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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

Wednesday, March 30, 2011

P R O C E E D I N G S

CAMILLE BREWER:  Could we take our seats please?  Good morning and welcome everyone. My name is Camille Brewer and I will be the presiding officer for this hearing today.  The title for this hearing is Ensuring the Safety of Imported Foods and Animal Feed, Comparability of Food Safety Systems and Import Practices of Foreign Countries.  The docket number for this hearing is FDA 2011N01351.  The docket will be open until June 29th.

Yesterday FDA held a public hearing on the imports provisions of the FDA Food Safety Modernization Act, or FSMA as we call it.  This hearing is a bit more formal. Today we will provide our stakeholders with information and updates on activities that are already underway. We will have the opportunity to obtain detailed information from experts on these activities.

For this Part 15 hearing we will narrow the discussion on imports to a set of issues that will address how to identify and leverage with other countries that have food safety systems similar to that of the United States.  We will explore the use of comparability assessments as one of several ways to enhance the safety of foods and feeds imported into the United States.  We will talk about our pilot programs. Tomorrow we will discuss our efforts to gather information from regulators in other countries on their best import practices.

The hearing today will begin with an overview by Mr. Michael Taylor, our Deputy Commissioner for Foods. Then there will be two panels that will help provide a context for comparability and that background is going to be very important for our discussions.  The first panel will discuss FSMA and the relevance of FSMA to comparability.  The second panel will discuss WTO, Codex and other issues relating to equivalence and the recognition of other food safety systems.

After lunch we will provide detailed information on the FDA experience and hear the perspectives of those that have participated in our pilot programs and the perspectives of other countries as well.  At 4:00 p.m. today we will receive testimony from those stakeholders who have registered.

After each panel questions will be presented to the panelists by the FDA enquiry team which is comprised of FDA senior managers and we do have a participant from the FSIS as well.  So the enquiry team is comprised of Dr. Steve Solomon who will be the chair, Dr. Murray "Mac" Lumpkin, Mr. Don Kraemer, Ms. Roberta Wagner, Dr. Merton Smith, Dr. H. Michael Wehr and Ms. Mary Stanley from FSIS.  In addition, there will be senior advisors to the enquiry team including Ms. Sharon Mayl, Ms. Charlotte Christin, Mr. Howard Levine, Mr. Matt Eckel and Mr. David Mednick.

I have just a few housekeeping notes.  The restrooms, as you exit the auditorium, they're located down the corridor to the right.  There are two reception areas that will be to the left and the first is reserved as a reception area for representatives of embassies and representatives of other governments and our Office of International Programs will have staff there to welcome you and to assist you as needed.

I hope everyone got an information packet.  It should contain an agenda.  Speaker biographies, we will not be reading those as we progress through the program.  They're there for your reference.  There's a truncated version of the International Comparability Assessment Tool or ICAT.  There's a summary of the GAO study on food safety; Selected Countries’ Systems Can Offer Insights into Ensuring Import Safety and Responding to Food borne Illness.  There's the FR notice for this meeting.

There's a list of restaurants and also food will be available at the cafe right outside the entrance of the building.  Just a reminder, please leave the food outside.  We don't want food in the auditorium so thank you for that. 

I believe we do have some press in the auditorium.  Could you please stand so that we might know who you are?  Thank you.  If you have questions could you please see Mr. Sebastian Cianci who's at the back of the auditorium and he's raising his hand there.

If you have not signed up to make public comments and you would like to do so, please go to the desk and contact Ms. Juanita Yates.  Juanita, can you raise your hand so folks can see you?  And if you have any questions at all there's a full staff available to help.

Now let's move onto the main part of the program.  Over the past year or so it's been my great privilege to be the lead for the comparability workgroup.  We were a cross-agency team that did much of the homework in developing the comparability model.  We can't go any further without you.  This is the moment where we talk to you, where we describe what we've done and we get input back from you.

I want to encourage you to send comments to the dockets.  We don't have a regulatory definition for comparability.  Your input will help guide us.  The meeting today will help guide us so please don't be shy about sending in your comments.  And with that, I'm going to turn it over to Deputy Commissioner Taylor.

MICHAEL TAYLOR:  Thank you, Camille, and good morning everybody.  I want to first just, if abandoning the formality of a hearing process, thank all of you for being here.  If you've looked down the agenda it's just an amazing group of folks who have come to make presentations among our fellow government partners, among stakeholders in the United States and then partners from other governments as well, international organizations and I think we're deeply indebted to folks who have invested the time to come and participate in this hearing including all of you.

I also would just thank Camille's team, the whole group.  The work that's been done on comparability is really important to the future of the foods program and our ability to ensure the safety of foods imported to the United States and again, deserve a lot of credit for the work that you've done.

I think most people in this room are aware that we've got a lot going on here at FDA, the Food Safety Modernization Act on top of a lot of other things that go on in the Center for Food Safety and Applied Nutrition, the Center of Veterinary Medicine and our field force here.

There might be a temptation for us, at this stage of the game, to just want to hunker down and do the work but we really think that that's not the right approach, that more than ever we've got to engage our stakeholders, our partners, and figure out how to do the work, how to get it right.  And I think this hearing is one part of that process as we move down a pathway to make a really, really significant change in the way in which we oversee the safety of the food supply.

This meeting, this hearing, really does relate very directly, in my mind, to the core prevention goal of the Food Safety Modernization Act, which was the subject of yesterday's public meeting that I know some of you attended.  The whole idea behind the Food Safety Modernization Act is to figure out how we can be more effective in reducing the risk of food borne illness, preventing illnesses before they happen, whether arising from foods produced domestically or overseas.

This hearing also though really reflects the FDA's longstanding recognition that we need to revamp our approach, particularly to ensuring the safety of imported foods.  We've known that we need to push prevention offshore and not just rely on our port of entry examination.  We've got to leverage the efforts of others to avoid duplication of effort and to better target what we do.

FDA's been working in this vein for some time and the comparability assessment work has reflected that but this is also, these ideas of pushing prevention offshore, leveraging the efforts of others, are really essential to the vision of the Food Safety Modernization Act as well.  And of course that law has really given us a whole new toolkit, a very rich new toolkit for import oversight in particular, again the focus of today's hearing, beginning with the core idea of importer accountability for assuring that the imported food meets our standards.

-But beyond that, it includes really a list of important new tools for us:  the Voluntary Qualified Importer Program, to speed entry of products that can be demonstrated to be with a high level of confidence that they meet our standards; the Accredited Third Party Certification Program, mandatory certification of high-risk foods in some cases; enhanced FDA inspection of foreign facilities; and also, very importantly in this legislation, a clear message that we actively collaborate with foreign governments to help ensure the safety of food imported here.

Now all of these tools, the way we see them, are aimed at really the same thing, which is providing the assurances we need that food produced overseas has in fact met our standards, been produced under conditions that meet our standards.  The Food Safety Modernization Act spells this out in terms that I think are very practical and understandable that they want the assurance that the food has been produced under conditions that provide a comparable level of public health protection.

So while comparability assessments per se are not mentioned in the Food Safety Modernization Act, we really see them as an important part of the toolkit going forward in our import safety program and we see the use of comparability assessments being completely consistent really with the Modernization Act's vision for import food safety.  I've just hit some button here which has caused a change in what you're seeing but don't watch the man behind the screen.

One thing we want to emphasize, I think you'll see from what is presented today, that this idea of assessing foreign food safety systems is not new by any stretch and so we're not starting from scratch in the work that we've been doing. Obviously the Food Safety Inspection Service has been making equivalence findings for years, decades really, to implement its import oversight authorities and responsibilities.

And as you'll be hearing today, we've been working for some time to develop a comparability assessment tool and we piloted it with New Zealand.  You're going to hear about that today.  And we're also in the midst of comparability assessments with the European Union on each other's shellfish oversight systems.  So we have a new law that's come into play that gives us a whole new toolkit, a whole new motivation to use this tool, but we've also got a lot of work under our belt to figure out how to use it and you'll be hearing about that today.

The question really is, I think for today's hearing as much as anything from where I sit, is so where do we go from here.  You're going to be hearing about what's happened so far but where do we go from here and what role do we envision comparability assessments playing in the future food safety system with respect to imports. 

We think there are a number of possibilities.  Better targeting our border inspections is one possibility.  Better targeting our foreign inspections is another possibility.  Possibly considering foreign oversight and foreign government inspections in gaining the assurance that we need about the safety of imports.  There are no doubt other possibilities and so that's really what this hearing is all about, letting you know the work we've done and inviting your input about how we can use this tool to gain the assurances that we need about the safety of food imported here.

One thing that we're very clear about, I think we've made clear yesterday, is that we know that there are trade implications of changing the import oversight system that's fundamentally, as this new law calls on us to do, we're very keenly aware of our obligations to do this work in accordance with trade agreements.

In the case of comparability assessments, we do really see the tool actually being a way to ensure food safety while also facilitating trade if we use the tool right.  It's certainly -- we don't see comparability assessments being a prerequisite for entry for example.

So again, this is a discussion that we welcome, we need to have.  We have USTR here, and Clete will provide a perspective on the trade issues as well.  Just want to signal that we very much appreciate that while our job is food safety, our job is protecting the health of the American public, that we feel we can do that and we will do that in a way that is consistent with maintaining trade, which is also an important public interest.

So I'm going to stop there.  Again, the whole idea here is to tee up a set of very important topics and really get your input and the input of a great group of folks who have agreed to make presentations and I look forward to the day very much.  Thank you.

CAMILLE BREWER:  Thank you, Mike.  The first panel is Setting the Stage and we have Caroline Smith DeWaal who will give us consumer perspectives, then Marsha Echols, industry perspectives, and Mary Ann Green from CFIA, trading partner perspectives.  Caroline?

CAROLINE SMITH DEWALL:  Good morning.  I want to thank FDA for holding both yesterday's hearing and this morning's hearing.  I think it's a good sign that less than four months from the time the bill was signed, FDA has clearly fully engaged in meeting some very demanding timelines that are before it for implementation of the Food Safety and Modernization Act.

My job on this panel is in part to describe the bill itself and these components of the bill and how they fit together and also to give some perspectives from the consumer community on how FDA might meet some of the obligations under the Act.  There will be other speakers from consumer associations later in the day I think that will more fully outline that.

But just to give some background on why we're here, there were a number of very strong pressures on the U.S. food system that resulted in congressional passage of the Food Safety Modernization Act.  First there were emerging pathogens, E. coli O157:H7 but also different strains of salmonella.  We now have salmonella typhimurium and salmonella newport, which are antibiotic resistant, so we have different pathogens that are moving through the food supply and impacting consumers.

FDA was also facing huge challenges as the volume of imported food really increased over the last I would say two to three decades.  If you see how the growth of imports really impacted the Agency it was exponential.  They were dealing with more and more imports and with either exactly the same staff or sometimes less staff.  So clearly their oversight of imports was not adequate.

They also were facing many challenges with their mandate, although not one that was as well described in the old law as it is now, but their mandate to inspect commercial food facilities including their mandate to ensure that foreign food facilities that ship food to the U.S. were maintaining adequate protections.

And then finally, in the U.S., we have a growing population of people who are at high risk for food borne illness.  And each year the CDC estimates that about one in six Americans will become sick from something, from a contaminant in the food supply.  So this was a very important issue for FDA.

So a number of us were working on what was the right format, what was the right frame for food safety legislation.  Our laws really originated in 1906 and they needed updating fairly dramatically and this is a very nice little frame of what modern food safety system we think should encompass.

This kind of platform was worked on.  We worked on a platform together with the World Health Organization and the Food and Agriculture Organization.  We also looked at problems, outbreaks we were experiencing in the U.S. and this is the framework that many of us who were working actively on helping Congress develop a new framework for food safety legislation were working off of.  And today we're just going to talk about the import controls but it's important to understand the larger framework.

So for both domestic and imported foods there are new requirements.  There are mandatory requirements for preventative controls for food companies.  We think these mirror what also has been done in the European Union and will bring our FDA regulated foods more in line with mandates currently in place in Europe.

It also gives FDA new inspection mandates.  FDA, at the time that this bill was passed, was inspecting food facilities on average about once every 10 years.  Sometimes it would go a bit lower to once every seven years, but I've also heard it can be even less than that.  So the bottom line was FDA needed mandates and they have them now.

Finally, there are also requirements in the bill for importers and companies that source ingredients from foreign countries.  There's a new set of requirements.  Mr. Taylor has mentioned some of those and we also think that the bill provides opportunities for FDA to partner with other federal agencies like NOAA and the Food Safety and Inspection Service and others, also with foreign governments and with third party certifiers.

So, the World Trade Organization has, as part of its framework, they have reserved certain powers to national governments.  So under the SPS/WTO agreements, governments can determine the appropriate level of sanitary or phytosanitary protection needed to protect human, animal or plant life or health within its territory.  So this new law essentially is the new standard for FDA regulated foods.  It is our new standard that will then slide into this frame for the WTO.

And so in terms of the model that we're looking at today on comparability, I think it's important that FDA recognize that while they've been working on comparability and it may fit seamlessly into the new frame of the legislation, they really need to evaluate that.  That's part of their process I think today, to evaluate how it does fit into the new legislation.

So moving on to the issue of the specific import provisions, Mr. Taylor mentioned what he likes to call importer accountability.  It has a legal name in the Act; it's called the Foreign Supplier Verification Program.  And that will start I think within two years' time.

Maybe I think one year you're supposed to have a reg out, but let's say within two years' time that will impact all imported food coming into the U.S.  So that has a broad sweep that will impact all food, all imported foods coming into the U.S.

In addition to that, FDA has a series of provisions in the Act that are not as broad in scope.  They're essentially what we like to call the toolkit for FDA and this includes the authority to require import certifications for food, that's the mandatory certification requirement.

There's a section dealing with building capacity of foreign governments with respect to food, provision on the inspection of foreign food facilities and then also the accreditation of third party auditors.  And we'll go over each of these briefly.

So with respect to mandatory import certifications of food, FDA is authorized to identify certain high-risk foods or even high-risk countries, countries that might require that all food coming from, either all foods of that type or all foods coming from that area, be certified as meeting the requirements of the Act before they can be brought into the U.S.

In addition, they can recognize an agency or representative of the government of the exporting country to provide such certification and they can also recognize an entity under Section 808, which is the third party certification provision of the bill.  So really they either have a government agency doing this job or an 808 entity which is the third party certification.

Under the third party certification section, we talked about this a lot at the meeting yesterday.  The third party certification is really a platform that's going to be used both in the mandatory certification section and also in the voluntary qualified importer section of the bill.

And under this section FDA is authorized to identify and approve an accreditation body and if one cannot be found within two years, if they don't have these approved entities within two years, FDA itself can accredit these bodies.

And these bodies will then accredit third party auditors and those are the entities that can approve imported food for entry.  And importantly, auditors can be a foreign government or an agency of the foreign government and most of the language you're seeing on the screen is directly coming out of the Act.

So the next piece is, and my staff person loves this, those little arrows are FDA inspectors going out to inspect their foreign facilities so.  But if you represent a foreign government, don't get nervous because I'm going to tell you why you shouldn't.

The next piece is the foreign facility inspections schedule and again this is outlined in the legislation.  And this requires that FDA essentially double the number of inspections it conducts every year for the next six years.

This is a huge mandate and one that would be challenging in the best of circumstances for FDA to achieve but with current budget restrictions I would say well-nigh impossible.  In 2010 FDA conducted about 350 foreign facility inspections.  So you can see the scope of the ramp-up in this area.

So the next slide though tells you why I'm not actually as worried about that mandate as I think Steve Solomon might be because the bill also provides a very important section where FDA is authorized to -- it's under building capacity which is a really good interesting heading -- but in effect it's giving FDA the authority to develop bilateral and multilateral arrangements and agreements including provisions to provide responsibilities for an exporting country to ensure the safety of food.

And under this section they can develop systems for secure data sharing, they can develop mutual recognition of inspection reports; they can train foreign governments in the food industry on U.S. requirements and provide for multilateral acceptance of laboratory test results.

So while from a consumer perspective we would like to see a robust FDA inspection force running around the globe inspecting all these foreign facilities, I think many of us are very satisfied that if FDA does the job and they develop these agreements, these data sharing agreements, this laboratory accreditation and acceptance of laboratory results, that in fact we may have as robust a system, and in some cases the foreign governments may even have better systems.  But the bottom line is that we can have assurance that the food that is coming from foreign countries is safe.

So in summary, the bill really extends FDA's reach beyond the border inspections which have been its traditional mode for controlling the safety of imports.  Importers will be more accountable to FDA and if there is a problem, FDA will have a first stop with importers to find out what went wrong.

But in addition they've got new abilities on the assessment of foreign food safety programs, mutual recognition of inspection reports, new programs for certification by foreign national governments, both of their systems and also of specific foods.

So I think FDA has the type of new toolbox that it needs to meet the challenges of the global food supply that it was not equipped to meet prior to the enactment of this law.

So the timelines, I'll run through them quickly because I know Nicole's about to flag me down.  FDA can define any food at this point as high-risk and needing to be certified.  Of course they don't have the certification system in operation yet but they do have the authority, as of now, to define a high-risk food that might need to be certified.

They need to implement a certification program in about a year and a half including -- well there's proposed regs and final regs and some of the timelines in the bill don't make complete sense, but they've got to identify accreditation bodies within two years and the foreign supplier verification program must be in place two years after enactment.

So I'm sure they're going to tell us more about their timeframe for getting this all done but we're certainly looking forward to working with them as they move forward.  Thank you very much.

CAMILLE BREWER:  Thank you, Caroline.  You can join me here if you would like or you can stay at your place.  Ms. Echols, welcome.  Please join us.

MARSHA ECHOLS:  Good morning.  I've been asked to make a statement today on behalf of small food companies.  So I am here representing the National Association for the Specialty Food Trade.  NASFT is a trade association based in New York City which represents all segments of what it calls the Specialty Foods Industry, and I'll explain a little more about what that means.

But in effect, these are small businesses, small companies, that have particular characteristics and a particular way of doing business that we urge FDA to take into consideration as it considers all of the provisions of the new law that apply to prepared foods.

But first let me start by repeating something that I heard yesterday.  Commissioner Taylor and FDA was asked to come to New York City to hold one of the listening sessions there.  New York City has many manufacturers.  It has distributors and importers and others who are very important in the industry and will be affected by not just the comparability provisions and the importer provisions, but many other aspects of the new law so I hope that you will consider that as you work through the implementation of the law.

Maybe before I start with the slides, because I'm not sure I'll get through all of them, I'd like to make a few points first.  As I said, I'm representing small food companies.  These are companies that are small, produce products in small volume but have many SKUs, have many variations.  So if a company produces cakes it might have 20 different flavors of cakes.  It might produce only for a limited geographical area, have a small volume as I said, not be highly profitable, but still looking for ways to extend the line and the number of cakes, or the number of jams, or the numbers of flavors of tea or juice that it produces.

And the companies might source all from the United States, but many of them travel around the world and try to find new flavors and new products to use as ingredients.  Or our retailer members go around the world and look for something that can distinguish them and the line that they're offering to consumers.

So if you go into the gourmet section of one of our large local companies, a Safeway or a Giant, if you go into a Dean & DeLuca here or a Balducci's here, you're looking at many of the products that are made by small specialty food companies. 

