank or anybody else, this is me personally, from my experience at WTO, representing the bank for a couple of years, that it would be better to constructively engage and use the private power and evolving structure as well as schemes and benchmarking schemes and certification and audit systems to better reach out and actually multiple, leverage your own outreach as regulatory bodies.

We found that the effort by industrialized countries to raise the food safety bar have the danger and in fact are in fact creating a two tiered system with significant exclusionary affects.  The aflatoxin case mentioned in the morning by the EU, the bank did a study on that and found that $650 million of opportunity it caused for foregone exports of aflatoxin susceptible products like ground nuts. 

If product cannot make it into export markets where does it go?  It doesn't get thrown away, it gets eaten.  In the absence of regulation systems which allow for different levels of tolerance for aflatoxin, the affect of exclusion is in fact to leave it in the food system and to exacerbate the history and nutrition problems associated with aflatoxin.  So developing countries - in the EU and in the United States have different systems and different uses, depending on the presence of aflatoxin.  That does not exist anywhere in the developing world.  So there's a direct exclusion causing by tightening the bar for your markets and it causes exclusion of supplier countries or supplier sources, which are a major problem.

Future efforts to explicitly provide a continuous improvement pathway as well as incentives are needed.  More work is needed, more attention and we need your help.  How do we actually raise the bar in the developing countries themselves?  So you can do all you can to improve food safety into the United States, into the EU and other industrialized countries, but you're leaving behind the entire developing world where most of the population is going to be, where most of the increase of food consumption is coming from and where most of the problem resides.  And in both cases, the lack of data contributes to that problem.  

So where are we going from here, to finish up.  Round phase seven was started just a few years ago.  There was a collective effort among the -- some of the international -- some of us within it to participate in global efforts to deal in a coordinated way.  One World, One Health is an example in the animal health and human health area, (inaudible).

There's a phase that started just a couple of years ago of trying to do multi-country food safety system upgrading through public/private partnerships.  More recently, as I mentioned, this partnering with nontraditional development organizations such as The Gates Foundation which is increasing, had already been strong in health, is now heavily involved in agriculture and is increasing.  That's a nascent cooperation which isn't a product specific -- I can't remember the term, that was the beginning of the four word term, but this is in fact a risk-based problem.  So here we're targeting not a product; we're targeting a range of products that are subject to the same risk and hazard.

Most recently good examples of bringing together best practices which include governance, risk and economic analysis and food safety management and we're trying to work with FAO and others to come up with a way to better build the capacity to actually deal, using risk analysis, risk assessment and best practices in the food safety arena, this whole range of rather difficult.

In conclusion, from our view, from the developing -- development assistance viewpoint, if I can generalize, which is a bit risky but I will, we see progress continuing to occur but there's a long way to go.  International organizations have been making a contribution to the extent they can, but it should be bigger.  We need better data, more effective client demand collaboration with sources of excellence of the kind you represent and more readily available and usable approaches and tools, which we have difficulty developing.

On the other hand, the private sector, as I said, needs to invest money and expertise more heavily in a precompetitive manner and give greater emphasis to small suppliers and sources.  That's happening to some degree with some of the programs, but the same exclusionary affect that I mentioned for using the example of aflatoxin also occurs as the private standards rise and that is an issue that is also a development concern.

Thanks very much for your time.  Sorry I ran over.  (applause)

DR. SANCHEZ-PLATA:  Hello.  My name is Marcos Sanchez I'm representing here Inter-American Institute for Cooperation on Agriculture.  Before I started I would like to thank FDA for the invitation and letting us share some of our experiences in the countries that we serve.  If you haven't heard of IICA I hope that by the end of this talk you will be more familiar with what we do.

We provide technical cooperation, innovation or specialized knowledge to our member countries.  The idea is to help in sustainable development of agriculture in the Americas. We have 34 member countries, including U.S., Canada, Latin America and the Caribbean.  We have offices in each of those countries.  Our headquarters is actually located in Costa Rica, but we have offices in each country and with technical staff in most of those offices.  In addition, we have an of course in Miami where I am stationed and another one in Spain that is helping us to bridge some activities with the European Union.

One of our -- some of our advantages, and I want to mention first that we try to link with officials in the country that we work.  We work with Ministries of Agriculture which are our main bosses in each of the countries, but we also work with commerce, health departments and try to associate with those organizations. 

I'll just mention that we are in the finishing stages of signing an MOU with the FDA on cooperative work.  We also align with trade organizations and export organizations from the countries to work on some of those activities.  And of course we partner with NGO's and institutions such as FAO for implementing some of these projects in the countries that we work.                We have a limited funding, as we -- has been the common theme in these sessions.  And we try to maximize the use of our resources by keeping these technical staff in each of the countries that will help us keep those activities running and operating and measuring how they work.  We have a network for technical specialists.  We try to get together and we emphasize a lot on communications.  We spend some funding on keeping us connected with video conferencing, Internet type of communications.  I don't know if you know this tool called Elluminate, but you can host meetings and document sharing and cooperation.  So we emphasize a lot of that, try to maximize the use of our funding and reduce the travel.  Although it doesn't work that much, because we travel a lot.

Sorry for the images, it doesn't look very well, but what I want to emphasize here is that we have several programs, targets to different things.  But for the purpose of this hearing it's going to focus on two programs, the Agribusiness and Commercialization program, PAC, that we have in Miami office and the Agricultural Health and Food Safety programs that we have in each of the countries, but the headquarters is in Costa Rica.

Some of the lines of action of our programs, I'm going to mention a couple programs involving each of these -- a couple of initiatives or lines of action on each of these programs.  In the agricultural health and food safety we have the ELFS Program, what it is is Executive Leadership in Food Safety.  We train, we work on leadership with people that have been identified in each of the countries, one or two in each of the 34 countries that are drivers.  That are drivers, that are leaders, that will push some of the initiatives that we put in the countries and that are working at official institutions or associations that will make an impact in the country.        

One of the advantages of these ELFS Program is for example we have some FDA people involved, USDA people involved, people from other continents involved.  And the people that have participated, we are in our second ELFS Program, it takes two years and we have four modules that the participants take, they tend to, about at least 50 percent get put in higher up positions wherever they work and 90 percent of them get more responsibility in food safety.  So they really become the drivers of some initiatives in the countries.

Another one that is starting right now is the development of a regional school of inspectors that will support some of the food safety initiatives that we're mentioning in these hearings.  And this is starting with the regional school for inspectors in Central America. 

Another tool that we've been asked to expand a little bit at the end and hopefully the time will permit it, is called the Performance Vision and Strategy Tool.  It's an instrument that we use to measure the capacities of the countries on different topics.  I'll focus on the one that is focused on food safety systems in the countries, the PVS.

In addition we cover capacity building, as we've been talking in this session.  And we agree with FAO that we cannot just talk, like do a training and try to get -- hope for the best for those people that have been trained to do the job.  Any training activity that we get involved has to be accomplished in joint operations with institutional support, where we try to build institutions and also with the goal of changing policy.  So, no project is approved if it's only a training experience but rather has to be fulfilled with institutional support and policy development.  So we agree with that perspective from FAO.  And with the training, of course, we go through practices and GMP's tied up with some of these initiatives.

We have some training also from this program on risk assessment, training -- working with risk managers and with risk assessors.  I would say that the risk assessment teams in the countries is -- are not fully developed, they are in the initial stages and but we're working heavily on bring them up to date with other countries.

Other initiatives that IICA is involved with the food safety program are support and participation in WTO meetings and Codex Alimentarius meetings.  We not only support countries to go, but we also provide the technical expertise to help them participate in the meeting with the knowledge of what they are getting into.  And this program has been very successful in the last two years and it helps put some of the countries that probably before were never able to attend the meetings, to go and present their positions and those points are being taken into account.  We're trying to get partners to keep supporting us, we always try to get three to four people -- three to four countries selected for particular Codex meetings and we're looking always for funding.  USDA has been a great partner in that that has been supporting some of these initiatives.

Some initiatives in sanitary or phytosanitary measures.  With training, we try to use some of those online tools.  And the training on sanitary and SPS measures have been very, very successful and received very good input.  And the PVS Program which the site just a tool to measure the capacities in a country, but also with the idea of creating a common vision for where do we take this information.  There's one for food safety, there's one for animal health, one for plant health and a new one on what is the capacity of the country on SPS measures.  And I will explain a little bit how this works.  But we get -- we put their stakeholders in private, public and consumer groups, kind of like a hearing but in a very active manner. 