So they are low in volume in terms of unit sales of each product but a large number of variations on a line of products which means that each of those products could be affected by what you are considering for the new law.

So small volume and many SKUS, several of them are sourcing directly, some go through some middle person but many go directly to the source to get their products from the source because they want to have something that no one else has which means that, with regard to imports, they're traveling overseas.

They might spend a month in Asia, a country in Asia, or a region of India, just trying to know that region and everything about it and that affects what they bring in and how they do business.  So it's a different model for how business is done and it is I think unique to these companies.

The fact that they're looking for something new in Asia, or Africa, or Latin America means that as you think about the countries that are high-risk, or the products that are high-risk, you might be affecting them in particular.

As you determine that the countries don't have to enter into comparability assessments or so on, maybe you're putting more pressure on the importers of those products because they have a much higher level of liability and responsibility now under the new law.

So a couple of things as I go through the slides and as you think about your regulations and your implementation, there're a few themes that I hope you will always bear in mind.  The first is can what you are planning be simplified?

Small businesses need simple, clearly understood, easily implemented regulations.  And my impression is that you have a complex law but you're planning an even more complex system and if you can simplify that, I think it would help all businesses but that would be especially important for small businesses.

Another question I think you should always ask, is this necessary?  You have a mandate from the Congress, which also has to keep in mind what the WTO rules are, but you can still say is what you are planning to do necessary for food safety to carry out the mandate in the law and so on.

What will it cost and what will be the added cost?  And again, what you have in mind, I think, is going to add a great deal of cost for small companies.  Will those costs be necessary?  Is there a way to do it more inexpensively and still maintain the safety of our food supply?

Is there the capacity to do it?  So there's a capacity question in the United States.  Imagine what the capacity questions will be in other countries, in smaller countries.  And will what you are designing really make it less likely that new foods, for us newly discovered foods, won't get into the United States, won't be available to consumers because you have a system under which importers will say I won't take a chance.

You know you've found something in Latin America that's well-known there.  We don't know it here.  A manufacturer wants to use that as an ingredient, or a retailer wants to stock it, but an importer will say no, you know I'm not sure what will happen so we won't do that.

So those are some of the overall thoughts that I have.  And I would go back to yesterday; a representative from AMS at USDA talked a little bit about capacity and the difficulty of building capacity.  How long will it take?  What will be needed to have the capacity to do what you're discussing?

So I've said we, NASFT has a national membership.  It represents all segments of the industry, mainly small businesses.  These are some of the activities of NASFT.  Research, like the state of the specialty food industry and that's where I'm going to get much of the information I'll present today, state of the specialty food consumer.

And the other point I'll mention from this is that the organization sponsors, the fancy food shows that many you might know in San Francisco and in New York, but the New York, what is normally the New York show will be in Washington this summer.  So it will be here in July.

These are characteristics of specialty foods.  So they're in the same broad categories as all other foods but with some distinct characteristics.  So the companies are looking for novel ingredients.  They're saying, okay salsa is popular but maybe I'll make a salsa from a fruit that comes from Asia.

I will flavor a tea with coconut water, something very different.  These are small businesses, often family-owned.  Women are very prominent in the industry and creativity is also.

Low volume production, I mentioned.  The products are often distinguished by very high upscale packaging, which adds to their cost.  So these products are usually beyond the -- they're not everyday foods in terms of price.  But the packaging becomes their advertising.

They're small companies that cannot advertise.  They can't afford advertising so they're using the packaging for that.  And they are, I would say, trend recognizers but also trendsetters.  These are sales, so specialty foods represent 13.1 percent of all food sales at retail.  Now that's not all our NASFT members but that is the idea.

So these are the ideas that I'd like to try to cover quickly.  Safe food we all agree is necessary, important, but there are special circumstances for small food companies.  What does that mean as you think about comparability and what are the implications of your plan for the WTO and Codex standards that you still have to meet?

And I will remind you as I expect Clete will say, that the WTO rules in the SPS agreement are about the application of sanitary measures.  So it's not just the measure but how they are applied.  So yes, safe food for America.  These are just some quotes from FDA, you know which don't give us a lot of idea about what is planned and what will happen.

These are some of the questions that I think are open and have to be considered.  How will FDA choose the countries for the comparability review and which ones will be left out?  If you begin with the -- you know you've talked about New Zealand and I think Canada, the EU, I think that's fine but if you spend your efforts with those, what happens to a small country in Asia or a country in the Caribbean and what will be the impact on their exports?

Most foreign governments choose between equivalence and comparability.  How do the two fit together?  Is each comparability step a WTO measure?  Because if you look at the SPS agreement and the WTO rules and case law, they focus on a measure.  So is the measure each part of what you're doing, the comparability?  Is it the whole new law?  What would FDA -- what would the WTO look at and what do you have to bear in mind as you're going forward?

What about imports from countries that have neither the comparability assessment or an equivalence agreement but have suppliers of safe creative trendsetting foods that NASFT members would like access to?  What happens with those?

So I'd like to give you some information about specialty food and small food companies.  So the state of the specialty food industry says that mean annual sales by specialty food companies, fairly small compared with some of the large industries.  But there really are -- there's a huge range.  So there are companies that are making $200,000 a year and you saw others that are making $2 million. 

As I said, small in number of sales but with a great variety of foods.  So the average manufacturer markets 51 SKUs.  If you're making $2 million a year and you have 51 products that are going to be regulated, what does that mean for your business?

So here is the mean number of SKUs by type of supplier.  Manufacturers with 51, as I said, but specialty food importers are handling 141 SKUs.  I mean how do they really cope with the new law and will they start to say I've got to eliminate some of these products so that I am not overly liable or at risk under the new law?  And it's not that the foods are unsafe.  No one has proved that they are unsafe, it's just that the importer might say no.

The other point, as I mentioned, is that there are a great deal of direct purchases.  So the manufacturers and retailers are going to the suppliers and trying to find something different.  Again, it’s a different model for what happens.

I said they're sourcing from around the world so the majority of the importers are bringing in products from Europe.  So that's the history of the specialty food industry, products from Europe.  But you see many importers are now carrying -- a third of them are carrying products from Asia and you see products from South America, from Africa, and I've left out some other countries.  So it's worldwide sourcing for the importers and problems that might arise for them.

And I mentioned emerging cuisines because this is where they're going to be trying to bring products from.  The specialty food manufacturers sell to retailers but they also sell to restaurants, and to hotels, and to airlines.  So what can they offer that is going to be novel, catch the consumer's eye now and these are some of the areas that they will be trying to bring in products from.

So comparability, will it limit the choices by importers?  Will there be a trade effect that is maybe you would say indirect a choice of the importer but in effect mean that you will have fewer, a smaller variety of products offered by some of the importers?  Or will they just say we're going to handle products from only countries where we think there is going to be a comparability assessment or an equivalency agreement because we think FDA is going to be a little tighter?

These are statements by FDA that made me wonder.  So what are comparable countries and who are those?  Are they comparable to each other, comparable to the United States?  What does that mean?  And as I said, what is low-risk, what is high-risk and how do you determine that?

So the governments of many countries and the facilities supplying specialty foods and ingredients cannot immediately meet equivalence or comparability standards.  How long will that take?  What capacity building will that require?  And also here, what will be needed?

So on the trade side, as we've said, yes, yes the Article 20 of the WTO says that the trade rules can allow a government to restrict imports on safety grounds but that is not a free use and there are some constraints on that.  Equivalence is a term that's used in the agreements and again, are we moving away from that.

So let me move to the recommendations.  Simplify the rules and procedures.  Aim not to add cost.  Extend the timing for small companies.  Understand the heavy, maybe unnecessary burden that you're placing on small importers.  Create simplified procedures for small companies. 

One of the speakers yesterday discussed possibilities for special programs under the Farm Bill.  Why can't something like that be done here, still ensuring safety and plan extensive even U.S. capacity building?

These are other recommendations.  I think the main one is the bottom one.  It's that the measures must be necessary.  They must be applied only to the extent necessary and there must be sufficient scientific evidence.  For the restrictions that I think will come, I'm not sure there is a scientific evidence to support what is being done.  Thank you.

CAMILLE BREWER:  Thank you.  Marsha, would you like to join us or you could stay there as you please?  Next we'll have Mary Ann Green from CFIA.

MARY ANN GREEN:  Thank you very much and I really appreciate the opportunity to make a presentation.  I'm with the Canadian Food Inspection Agency so representing trading partners and I have had the privilege to work closely with FDA and Camille's group on this project and it's been a great privilege to do so.

What we were asked to do, or what I was asked to do was really look at, given the new Act has come into effect with the title three of Improving Imported -- The Safety of Imported Food, what are the associated opportunities, implications and challenges for trading partners and so that's what I'd like to focus on.

Other speakers have clearly given an overview and an understanding of the various parts of the Act.  In trading partners' views, in my view, what we were looking at is really there's key parts.  There's industry controls that are really focusing on what does industry have to do and there's the concept of enhanced government controls.

And these two concepts will work together and actually build the system that is going to deliver the increased safety for imported foods.  But what the U.S. is doing is not unique.  It's very much challenges that are being faced by importing countries around the world.

The increasing volume of imported foods, the number of lots, the kilograms, really have made the more traditional intervention model where you're really looking at border sampling or even sampling at the importer level with perhaps additions of offshore inspections, there is not the level of confidence in that model nor is there the level of resources for that model that are really going to make it effective in terms of moving forward.

One of the other areas that is very difficult to manage is of course the increasing number of trading partners.  You don't work with one or two or three that are adjacent to you, you could work with 100, 130, 140 or up and each one will have one or more competent authorities, will have one or more different systems, legislation.  I mean in Canada I can count five right off the bat, easily.  And they all look at having oversight of that food system in a very different way.

So the system under which we work for ensuring imported food safety is very complex and very different.  And one of the fundamental issues, which has been mentioned on a number of occasions, is the demand for effective use of resources.

In these times where governments are tending to cut back and are saying how can you do things better, provide the same level of assurance but do it with less cost, there has to be more of a focus on prevention, that the foreign processors and supply chains meet the food safety standards.  This is already being done in some countries, or as in the EU.  There are already examples of how this is working. 

So, as I indicated, countries are seeking greater assurance of imported food safety.  And this is happening with the countries around the world.  It's not simply the U.S.  One of the key areas that helps is to get advanced knowledge, to get advanced information, to start that process of collaboration before the product reaches the country of import.  And that is the key, is working with foreign governments to provide that assurance.

One of the critical areas is not just saying that we're going to recognize a facility or look at a single product.  If you look at the hierarchy, if I look at a product and I sample it, I can tell you that sample was compliant.  If I look at a facility I can tell you that facility was compliant on the day that I was there.  If I look at a system of a plant, I can tell you that plant is most likely compliant before or after based on what I find in terms of evidence.

But I look at the foreign government oversight processes and the system that is looking at those plants, then I have more, greater confidence that the country is going to be able to produce product on an on-going basis that's going to meet standards.

And one of the areas that is really critical to that recognition is understanding that the country has a commitment to a food safety system to protect its own consumers.  Because in those instances, they're not doing this because they're trying to export to somebody, they're doing it because they have an obligation to protect their own consumers.

But when you look at recognition of the foreign food safety system, there are a number of options that you can move forward on.  One is equivalency determinations.  Another is the comparable or systems recognition.  And the third is third party certification.

It's been mentioned a couple of times so I will go over it very briefly.  The equivalence applies to a measure or a group of measures or a system and it is based -- and this work can be found under the CCFICS -- and it's based on the exporting country demonstrating its measures achieved the appropriate level of protection.

Comparability or systems recognition is a review of the foreign country's regulatory systems, the statutes, regulations and implementation and is based on being able to demonstrate the systems are similar, they have similar elements and they provide a similar level of food safety public health protection.  So it's a much more global assessment is perhaps a better way of describing it.  Third party certification often applies to a plant, a facility or commodity and generally applies to provide assurance for the production of that facility.

So the Food Safety Modernization Act does have those full range of new approaches with a focus on high-risk products and facilities but it also provides new opportunities.  And trading partners that have a good regulatory system designed to protect their consumers will often have, when those products are exported from those systems, a good compliance history.

And the critical opportunity there is you can have an option of being seen as a lower risk.  So products produced from a system with good compliance history, or low residual risk in another term, could have greater admissibility around the world to many other countries.

And the concept of having a U.S. importer that has to have a foreign supplier verification program may be able to use that recognition of the systems and the good compliance history as part of that import control that's being put on the importer.

Some of the examples that are often used are the Canadian seafood industry that the U.S. has had supplier assurances for a number of years and the Canadian system for seafood has been recognized in many cases as providing part of that assurance.

But the Food Safety Modernization Act also provides another great advantage to trading partners in terms of collaboration.  And this is not just in terms of collaboration that the exporter can have assurance product meets the U.S. standards, there's also the option of collaboration in the other area.

Particularly with regard to Canada and the U.S. we have a large trading relationship, food goes in both directions, and there's also an opportunity for collaborating to assure that the products coming into Canada will meet the standards as well.

There are other options looking at either third party certification or systems recognition.  Again, what we're looking for is a cost effective means of providing the appropriate assurance.  There are challenges of course.  Nothing of the implementation of changes to regulations, acts or even new processes happen without challenges.

One of the critical issues, and I'm looking particularly around the recognition, requires a clear standard and in audit terms we talk about a reference standards and that's the sort of concepts I'm thinking about.  What's going to be assessed and how will it be assessed?  And these are going to be critical to take advantage of some of the opportunities that are provided.

There are talks about being consistent and transparent and those again are going to be very important because the ability to demonstrate that you are treating people the same, that if you meet the same standard you can have these same outcome, are going to be very, very important.

It's not just important to be consistent and transparent with the standards, you also have to have a transparent process of assessment.  That requires good communications.  It requires an understanding on both sides of what's going to be recognized with the criteria, the rules for approval and one of the key areas that I would suggest is an understanding, before you start off, of the process for discussing differences.

Sometimes it's very easy, when you have very, very similar standards or identical standards, there aren't any differences.  But language barriers, cultural differences, all can lead to misunderstandings not because of willful or deliberate, but simply because you haven't understood each other.  So having a process to start the discussion of any differences prior to going down the paths are important.

Resources are also key.  We started off a number of places of saying that there's a demand for more efficient processes.  You can have multiple trading partners seeking recognition.  How are you going to decide which one?  Where are you going to put the resources?  It doesn't mean recognition is going to stop trade or it's one tool to be used with regard to trading partners.

There also needs to be a process for maintaining that recognition.  Things change.  You've heard today already emerging pathogens, changing trade.  There's all sorts of differences.  There has to be confidence and understanding of what that process is so that there isn't a surprise at the end of the tunnel and saying guess what, you're no longer recognized as a comparable.

With regard to the FSMA and its implementation, there are clear opportunities to work with trading partners to build set system recognition.  That has some advantages in terms of providing assurance that imported food meets regulatory requirements.  It also allows resources to be effectively allocated to high-risk products and facilities.  It does provide, from the trading partner's perspective, a clearly opportunity for enhanced food trade.

But I think one of the clearest areas that I believe has the greatest advantage is the collaboration and communications between trading partners.  Where there is a lot of collaboration and communications, there's also the opportunity to leverage one another and to work with each other to ensure the smooth trade and advantage to both partners.  And I thank you.

CAMILLE BREWER:  I'd like to invite our panelists to come to the table and Dr. Solomon, I'll turn it over to you.

STEVE SOLOMON:  Thank you very much and thank you to the panelists.  We enjoyed those presentations.  I'd ask all our folks on the hearing groups to think about questions you want to ask and please announce your name and we'll call on you and I'll take the first question.

All of you had a discussion about WTO requirements or trade agreements.  I'd ask each of you I guess to go through and give us your thoughts about, with the passage of the Food Safety Modernization Act, do you believe there's requirements that we have new agreements, because some talked about that this is the new standard, others talked about this might be an onerous requirement, others talked about kind of the clarity that's necessary.  Do you think that new agreements are necessary in order to implement the Food Safety Modernization Act?

CAROLINE SMITH DEWAAL:  I'll start.  I think that new agreements are an option.  They're not a mandate but new agreements with foreign governments are certainly provided for in the plain language of the legislation and also its agreements and arrangements.

So I think the legislation gives FDA the maximum flexibility to utilize foreign governments in the way that would be most effective to ensure food safety.  I mean it's a challenging area I think and a lot of international work and work at WHO and FAO, who are sister agencies of WTO, has already been done on how to do that kind of framing.  But I think you definitely have the option in the bill to use that.

MARSHA ECHOLS:  I guess I would answer your question no.  They are not necessary.  And I think that it is possible for the agreements and as they are described, to really go deeply into the domestic systems of other countries.

I would say -- there's an expression that we use, what goes around comes around.  So to the extent we begin to ask other countries to do some of the things I think you have in mind, in a few years expect them to ask the same things of us.

And will that affect U.S. exports when the idea now is to increase U.S. exports?  Will other countries, maybe not as extensively as we could, but will they begin to require some more inspections or more documentation?

So I think that probably -- the idea is harmonization.  The WTO talks about harmonization and we seem to be moving along a system of this is the way we want to do it and we're going to take that around the world.

That seems to be moving away from what the SPS agreement talks about with harmonization, what Codex is about and what are some of the other initiatives we could take and some other approaches we could have.

MARY ANN GREEN:  I guess my view is a little bit ambivalent and maybe.  So you're going to have the three of them.  And the reason I say maybe is it really comes down to what the arrangement or the agreement is and it depends on an outcome-based or a prescriptive-base and what is trying to be achieved.  Is it a bilateral?  Is it a unilateral?  Is it a multilateral?  Because there may be trading partners, and I guess the EU comes to mind, where you're talking about doing it with many countries through the EU.

So what are you trying to achieve with the arrangement?  What are the existing arrangements allow that achievement without a change or whether or not there's a better way of writing that arrangement.  So I don't think -- and it comes back again to some of the comments that Marsha made.

I don't think you're looking at prescriptive or one size fits all.  I think you're looking at how do you achieve your objective which is safe food for the U.S., but also partners' ability to export to the U.S. and maintain that relationship.  You don't trade without partners and so that's the two objectives perhaps that you're looking at.

STEVE SOLOMON:  Thank you.

MARSHA ECHOLS:  Excuse me.  If I could just add to that on the WTO rules, that's something that I didn't mention, the whole point of nondiscrimination.  And I think that you have -- the WTO rules, SPS rules, say don't discriminate and they say it in different ways.

So that's another point that I think you've got to bear in mind as you implement, design a system of implementation, but also if you are deciding we'll have agreements with some and not with others, or some foods are high-risk and some are not.  The whole point of nondiscrimination is important.

STEVE SOLOMON:  Thank you.  Let me ask other folks.  Mike Wehr?

MICHAEL WEHR:  Thanks, Steve.  This is I guess a question that follows on to what has been said here with the last question.  And you know, I think Mary Ann and others, in your talks you've presented a variety of tools that are there that we have available to us.

And in looking at those tools and then looking at the fact that country capabilities around the world vary considerably in terms of their food safety systems, I guess a question for all of you is how do you see this toolbox that we have of ways to assure the safety of imported foods, how do you see that being applied to the broad spectrum of country capabilities that are out there?

MARY ANN GREEN:  Canada has been giving it some thought and we've actually done some of the use of tools for arrangements.  Some very narrow with some developing countries that had particular issues and it's a combination of confidence building between the partners and understanding their system and it takes time and energy and resources to learn the system enough to have confidence in it.

It isn't a question of discriminating, it's a question of being able and being willing and having the tools, the legislation and the resources to go out and have those discussions and figure out what is the most appropriate controls.  Perhaps it's certification on a lot by lot basis.  Perhaps it's accepting the certification from a government organization of a list of establishments that are allowed to export.  Perhaps it's an acceptance of a foreign recognition of system.

And I believe it really has to come down to what the objective is.  In Canada's case with regard to imports, we want the products coming in to meet our requirements and we want the most effective use of our resources.

I don't want to test 100 percent of the lots coming in.  I don't want to test or detain or have all my importers yelling at me because they're waiting six months for those results.  There may be some combinations of importer controls in country and foreign country controls that are a best combination.

But all of those are not around the country, they're around the objective that you are trying to make.  And you can build some very good capacity in a foreign country by listening to how they can meet your needs.

STEVE SOLOMON:  Thanks.

MARSHA ECHOLS:  I would agree that you can have different models to use and I think that's what you would have to do.  And they could vary by -- I think you'd have to look at how to vary them but I think you could have, and you would have to have, different models for different either products or sizes of countries or you think about the paradigm that you're trying to create, but some differences.  I think it could not be one for all.

CAROLINE SMITH DEWAAL:  I would just add that I think FDA is going to have to prioritize the countries as it moves forward because the process of determining comparability is going to be resource intensive.  So identifying some countries early on that might meet our standards and also can provide coverage on some of these inspection questions I think will be important.

But interestingly the bill does provide, under the framework of building capacity, for a longer term plan in terms of dealing with countries that might have capability in the long run of meeting our standards.

ROBERTA WAGNER:  I'm Roberta Wagner and this might be mostly geared toward Marsha and perhaps Caroline as well.  I mean obviously our intent is not to limit the availability of new and novel foods or food ingredients permitted to enter into our country.

You mentioned that a lot of folks will go overseas to find these new and novel foods.  When they do those visits are they or is there a potential for them to consider food safety when they're looking at these new and novel ingredients and products?

And I would also say that there has been mention of comparability assessments use of third party certification programs, et cetera.  Are there other things that you have thought about that could be utilized to provide food safety assurances for these new and novel foods?

MARSHA ECHOLS:  I would yes the companies that are looking overseas for products are thinking about food safety.  Maybe not in the way you have in mind, but they are all aware that they are potentially liable here in the United States, a law suit, a product liability lawsuit.

So it's a different framework that is probably most in their mind.  We don't want to bring something into the country that's going to make Americans sick or that's going to be harmful.  So it's considered in a different way.

ROBERTA WAGNER:  I'm just wondering if there might not be a way for us to partner in that respect.  Could we somehow, as those visits are occurring or as folks are considering bringing in these new and novel foods, could we kind of put the food safety piece at the forefront so they don't run into problems when the time comes that they want to start importing these types of products?

MARSHA ECHOLS:  I think that's possible, yes.

MURRAY LUMPKIN:  I had a couple of questions I just wanted to ask.  We've talked about these different mechanisms of comparability or equivalence or whatever and I'd be very interested in your thoughts on okay, so we do this, then what does it actually mean in two settings?  Both at the border, does that mean you get a free pass?  Does that mean you get a quicker pass?  Does that mean you get less testing at the border?

And also what does it mean in terms of in-country as far as the FDA is concerned?  Does that mean no in-country FDA specific site inspections?  Does it mean for that country we switch from inspecting individual manufacturers to doing country systems audits?  You know, I mean what does this really mean at the end of the day after it's done in both of those very practical senses?

And the final one is we talk about this in terms of the country's system but I think we all know, as Mary Ann was pointing out, there are hundreds of countries and territories that we're dealing with here.  And the reality of all of them in our grandchildren's lifetimes being found comparable is probably the same reality of us making 19,000 inspections in the next six years.

That being the reality, what does it mean for an individual manufacturer though, in one of those countries, who actually makes the effort and really can manufacture at a level that we expect in this country?

Are they penalized because they happen to be located in a country whose system is not comparable but their individual capabilities is comparable?  And then how would you want us to handle something like that under this kind of a system?  So it really is what does this mean in these three different areas?

CAROLINE SMITH DEWAAL:  I think the bill actually anticipates each of those areas.  I think I'll start with the last one.  The company, the high performing company in a country that does not have a comparable system, those companies will, in the long-term once the bill and the tools become in place, they will have the ability to enter into a voluntary importer accountability system.

So if they're not defined as high-risk, there is a tool available through third party certification that should allow them to be recognized by FDA as meeting that higher standard.

But with respect to both the in-country systems and the border systems, I think you need to look at your sister agency over at FSIS.  I mean FSIS has a system of equivalence determinations of the national systems.

They then conduct audits of those national systems periodically, I think it's annually or bi-annually but they conduct them pretty frequently.  And then they also do a verification check because they do a fairly intensive, compared to FDA, inspection and sampling at the border.

So they've got this verification component.  The border inspection really slides into a verification component of what is already an existing national system.  Now that's mandatory for all countries that want to export meat or poultry to the U.S.

And under your system, you will still have food coming in that doesn't meet any of those requirements and that.  I mean you're going to want to put a lot of testing at that level and a lot of border inspection at the level of somebody who's not from a country that's comparable who's not in a voluntary program.

But you will still want to preserve a certain amount to do verification that the countries that you do have those comparability agreements are actually living up to your expectations.

MARY ANN GREEN:  I guess I'd like to echo on in terms of the FSIS has set out as a prerequisite that you have equivalence before you come in.  And FDA, as I understand it, has been very clear that's not what they're putting in place.

And so fundamentally, with the concept of you're trying to do both in-country and border inspections and trying to target them to the biggest risk.  And this is countries, all importing countries face it.  How to determine residual risk?

And there is an inherent risk in the product that has a huge range, you know, from the highest risk to the lowest risks.  That then is added to the process control system.

So a company or a country -- sorry, a company with a clear and very explicit process control system can reduce that risk that's associated with the product.

This can then be, again, complemented by a country system that can again provide assurance that both the product and the process control system risks are being managed and this country system, if it's not appropriate, could also be augmented by a third party verification.

There's also then some sort of spot check, at either border, country or in-country whether by importer self-checks, government audits if the importers have systems in place.

There is this verification so when I hear a system and I think of what there is in place in many areas in Canada, what you find is there's this checks and balances and you're trying to build a system that has these checks and balances so that that data that you get from that system will tell you if your program is working.

You're actually, although you do assess whether the product meets compliance, one of the critical areas of sampling and monitoring is to assure, give yourself enough data so you can calibrate your system and change the trend to the right high-risk product and that may change.

Who knew six months ago that we were going to be looking for radioactive product in Japanese food?  That trend, the environmental scanning, the information, the ability to shift your resources to a different high-risk product is part of building that system.  So I hope that answers your question.

MARY STANLEY:  Yes, this is Mary Stanley with the Food Safety Inspection Service.  And Caroline, you had mentioned early on in your presentation the opportunities for FDA to partner with other federal agencies and I think we all recognize the complexity of importing foods through all the multiple agencies that touch on this and I was wondering if you could expand a little bit and any thoughts that you might have as well as the other presenters because --

CAROLINE SMITH DEWAAL:  Thank you, Mary.  And actually in my remarks yesterday I gave more of a consumer perspective and we talked a little bit about trustworthiness.  And I mean from a consumer standpoint, we first of all trust FDA inspectors to enforce FDA's law, but on the next tier are other U.S. government agencies.

So FSIS is in I think 32 countries, at least periodically to do audits.  NOAA is in some foreign countries.  APHIS is in some foreign countries.  So looking at the entire complement of U.S. government agencies I think is part of the solution here. 

Secondly, then on the next tier are foreign national governments and the comparability assessments I guess we're talking about here would fit into that.  But then lastly are third party private certifiers.

So those, in terms of a consumer perspective, the scale of trustworthiness is fairly clear cut and we think that it's not only FDA's job but the U.S. government needs to do a better job of cataloguing where are its inspection resources overseas and making sure that they are being used in the best way to achieve the food safety objectives as well as the other objectives for other agencies and the Acts.

I mean at one point, I'm not sure it's still true, but APHIS had inspectors at almost every foreign port that was exporting to the U.S. to check for insects and animal and plant diseases.  And yet they weren't checking for produce safety or they weren't even being tasked to even look at that.

So those are the kinds of issues that we think -- it's a bigger job than FDA can do but it's something that needs to be done if we're going to have efficiencies in this area.

MARSHA ECHOLS:  I would say from the small business perspective it would be good to know what each agency is doing and to have them work together.  But maybe that would also help you realize where there is some overlap and how much of a burden you're putting on businesses and what the costs are that are associated with all of this.

In the new law you're adding layers, so certification adds a layer.  You're building a new business basically through certifications and audits.  And what will that mean for small companies?  Again, you're just adding to a burden that's already there.

CAMILLE BREWER:  Dr. Solomon, you have time for one more question.

MARY ANN GREEN:  Can I just please, the trading partners really don't want to see five or six competent authorities coming through each country.  I mean, you know, we chat and we talk about oh, we have five missions this week.  We have 10 missions a month later.  You know, in the next five months we're going to have 15.  When we have a country come through we'd like to be able to plan it and have a country rather than having them come three, four, five, six times and I'm sure you're the same.

MERTON SMITH:  I'm Merton Smith.  I knew there was a reason to come to this meeting today.  I'm the Director of International Programs apparently for the entire FDA.  But I am with the Center for Veterinary Medicine and we're very much involved in food safety as all of you know, particularly the safety of feed that is fed to food producing animals and drugs that are used in food producing animals.

I just wanted to make a comment and sort of a historical perspective on this since I've been involved in international work at FDA for a long time.  All of us, many of us here know that the idea of having mutual recognition agreements or memorandum of understanding or third party certifications is not something new with this legislation.  It's very exciting that the Congress has given us more emphasis in this area and I hope that we'll obviously go down that road to help us leverage our resources.

But even when Mike Taylor was here in the early '90s we produced a report called the International Harmonization Task Force Report and one of the main recommendations in that was to put together these kinds of relationships with foreign governments that would leverage our ability to have confidence in imports.

So we've been trying to do that for a number of years and my thought is that there needs to be almost a cultural sort of change within FDA because people in the Commissioner's office go out and craft these international agreements with some representatives from some of the centers.  They come back with confidence about other countries' ability to control their exports coming to the U.S.

But somehow that doesn't always filter down to the people that are at the ports of entry.  They don't take advantage of that work and I'm wondering if Canada, or New Zealand, or other countries have had problems in that area where the people that are actually looking at the imports coming in are less likely to understand or take advantage of work that's been done to build confidence in the regulatory systems.

MARY ANN GREEN:  Culture change is always a challenge.  It's not something that happens overnight.  I can remember when I actually started as an inspector and we had some very old inspectors that wanted to count flies on the wall and paint peeling and flakes that were coming off and we kept saying no, no, you've got to look at their system.

Culture change takes time.  I think now that there is a good understanding of systems but that's a 30 year process.  I hate to say it.  It takes training.  It takes patience.  It takes time and often the inspector is often overloaded.

I'm sure this happens everywhere and you end up, when you've done an international agreement they went oh no, not another one.  We have to be aware of their workload as well as their understanding of what we're doing as well.  So it's a two-way communication and that I think is absolutely critical to success.

STEVE SOLOMON:  Let me thank the panel again.  Thanks.

CAMILLE BREWER:  Again, thank you panel and thank you enquiry team for those fine questions.  We're going to have a 15 minute break.  I do want to remind you that we have the reception area for representatives of embassies and foreign governments.  Could the folks from OIP and the international officers from CVM and IAS raise your hands so folks will know who you are?  Okay, enjoy your break.  Please be back at 10:47, 10:47, and I'm not kidding.  Thank you.

(A brief recess was taken.)

CAMILLE BREWER:  Can we get started please?  Could I ask the OIP and IAS staff to gather the participants from the hallway please?  While we're waiting I'd like to acknowledge that tomorrow we will have some additional FDA staff on the enquiry team.  We'll have Dr. Katherine Bond from the Office of International Programs, Dr. Julie Moss from CFSAN, Commander Domenic Veneziano from the ORA, Dr. Michelle Twaroski will be an advisor and she's from here at CFSAN.  I'd like to also acknowledge the presence of Associate Deputy Commissioner Mary Lou Valdez who is here with us today.

So we're going to move directly into Panel 2 and the discussion will be about equivalence.  We have with us Clete Willems who will talk about our WTO obligations.  We'll discuss the FSIS model.  Mary Stanley will do that.  And we'll provide a Codex framework for our discussions on comparability.  And Karen Stuck, the U.S. Codex manager will do that presentation.  And so I'd like to invite Clete up.  Thank you.

CLETE WILLEMS:  Hello.  Hi, I'm Clete Willems.  I'm with the Office of the United States Trade Representative.  I'm an attorney over at USTR where my practice focuses on both policy and litigation related to food safety issues and to other issues that may come up under the SPS and the TBT agreements.

In this capacity I was one of the leads for USTR on the food safety legislation.  I work with FDA and some of the other agencies on the food safety working group and I'm happy to be here again today discussing food safety issues with all of you.

For my presentation I was asked to give an overview of the international trade obligations of the United States that are relevant to food safety issues and that are relevant to equivalence or comparability procedures.

Most of the U.S. obligations that are relevant to this discussion relate to the commitments that we made when we joined the World Trade Organization.  We also have some commitments under our FTAs such as the NAFTA agreement with our trading partner Canada, and Mexico of course.  But in today's discussion I'm going to focus primarily on our WTO obligations.

In doing so I thought what might be helpful would be to start at a bit more of the 30,000 foot level and to discuss some of the general principles behind our obligations and then I might delve a little bit more into the specifics of the pertinent provisions as they relate to equivalence and comparability.

Before I start I want to apologize, I don't have any really fancy logos or a very nice looking PowerPoint presentation so please don't hold me to the high standard that was set by the first panel.

The primary WTO obligations of the United States, as they relate to food safety, fall under the agreement on the application of sanitary and phytosanitary measures which all of us know as the SPS agreement.

And the first thing that one needs to know about the SPS agreement is what measures does it apply to.  And it's important to note that the agreement only applies to measures that are adopted by a government, measures that directly or indirectly affect international trade, and measures that are applied to protect human, animal or plant life and health from a series of different risks.

And the SPS agreement spells out these risks in some detail.  I'm not going to bore you by reading these but what's important to note among these different categories of risk is that it's any measure applied to protect animal or plant life and health from things like animal diseases or diseases that exist in plants and can be transmitted from one to the other.  That's what the first category is talking about.

And the second category, which is a bit more relevant to our discussion today, deals with contaminants, toxins and additives in food products that can cause a problem for humans if they are consumed.  So those are really the two main categories of issues under the SPS agreement.

Examples of different kinds of SPS measures might be a requirement to inspect products at the border for certain microbiological contaminants.  It could be a maximum level for pesticide residues.  Or it could be the procedures that a member puts in place to make sure that the imported food that it receives meets its level of safety.  So there's a whole broad range of measures which this can apply to.

Another important thing to understand about the SPS agreement are its objectives.  First and foremost this agreement recognizes that WTO members have the right to adopt measures to protect human and animal life and health.

Members can do things like adopt new food safety legislation or put all kinds of procedures in place to make sure that food that is consumed from both foreign and domestic sources is safe.  That is explicitly permitted.

At the same time, you know the agreement does recognize that sometimes a member can put a measure in place that, based on the way it's designed, based on the way it's applied, may actually have an adverse impact on imports and it may be designed in such a way that it actually has overly burdensome or unduly restrictive requirements on imports and maybe those imports don't apply the same to domestic products.

And as a result, the agreement puts in place a set of rules and obligations that all WTO members have to follow.  And these are things like needing to base your food safety measures on scientific evidence, needing to make sure that you do not unfairly discriminate against imported products.  And obviously it's easy to see why this is so important to all of us.

The United States is a major agricultural exporter.  We send over $100 billion in our products to overseas markets.  And I know a lot of you in this room represent governments who send a lot of products to the United States and it's important to all of us that we have the tools to address barriers that are unjustified and that impose a burden to our exports when they arise.

And the SPS agreement is an agreement that gives us those tools at the WTO and we can challenge measures and if a measure is found to be inconsistent with our obligations, there are consequences to that.  And that's a long discussion in and of itself so I won't get into that but suffice it to say members generally try to avoid losing the WTO dispute.

So these are the concerns that we have when we look at any food safety measure that we adopt.  And in the United States, as we pass the food safety legislation and as we now look at our implementing regulations and what we're going to do to enforce that law, we have to be cognizant of these concerns.

And as I've noted, the SPS agreement allows us all to adopt measures to address food safety risks.  But one of the things that we have to ask when we do so is what is the level of protection we're trying to achieve for our consumers.  In WTO parlance this is called the appropriate level of protection or ALOP for short.

And what this really means is that a member adopting a measure needs to ask itself what level of risk is acceptable.  Am I going to do everything I possibly can to completely eradicate this risk without regard to any other considerations such as cost or feasibility of doing so, or am I going to adopt maybe a more practical approach and try to go as far as possible given some of these other considerations?  And what you end up with is what's called your ALOP.

And once you've determined that level of protection, you can take measures to achieve it but each measure you take needs to follow a set of basic obligations.  First and foremost your measure needs to be based on scientific evidence.  You need to have sufficient scientific evidence of some risk to human life and health.  You need to make sure that your measure is only applied to the extent that is necessary to address that risk.

Third, you need to make sure that your measure is not applied in a manner that discriminates between imported and domestic products or in a manner that discriminates between different foreign suppliers.  And these are some of the basic obligations that we have to adhere to in the WTO.

Now to elaborate a little bit further on each of those core principles.  The first one, based on science, and really there's -- this is oversimplifying a little bit but there's really two ways a member can fulfill that objective.

And what it can do is it can base one of its measures on the international standards, guides or recommendations that are put forward by the three sisters, which are Codex, the OIE, or the IPPC, or it can conduct its own risk assessment.  It can say I want a higher ALOP than those international standards but in doing so it really needs to have evidence to suggest that a higher risk is out there and it's something we need to protect against.

And there's a bunch of requirements that applies to the way that a member conducts its risk assessment but again, the important point behind this is that there has to be a real risk out there that you're trying to get after and there has to be scientific evidence to suggest that.

Next issue is the trade restrictiveness component and the basic principle there is a measure cannot be more trade restrictive than necessary to achieve your ALOP.  And one could conceive of a situation where, to give an example, a country recognizes that there's a risk of an insect in their fruits and the science suggests that all you have to do is fumigate and you're going to be okay, you're going to reduce that risk to an acceptable level, but the country then imposes an import ban.

Obviously that's an example of something that's going to be far more restrictive than necessary to protect life and health.  And so those are the kinds of things that this would address.

The nondiscrimination principles, I talked about these already a little bit.  You know most favored nation, the need not to discriminate against products of different countries and to apply your rules consistently between countries.