The other program, the agribusiness and commercialization one that I monthly attach but I work for these two programs, deals with linking farms to market, value adding and some other lines that I'm not going to mention because they're not relevant for this hearing.  But in the first two lines of action we work directly with the associations of exports. 

What I've been concentrating these two years as I've been in IICA is developing a portfolio of programs for supporting the institutionalization of food safety training and requirements for exporting with associations with expert association, with co-ops, it depends on -- we adapt to the size of the customers that we're working on.  So we can work with very small operations all the way to large corporations -- operations that have fully developed associations. 

And having the presence of some of the countries that we help -- we help the countries go and export and we take, for example, a group of 20 companies and we train them all the way in business plan requirements and we take them actually into a fair or a mission to the countries that we serve.  And we have some publications that are freely available on the Internet.  We actually partner with Google to have all our documents publicly available on Google Books.  And mostly we have it in English and Spanish but we also have documents in Portuguese and French which are our four official languages.

So the programs related to what we're talking here is training on FDA requirements.  We actually have a guide, "The United States Guide for Requirements for Exports" that we just updated last year.  And we included -- it was -- we were waiting for the Food Safety Modernization Act to come out, but it didn't come, it didn't come so we have just a chapter at the end where I summarize the main findings.  But now that we have the final law and it's been implemented we'll probably come up with a third edition with those changes.

We also do equivalence of inspection training and we collaborate with -- we use the FAS, with the Office of Capacity Building.  We do the training with the inspectors and companies that are willing to export meat and poultry to the U.S.  So I'm heavily involved in that program.

HACCP train the trainers with the International HACCP Alliance to get trainers to do the workshops for us rather than just us doing all the workshops all the time.  Better process control school, we partnership with U.S. universities.  We were involved in the GAP Harmonization Initiative with the U.S. Fresh Produce Association, tried to use that code that was developed to strengthen our GAP training.

All our training and activities are focused on this parameter of the food safety management systems where we have the consumer -- we have the industry and the public side.  And I'm just going to go and explain that we're trying to focus our training in the country level, in the institutions, the government.  So here we go with the PVS Program.  I'm going to probably steal a couple of extra minutes, just to explain this program.

It has three stages of performance where we measure, bring into a hearing a lot of stakeholders.  We bring the industry, we bring private partners, we bring the government, we bring customers.  We develop a vision of where do we want to be next and it's -- the beauty about this process is that in the end, the end product has been tested or at least has been worked out by all the players, all the stakeholders in the system.  So the program at the end becomes actually they become proud about the program that they developed and it becomes property of the country. 

And then we develop the strategy.  I have some of the documents and they are freely available online if you want to download the document.  This is the PVS for Food Safety Systems.  Again, it has four fundamental components, I'm just going to mention that.  The first one we get all the stakeholders in a meeting and try to get the input.  And we have like a questionnaire -- active questionnaire, but the beauty of the questionnaire is that it has metrics.  Actually every little point or core competency that we measure has a level that is all the way from non-developed to all the way to fully developed.  And we get the measurement, a scale from 1 to 5, 1 to 6, where we can actually put that information into numbers.  And this creates benchmarks where they can identify where they need to improve and also benchmarks to find out where they were and where are they going to be in the future.  I'll try to show at least one picture to show this effect.

So we get the public and private sector involved on this.  So you're going to get some divergence in the comments, for sure. The public sector is going to think everything is fine and the industry sector is going to be on the other side, so you're going to see that.  Once you get to the meeting you discuss what needs to be improved, what needs to be changed, once you get these metrics that I was mentioning.  And the common policy at the end.  The idea is that at the end we will have a project to submit to the government that they will look for funding these changes that we are proposing.  We look for partners there, international organizations that can fund the countries to make those changes possible.

And then define the actions at the end, the schedules of when are these going to be implemented, who is going to be responsible for the different stages and what would be the new food safety system in the country. 

Just to finish up, I want to show the four components of the food safety system are technical capability, human and financial capital, interaction with the private sector and safeguarding public health and market access.  Each of these four components has between six to eight core competencies that the countries need to fulfill.  I'm just going to show this, you're free to download the document, it's online.  You can read all these components.  Some of these are included in the tool that FDA is currently using and testing.  So I see there's some comparisons here.