National treatment again deals with making sure that you treat imports and domestic products in a consistent manner.  And that doesn't mean you have to apply the exact same rules.  It doesn't mean you can't do things slightly differently.  They just can't create an unfavorable environment for the imported products.

Finally an issue related to all of these core principles is the concept of equivalence.  And I've put the specific article dealing with equivalence up here on the screen.  I'm not going to read that but basically what this is all about is recognizing that members take different measures to achieve the same level of protection.

And the WTO recognizes that not everyone does everything the same way and they shouldn't be required to do so.  So the concept of equivalence allows a member who wants to export to a particular country to demonstrate to that country that its measures achieve the same level of protection and that's what this is all about.

The agreement doesn't specify all the details of how one has to put in place an equivalent system and there is quite a great deal of flexibility out there.  Anytime we do something along these lines we have to be cognizant of the general principles that I discussed before.

There's a great deal of flexibility but at the end of the day, you need to go back and make sure that your system isn't designed in a way that is going to be more trade restrictive than necessary, that is going to be discriminatory and things of that nature.

I was going to say a little bit more about equivalence but I'm running out of time here.  I can get into that more I guess in the questions if we'd like.  But I do want to conclude with is I want to say something brief on the food safety legislation.

During consideration of this legislation USTR was very cognizant of the need to modernize FDA's tools and to make sure that they had the best available tools to ensure that all food, imported and domestic, was safe.

At the same time, obviously one of our roles in the process was making sure that what was ultimately enacted was also WTO consistent.  And I can just say on behalf of USTR, we were very pleased that our colleagues at FDA, and really throughout the inner agency, had a grasp of both of these objectives.

And we worked together to carefully craft this legislation with the inner agency, with Congress and we're confident that what came out of that process is fully WTO consistent.

You know that said our job is not done.  We still have to work together.  We have to work together on the implementing regulations.  We have to work together on anything that's done in the arena of equivalence or comparability.

And based on the experience we've had I'm confident that we can continue to work together in a positive way that meets the needs of U.S. consumers, that recognizes our WTO requirements, that recognizes the interests of all the exporters sitting in this room.

And so I look forward to continuing to work with all of you.  I look forward to your questions and thank you very much for the opportunity to present here today.  Thank you.

CAMILLE BREWER:  Thank you, Clete.  And Mary, I was looking for you so please join us.

MARY STANLEY:  Thank you.  And thank you, Camille.  It's a pleasure to be here to be able to present the Food Safety and Inspection Services equivalence process.  And you heard from the panel previously that I believe many of you are intimate and very familiar with our process but at any rate.

FSIS ensures that the nation's supply of meat, poultry and egg products is safe, wholesome, correctly labeled and packaged.  And that includes the importation of amenable products to our regulations and we operate under the Federal Meat Inspection Act, the Poultry Products Inspection Act as well as the Egg Products Inspection Act.

The regulations are in Title 9 and what's really confusing to importers is particularly because the meat and poultry and egg products that we regulate are defined very clearly in our regulations but it doesn't encompass all meat products.

And so that does present quite a challenge when people are bringing products into the United States.  Is it an FDA regulated product or a Food Safety Inspection Service?  So it's very clear in our regulations.

Within these regulations is embedded the import portion of the regulations.  For meat it's in Part 327 and for poultry it's in Part 381, Subpart T, and for egg products it's the import regulations are outlined in 590.900 to 970.

Prior to 1995 FSIS was evaluating food meat systems, or foreign meat systems and poultry systems under our inspection laws that incorporated the terminology at least equal to.  As you just heard, with the adoption of the SPS agreement in 1995 these regulations were modified to replace the equal to with equivalent to as a standard for eligibility.  In concept the term is quite clear; in application it was very challenging.

So the concept of equivalence, as you have just heard from Clete, is the different sanitary measures may be used to achieve the same level of food safety.  In the case of FSIS, our authority is very clear in that it is a prerequisite for trade.  And so these equivalence determinations are made in advance of any product moving into the U.S. that we regulate.

    FSIS developed the equivalence process that I'm going to be describing to conduct our equivalence evaluations in three areas.  And the first step is obviously the initial equivalence of the foreign country's food regulatory system, but also incorporated with that is once they are found to be equivalent, then it is an ongoing process as well.  So that's our ongoing evaluation of the food safety system.

And then embedded in that, as changes occur within the foreign country's food regulatory systems, we are frequently requested to conduct an evaluation of individual sanitary measures.  One other point to make is that the criteria that we apply to all these are outlined in our regulations.

So once a country is successful in achieving equivalence, we do -- and this is through the administration process and so the eligible countries are listed within the regulations.

It's also an important point, this is a systems evaluation and so once we've recognized the equivalence of that system, then it's the responsibility of that competent authority in the foreign countries to certify the individual establishments that are intending to export to the United States.

So the list looks pretty simple in regards to steps for initial equivalence and I'll be going through these in the following slides but essentially the country makes a request, we look at the documentation that they have submitted and then there is an onsite verification to ensure that it's been delivered.

And then through the public notification, through the proposed rule and the final rule states that's when the equivalence determination is finalized and then the foreign country is certifying the establishments.

So the first step, and I want to emphasize it, is a government to government communication.  And so any country can seek eligibility by submitting a formal request through a letter to USDA/FSIS, the Office of International Affairs.

And that just is a very short intention of what they intend to seek equivalence for.  In the case of FSIS, we will do an equivalence determination independently for the meat, poultry and egg products because of the way that our regulations are structured.

Now FSIS will respond to this request in writing and with that we will provide the foreign country with what we have recently designed as a self-assessment tool.  This is replacing the questionnaires that we used to give the foreign countries to respond to.  And those of you that are familiar with the iCAT that FDA has designed, it's very complimentary to the self-assessment tool that we have in place here.

And the design of this tool is to assist the countries in providing the detailed information that we need.  It outlines a very structured approach and the six components that we are approaching this, organizing the information, is government oversight, the statutory authority and food safety regulations that they operate under, sanitation controls that are in place, the HACCP systems, chemical residue control programs and then microbiological testing programs.

    And we carry through that organization through our entire process.  So the country will complete this self-assessment tool and then throughout the process, once they become eligible, it's carried through into our ongoing assessment as well.

We also provide related reference materials.  One is a response or a completed, or partially completed self-assessment tools that the foreign country will have an idea of how to complete this, as well as all the underpinning regulations, guidance materials and directives that we have available to manage the Food Safety and Inspection Service system domestically.

And so the country completes this and provides the supporting documentation to us.  We also offer assistance to governments in regard to understanding the requests that we've made and to assist them in the completion.

So once we receive this package of information then a team of FSIS experts will review this.  The actual equivalence work is done out of the Office of International Affairs and they assess, first they assess the document to make sure that the response is complete, but then they reach out to technical experts throughout the agency, whether it's the Office of Policy or Office of Public Health and Science, wherever the expertise is needed in order to do the complete assessment and to review all the supporting documentation.

Delays frequently occur particularly in regard to the translation of the documents.  It's a massive amount of information that's coming from these countries.  A lot of countries go ahead and translate the information into English prior to sending it but some don't and so that's a tremendous resource burden for our agency but the countries have the option to submit in their native language.

And also there's always a back and forth exchange in regards to clarification or request for additional information in order to complete the assessment.  And that takes time whether it sits in FSIS or whether, you know once we make the request sometimes it takes an extended period to respond to the questions.  And so that is a frustration to the whole process that we follow is the time involved in regard to completing the assessment.

Once that completion is done and we're satisfied with the documentation and have made that initial assessment of equivalence, then a recommendation is made for an onsite audit so that we can go into the country and verify that what they have actually put on paper they're actually capable of delivering.  And again, this is from a systems viewpoint.

The goal of the systems audit is to verify the objective evidence and the team is comprised, it may be one or two individuals or it may be a highly complex team pulling from the laboratory system or technical experts that would be needed.  That's driven by the complexity of the government, the regulatory foods safety system in the foreign country.

And the way that we approach the audits is in three sectors.  We are looking at the government offices, which is the organizational structure, how they're staffed and how they control and supervise both at the national level and then any district or regional offices that they may have.

We also take a sample of the establishments so that we can observe the in-plant operations but again the focus there is on the competent authority's controls and delivery of their inspection systems.  And then we will also visit laboratories for the residue controls as well as for the microbiological.

And once those results -- once the audit is completed then we do write a report.  The draft report is shared in advance of publication with the foreign country and enables them to provide any additional information that may be necessary and then the final report would be posted up on the FSIS website as a measure of transparency.

With a successful audit and the documentation completed, at that point we move into the administrative process where we will propose a rule.  And this is essential.  It's based on these, you know, both the onsite audit and the document review but this enables us to be transparent in regards to our findings and give the public an opportunity to comment on the findings and the recommendation that FSIS is making for the eligibility.

And depending on whether it's a significant or non-significant rule, the economic impact analysis would be included in the proposed rule or in the final rule but there is that element of the process.  So once we've gone through the proposed rule stage, we would evaluate all the comments and address all the comments that are received and then, at that point, based on the entire package, the publication of the final rule would be made in the federal register.

And then at that point, again that's when the foreign country would be eligible and would be able to provide a list of the eligible establishments within their country that are trading with us.

Now for ongoing equivalence, I've made reference here to what we're calling the self-reporting tool and this is an extension of the self-assessment tool.

This self-reporting tool has been designed and used to maintain up-to-date information of the eligible country's system and it is enabling us to gather that information regarding any changes to the foreign inspection system and that we make that assessment in advance of going into the country for the audits.

And it drives the performance based analysis that we're doing in regard to determining the scope of the audit as well as the frequency of an onsite audit.

FSIS is also robust in the port-of-entry or point-of-entry re-inspection activities.  By legislation we are required to look at 100 percent of all the shipments coming in.  That doesn't mean that we sample every shipment in regards to product sampling but every shipment does have to stop at a FSIS regulated establishment for inspection.

    And so under that authority it's able to monitor both at port-of-entry and we conduct these audits and maintain a good exchange of information so that we remain up-to-date in regards to what's going on in those foreign systems.

And I also mentioned that we do the equivalence of individual sanitary measures.  Some examples of these include we get a lot of requests for evaluations of microbiological or residue method analysis.

There may be changes to or modifications to sample sizes and sampling sites in regards to methodology that we apply in the U.S. and so we make considerations for those under these individual sanitary measure determinations.

Some governments are applying different postmortem inspection procedures and also the use of private laboratories.  Those are the most common measures that we have been looking at.

And again we have a construct of FSIS technical experts that are reviewing this against criteria that have been set forth within our regulations or policy guidance and we're transparent with the criteria that we're applying so that the foreign governments understand how the assessment was made.

And so once we've approved an individual sanitary measure, that is factored into the audit's performance based schedule.  And so when we go in country, that would be something that we want to verify.

So in conclusion, I think we want to emphasize the fact that it's a very structured and well documented process that we apply here.  The framework that I've outlined here has been in place for many years.  It's been refined and modified but at the same time it's not too different than what we started with once the SPS agreement was implemented.

This equivalence process does give us a foundation for the confidence and knowledge of knowing the system and the capabilities of that competent authority.  The experience comes in as the trade starts to occur and so that information is factored into the ongoing equivalence process.

And I want to emphasize again, it's a public process so that there's transparency.  We post the equivalence determinations on the website as well as the audit reports and then the equivalence determination for eligibility is through the federal register process.  Thank you.

CAMILLE BREWER:  Thanks, Mary.  Ms. Stuck?

KAREN STUCK:  Thank you very much.  My job here today is to explain how Codex has treated the concept of equivalence over the years and what Codex has to say about the topic.

To introduce Codex to those of you who may not be familiar with it, it was founded in 1963 as an organization under the umbrella of the Food and Agricultural Organization and the World Health Organization, both of which are within the United Nations, thus it operates under the rules of the United Nations.

As you heard, members, WTO members under the SPS agreement are obligated to base their measures on science and so the agreement mentions three organizations, along with Codex, mentions the OIE and the International Plant Protection Convention as organizations that established science-based standards.

We talk about two mandates of Codex, the protection of the health of consumers and ensuring fair practices in the food trade.  Notice that it does not say facilitate trade or promote trade; however it's obvious that fair trade practices will generally help facilitate and promote trade.

Codex really increased in providence when the sanitary and phytosanitary, the SPS agreement was agreed to because, as I said, it established the Codex standards as a benchmark along with the OIE and the IPPC.  And what that means is that Codex standards can be referenced in dispute settlement cases, the WTO, and that a country that adopts the Codex standard meets the obligations of the SPS agreement.

Many countries, especially those that don't have resources or the ability to conduct risk assessments or develop science-based standards do adopt Codex standards and guidance such as that that's provided on the topic of equivalence.

It's important to emphasize that Codex standards and guidance are voluntary.  Countries have a sovereign right to set their level of protection and to adopt standards that meet that level within the disciplines of the SPS agreement.

For those Codex members who are members of the WTO, there's a very strong correlation between the two but not all Codex members are WTO members and vice a versa.  The subject of equivalence comes up within the committee on food import and export inspection and certification, affectionately known as CCFICS.

The subject has been on the agenda in one form or another since the committee was organized in 1992.  It has not been an easy topic for the committee because it was a new concept having been memorialized in the SPS agreement.

There are currently two guidance documents that relate specifically to Codex, one relating to the development of agreements, equivalence agreements, and another to the judgment of sanitary measures.  It was the seventh meeting of the committee when the first document on agreements was finalized and it took five meetings from the initiation of work on the determination of equivalence of sanitary measures to the time that that was finished within the committee.

Now some people might say that's somewhat typical of Codex but it isn't necessarily typical of a lot of guidance and standards that work through Codex, and particularly this committee that is very efficient at moving things through.

So I'm emphasizing that this is a long time for this committee to take but it was a very difficult topic.  It was a new topic and there was a lot of work within the committee and between committee meetings trying to get an understanding of what this meant because you're talking about, in a committee meeting up to 80, 90 countries present, all of which are looking at this in terms of how is this going to affect me and not quite sure.

There are other Codex documents, besides the two I'm going to talk about, that reference equivalence but I'm just going to focus on two main ones today.  The committee recognized early that there would be benefit in a country's ability to apply principles of equivalence in trade and this statement from one of the guidances really sums it up.

"Application of the principle of equivalence has mutual benefits for both exporting and importing countries.  While protecting the health of consumers, it serves to facilitate trade and minimize the cost of regulation to governments, industry producers and consumers to achieve the appropriate level of protection of the importing country."

As we review the Codex text on equivalence, some important themes emerge that I want to note:  the importance of transparency, the need for dialogue between the parties, the provision of technical assistance for developing countries and the need to communicate very clearly, including permitting public participation when decisions are made so that public confidence in the process is preserved.  And as we've listened to the two previous speakers, you're hearing -- starting to hear a little repetition.  We're all on the same page here.

The first equivalence document that was adopted by Codex was the Guideline for the Development of Equivalence Agreements regarding food import and export, inspection and certification systems, which was finalized in 1999.

This guideline provides guidance for entering into bilateral and multilateral agreements, can relate to one-way trade where one country is the importer and the other the exporter, or it can relate to essentially a mutual recognition agreement that permits trade going both ways.

It is the intent that agreements could be either single or multiple issues, that is limited to a specific area of trade or specific products.  It was during committee discussion of the purpose section that it was agreed to use the term requirements and these were defined as standards and other measures set down by the competent authority related to trade and covering public health, protection of consumers and conditions of fair trade.

It was not the committee's intent that requirements as covered by this guidance would include commercial quality factors.  The guidance also defined equivalence as the capability of different inspection and certification systems to meet the same objectives.  One thing you'll notice about Codex documents is flexibility.  They tend to provide a range of options for countries to select from so that makes them kind of long sometimes.

The committee noted that the purpose of the agreements as one providing an enhanced means of assuring that exported products conform to importing country requirements, elimination of duplication of activities, providing a mechanism for cooperative exchange of expertise, assistance, information.

Both guidelines provide a road map of information that you would request and information that should be provided and a checklist of information that should be made available to the exporting country.  And then possibly another purpose is that they could reduce rates of physical checks and sampling by an importing country and less certification by the country of origin.

    Some considerations that are pointed out that need to be noted by countries before they enter into equivalence agreements, first of all is resources.  In general, as we've heard, a significant amount of resources may be needed to develop agreements and the guidance suggests that countries may need to establish priorities for consultations.

Prioritization could be based on product categories with higher public health risk, the level of trade in the product, whether an equivalence agreement would actually facilitate trade, whether the exporting country has sufficient infrastructure and resources to maintain an appropriate system, the compliance rate of the exporting country's products and whether significant resources would be saved as a result of the agreement.

And then finally, can the importing country conduct assessment and verification activities both before and after conclusion of the agreement?  These are things to be thinking about or suggest that countries need to think about before they go into the process.

The guidance describes a consultative process.  As a first step, the importing country should provide texts of its relevant control measures and identify the objectives of the measures.  As you can see this was developed back in the paper day when everything was paper so I imagine you could provide them in a variety of ways.

For food safety measures, the public health risk that is being addressed by each measure should be described.  This will include information on legislation, decision criteria, control programs and operations, facilities and equipment, laboratories, inspection personnel, et cetera.  The exporting country then provides information that demonstrates that its control system achieves the importing country's objectives and its level of protection.

And again, repeating something I heard somebody else mention as being important, the countries should identify a process for jointly considering differences in measures and requirements.

And we hear a lot of this importance of dialogue, importance of conversation back and forth and thinking back to when the committee was talking about it, there was a lot of discussion at the time the committee was developing these about this very thing.  So it was a major concern.

Once the information is exchanged, the importing country has to verify that the exporting country's control systems operate as indicated in their submissions.  Countries are referred to another Codex document for guidance on the assessment verification processes.  I indicated there are other Codex documents that will assist in carrying out equivalency determinations.

Once equivalence has been established, the exporting and importing country should develop a problem resolution procedure that may include provisions for the importing country to reexamine products for verification.  There may also be an agreement on the use of certificates and the requirement of an establishment list.  And then finally, there should be procedures for ongoing information change.

The guidance also includes information that suggested information to include in an agreement and recommends the publishing of a notice to the public with the text of the agreement as the guidance note providing this information will enhance public confidence in the agreement and in the process of the competent authority.

The second Codex guidance devoted to the subject of equivalence is called guidelines on the subject of equivalence of sanitary measures associated with food inspection and certification systems which was adopted in 2003.  Work on this was begun at the very time that we finished work on the first one and they're intended to be read together.

And again, we have a definition of equivalence in this one, which has somewhat of a connection I think with the language of the SPS agreement, the state wherein sanitary measures applied in an exporting country, though different from the measures applied in an importing country, achieve as demonstrated by the exporting country, the importing country's appropriate level of protection.

This time the focus goes beyond agreements and talks about individual sanitary measures.  Measures are characterized in three ways:  infrastructure, which is laws and enforcement systems; program design implementation and monitoring, which is the documentation, the decision criteria, laboratory capability, audit provisions, et cetera; and then specific requirements, that might be facility requirements, equipment requirements, your inspection procedures, the laboratory testing procedures, methods of sampling, et cetera.

Some general principles that are articulated in this document.  We see again the focus on transparency and on technical assistance, both of which relate back to language that you heard from the SPS agreement.  Those people who were involved with the development of the SPS agreement I know can talk about how those provisions got in there and you can sort of imagine how those provisions got in there, but it is important that countries consider providing technical assistance in those cases and it's generally related to technical assistance to developing countries.

In the context of this guidance, an equivalence determination can be sought for a sanitary measure or a set of measures relevant to a food product or a group of food products.  The extent of the determination will depend on prior experience, knowledge and confidence, a phrase you just heard recently, and that the importing country has regarding has the food control measures of the exporting country.

Experience, knowledge and confidence, as used in this Codex document, includes the history of food trade between the countries, the history of compliance by the exporting country, particularly for the food products that are the subject of the equivalence evaluation.

Experience, knowledge and confidence may assist in facilitating familiarity with information provided by the exporting country and thus reduce the resources that are needed for the equivalence determination.

And transparency is essential so that the use and application of the information is clear to all the parties involved.  So when we talk about transparency and communication we mean between the two countries as well as between the countries and their constituencies.

The guidance also provides information on applying an objective basis of comparison, which is a tool to bridge between equivalence and the measure, to determine if the exporting country's sanitary measures achieve the importing country's ALOP, the level of protection.

The importing country, to do this, should specify as precisely as possible an objective basis for comparing sanitary measures that are proposed by the exporting country with its own measures.  This could include information about the purpose of the measure, the specific risk the measure is intended to address, how the measure achieves the level of protection and the scientific basis for the measure.

The objective basis for comparing sanitary measures that are described as, or categorized as infrastructure is likely to be qualitative, the ability of the food safety legislation to achieve broad safety goals for example.  When you're comparing measures that are classified categories to specific requirements, that's likely to be quantitative, for example comparing the levels of hazard control that is achieved by a measure.  And then for those measures that are categorized as program, the comparison is likely to be a mix of qualitative and quantitative elements such as the correct application of principles, establishment of appropriate limits in a HACCP system, et cetera.

As I indicated earlier, there's a number of Codex documents that have guidance on this.  I've focused on two main ones, which I hope were helpful to your planning.  Thank you.

CAMILLE BREWER:  Thank you, Karen.  Mary, if you could join us and if we could have the enquiry team reassemble.  Dr. Solomon, you have until 12:30 for your enquiry.  The panelists from Panel 1 are still here and you may opt to bring them back if you have additional questions.

STEVE SOLOMON:  Thank you very much.  Thank you for the presentations.  That was a tremendous amount of information.  I'll start and then ask others to jump in and ask questions.

Just sort of listening to the process, we would like your advice on sort of how to balance different pieces here.  So we talked about WTO, we talked about Codex, we talked about how FSIS has implemented these processes and we're faced, in the initial presentations when we got an overview of the Food Safety Modernization Act, with a tremendous, very aggressive timeframe for implementing of the Food Safety Modernization Act.  Most of these pieces are one year, two years, you know, getting regulations out in place.

And the process that you describe -- I guess I want your thoughts on how dynamic is the process you just described for us.  We have changing food safety hazards, we have the world changing, governments changing as we've seen recently throughout the world and the process that you describe, does it have the dynamic ability to provide the protections that are needed to do it?

So it's kind of two parts.  One is the timeframe for implementation of the Food Safety Modernization Act and then two, how dynamic is the process to meet the food protections that's needed at that considering new risks and challenges that were presented early on?  I'll just basically go through the panel.

CLETE WILLEMS:  Thank you very much for your question.  You know it's hard to say precisely what the best way to do something is.  The WTO agreements are intended to give members some deference in how they achieve their appropriate level of protection and it's intended to be, I think, quite dynamic and without getting bogged down in the details.

I mean there are various provisions that envision members responding quickly to new risks as they emerge.  And I think that there is flexibility, great flexibility provided as to how a member implements its measures as long as it follows some of the broad principles that I outlined.

So I think, you know, the question -- your answer is I mean I think there is certainly a way for the United States to be able to fulfill its WTO obligations while also fulfilling its statutory ones.

It's always a challenge and I think as long as we're cognizant of those broad principles of nondiscrimination, of transparency and of all of those things, we can definitely get there.  But again, obviously it's a challenge and that's something that we look forward to helping you with as you try to put your program in place.

MARY STANLEY:  When FSIS embarked on the equivalence process the timing was quite challenging because it was about the same time we were implementing HACCP.  And so when we went into an equivalence mechanism, the foreign countries or the foreign systems that were listed in the federal register at the time were carried over but we still had to do a robust equivalence determination of the design and delivery of the HACCP systems and it's an incredible, it was an incredible resource drain.

And so as you're faced on the tight timeframes, which are outlined for the Food Safety Modernization Act, it's going to be very challenging in regards to deliver in those timeframes, particularly if you embark in a very structured and well documented process that is expected under these obligations because listening to the panel earlier, the advantage is that the flexibility that you're given.  We are far more -- we apply the application of risk so much more now that that really is the tool that is going to help you deliver where you put your resources and where you deliver the program.

MICHAEL WEHR:  Okay, thanks.  I guess maybe I'm jumping ahead a little bit on this question but I'm going to -- Mike Wehr, FDA.  I'm sorry.  Maybe jumping ahead a little bit on this question but I'm going to ask it now anyway and perhaps come back later in the day too.

But as I look through the discussion here on equivalence and it strikes me that there is a lot of similarity with comparability and we haven't covered the ICAT yet but we'll do that this afternoon, but the components of the ICAT which were actually mentioned here a little bit earlier I think.  But in your mind, what do you think is a real distinction between equivalence and comparability and when would FDA use one versus another?

MARY STANLEY:  Okay.  There really isn't a significance of distinction between equivalence and comparability if you're approaching equivalence from a systems approach, in my mind, because if you look at what's been outlined in your ICAT and you look at what's been outlined in the FSIS self-assessment tool, the distinctions are not significant in regard to the assessment of the foreign inspection, or the foreign government's ability to deliver their food regulatory system and there's a lot of similarities there.

Where the process that FSIS has applied is perhaps a little more stringent and takes it down to the sanitary measures, individual sanitary measures level, but you have to think of where we were when we started the process and you're handed the SPS agreement and the Codex was evolving, the documents were evolving through Codex and we had to develop our process.

So as you approach, the emphasis here is the systems recognition and the focus on what the government can do in that foreign country, what the industry, the process controls that the industry has in effect with each commodity.  You know, with FSIS it's mandated HACCP so that's one approach, but there's really not, in my mind, a significant distinction.

MURRAY LUMPKIN:  Kind of following on that, you know in looking at the traditional approach that you all have been talking about today on equivalence and how it's done, one might argue that the inciting event for such a determination to occur is because a given nation wishes to trade with another nation.  And it says, and we have a very good system and you need to give us the opportunity to prove to you that we have a very good system.  So there is this fundamental kind of trade impetus that starts the process.

Whereas I think on the comparability, we've been thinking about it in terms of a, it's really from a public health perspective that we are reaching out to another country and saying we want to use your knowledge to help us make our regulatory decisions.  How can we get the trustworthiness?  How can we get the assurance that your knowledge we can use to make the decisions we need to make here?

My question to you primarily is on the equivalence, and particularly at the FSIS model, since it appeared from what you said that trade does not occur unless you do this under your law and the way you've implemented it, is this considered kind of the cost of doing business and do you actually have a budgetary line or money that allows you to accomplish this?

And so it kind of goes to this issue of resources.  If this is the cost of doing business, should it be run under a fee service or should it have appropriated dollars that allow it to occur?  And I didn't know if that happened in the FSIS system or not.

MARY STANLEY:  The line is getting tighter and the process that we've applied, it is through appropriated funds.  We can't and don't charge for the equivalence determination or the actions and the time that is spent in these evaluations but you also have to look at the impact that it does have on trade.

And some of this is carried over from very old legislation so those are the cards that we've been dealt.  But you look at the queue of countries that are seeking eligibility in order to make this trade happen and it's almost as long as the list of eligible countries.

That's what's driven some of the change that FSIS has embarked on in regard to refining the tools and the way that we collect the information so that we facilitate how we evaluate and try to simplify and leverage the means of communication that you have access to now so that we can shorten the timeframe.  But it is, you know, the better a country prepares the information and presents it to us, the faster the team can ramp up and make the determinations.

And particularly the outreach that we're able to do, whenever we get the opportunity to make presentations in whatever international forum to demystify the regulations that FSIS operates and what our expectations are, that's critical.  But I would say an average timeframe, I avoided it in my presentation, but for an equivalence determination, start to finish, you know you're looking at, for FSIS, between two and a half to three to four years.

MERTON SMITH:  I'd like to follow-up on that, Mary.  I really appreciate the description you gave of the equivalence process at FSIS.  I understand that this has been going on for a number of years.  I guess in 1995 you, before that you were doing same as assessments and then after that equivalence.

Can you give us a sense of just generally, without naming the countries, how many countries have applied to be equivalent, or desire to be equivalent?  How many have, I imagine I should know this, how many have been given equivalence?

And this involves a number of establishments in each country sometimes, or just one establishment?  Could you just give us a better sense of some of the details of how, you mentioned how long it had taken you.

MARY STANLEY:  Yeah, I could ask Sally White to put up her fingers in regards the number of determinations.  I don't have that number specifically in my head but there's been maybe five or six initial equivalence determinations that have been conducted over the most recent years.

Again, we look at the system as a whole.  And so I know of one country that has one establishment that is certified as eligible and then you look at other trading partners that have in excess of 500 establishments that they have certified to us.  Yeah, currently the queue is about 34 countries that we're looking at for initial equivalence right now and they're at varying stages.

And again, this information, we're very transparent in the status of the equivalence; the list of countries that are pending equivalence determinations is posted on our website and the status as to which court the ball is in is communicated there as well.

And we also, we do close out the determination, or the request for determinations if there's no activity for a certain period of time.  We just don't keep holding the file open because some countries, for whatever reason, things change.

They may have had a government change or there's no longer the request because generally when a country is requesting it's because trade is being pursued.  So hopefully that gives you sufficient --

ROBERTA WAGNER:  Okay, and these are for Mary, a few follow-up questions.  Are the majority of the requests from developed versus developing countries or do you see somewhat of an equal mix?

MARY STANLEY:  We're seeing more interest from developing countries now in that we've -- that's where some of the assistance in regards to demystifying the complexity of the U.S. regulations and laws is essential.

We've actually gone, you know taken teams into countries, developing countries, and provided assistance in regard to sitting with them side-by-side and helping them to complete the self-assessment.  Or if they've sent a delegation into Washington, well we'll work with them in that regard.  But there is certainly more interest, a growing interest, in the developing countries to access the market.

Some countries are very transparent in that they don't expect trade but it helps them in other markets.  And so, you know, but once they receive that package, it can be a little overwhelming.  It used to be a box about like that and now it's a big email file so.

ROBERTA WAGNER:  Just a quick follow, how do you prioritize which equivalence request you're going to go for with versus a first in, first out or how do you make that determination?

MARY STANLEY:  It's generally, you know when the application, or excuse me, when the request is received, that initiates the exchange and then it's driven by how quickly they get the information into us.  Because luckily they don't all come at the same time and they're sort of just staged.

ROBERTA WAGNER:  Okay, and last question I promise.  How often do you -- do you always end up doing an onsite or are there certain instances where you may stop after they submit the package of information?  And what, you know under what circumstances wouldn't you move to that next step of performing the onsite if you were to stop in the middle of the process?

MARY STANLEY:  For an initial equivalence determination we've always done an onsite assessment and I'm not aware of any movement away from that.  Delivery of the program is just as critical as having the written document.

STEVE SOLOMON:  Steve Solomon.  Question I guess for you, Mary, to start and then one maybe for anyone.  You said, you described the process of developing equivalence and then you do individual establishments in that country.  How does that determination become that each establishment gets covered by it?

Do they have to be in good standing?  Do they require individual audits or inspections of them even though you've already looked at some in-plant establishments?  Is there a process for removing individual establishments if necessary?

And then the broader question, has there ever been a process -- is there a process for rescinding equivalence?  So we've described the process for developing equivalence, is there a way of rescinding that process?

MARY STANLEY:  Yeah, and thank you for asking for clarification on the role of what we do and the roles and responsibilities in the establishments.  When we do an onsite verification or an audit, it is of the regulatory food, the competent authority and the way that they deliver their food safety system.

And so when we, we do take a sample of establishments.  On an initial equivalence, the government will indicate the companies that may be interested.  It's not the certification of eligible establishments, but they indicate the companies that may be interested.  And so we would take a sample of those, looking at representative of different products or processes, production of products, so that we get a snapshot of the delivery of their food regulatory system controls.

But when we're in those establishments and, you know I'll be honest, and I know that other countries that do audits are dealing with this same -- you know, making that transition from an inspection to an audit, a systems audit, has been a challenge for FSIS as in other for other governments.

But when we're in that establishment, we're not looking at the establishment controls; we're looking at the government controls in that establishment.  And so we're really observing the activities of that foreign government and ensuring that what they said they'd do and how the manage their system in that establishment is what we're evaluating.

And so, you know, the number of establishments we go into, we have a calculation that will generate how many we should go into, but if it's just a handful of companies that are being offered, we may visit all of them.

In regard to rescinding equivalence, you know, going through the administrative process is part of the length of time that it takes for the equivalence determination.  So once a country's listed as eligible in the regulations, I may be wrong but I'm not aware of any that we've actually taken out of the regulations.

But that doesn't mean that if that country is no longer delivering the system that they committed to then they would be suspended and then we would take actions to ensure that before they had any -- and the control that we have is the fact that there would be no eligible establishments certified.  That's an annual certification on an ongoing basis that the government provides these establishment lists.

And so if we go in and have an audit and it's showing deficiencies, that there is concern that the delivery of the system then there's an exchange of corrective actions, verification of those corrective actions that have to be made in regards to ensuring that the government regains the controls before the establishments would be relisted.  So there is that control factor there.

So it really is suspension as opposed to rescinding the equivalence determination.  We've never gotten to that point I guess.  I did pull one example out of our files in regards to an individual sanitary measure where we rescinded the equivalence determination on an individual sanitary measure.

But interestingly enough, upon review and appeal, it was reissued and so on an individual sanitary measure, it has been done but in this case it was reissued.

CLETE WILLEMS:  I would just note in the context of the SPS agreement, and there's no language that specifically relates to rescinding equivalence or anything like that.  But, you know, it's important to note that one of the fundamental principles of the agreement that I talked about before was the notion that members can take measures to achieve their appropriate level of protection.

And if they had reason to believe, they had evidence to suggest that there was a risk posed by a particular country, or a particular country's system, that at one point in time they felt was okay and now there was evidence to suggest that it wasn't, I mean there's no reason that a member would have to subjugate its interest in protecting its consumers.

So again, no specific provision that deals with this but just looking at the broad principles of the agreement and the notion that a member can always take measures to protect human life and health, I mean there's no reason that just because at one point in time a member was seen to have systems that provided the same level of safety that that would always be the case.

KAREN STUCK:  And just to note the Codex guidance on that, in the guidance on agreements it talks about after enhancing public confidence by making public what you're doing.  And participants in the agreement should agree to procedures for terminating the agreement in case either party is not satisfied.  I think the point is, it's a good idea to agree in advance about what it is might lead to termination of the agreement.

MICHAEL WEHR:  Mike Wehr.  Two questions I guess, one a broad one on scope and the other one more directed to Mary and FSIS on capacity building.  But on the scope issue, going back to the Clete's presentation on the SPS, the scope of measures under SPS is very broad, encompassing in terms of the whole system from authorities and regulation all the way down to precise measures.

When you look at really an equivalence determination or really a comparability determination, are there some measures that ought to be excluded from that let's say labeling requirements or pesticide residue MRLs or food additive permitted usages.

To get a viewer to show equivalence you need to really show, in terms of with equivalence, the same level of public health protection so a risk assessment probably involved or something like that.  But are there measures that normally you would think would be excluded from a routine determination I guess is the question?

And then the capacity building question to Mary is, apart from sitting down with countries and helping them do the paperwork and work through the process, are there capacity building activities that FSIS has had with countries to help them come up to speed if you will, their systems, whether regulatory or the production piece?

CLETE WILLEMS:  Just to make sure I understand your first question.  You said are there measures that are excluded from a routine determination?  Do you mean of equivalence from the agreement or --

MICHAEL WEHR:  No, not from the SPS agreement because what's in SPS is there but when you go in and do an equivalence determination, if you're looking at a system and not just a specific major, a request might be major, but if you're looking at a system, you're looking at everything.

And a chunk of that is going to be things like pesticide residue MRLs, or food additive permitted residue, permitted levels, contaminant maximum levels that drug MRLs, all of those have -- in studying them you've gone through a formal risk assessment.  You have a clear level of protection that's associated with those.

When you do an equivalence determination, presumably if you're going to accept another country's MRLs, they would have the same level of public health protection.  And so, at least in my book, if you look at those, that's an inordinate task.

So do you say okay, you're not going to consider those?  You have an agreement amongst the parties that those are going to be out of the determination and you're going to focus on good manufacturing practices or those kinds of things?  Or are they always all in?  How do you, you know -- just a question.

CLETE WILLEMS:  I think it's difficult to say for certain under the SPS agreement what would be in and what would be out.  You know, some measures are undoubtedly SPS measures.  Others, you know, some people say they are, some people they aren't and we often, unfortunately, some countries have litigated over that issue.

And so I don't want to opine over what would be and wouldn't be covered, I would just repeat what I've said before is that with regard to equivalence specifically, there's quite a bit of flexibility as to what a member can look at and which aspects of a member's system are relevant to that determination.

But it's hard for me to say specifically what should or should not be included or excluded.  And in terms of our process of determining that, I mean I think that's maybe more of a Mary question.

MARY STANLEY:  Perhaps.  It's probably a larger question than myself because you know as I had indicated, what we are looking at through an equivalence determination are really what's outlined in our regulations and what acceptable level of protection we're applying domestically and ensuring that the foreign countries have an equivalent process.

I think, Mike, what your question is probing is to what level.  You know, and I'll take an example in regard to the delivery of an ante mortem and postmortem inspection in a slaughter facility.

To what level as a government makes some changes in their techniques, you know at the end of the process are they delivering the same safe carcass that we are delivering even though they use different techniques?

Should that be driven by individual sanitary measures every time you want to make a change in your country to seek that determination from FSIS?  I don't have the answer in regards to the yes or no but I think that's what you're probing there.  And I also believe that that's a question that Codex will probably be undertaking at some point.

In regard to your question on capacity building, you know we do go in-country and assist on an individual basis but we also take every opportunity to partner either in workshops or when there's a lot of efforts when FDA is conducting a workshop, you know we would be there to demystify FSIS as opposed to FDA regulatory authority.

We have traditionally had inspection seminars that we sponsor and bring together multiple countries to present the FSIS regulatory process in depth.  You know folks will spend two to three weeks, depending on which course they take, to understand the FSIS inspection process and it goes into great detail.

And we have benefited tremendously from those types of activities where you've got a broad audience, you've brought together a lot of international representatives and they're at varying levels of the government that have an excellent discussion and get a foundation of what's expected.

They take that home so if their government is applying for equivalence they have that knowledge.  So there are some activities in regard to that.  But at the end of the day, when you receive that tool to complete, it can be daunting and so we do try to simplify how to put the information.