This is the second component, human and financial, interaction with private sector and safeguarding the public access.  But how do we use it is this.  At the end you're going to get -- how do you set priorities?  You're going to find out what areas your metrics are telling you that you're okay, or that you need improvement, in the four components that we have.

So, they can measure where they are, they can target the funding to make the areas that were their the weakest and that way the funding the better used.  And also they can measure this later on, or the post mortem, let's call it, where they will know how was that progress completed.

And I'm not going to take anymore time, but there's going to be a little couple more slides with information in the document that should be available at the end.  Thank you very much.  (applause)

CARLOS ALVAREZ ANTOLINEZ:  Thank you.  I'm going to make this very short. 

I'm not -- this is not about the whole of the activities carried out by the Commission, the European Commission or the EU in terms of capacity building, it's only about one specific program, which is conducted by the part of the European Commission which is responsible for food safety.  So in this respect it is something which is unusual because it's not something that we normally do and it is very, very targeted.

Otherwise, what we do, speaking from the perspective of DG/SANCO, that's the part of the European Commission dealing with food safety, what we do is to try and promote SPS issues in the general development agenda of the European Commission. 

We also try to coordinate activities with member states.  And this program is called "Better Training for Safer Food."  It covers the SPS field.  There is a lot of information on the web about this, if you Google BTSF or the whole thing, you will find a lot of information so I'm not concerned, because of the lack of time.

But I just wanted to say, we have two main objectives.  I mean to some extent this is a selfish activity.  We want to train staff involved with exporting food to the European Union, but also trading food with the EU.  So it's not just specifically  -- the program is not just specifically or exclusively for imports, this is for the whole of the food safety within the Union.

And there is another dimension which is to try and -- sorry, to train staff in developing countries to secure a safe local food supply.  So there is also this food security dimension.

It covers, as I said, SPS issues, all areas  of our food law, animal health, plant health, animal welfare, is demand driven and in terms of what we actually do there is again a panaplea of different activities, but many training workshops but includes also practical site visits, export assistance.  So when we go to training missions we may send expertise to particular countries for a relatively longer period than just workshops.  And there are other activities that you can see there, e-learning modules are becoming more important.  And the target audience, that's only for competent authority.  So we are dealing with competencies in members states but also in non-EU countries, exceptionally private representatives can participate but that's not the target audience.

Here you have some figures about the program in 2010.  I don't think I need to go through this.  It's a relatively modest amount but it is very targeted and again, from our perspective it's a very useful instrument.

This is about the type of activities in member states, which are less relevant.  And this is about the programs in 2010 addressed to third countries.  So you can have there the list of the topics addressed, the hosting countries and also the participants.

In Africa we have a particular emphasis and there is where maybe the issues on food security are more important.  On this slide you have a little of our description of the kind of objectives that we specifically for Africa.  Some data about 2010, so there is a little of increase, not huge but still -- so it is expanding. 

Some novelty elements, more quality schemes, the traces element that we mentioned earlier, this has been incorporated.  There are all the initiatives, new elements in the programs and also more about e-learning.

Overview of activities in 2011, these two slides were about member states, but (inaudible) again you have the list of topics or issues that are being addressed.  Some plans or estimates for 2011, a little increase again.  And just what I want to say is that this program is currently being under evaluation by the Commission Services and in general, I mean there are many positive elements but there are also some elements where we think we need to improve.  More collaboration, both with member states but also with third countries, coordination externally.  And externally there is a lot of dialogue with some of the guys who have been speaking earlier here.

And my final point would be probably that it's a good opportunity for us to explore synergies.  I think you are going to embark probably in a bigger endeavor and I think we would like to explore with you synergies and possibilities.  Thank you.  (applause)

CAMILLE BREWER:  I would like to thank all the panelists and invite you to come down to the head table.  As the clock is ticking, I would like our two stakeholders who would like to testify to come down to the first row as well as.  That's Katherine Means from the Produce Marketing Association and Kevin Edwards from the SGS North America.

STEVE SOLOMON:  Thank you again.  They were wonderful presentations and we very much appreciate them. 

So we heard a wide variety of approaches was not surprising, from the different folks and organizations representative interests.  In the capacity building, I would like folks just to sort of go down and give your thoughts on when the question of development of food safety in the country, a developing country, should the focus be on the export market in order to help build that economy or focused more on food safety that's going to affect both their domestic and export market?  And the relevance of this comes to the discussion yesterday where we were looking at systems of looking at exporting countries and whether we can rely on systems that are based only on export or whether we need to rely on systems that have both equal protections focused on both their domestic and export market.

CAMILLE BREWER:  Who wants to start?

DR. SANCHEZ-PLATA:  Well from IICA perspective, it's actually -- the export market is one of the drivers, but in the end it's got to be about the local population.   You know, there's a -- for example, the tool, the PVS tool we apply in the country and it becomes property of the country for their own improvement of the food safety system.  So in order to make it, it's got to be the equilibrium between, "Yeah, we support you for exports but it's going to benefit you and the country-wide because your -- the food in your country is going to be safer and your population will be protected."  So we always concentrate on first the internal and then if you have the need to export then better if you reach those markets.

MR. LAMB:  Go ahead.

RENATA CLARKE:  As someone already noted, the driver is often exports so countries often come to us, they're more likely to come to us when they see a very concrete and immediate need and gain, although ultimately what we would like to build capacity for is that they are able to understand, more concretely, the impacts and make sensible decisions.  So it's not that we want to focus on exports, or focus on domestic market.  We would like to build their capacity to understand well the implications of the choices they make and the underlying skills for improving food safety are the same.

MR. LAMB:  Let me just add for the bank's perspective, particularly the allocation of funding towards export development is declining in share relative to allocation for regional exports.  By export I mean to industrialized countries.  The sense is that the -- those that -- it's not a new game anymore and that the major push has already occurred and now that it's a question of refining it and working with the private sector particularly to perfect it and to respond to shifts in the requirements of the target markets, whether it's the U.S. or the EU. 

So the bank's position, and I think this is true to some degree of the USAID, is to work mainly with the private sector on value and supply chain development, making sure that that work takes into account present requirements or emerging requirements as well as the risks associated with continuing to be in the marketplace and expand the presence, but work the export deal in effect with and through the private sector focusing on commodity -- or value streams, you might say, of interest that go to different target markets.

The greater concern is that maybe the amount of investment that's already occurred to develop nontraditional ag exports in particular, which we all love and everything we feel like personally came out of, was excessive relative to the number of people involved. 

If you take the case of Kenya, for instance, in the EU there's probably a million producers of fruits and vegetable sort of whom at any given one point in time only 30,000 are involved in the export deal, so it isn't a good use of development resources to continue to work perfecting a deal that should and to some extent already does stand on its own. 

So our concern is regional trade in domestic marketplace.  And that's where you need much more work with the government, because the incentives aren't -- the market driven incentives to comply are not there and the -- as I mentioned, the Ministers of Finance are not asking for the health.  And the marketplace isn't paying for it, so we're sort of bifurcating.  If it's work with the private sector mainly for export problems, work with the public sector mainly for domestic and regional trade.

CARLOS ALVAREZ ANTOLINEZ:  Can I just say from our side, as I think I said in the presentation, this objective -- and it's always speaking from the perspective of this particular problem, not the global capacity building of the Commission.  But it has a double objective.  So one is about training and staff involving exports or trade within the member states, but the other one is training staff in developing countries to secure a safe local food supply and promote local and regional markets.  So we have the double objective.

I would like to think that the investments that you make in training the trainers in developing countries even if originally your concern was about exports, would have a benefit for the domestic production, because normally in -- and I'm speaking of our program, the same authorities, the same office is responsible for export or control of the safety of the export would also be responsible for control of domestic products.

MS. ROCHETTE:  And I would just add, on behalf of the private sector, of course GMA represents multinational companies that operate in those markets as well.  And I think the other speakers at the table have expressed it very well, that of course in the context of this hearing I was kind of surprised at the question, but I think that they are absolutely correct, that there is a dual objective here.