MURRAY LUMPKIN:  I have a clarification question; primarily I think it's for you, Clete.  Mary, you might have some practical experience.  And it goes to the fundamental concept at WTO in equivalence and the bi-laterality of equivalence.

I mean is the idea that if country A finds country B equivalent, the reverse is implicitly true, that country B's system is equivalent to country A's so that there really is a bi-laterality?  And one country could say to another, we're not going to find you equivalent until you find us equivalent and is kind of held up that way.

Or is the idea really that you could -- it's not that you're equivalent, but it's that you are at least as good as so you might have country A has a better system than country B so clearly country A is at least as good as country B but country B might not be at least as good as country A.

And is that what WTO was looking at that it's this one-way then going both way or is it really that it's the bi-laterality and that you can hold it up that you won't find one country until the other one finds the -- country B finds country A also.

CLETE WILLEMS:  And that's an interesting question and I have to be careful about what I say here.  Let's just say that, that issue is one that if you look at some of the literature regarding what is the meaning of this provision, I mean it's something that is debated.  And there's a question of is it better than or equivalent to and that is a question that no WTO panel or not the appellate body, you know they have not addressed at this point.

And so I think it's -- you know it's my safest answer and probably the most accurate answer is that it's a little bit of an open question.  In terms of the bilateral or how do you do that, I think it's interesting.  One issue I didn't get to at all in my presentation was you know there's another article under Article 4 of equivalence, there's 4.1 which is what I put up on the screen and there's 4.2 which talks about members shall upon request enter into consultations with the aim of achieving bilateral and multilateral agreements on recognition of equivalence.

And so, you know, I think again there is some flexibility to do it in different ways.  I probably wouldn't advise many governments to say, you better help me out first before I recognize you but I mean at the same time, a lot of this stuff really is an open question in the eyes of WTO.

MURRAY LUMPKIN:  So I have another question, I'll pick on Mary still.  When you do your equivalence assessment is it restricted to what is happening in the slaughter plant? In other words, are you looking to see if the government has controls on the safety of the feed that is fed to animals before they go to the slaughter plant, the practice of veterinary medicine in the country at the farm?

Or is it just restricted to assessing the carcass when it comes into the slaughter plant to see if there are problems out on the farm?

MARY STANLEY:  Our authority starts when the animal arrives at the slaughter establishment and so we do not send our audit teams onto the farms traditionally.  There have been certain special case situations where we have done that and in partnership with FDA or in consultation with FDA.

But when we make an equivalence determination, part of the technical team may be an outreach to APHIS or at least advise APHIS in regard to the application so that we -- FSIS would not take into consideration the animal health restrictions other than to coordinate once it became eligible that we would underpin any restrictions that APHIS is operating under.

We also have reached out on numerous occasions to FDA for consultation on residue controls in the review that we do of the residue control programs in the foreign countries because many countries do operate their controls at the farm level as opposed to doing SIT testing further up the chain.

And on the finished product side, the movement from the establishment where the product may be certified by the foreign government to the point that it arrives in the U.S., there's the whole gap of supply chain control that we work in cooperation and collaboration of ensuring that those controls are in place so that there's no adulteration or contamination of the product in the transportation.  Though we don't have the direct authority, it's still part of the process.

So we do take that into consideration, ask the right questions, interview, collect information to round out the understanding of how that foreign government is maintaining those controls throughout the entire chain.

DON KRAEMER:  Don Kraemer, FDA.  This goes to all of the panelists and it's a follow-up to Mike Wehr's question before.  If you could divide the kinds of measures that would be available into conditions of manufacture that would be things like good manufacturing practices of HACCP type regulations, those are the things, the kinds of measures or controls that are necessary in production, versus conditions of the product itself and this would be the kinds of standards that Mike was talking about before, tend to be numerical standards like levels of a pesticide that are allowable or drugs that are approved in the product.

So if you could divide the standards those two ways, do you see any difference in how you would deal with those two different kinds of measures in an equivalence process given that at receipt into the country, into this country, there's no way for us to verify, independently at that point, the conditions of manufacture but we still have a concern about whether or not that product meets our numerical standards.  Thanks.

MARY STANLEY:  Well in my mind this is a tremendous opportunity.  I'll speak for Karen on the Codex, put a Codex hat on.  You know the recognition of the international standards would really facilitate this process, particularly in the areas of residue controls, the MRLs that you're speaking of.  Because if the U.S. has established the MRLs that are inconsistent or different than Codex then there does have to be that determination.

So you know, that's where international standards, if you're operating under the international standards in both countries, it's kind of like a check and move on in regard to the determination.  We don't live in that world though so, and that's where it does get quite challenging.

ROBERTA WAGNER:  Okay.  Roberta Wagner.  Mary again, sorry.  What is the point of determining equivalence and then periodically doing systems audits after you've determined equivalence and then doing 100 percent screening at the border?  And have you been challenged relative to appropriate level of protection relative to that strategy?

MARY STANLEY:  Challenge is probably a strong word but we are constantly being asked in regards to the approach that we're taking and some of it is statutory.  You know, it's a carry over to the laws and regulations and you have to think where the laws came from.  You know in 1906 we were thinking a little differently.

Does it mean that we should be making a change?  Well we have made changes over the years in regards to the approach that we've taken on the frequency and the scope of audits, the approach that we take for audits.  But we place a lot of value in having an onsite presence periodically.

And you know many, many years ago, I think they had pulled the foreign auditors out of the countries, I think in '87 or '88, but we used to station folks in the regions and they would do their more frequent, probably as frequently as quarterly, audits in country.  And we pulled those individuals out of the countries and set up an audit process based out of Washington.

And we've been evolving over time because as you get more access to information and accurate information and the speed in which the information comes, and that's including violations that are detected by the foreign inspection government or system as well as detections that we make at our port-of-entry, access to information, you don't have to travel to the country and look at the papers in today's world.

In regard to the 100 percent re-inspection activities, again I'll emphasize that that's not actually looking at actual product but it is a burden on industry and we do get pushback from them of having to make that additional stop on the entry into the United States.

They have to arrive at an import establishment and be staged and certification is verified because every shipment is covered by a certificate.  That's again regulated.

MICHAEL WEHR:  I think we'll try and squeeze.  Who has a question?  Dr. Lumpkin?

MURRAY LUMPKIN:  Just a quick question.  The equivalence determinations that we've been brought into as the competent authority in the United States for a given commodity seem generally to be products that are of animal origin.

Is anyone aware of an equivalence determination that's been done on products of plant origin and are there any, if so, are there really practical differences in assessing systems for products of plant origin versus products of animal origin?

MARY STANLEY:  I'm not aware of any.

MURRAY LUMPKIN:  So it's primarily been animal origin products right?  Yeah.

STEVE SOLOMON:  Thank you very much.  We appreciate your time.

MARY STANLEY:  Thanks.

CAMILLE BREWER:  Okay, thank you all and Dr. Solomon, thanks for keeping us on time.  We will reconvene at 1:30 sharp.  At 1:30 my mouth will open and we will start the next session.  So have a good lunch.  I would like for the panelists, all panelists, wherever you are in the program, the SMEs and the enquiry team to meet Dr. Moss right here.  Thank you.  Have a good lunch.

A F T E R N O O N   P O R T I O N

    CAMILLE BREWER:  Good afternoon.  It's 1:30.  Can you confirm that.  Yes.  We'd like to get started.  We're going to start this afternoon with a series of presentations by FDA officials, and we're going to walk you through our thought process, the development process for our comparability model.  We'll start first with Roberta Wagner, move to Don Wagner, and then Julie Callahan.  So Roberta?

ROBERTA WAGNER:  Good afternoon.  As the slides sates, I'm going to be doing, giving you some background information on comparability, and then we're going to move on to some other speakers.  Comparability background, I'm going to cover Why Now.  Why is FDA considering this now?

I'm going to talk to you a little bit about -- we had this concept of moving forward with comparability in 2009, quite frankly, so I'm going to talk to you a little bit about how we progressed from a concept to an international comparability assessment tool to actually piloting the use of that tool.

I'm going to talk to you about how FDA believes that comparability assessments align with the new food Safety Modernization Act.  I want to let folks know that the Food Safety Modernization Act, the acronym we use is FSMA, so I'll be saying FSMA quite often.  And then lastly, what are the benefits to both FDA and industry of moving down this comparability assessment road.

So Why Now, and a lot of folks have gone through this already earlier today, so I'm going to move fairly quickly through these slides.  So in the U.S., we have over 240,000 registered foreign food facilities.  Over 200 countries and territories export food to the U.S., and that's through about 300 land, sea, and airports.  About 20 percent of the food consumed in the U.S. is imported, and for certain commodity types, a much higher percent.  For example, 80 percent of the seafood consumed in the U.S. is from foreign countries, and about 35 percent of the produce.

Import entry lines, they continue to go up and up and up.  In 2009, we received 18 million import entry lines of FDA-regulated products, the majority of which are food.  Globalization, I think most everybody in this room is aware of the challenges of globalization.  It has fundamentally changed the environment for regulating food, and again the challenges are there is more food facilities supplying -- and I'm speaking on behalf of the U.S., so supplying the U.S.; increasing volume of imported food products, more outsourcing of both production and manufacturing, greater complexity in the food supply chains, and imports of food products, quite frankly, are coming from countries with less well-developed regulatory systems or food safety oversight systems.

Borders.  Borders continue to be our jurisdictional boundaries, our legal boundaries, but they're not barriers to disease, information flow, product acquisition, the challenges of globalization, nor are they barriers to the realm of FDA's activities.  We now do have foreign posts.  We have inspectors at those foreign posts.  Borders, as other folks have said already today, cannot be our first line of defense against substandard products.  We can't inspect out bad products at the border.  They need to be places where we audit that quality or safety has been built in at the point of production or manufacture.

Responsibility and accountability, and quite frankly, if you read FSMA, this is all over FSMA.  All entities involved in the production and distribution of imported foods -- and I should say domestic foods as well -- must take responsibility for assuring safe foods.  This includes foreign and domestic governments, growers, manufacturers, processors, holders and distributors and transporters, importers and consignees. 

So why now?  Why comparability assessments now?  The huge volume of imported foods into the U.S., and we absolutely cannot provide food safety assurances at the border.  So due to this ever-increasing volume of imported food, FDA must leverage their resources with that of their international partners who possess comparable food safety systems.  And when I talk about a comparable food safety system, we're talking about food safety systems that provide the same standard of care, level of protection.  I've also heard folks use the same public health protection as that of the U.S. food safety system.

So a little bit about how we've progressed relative to the concept of comparability assessment.  In 2009, we issued FDA's five-year import food safety strategic plan.  This was an FDA centric initiative.  It was a group of -- a very small group, quite frankly, of experts from FDA that put this plan together. This plan outlined an overall import food safety framework.  One component of that framework was comparability assessments. 

Creation of the Office of Foods occurred in August of 2009.  Dr. Hamburg, FDA's Commissioner, formed that new office, and you heard from Mike Taylor this morning.  He's the leader of the Office of Foods.  Mike, as soon as he came in, became the leader of Office of Foods, established an executive leadership team that was comprised of senior leaders from CFSAN, or Center for Food Safety, Center for Vet Medicine, as well as ORA, so all those components in FDA that have a part in regulating the food safety system. 

It was this executive leadership team from the Office of Foods that launched the One Mission, One Program initiative that was launched in December 2009.  And I'll talk a little bit more about that as we go through this presentation.

Now, I mentioned the One Mission, One Program initiative because the work for the foundation for the import core group, which was formed under that particular initiative, was based on the FDA's five-year important food safety strategic plan.  That was used as a foundation for the import core group established under the One Mission, One Program initiative.  Now we have FSMA, and we're doing FSMA implementation, and again, just so you can kind of see the flow here -- One Mission, One Program initiative, we had an import core group.  They put forward design recommendations.  In some cases those design recommendations were approved and we're moving forward an implementation stage.  That is the case with comparability assessments.  This work, the One Mission, One Program work, was closed out in January of 2011.  There was a final report issued.  The activities under that initiative have been folded into FSMA implementation -- the appropriate ones, of course. 

So I just wanted to read an excerpt from the five-year import food safety strategic plan, and this was just one component again of an import food safety framework.  It stated in that report, identify comparable countries, countries with food safety systems that provide comparable public health outcomes to that of the U.S.  We would rely on assurances that these comparable countries could provide of safe food through their established inspection and laboratory programs.  And basically, we would use those assurances from comparable countries to impact the speed of FDA admissibility decisions and to limit the need for FDA intervention and verification activities, specifically at the border.  So in other words, what we were thinking at that time is if a country was deemed comparable, no need necessarily to be performing foreign inspections in that country, no need to be doing a lot of sampling at the border, field exams at the border.

Again, One Mission, One Program, we took the work from that or the work and the framework from the five-year strategic plan, folded it into this One Mission, One Program initiative, and again, comparability assessments were outlined in that initial strategic plan.  So they continued through this process.  The One Mission, One Program initiative, there were ten core groups established.  The folks that were part of those core groups, hundreds of people from across the FDA organization with expertise in foods.  One of the ten core groups -- and they formed the core groups based on cross-cutting topic areas. 

For example, there was a preventive controls core group; there was a research and science core group.  There's a bunch of core groups.  One of them was the import core group, and each of these core groups was given a charge, and the charge for the import core group was as follows:  Design an import food safety program applicable to both human and animal food centered on public health outcomes, taking into consideration anticipated newly authorities -- because you have to remember, at the time of this initiative, we didn't have any additional new authorities, so we were somewhat guessing as to what they may be.  And that includes -- and basically in this design plan, we had to put forward strategies and goals for implementation.  So as I said, the One Mission, One Program final report issued in January of this year, and that entire effort was transitioned into FSMA implementation at that time. 

The import core group, we listed and provided many basic tenets, and I'm going to go over a few of those.  And these are basic tenets for the future import food safety program in the U.S. relative to FDA.  So we said that the foods consumed in the U.S. originating from foreign sources will be held to comparable safety standards relative to public health outcomes as those required for domestically produced foods.  And of course, they would have to be consistent with U.S. international obligations. 

We basically said, there will have to be a paradigm shift from a focus on food safety interventions after the arrival of foods and feeds into the U.S.  So at the border, to holding those that produce, process and import foods responsible and accountable for ensuring the safety of their products.  We recognize that there absolutely has to be an oversight system.  That oversight system needs to be risk informed, comparable to that provided by the U.S. integrated federal state system for domestically produced foods, rely in part on partnerships and agreements, and provide for appropriate resource allocation.  I mean, for FDA -- we have to allocate our resources between border interventions, so field exams, sample collections.  Now, importer, accountability verification activities.  The importers are going to be providing us assurances that the food they import into this country are safe.  We are somehow going to have to verify that that information is truthful and accurate.  And then we will still be doing some overseas preventive activities, and that would be things like comparability assessments, but also foreign inspections.

Key premise of our import strategy -- and this is very repetitive, but I'll say it again -- foreign governments, growers, manufacturers, holders, distributors, and transporters of foods, as well as U.S. importers, will be expected to take responsibility for assuring that safe foods are exported into the U.S. and that these foods will not make people ill or cause adverse reactions.

So one of the -- what these core groups had to do, they had to put forward key recommendations to the senior leadership in FDA, and the senior leadership made decisions as to which recommendations we would move forward into an implementation phase.  So one of the key recommendations of the import core group was that we absolutely have to have an integrated import food safety program, and that there has to be multiple components, and the work being done in one component needs to drive how we do work in the other components. 

And I think what you have to recognize in FDA, the import and international work is done across many different pieces of the organization.  So we recognize that we have to get all of these pieces together so that we actually have an integrative program.  So we basically said, these are the things FDA's going to do in the future.  Comparability assessments, we're going to accredit recognized third party certification programs.  We're going to do importer accountability verification.  And for all of those activities, if we invest in those, we'll be able to obtain assurances of food safety from public and private entities.  That's what we want to be able to do.  In this respect, once we do deem some countries comparable, for example, we become then systems auditors and we will be auditing auditors -- a different role than we played in the past. 

Other parts of an integrated import food safety program.  We'll still do foreign inspections.  We will have our border operations.  We have to make admissibility decisions.  We'll do field exams.  We'll do sample collections.  They will be risk-based.  We'll do enforcement when necessary.  We will also continue participating in other leveraging activities, establishing partnerships, MOUs with international partners, participation in international standard-setting organizations, Codex, et cetera, capacity building.  So this is the integrated import food safety program in the future that was laid out by the import core group. 

This is for illustrative purposes only.  The foundation -- I'm surprised I didn't hear Caroline say this, either, because she traditionally says, there is risk-based language throughout the FSMA legislation.  It says you have to do this based on risk, that based on risk.  We have to apply our resources and allocate our resources based on risk.  So what we'll do is if that integrated import food safety program I just laid out for you, if we have comparable countries, if we have identified countries that have robust country commodity export programs, perhaps their overall food safety system might not be comparable, but they're exporting a ton of seafood; they have a good export program.

Those types of situations, when we learn of them, we're going to limit the resources that FDA is going to expend doing our traditional activities -- field exams, sample collections, et cetera.  We would do systems audits in those cases, so not the facility by facility inspection.  We'd go into the country, if it's a comparable country, and look at the systems and make sure periodically, we'll go back in, very similar to what FSIS was saying, and make sure that they're still implementing their systems. 

Recognize third party certification programs, robust importer accountability programs -- pretty much the same thing.  Where we would expend FDA sampling, field exam, and where we would target our foreign inspections would be in those countries that we know little about that don't have a food safety system where regulatory oversight and that export high risk foods.  And when we say high risk, they could be inherently risky, so in other words, they support the growth of pathogens, or they can be a risk because of the process that is used to manufacture them.

So the import core group also laid, put out some other language around comparability.  I'm going to go over this very quickly.  FDA will rely in part on obtaining assurances of food safety from foreign governments with highly comparable food safety systems to that of the U.S. relative to public health outcomes, and/or recognize third party certification bodies, including competent government regulatory organizations or private entities.  Countries will be assessed for comparability with U.S. food safety standards against an adaptation of the manufactured regulatory foods program standards.  These are the standards that we are currently using to provide oversight of state programs.  So this is where we're trying to do the same thing in the domestic arena, use the same standards as we want to apply in the foreign arena.  You're going to hear a little bit more about these standards; basically, the international comparability assessment tool.  These are the standards, some of the standards you're going to see there.  They align with those standards in the manufactured foods regulatory program standards. 

So incentives.  Where foreign countries food safety system is found to provide comparable public health outcomes -- and this should be a may and not a will.  This document was not, this is going to happen.  FDA may increase “may proceed” rates for product, subject to the oversight of that authority.  We would expect limited U.S. border testing and examination.  We would be doing periodic system audits to service ongoing verification of the country's own oversight programs. 

Where comparability findings cannot be made, certain products may need to be certified as having been produced under the conditions of manufacture that are required by the U.S. law to ensure product safety.  So we could potentially employ the mandatory certification provisions of FSMA.  We also may want to do capacity building in such places. 

Import core group, many subgroups were formed.  Again, this was part of the One Mission, One Program imitative.  Comparability was one of the sub work groups.  It continues to meet, even though the One Mission, One Program has basically ended.  And it continues to meet basically under the FSMA implementation scheme.  What they've done to date, they've created an international comparability assessment tool -- you're going to hear about that in a few moments -- a process flow chart for how we would conduct these comparability assessments.  They've done field trials or pilots of the ICAT tool or the international comparability assessment tool.  And they are responsible for this public hearing, actually, as opposed to meeting.  We want to promote transparency, we want stakeholder input, and we actually need stakeholder input at this point.