JULIE MOSS:  Julie Moss, FDA.  My question is regarding the directive in FSMA that asks us to have a consultative role in developing the capacity building plan.  A worry of mine is that I want to make sure that we're as impactful as we can.  So I'd like some -- to hear from you, if you have any suggestions, recommendations or expectations with regards to how we meet that specific directive of consulting our stakeholders in developing this plan.  And if you could touch on needs, that would be helpful too.

MS. ROCHETTE:  Okay, well I guess I'm a stakeholder.  (laugh)  And I think that you're off to a good start in holding these hearings, quite frankly.  I think this is a very good start.

Obviously GMA intends to be as engaged as possible in all of the various elements and mandates that come forward in this Food Safety Modernization Act activities.  There's certainly a lot of elements that we would like to be involved in.  You saw our slide on the four pillars to food safety and the importance that we place on capacity building for the U.S. domestic food supply and in general.

So, in consulting stakeholders I think the PTIN is a very good model in working together to move  things forward.  Certainly the PTIN can be moved from APEC to that model can be used in other capacity building areas.  But through the steering committee, through the steering group, through the interagency process and the PTIN and also through the international process, I think that there is an excellent opportunity to work together as a stakeholder in a model like that.

MR. LAMB:  I might add a couple of things, not as a stakeholder but as a shareholder and I think you have to distinguish.  There are development stakeholders and development shareholders.  We, the international agencies are development shareholders, really.  A reporter once asked, as I recall, Jack Welch, the former CEO of General Electric, what does he do for a living and his answer was, "Find good ideas and exaggerate them."  And I think that's a situation that we face here is that we would like to help develop, speaking for all the agencies, we would like to help develop systems that could be scaled up, can be done at a reasonable cost while retaining a sufficient amount of flexibility where the technical expertise necessary to really come up with the right system not only complies with regulatory requirements, but takes into account best practices coming out of the private sector.  Meld them together for different marketplaces and different priority products and then use resources from the international lenders, not just the World Bank but International Development Bank and so on to exaggerate.

DR. SANCHEZ-PLATA:  Just to add another comment on how to approach it.  Again I shared -- I concur that this type of hearings is going to be opening a lot of opportunities for collaboration.  We have organizations here that are working in capacity building and institutions that are working on capacity building.  And you have the opportunity to look at different models to see how they work, what are their performance.  I would suggest to try to get what has been the impact of some of those measures that have been applied.  And then again you're going to get some countries that are going to be directly contacting you about the capacity building.  I'm sure the main export countries are going to try to do that.  And some other ones will go through organizations such as the ones that are sitting at this table where we would like to have like a coordinated effort that will be more resource efficient.  So definitely the partnership.

The funding is going to be an issue, we need to look for the funding to support some of that.  Some of the advantages that if you're working with people that are already stationed in the countries or contacts you have in the countries, you get that little extra information that you're probably using your resources better.  So yeah, I mean you're starting, as it was said before, on the right foot and I think it's just building up out of this which of the strategies to select.

RENATA CLARKE:  Your question was a very good one, and I wish I had some very wise, brilliant idea to give you, which I don't.  But I will certainly -- we are a small group in terms of with limited resources at FAO.  We have to be very strategic.  There's some areas where I think we are -- where we have something more to offer.  So for me it's already important to know that I can engage with you and identify over -- in the upcoming period of time areas where I do see that your participation, your expertise.  John mentioned, yes, you have the expertise and there are many things the countries are asking us, "Well what do the other countries do," and we would like to be able to learn from you a lot better.

So I'm sure that, for me it's nice, it's good to know that you are open for this kind of collaboration.  And what I would try to do is speak with you periodically to plan what are those things where our interests overlap and then we can plan something substantial in the medium term.

MR. LAMB:  Could I have two more sentences?  If you don't mind?  Being quite specific, the only food safety expert right now in the World Bank's 17,000 employees isn't an actual World Bank employee.  It's Hudson Konmen (ph) from Canada.  Okay?  That's a problem.  So there's no championship of food safety in the World bank, there's no centralization of knowledge and there's no promotion going on other than what people do voluntarily in their spare time.

So the -- that's not a strong basis on which to build a collaboration.  So I think that a serious discussion between FDA -- I know people have shown interest from elsewhere, Australia, New Zealand and so on, in coming to the bank, creating a center of excellence from various sources, a multi-donor or multi-country center of excellence that's tied to possibilities of leveraging funding is really what's needed to make this thing work well globally.