So benefits.  Shift resources for FDA; shift resources from low risk to high risk country commodity combinations; determine if we can count inspections conducted by comparable countries towards FDA's foreign inspection frequency mandate -- just throwing that out there, as for rapid follow-up by partner country, if we or they identify a problem.  So those are just some of the benefits to FDA.

To industry, expedited entry, perhaps.  And when you think about importer accountability requirements, the Voluntary Qualified Importer Program, the fact that a country is deemed comparable, that might make it a little bit easier to provide assurances that you're importing safe food.  Okay, and I'm going to end there, and the first one should be Section 301, but there are several provisions in FSMA that align with the concept of comparability assessments -- Section 301, 303, 305, and 307.  You guys can take a quick read while we switch speakers at the podium. 

DONALD KRAEMER:  Okay, thanks.  I'm going to pick up where Roberta left off, and re-emphasize I guess, some of the points that she made as well as burrow in a little bit into some of the points that she raised as well.

I'd like to first start, sort of step back a little bit, and talk about what is comparability.  And this is how we see it, our current thinking here at FDA.  It's a process for determining that a food safety system provides a similar though not identical set of protections as the U.S. food safety system.  Again -- and you've heard this before, but I'll emphasize it -- we are looking at the food safety system in the country under review, and I think that's very important.  I'd like to make a few points there.  It does include a look at the standards that are in place, and particularly the standards related to the conditions of manufacture, which we can't look at at the time that the product lands at our shores.  So we're particularly dependent upon the foreign government for assuring those kinds of standards, so we're very interested in how those are dealt with in the country of export, and sort of related to the question that I asked earlier today.

But by no means are we inclined to look measure by measure, which is much more of an equivalence kind of process.  It is not our intent to look at each of the elements of the country's legislation and regulations, but more as an overview of what's there.  Looking also at the ability, and I think very importantly, of the ability of the country to enforce their own standards.  And importantly, and I think this is going to be something that we'll be asking some questions of the panel later on at the end, or I will, is also the science-base if you will, in that country to establish standards.  So what's important for a long-term comparability relationship with another country is not just what the snapshot of conditions are at the time that the review is done, but you want -- if you're going to invest that resource upfront, you want to be able to have confidence that that country has a robust scientifically supported, and I would call agile learning system, that would allow them to continue into the future and when new problems occur, they're able to deal with those and come to reasonable decisions, appropriate decisions.

I'd like to talk a little bit about some of the principles, and these will -- you'll see these in some of the comments that Roberta made -- it is truly a component of a larger import strategy.  And Roberta talked a lot about that strategy.  We don't see comparability as something that would work for all countries exporting, by any means.  In fact, we think that there will be significant challenges to everybody being able, every country being able to meet this standard.  But we don't want that and cannot have that be a barrier to importing into the United States, so again, as I said, we see it as a component of a larger system.  The legislation, FSMA, does not envision an arrangement such as the USDA system that we heard about, that requires this kind of a finding for importation.  That's not what our vision is here.

So there have to be other ways for products to come in, and indeed they can without any kind of arrangement.  But there will be circumstances again, as Roberta mentioned, where we will find the need to require certification, some kind of confidence before the product can come into the country.  That can be achieved in a couple of ways.  One can be certification received by the exporting country.  And again, as Roberta mentioned, there are countries that have robust export certification programs, even if their domestic production systems are not comparable to that in the United States, and therefore wouldn’t support very well a comparability finding.

And so there is, in that group of countries there certainly would be the possibility of export certification by the competent authority.  And there are countries where that is not even possible, where there is not a robust export certification program and there isn't the ability to find a comparability finding, and that's probably where the most important role from our standpoint is for third party certifications if certification is in fact needed.

Again, Roberta mentioned efficient use of resources.  This is all about, in my terminology, reducing the size of the haystack.  We need to be able to apply our import controls at the border in the most efficient way, and if you can think about the haystack as those 18 million entries that are coming in, we need to get to those few needles in that haystack that we're trying to find, and the best way to do it is to lop off as much of that haystack as we can.  We think comparability is going to be a very important tool for getting us there. 

Consistent with international obligations, there's been discussion about that already.  Compatible with U.S. domestic activities -- and this is in part related to the need for consistency with international obligations -- we expect that we need to be holding others accountable to a system similar to what we hold ourselves accountable, and Roberta mentioned the integrated federal state system that we intend to do that with.  It needs to be transparent to stakeholders.  We need to be able to replicate this process country after country, so it can't be arbitrary and capricious if you will.  The standards need to be rigorous.  This is a system that we would envision putting a lot of confidence in, and expect that it would be affecting our decisions at the border in a great way.  So we cannot do that lightly.  We need to have this be a rigorous system. 

The standards -- as I mentioned a minute ago, the complexity of a comparability finding where the domestic standards are different from export standards, is I think a giant challenge, and I think this is going to be an interesting discussion point, because what we're saying here is that no matter what product leaves that country, we would have confidence that it was made in a system that would deliver comparable public health outcomes.  And a system that is relying heavily on export certification for that, that's quite a challenge.  And I think -- I know I personally would be very interested in thoughts on that as we go through the speakers and the questions.  And then this is a first step, so we know we're going to need to modify where we are today.

You'll hear more about this, but our original thinking on comparability came from a process that we use for evaluating our state counterparts, and that is because we had to approach that with what are the fundamental elements of a food regulatory system; what does it take to run this system properly.  And the list here in front of you is essentially what we have come up with.  It's been modified somewhat to work better in an international setting, but it's very, very similar to what we in fact use for auditing our own state programs, and therefore we see it as an appropriate tool for the international arena as well.  I'm not going to go into any detail, because Julie will, I think, in the next talk.

Roberta also mentioned this, so I'll go through it briefly.  There are two major reasons why we would use comparability, what effects it will have on us.  One is admissibility, and there are several ways it can affect admissibility.  This is admissibility of a product coming into the United States.  And one way is the good importer controls in which a competent, or a third party certification, which is a very compatible or similar arrangement to a comparability finding, could be used as a basis for the good importer getting into, if you will, the green lane.  That's a bit of an overstatement, the green lane concept, but I think people get their heads around that quickly.  So it's very likely that an import coming into the U.S. from a country with which we have a comparability agreement in place, would be able to move quickly through that system.  The other possibility is where we would require export certification because of the conditions laid out in FSMA, where we have concerns about that product from that country.  Clearly, highly unlikely that we would demand export certification from a country with which we have a comparability finding.  So it affects admissibility in both of those circumstances, on the good end and on the not-so-good end. 

And then the other is on equivalence finding.  When we are asked, or in essence when it is demanded of us that we do a comparability, an equivalence finding, we can find -- and there'll be more discussion about this in subsequent speakers -- that a comparability finding may in fact be able to take its place and be a much lighter system. 

And then I'll jump here -- I think this is my last slide -- on why we did get into this.  I mentioned already the need to reduce the haystack.  That is the primary reason, but there are some other international pressures that are complimentary to that pressure, if you will.  One is that the quads countries, Australia and New Zealand, Canada and the U.S., there has been significant activity of late on the issue of comparability or systems equivalence, if you will, so that has moved the dialog along in the U.S. as it has in those other countries.  Also, EU equivalence determination request with shellfish, so there was a demand if you will, on shellfish, and as a result we've moved in that direction.  And then you'll hear from New Zealand on their request to update the MOU on shellfish, seafood and Non-Grade A. 

Very quickly on that, before Bill Jolly gets his chance to characterize it in his way, I will say that we do have existing MOUs on existing seafood/shellfish and Non-Grade A.  They were getting ready to expire.  New Zealand requested to combine shellfish and seafood MOUs into one agreement, and I think it's fair to say that New Zealand was uncomfortable with the concept of a continued compliance-based shellfish MOU, which was in essence what we had had for many years with New Zealand, and so those collected things are what drove us to a comparability analysis to cover those three kinds of commodities. 

With the European Union situation, we have a veterinary equivalence agreement for some years now that has committed the U.S. and the EU to an equivalence determination on shellfish.  Little progress had frankly had been made, although a lot of effort had been had gone into it in the intervening years, and as a result the EU subsequently suspended imports of U.S. shellfish in the absence of that progress.  So we're now in the process of working through sort of a hybrid comparability equivalence finding in that area.  And I believe with that, Julie is up.

JULIE CALLAHAN:  Okay, thank you.  I think after listening to several talks already today, one decision we'll also have to make is whether we're going to say comparability -- or comparability.  I fall in the comparability team, but I'm from Boston, so I talk funny, so we'll take it from there.  I'd like to discuss sort of the comparability process in action, how we go about a review and what we've learned so far in the pilot that we did with New Zealand.  And just as an initial caveat, being a pilot, we were sort of sorting through the process as we went along, so nothing I say today will be set in stone.

So prior to any kind of comparability analysis being undertaken, there has to be some sort of pre-review.  So what we're intending is that comparability, as we've heard through several talks already, it's not a requirement for U.S. market access in any way, and it's very likely that many countries will choose not to pursue a comparability determination, because I'm sure we'll hear from Bill Jolly shortly, the process is very resource-intensive, not just for the U.S. but for the country that's being assessed.

So our thought is, from moving on from here, prior to initiating any comparability determination or comparability review, we would meet with the country that comes forward and requests a review, and go through the process with them, explain in detail what's required, what the process entails, what elements need to be met, and also discuss other tools and other options that they may decide to pursue instead. 

And also, a question came up earlier as to whether the U.S. would be deciding on countries that we’d like to review, but at this time, the feeling is, we are not going to solicit countries to participate.  I have the feeling a lot of countries will come forward on their own, so we'll kind of take it from there.  As a country approaches us and says they'd like to do a review, we'll have an initial bilat to see if that's the right way to go.  So the process that we used in our pilot, it was sort of a four-step process, if you will.  The first one was giving New Zealand the ICAT, the international comparability assessment tool. 

And I'll get into the tool itself further along in the talk, but the first step really is the country fills out this self-assessment.  Second, the submission comes into FDA, and we conduct quite a thorough paper review of that submission.  And I would say step two, it's really an iterative process, because the country may or may not understand fully what we're looking for in each element, so there's a lot of back and forth during the paper review to make sure we have a full picture of the country.  After that, there's a meeting between FDA and the country to review what we've found in our paper review and really to decide at that point whether we're going to move forward in the process or not.  And then finally, the fourth step is the on-site verification, and that - once you're at this fourth step, you really have a clear sense of the country's system, you know what it looks like on paper, but that verification is just to see what the system looks like in the implementation.  So it's kind of like, you could have a manual for an iPhone and it tells you everything it does, and another manual for another Smartphone, and they look the same, but it's not until you use the phones that you know whether they're really the same or not.  So this verification in-country is really to see what does the country's system do when it's in action.

So stepping back prior to the pilot, of course, we had to develop the ICAT itself, and as you've heard alluded to twice already that it's based on the state Manufactured Foods Regulatory Program Standards.  We did modify it a bit and added a ninth standard, which is International Communication/ Harmonization, but other than that one standard, basically all of the elements in the domestic standard are included in this international standard.  With just some modifications for language and ease-of-use, user friendliness, and under each of these ten standards, the specific elements that the country will need to meet in order to satisfy that standard.

The formatting, there's really two descriptions of each standard.  One is in a narrative form, and that should be in your packets that you received today.  And the narratives go through just the general description of: this is the purpose of the standard; these are the elements that you'll need to meet; and this is really what we're getting at as we go through the elements; this is what we're looking for, for each of the standards.  And then there's the actual worksheet itself, which is a matrix that the country fills in.  And here's an example of the ICAT worksheet.  Each of the ten standards is formatted the same way.

So there are five columns.  The first lists the comparability element.  The second column is the U.S. reference, so that the country can take a look at, okay, here's the element, this is what the U.S. has; do we have something similar to this that satisfies the same element.  The third column is for the country to name what they have to satisfy the element; after that, a space for them to put a reference, like a web link or even a citation that says, see attached, and they can attach a document that describes that element fully.  And then the last column is really the key.  It's a space for the country to be able to tell us how they think their element, even if it is different, might satisfy the comparability challenge, if you will.  So it's their opportunity to say, well, we don't have the exact same element with the same name, but this is why ours essentially does the same thing.

So the paper review.  Once a country submits their complete ICAT, we formulate the ICAT team that goes over the submission, and that involves specialists from International Affairs, Office of Food Safety and also FDA's Office of Regulatory Affairs.  And the country's submissions, as I said, are really done in an iterative process, so that if a piece of information is missing, it's not just, okay - X - Does not meet.  Instead, we'll go back to the country and say: this is what you supplied; we feel like this is missing, and then we'll get the follow-up information.

And for the New Zealand pilot, I think we were probably a little spoiled in this way.  New Zealand actually sent three people over toward the end of our review process to really go over their submission element by element to see if they had missed something or if we needed clarification on anything, so that was a great help.

And as we went through the review, we came up with a second matrix just for our own use, so that we could go through the elements and also pinpoint the questions that we still had.  This was just prior to the New Zealand team coming to the U.S.  So for instance, element one, does the country have a competent food safety authority?  Well, we knew going in, yes, New Zealand has the New Zealand Food Safety Authority.  But there were still some questions as to whether everything would be at headquarters, whether the team would have to go to other places in New Zealand.  So we listed all of the questions that we had, and then after that follow-up meeting, we filled in all of the blanks that New Zealand filled in for us during that meeting, and were left just with a few remaining questions that we had to pursue.

So the in-country bilat was again here at CFSAN, and during that meeting, we were able to go through each of the elements, figure out any missing pieces.  But just as important as that meeting was for us to make sure we had everything we needed on paper, I think it was equally important to New Zealand for them to find out what exactly we would be looking for during the in-country review.  So we didn't want to arrive in New Zealand and say, surprise; we have this list of surprise elements that we want to do a pop quiz.  So it was much more a two-way communication of what was needed for success. 

So in terms of the ICAT team, the team went over to New Zealand and had, as I said, sort of a preliminary list of items that we needed to see from New Zealand's electronic documentation system, and were allowed to go through specific case studies that we were kind of walked through, but also we had pretty much access to all of their electronic data that we wanted to look at.  So we could see inspection reports, audit reports, pretty much as we went through all of the elements and all of the standards, we had access to their records and could see how they were really implementing their process.

In addition to the ICAT team that was really focused on documentation, training records and regulatory foundation, we also had teams of specialists that focused on the specific commodities that were involved in the MOUs that Don mentioned earlier.  So we had a team of Non-Grade A dairy specialists, seafood, and also laboratory team.  And they were there to observe the oversight activities of NZFSA and also of third-party recognized agencies.  And similar to what we heard from FSIS earlier, this was not a trip to inspect firms or even to audit specific inspectors.  It was really to see NZFSA, what is their oversight over the firms and what's their oversight over their inspection program. 

So the teams looked at implementation and field audit programs, the technical and professional skills of the auditors, whether the overall inspection program appeared likely to result in food safety outcomes consistent with FDA's inspection program, and also the lab people -- not looking at specific labs and what the specific labs were doing -- but more, what is the laboratory oversight and how do they accredit labs and what is the oversight over accreditation.  So it was the higher level audit of the system itself rather than individual locations.

We had a fourth team that went over, and this was really a highly specialized team, that focused specifically on bivalve molluscs, and this team had sort of a special ICAT review because of the inherent risks of shellfish itself, so it was really due to this unique characteristic of this commodity, and New Zealand was interested in combining shellfish in with the seafood MOU.  So we had a shellfish team that really did their own ICAT analysis, and looked at very specific measures. 

So this definitely would not be done for every country; it's really specific to a country that requests a review of their shellfish program itself.  And they looked at everything from the program administration, legal authorities, staffing and training.  So really they went through all of the elements and all of the standards of the ICAT, but specific to shellfish itself.  And they also went out on sanitary surveys and looked at their growing waters.  And so it was a very specialized team, but again, looking at the oversight of the program, not the specifics of locations and things like that.

So lessons learned.  After going through the pilot, definitely there are things we'd like to keep and things we'd like to get better at.  The paper review team, I would say, should continue to include the commodity specialists.  They're the key.  They're the ones that know what the inspection audit system should look like, and they were crucial to the success of this pilot.  The administrative coordination/communication, both within our agency and between FDA and the country is critical.  And the on-site review teams from here on should be customized to some extent to the country.  So clearly, if a country is not interested in exporting seafood, we would not send a seafood team over.  So for each country, we would have to see what the country intends to be exporting before we develop the teams.

Okay.  For planning for future success, one of the keys, I would say the most critical key, is to determine prior to that verification visit, that the country is really likely to be comparable.  There's no point in spending resources to go to a country that's very unlikely to have a positive comparability assessment at the end.  So from the start, during that planning stage, as much as possible, I should say, we should have a clear idea of how the systems works -- but as I said earlier, you can't really know the system until you get there -- but at least on paper it should look like it's highly likely to be comparable.

Also prior to departure, the FDA, we need to make sure we do supply the detailed list of any issues and documentation that we're going to need to see in country.  The trip to New Zealand was extremely well organized in terms of logistics, and because we had supplied that list in advance, they knew what we were going to be looking for and could help us to plan day-by-day what we would be going through and which offices we needed to visit, and they could really help us to facilitate our visit while also we weren't surprising them with unexpected requests.

So clearly, two-way prompt communication throughout the submission and review process is key.  With this pilot, we were really on an expedited timeline, so I think for both countries, there was a daily push to make sure all of the information was together, reviewed, timetables were being met.  So that was really a key to success, because as everybody knows, once it gets to the backburner, it's difficult to really progress through an assessment.

So you've heard this before.  Benefits of utilizing comparability: shifting resources from low-risk to high-risk country commodity combinations, the ability to accept assurances from comparable countries in terms of firms in good standing.  But looking ahead, this is my slide of impossible dream maybe, but just thinking about the possible future uses of comparability determinations to enhance food safety.  As Mary Ann from Canada mentioned this morning, no country wants five countries coming at the same time to audit their systems.  So the question is, could countries that are comparable to each other decide, okay, maybe we all don't need to visit this one country at the same time, and instead share data and leverage resources so that not only the country being inspected would appreciate the less frequent visits, but also the countries that are comparable can focus their resources where they're most needed. 

So work sharing, information exchange, avoiding duplication of work, those are all key goals aside from the trade facilitation that we've also heard about.  So the progress report.  I think you've probably seen this before.  We finished up the pilot in New Zealand.  That report is nearing its conclusion now.  With the EU, we have received completed ICATs from several member states as well as from the Commission, and that review is being undertaken as we speak. 

Next steps or current steps, I should say.  The public hearing today is an excellent opportunity for us to get feedback on the process, what may be the best way of moving forward.  I know there's certain technicalities that we'd like to tweak in terms of the ICAT itself.  Ideally someday it'll be a web-based program that countries can log in and import files. That would make it easier for us and easier for the country.  So there are definitely steps that we'll be taking to improving the process, but there's lots of things to work on that we would appreciate feedback on as well.

So the EU, the European Commission and UK, a review is going on right now.  May and June, Denmark and France will be reviewed, and then in the summer and fall, hopefully if everything is on track, we'll continue on with Netherlands, Spain, Italy and Ireland.  And that's it.