CARLOS ALVAREZ ANTOLINEZ:  Can I just say for myself, I mean I agree with the others and I suppose without prejudice to other initiatives that you might have, I think that our emphasis will be in discussing with either organizations a group of countries which are already engaged in training on food safety.  In our case we have -- we work together with African Union Commission or AIBC, FAO, UNIDO or et cetera.  So I think that this is very important, so this kind of discussion has to continue on and then go deeper.  But I'm not saying that this is the only way.

STEVE SOLOMON:  We'll try one more question.

KATHERINE BOND:  Thanks.  Katherine Bond, FDA.  And again many thanks to all of you, it's been a very, very rich discussion.

I think my question actually is being reformulated based on some of the comments from the previous response.  But as each of you have described these various efforts going on and alluded to the need for some greater convergence or coordination or collaboration.  Are you aware of or what sorts of models might we look to, institutionally or with respect to other kinds of initiatives that have successfully brought this about, in order to see this move forward?

CARLOS ALVAREZ ANTOLINEZ:  Let me start by saying I don't know.  I don't have any information (laugh), but one thing I knew, we would like to be a part of it, whatever it is.

DR. SANCHEZ-PLATA:  Kind of on the same point, but I think you cannot -- you're going to have to be flexible, because one thing may not be the magic bullet that works everywhere.  I mean you're going to have to be adaptable.  And we've been talking about this since yesterday that some countries you approach one way, some countries will approach you before that happened, some other ones will come in groups.  So you're going to have to be flexible.  I would suggest you have a portfolio of options rather than focus on one, because some of them work in some countries, some of them don't.

And then you leverage with the organizations that have been active in those countries to find out what works here, what doesn't.  And then see -- then choose the right approach to that country, otherwise if you try one approach it may work in one country, but in another one it doesn't and you lose the purpose and you lose that resource that we want to use better.

So be flexible and have the portfolio of options available.

MR. LAMB:  Let me add, because that's a very interesting question.  And I can't think offhand of a clear example but I think I could if I thought about it for a while.  But the -- I can talk about the characteristics of what an arrangement would be.  One of the dilemmas that we've had as we've had discussions at the World Bank with FDA was to what extent can an international public organization that is 182 members, even recognize the U.S. as the biggest shareholder, do something that's specific to the U.S.  And so it has to be multilateral in character in order for international organizations to do it.

And multilateral not just in the sense that it's global and straddling the globe, but I think that it has to be multilateral in the sense it also includes major stakeholder who represent other sources of funding or technical expertise. 

So if a global public partnership were formed to raise the bar on food safety globally, it has to take into account all of the major markets, all of the major partners and it has to involve other players who can provide you the technical and financial resources, which would mean, financially speaking, Asian Development Bank, African Development Bank, Inter-American Development Bank.  It would include players like IFAD International Fund for Agricultural Development.  So it has to be bigger than what your already big agenda is, because the international resources can't be used to favor any particular country. 

So that's a design issue that has to be talked through, but there's a good willingness to do it, but a precondition, I repeat, is that there be a match between the geographic interests, the technical expertise and the financial resources all together.  So it takes some thinking and quite a lot of legwork.  But the cooperation that already exists between FDA and for instance, New Zealand and Australia and the EU and so on already sets the groundwork for that, but it has to be bigger and explicitly multilateral in purpose.  It can't be how do you implement better the new U.S. food safety legislation.

MS. ROCHETTE:  I would just like to add I think John is absolutely right.  Even within the limited context of the PTIN expertise, we had a project at the World Bank in May where we brought experts together to try to sort out the specific training gaps in the various areas that the PTIN had identified as their priorities and found that there was an incredible amount of work that was ongoing already and now as we go into this lab capacity sector we have decided we have to pull back again and do a needs assessment on that in order to make sure that the gap we're filling is not a duplicative gap and that we're using the expertise that's already out there in these modules.  And I think Renata certainly participated in that needs assessment initially and FAO is already doing a lot of this, obviously.

RENATA CLARKE:  We are, again I keep harping, we are small and whereas we're pushing for more coordination and collaboration that these coordinated mechanisms do have a cost and weight.  So they're already within the STDF.  As I said, right now you're currently chairing the STDF, I mean it's -- there are already existing fora that FAO is involved in, and several others, that can be used to good effect.

There are many collaborative efforts that are going on and it's -- that we would like to participate in but there are just so many.  Our program would then disappear.  So I'm not anxious to see more of them develop. 

STEVE SOLOMON:  Thank you so much for your input. 

CAMILLE BREWER:  Thank you as well.  If you don't mind just staying put where you are, I'm going to invite Miss Means to come up.

MS. MEANS:  Thank you all for hanging in till this last moments of the hearing.  I am Kathy Means, I represent the Produce Marketing Association and we represent 3,000 companies throughout the supply chain that market fresh fruits and vegetables, an industry worth $554 billion to the U.S. economy.  We're funded primarily by event revenues and membership dues.  

In our written comments we will address, in more detail, the questions posed by FDA in the request for comments, including our reflections on the comparability assessment tool, which we haven't been able to fully assess yet.

In our brief time today, we will stress the importance of global trade to the fresh produce industry, which operates in a truly global marketplace.  The United States relies on imports from a host of countries to provide a wide variety of fresh fruits and vegetables for Americans' dining pleasure and health. 

In terms of farm weight, imports of fruits and nuts, led by bananas, will account for 45 percent of U.S. consumption by 2020, up from 42 percent last year, according to the USDA.  Imported vegetables are projected to represent 24 percent of U.S. consumption in 2020, an increase from 20 percent in 2010.

The rules we put in place to protect our food supply must meet our obligations for world trade because access to non U.S. markets is as important to the success of U.S. producers as imports are to ensuring an abundant, year round supply of fresh fruits and vegetables. 

The export market becomes increasingly important for U.S. horticulture products and we must ensure that actions to protect the U.S. food supply are taken in ways that do not promote adverse actions on the part of other countries that will impede U.S. growers' access to global markets.  In assessing comparability of non U.S. food safety systems, FDA has indicated it will work to assure that they provide the same level of public health protection.  We urge FDA to ensure that these assessments can be completed as quickly as possible and with the least disruption to global trade.

The seasonal and perishable nature of fresh produce necessitate that these assessments move quickly and that interim measures be made available while the assessments are in program.

In addition, the United States imports from many countries and we urge FDA to prioritize its work based on import volume, again with alternative arrangements for those countries waiting for their own assessments. 

Thank you for the opportunity to comment and please call on us if we can be of further assistance.

CAMILLE BREWER:  Thank you very much.  So we've come to the end of the program.

Dr. Solomon, any last words, insights?

STEVE SOLOMON:  I would just really like to thank all the presenters from both days.  This has been outstanding.  We appreciate your time and input.  And we welcome more input.  We have an open docket.  This is just a start of a process and we really enjoyed getting the engagement and the interaction that we need in order to make the best decisions to move forward here.

So I thank the presenters, I thank my fellow people in the inquiry panel and everyone that attended.

CAMILLE BREWER:  Okay.  Once again we encourage you to submit your comments to the docket.  The docket will be open until June 29th.  Clearly FDA has a lot of work to do. 

I just want to -- I feel I've been remiss, I do want to acknowledge the work of my colleague Commander Dominic Veneziano, because he has led the all-agency import operations strategy plan which covers all commodities.  And there are lots of commonalities and lines of connection in all of these activities.  So I want to thank you because you've been our model for where we should do, Dom, so thank you for that.

So with that, I hope you have a good afternoon.  I hope you get to see the cherry blossoms in the sunlight.  And thank you so very much for your participation.

One last thing.  If all panelists from yesterday and today could meet here in three minutes.  And if all FDA staff could meet over there in one minute.

Thank you.  And good afternoon. (applause)

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         I, NATASHA KORNILOVA, the officer before whom the foregoing meeting was taken, do hereby certify that the statements was taken by me in audio recording and thereafter reduced to typewriting under my direction; that said transcript is a true record of the recording taken by me; that I am neither counsel for, related to, nor employed by any of the parties to the action in which this transcript was taken; and, further, that I am not a relative or employee of any counsel or attorney employed by the parties hereto, nor financially or otherwise interested in the outcome of this action.


                            NATASHA KORNILOVA

                            NOTARY/COURT REPORTER