(Applause.)

CAMILLE BREWER:  So, that's what we've been doing in the past year.  Next, we'd like to hear the perspectives of our partners with whom we did the pilot.  So we'll start with Dr. Bill Jolly from New Zealand.  We'll follow with Carlos Alvarez Antolinez from the European Union, and finally, from Mary Ann Green.  And as Mary Ann indicated earlier, she was a part of the development team for this area of work.  Bill?

BILL JOLLY:  I think I'm the person who's come the furthest, and I haven't slept for the last 72 hours with jet lag, so you'll have to excuse me.  The first thing I thought I'd do is introduce you, where New Zealand is, just to get the perspectives right.  It's not Down Under.  We do actually see the daylight first and each millennium first, and we like to stay here, which is one of the reasons we're here and participate in the pilot.

Just a couple other quick things.  We're about the same, and you'll see it in the next slide, the same size as Japan and the UK, and basically Washington, D.C., if you guys need a place in another world where you are.  And we're a lot further -- we're not quite as far away from you as the UK, but it's at least 17 and 18 hours flying. 

So we're a small country, 4.4 million people, but the same land mass as the UK and Japan.  We're an island nation, and sometimes we're considered to have a West Island, but we are not Australia.  Food is our economy.  We're actually, we're a big exporter of food.  We're a big consumer of food, and so it is essential.  And it's nice to be in a government department where you are essential to the economy, because you get the resources. 

Now, as with many government departments, we've been restructured so many times I can't even remember.  And just to -- we're no longer the New Zealand Food Safety Authority.  As of July last year we merged back with Ministry of Agriculture and Forestry.  We previously were attached to them, and previously part of us came from there and part of us from the Ministry of Health.  And there'll be lots more changes in the future as well.  The important thing is within the Ministry of Agriculture and Forestry, we now have the complete competent authority with respect to SPS, so we have all of Food Safety, we have all of Animal Health, we have all of Plant Health, and we also have some of the TBT aspects.  We have Organics, we have Grade A, we have Animal Welfare.  We've always had Veterinary Drugs and Pesticides and most importantly, of course, we've got Wine.

And importantly, too, my whole team just came over, just was plunked in, so it's the same people, same laws, same ethos -- just an evolving scope and overarching structure and organizational name.  So there's no change, and there's been no change all the way along, and I look in the room here and I've been dealing with most of the people in this room for 15 or more years.  And Phil Spiller sort of crept up the top there, and he reminded where we were sort of 12 years ago.

So my team is accountable for all of the import and export standards.  We do all the certification programs, and we manage all the international regulatory relationships.  We don't do promotion.  We don't do any of the other stuff, and we're heavily involved in international standards. 

This is the regulatory model that's in place in New Zealand, irrespective of food, so you can come look at dairy, you can come look at meat, shellfish, whatever you like.  This is the model we use.  Two things.  It's an inverted pyramid, a bit like inverted map of the world.  We believe the fundamental relationships between consumers and industry, it is the responsibility of industry to produce safe foods.  What the government does is independent of all that.  They're independent with standards, they're independents with requiring independent verifications.  Sometimes that's government; sometimes that's accredited third parties.  Other times it may be referencing to private standards even.  And what we do and what isn't in this, is as part of that regulatory triangle, we have our own compliance and enforcement group, which audits every one of those triangles, including my group.  So our auditors audit all of those to make sure. 

And so when you start talking about this process as being a bit like the FDA audits states.  Well, we're not a state.  We're a sovereign nation, and we actually treat the other parts of our system like you treat states as well. 

So how did we get into this process?  This is what I looked like when we started.

(Funny slide on the screen.)

BILL JOLLY:  Now, we have a long history of compliant trade both ways, and in this particular process we're interested in reciprocal.  We don't do reciprocal equivalence type things with many countries, but with developed countries where we have had a long history, we look at it very much on a reciprocal basis. 

We want to evolve our relationship.  We had a long history of alignment and cooperations.  People have interest in the Quads.  Our programs have replicated, have been informed by each other for a long, long period now, and we regularly meet, and we regularly review and go around from just an information-sharing point of view.

We also regularly share intelligence.  And in fact, we have a confidentiality agreement, where any issue that's happening around the world, we send each other e-mails and get on the phone.  And we've been integral to most of the major sort of incidents around the world in jointly managing them.  And we understood we needed to be smarter with our resources.

So you heard about some of the commodity MOUs, but in 2005, we actually signed an overarching MOU.  And this was the first, if you like, comparability-type MOU.  And it was done with Lester Crawford.  And it has a five-year review process, and that's one that's expiring, not the commodity ones.  So we're just about to renew that one.

This reflected a high level of knowledge, confidence and experience, as I've talked about, and it was a reciprocal acknowledgement.  The commodity MOUs weren't reciprocal.  Now, for my own selfish reasons, I wanted the new ones to be reciprocal, because I run the import program in New Zealand, and I don't want to have to overregulate some of U.S. production, where I have already have a high level of confidence.  We also wanted to cross-reference some of your systems when we started looking at other countries.  And we heard a little bit about that from Julie before.  So when we look at other countries' shellfish programs, if they've already been assessed by the FDA, then that's one way we can get assurance.  If they've been assessed by the EU Food and Veterinary Office, that's another way we can get assurance.  As a little country of 4.4 million people, we can't go out there and order and inspect every other country's system, so we're looking for partnerships.

In the 2005 MOU committed us to review and update and extend the commodity MOUs.  And I can talk a little bit about that later, but the reason we wanted to consolidate the seafood ones and some of the others, is they came under the same regulatory structure.  They had the same outcomes, and it was pointless for raw shellfish to be regulated at this point, but if it actually happened to be cooked, then it came under a totally different regulatory regime.  So we wanted to throw it all together.  And from our point of view, it makes sense, and I think we've slowly convinced people. So the concept of comparability was borne even before 2009, Roberta. 

In the vision of the likes of Mac Lumpkin -- sorry, Don, I spelled your name wrong -- John Sheehan -- not sure whether John's here today, but John's been really integral to this -- Camille, Julie, Mike Wehr, and Dennis, who's up there in the back there.  A common desire to change the existing paradigm, and we've heard of that from previous speakers.  And we're acknowledging preparing for changes in the legislation.  I mean, we've had copies of the various bills for the last three to five years.  Caroline kept on sending them to me, so I've read every single version. 

And we basically commence safety.  If you couldn’t do this with New Zealand, you couldn’t do it with anyone.  We are heavily aligned.  We have a very good system.  And most importantly, we have commitment both ways to resource and deliver to some pretty tight timelines, and that was really integral to this.

Initial concerns.  Whenever you're dealing with Julie Callahan, you have a few concerns, and we didn't know whether we could, a little country like New Zealand could be heard in a big environment like the U.S.  But we had a backup plan. 

(Funny slide on the screen.)

BILL JOLLY:  So what is system comparability, or comparability, Julie.  You can always find differences.  Some are real; many just exist on paper.  Everyone's laws are different, so that's actually a good thing.  Your laws should reflect your own environment.  They should be fit for purpose.  If you try and replicate another country's laws, you won't get it.  You'll get a concrete life check at the end of the day.  They've got to be designed to work within your own system.  There'll always be different hazard profiles.  And the U.S. has far more hazards than we will have, in many different ways.  What we collectively focused on, what was conceptually important to achieve, an FSA, Food Safety Assurance outcome. 

It's not about the differences in the way things are done or described; it's whether the system is designed to appropriately control whatever inherent risks -- remember that term, inherent risks, are associated with food production in the exporting country so that the residual risk to human health emanating from each system is comparable.  Inherent risk is residual.  It's about focusing on the macro components, because these are what ultimately delivers the assurances. 

Some things you can't control, and I was wondering who I should ascribe this to, and I couldn't remember whether Cathy Carnevale had a granddaughter, but I'll ascribe this to Katie.  Competent Authority Competency, and this is just another take on some of the slides you've seen, but sheer public health goals.  You've got to have a similar mission.  It's got to be adequately resourced.

Freedom from conflict of interest.  We've heard that in the last two days.  Transparency of standards and verification activity.  Demonstrated willingness to take safeguarding and enforcement actions, and again that's partly freedom from political interest and all the rest.  Commitment to science and risk assessment.  Without that, you're wasting your time.  And ongoing monitoring surveillance program.  All regulatory programs are about continual improvement.  None of us are where we'd love to be in the future.  We're all trying to make improvements.

So I talk about the five R's of comparability.  Registry-based, Resource, Risk-focused, Responsiveness. -- and again, it's got to be done after, it's got to be after emerging threats.  And Regular review, continual improvement.  It's about also about the 6 C's -- Commitment, Competency, Cooperative Environment, and we've heard about this before.  If you don't have a cooperative environment with the industries you're regulating, you will not be so effective.  Continual Improvement, Compliance and Enforcement, and Coverage of Potential Conflicts.  But let's not forget the two S's and T's -- Science-based Assessments and Standards, Safeguard Actions and Transparency. 

So based on a comprehensive analysis of food controls system in the country where it operates, you are confident that the system is likely to deliver the same or better level of food safety protection as your own provides within your own country.  It's not the same as, and there will always be differences, but it delivers the same level of assurance.  So the differences in the laws, administrative structures, and differences in the guidance and standards are not what is important; it's whether they are fit for purpose and achieve administrative outcomes for product from that country. 

It's not about looking to see if there are different hazard profiles.  As I said before, for example, the U.S. may have more pathogens and use more veterinary drugs and pesticides than New Zealand.  We heard Caroline at lunchtime, actually, talked about some of the multi-drug resistant bacteria.  And we track all the salmonella that had been identified in New Zealand, and we know we've only got about a third of what is in many other countries. 

The fact that both of us have appropriate control and monitoring systems, and use these results to inform and continue to improve our food control systems is what gives confidence.  So it's our ethos.  It's also not necessarily about looking to see if two countries have similar levels of human health burden for any particular disease.  The reason for disease stats are multi-factorial.  And sometimes, when you look at New Zealand and the U.S. stats, which are quite similar in a lot of ways, they might be higher than other less developed countries, but there's a reason for that.  We actually look for it.  Again, the fact that both of us do look and monitor and use these results to inform and improve our food control systems are what gives us confidence.

There's challenges.  Most countries haven't described their systems according to an outcome, a level of protection.  Most are still very process prescriptive.  So when you look at process prescriptive requirements, the comparison has to be at that objective level as opposed to a risk level.  The ideal is at the risk level, and we have actually, as a public health agency, we're one of the few who have set in our public goals and outcomes which are ordered by another government department, that we will reduce campylobacteriosis by 50 percent over five years.  That is campylobacteriosis in humans, not the level of hazard on product.  It is actually a human health outcome. 

Similarly, we have set a goal of reducing salmonellosis by 30 percent over the five years.  Accordingly, it's necessary for comparability to look for objectives in the approach.  Where there is salmonella, will you have the same sort of ethos?  Risk and perspective.  You can be beavering away whatever you like, but you mightn't always get the right result, so it's important to keep a perspective. 

Again, I talked about our model.  It's across a broad range of foods.  We have the same regulatory base; we have the same ethos for all foods.  Some, we have tighter regulatory controls.  We all regulate meat, probably all over-regulate meat.  You heard from Mary earlier today -- system comparability is system equivalence.  It's doing -- it's basically, your system is designed to achieve the same objectives as our system, same backwards.

So, having a common understanding, we leapt into this process, and again, I've aged a little bit since then.  There was a high, what helped -- and not all countries have this -- we have a high degree of historical alignment, approaches, statutes, regulations, and standards.  High pre-existing knowledge.  We used the guidance from international standards, and there was a huge amount of goodwill on both sides, and we're really thankful for that.  Mac, Don and Camille -- thank you very much.

A lot of commitment.  I dedicated a lot of my teams' resources to this, as did the FDA.  And we made sure that those people were fully available.  We focused on -- the focus was clearly on the objectives behind the legislation.  Rather than comparing hydroxy with hydroxyl, it was what we were trying to achieve in a macro sense. 

We focused on the haystacks, not the needles, and maybe this is a little bit of a culturalism.  I use the term, terminology slightly different from Don, but at the end of the day, if you want to change burden to public health, you look at where you can make the biggest impact.  You don't go after the smallest player who supplies sausages to a local fair.  You go after where you can have the biggest impact 

Long-term personal relationships help thrash things out as well, and that means we had the confidence.  What worked well, the collegial relationships.  Julie mentioned these.  We now have whole teams of people on both sides that feel as though they can finish each other's sentences and call each other when they want to talk about something technical.  Regularly getting on the plane, all the phones for discussions -- again, it's got to be an iterative process. 

So there were five coordinated in-country expert reviews focusing on different components, all led by a senior CFSAN official, and that was John Sheehan.  And that worked very, very well.  Each was escorted by one of our, one or more of our compliance investigation group, and/or one of our technical experts.  And they all had full authority to visit any premises, pull any record.  I notice you've just sort of enhanced that authority in your FSMA.  We've already had that.  Good relationships with all the regulated parties, even when we had to keep changing the program at short notice -- and we'll talk about that in a little bit.  And Julie says it was well-planned, but there were a few disasters on the way. 

Possible improvements.  The way the ICAT was designed is you took the way your laws were structured and you tried to retrofit it.  Now, we all know our laws are developed over a period of time, and they're slightly imperfect.  And as we go forward, and we talked a little bit in previous speakers about the international process, which has been led by the Quads and the EU -- looking at how we get a generic model.  And that will be more conceptually based, and it will be potentially more universally available, useable by other countries between them rather than just between the U.S. or used by the U.S.

And also, we always took this as a true reciprocal process.  Now, we didn't put the same disciplines on the U.S., but in answering their questions, we learned a lot about your system as well.  And we already did know quite a lot, but it was very useful from that point of view. 

Possible improvements.  Use of a shared web-based work space.  The files are too large.  We had 50 attached documents.  It's three gig worth of documents, and so we had to actually send ten e-mails just to have the attachments, quite apart from the bits that were able to be directly downloaded from the web.  This one comes from Jeannine, Julie -- don't use Excel spreadsheets!  Where's Mary?  Mary, we hate the self-reporting tool, because it's got Excel spreadsheets as well.  You're limited in each cell to 230 or 239 characters, and so while you're in the cells, on the computer screen you can expand it out, but as soon as you print it, you can't.  You don't see it, and it makes it very difficult.  Quicker turnaround reports.  We finished this process back in October, and we've only just got the draft report, so it's a possible improvement. 

The resource commitment was large.  At one stage I had 20 people involved, and there's more than 200-person days.  Three staff traveled to Washington three times in three months, and it's good for my frequent flyer miles, not good for a marriage.  And this was a very robust process.  We've heard about this.  It was the most intensive audit and review process we went through last year.  And we get visited by everyone, so it was more than we did with the EU Food and Veterinary Office -- and those guys are intense.  It's more than we did with the Chinese, and we've got a very active program with the Chinese, both capacity building as well as having them come down to audit us.  More than we did with the USFSIS, USDA FSIS, and they used to have an auditor permanently based in New Zealand back in 1998, as we heard.  Now, nowadays, they audit us every two or three years for a week.  It was more than we did for the Russians, and the Russians also caused a lot of problems in order to have a very robust audit process.

So was it worth it?  It needs to be, to justify the resources expended.  This is lessons learned.  It has to be, to entice other countries into the program.  It is arguably essential if the FDA ought to better target scant resources in the future, and we heard from Roberta to that effect.  It will ultimately be judged by importers and exporters as to whether there is an advantage of being or dealing with a high-performing country. 

What could have worked better?  Less natural disasters.  So the Christchurch earthquake made us change the program, the first thing that changed the program.  The second thing was we had a -- we just changed it and then we had a big snowstorm, and it caused a few problems, so we changed it a second time.  The fact that we could actually go anywhere at any time in our regulatory helped, and we also had the cooperation of the industry.  The Gulf Oil Spill also affected key resources, and normally, the shellfish team would have come along with the rest of the other team and possibly wouldn’t have done that sort of duplicate process to the same extent.  Personal injuries.  Where's Karen?  On both sides, I think it was one/one in broken bones.  We talked about commitment. 

So tips for future.  Stay away from the ring of fire.  Ninety percent of earthquakes appear in this little ring here, and New Zealand, up to Japan there, the Philippines and Indonesia.  We've had two major earthquakes in the last six months, and the second one we've of course had over 200 people to die.  That's been somewhat superseded by the Japanese earthquake, where I think we're up to about 27,000.  But let's not forget the Indonesian Tsunami in 2004, where something like 256,000 got swept away in the Tsunami.  It's a funny slide, but there's some serious messages behind that.  And the Chilean earthquake, of course, which caused incredible loss of life and devastation. 

So expected outcomes.  Each Competent Authority is accepted as acting as the other's risk manager.  We've moved risk management offshore.  That's what we're trying to do with all of our relationships with developed countries, so we can target our resources at high-risk products from high-risk countries, and get more bang for our buck.  Safe foods traded freely with expedited clearance.  Arguably, it doesn't give us any benefit re-inspecting your product at our border when you've already inspected where it's come out of a regulatory system which is comparable to ours. 

Enhanced cooperation and continued alignment.  Julie said, we don't want to stop here.  We actually want to redirect the resources that we're doing to inspect each others' programs, actually look at how we can actually inform each other, how we can actually make our programs better.  We've got a lot of cooperative activity there.  And again, ability to target our resources to less-controlled imports. 

A couple of last points, and these are the real sort of key.  Importers should not have to duplicate or be requested to duplicate information assurances from New Zealand exporters.  So the comparability assessment should serve as a recognized due diligence under the FSMA; e.g., for the foreign supply verification program or the voluntary program.  FDA should use its established knowledge, confidence, experience, in regulatory control systems rather than separately coming to audit commercial premises.  And it delivers a high level assurance; it's more cost-effective. 

The years I had discussions with my counterparts here, because the Office of Regulatory Affairs, came and independently audited some of our cheese plants, and they didn't even tell us when they were in the country.  And yet all the regulatory controls came from the Central Competent Authority.  So this way we can get a much higher level assurance; you're getting it from the Central Competent Authority. 

Commodity MOUs are updated.  And we're in the process of doing that, especially the 2005.  Extended and made reciprocal, providing for a recognition of comparability and the ability to continue to independently involve.  When Don said that we didn't like the compliance nature of the shellfish agreement, that wasn't quite true.  I mean, it is and it isn't.  One of the things we didn't comply with under the interstate shellfish service programs is our inspectors don't carry guns.  Our police don't even carry guns.  We couldn’t get our inspectors to carry guns, and that is a requirement under that program. 

That's an extreme example, but again, we have a different biotoxin profile.  It would be dumb for us to replicate the NSSP, when -- because it wouldn’t deal with the relevant risks.  You've got to have a program which can evolve to manage the risks as they exist in your country.  If you replicate someone else's, you don't have the resources to put in to target in the areas that really count.  So it's key to that.

We will be judged -- and I've made this comment several times to my colleagues -- by whether conditions of trade as noted by importers and exporters, and those will be different as of 1 July 2011 compared to 1 July 2010.  We've both put a lot of resources into this.  It shouldn't be redundant resources.  We've got a lot more confidence.  There should be some deliverable.  But more importantly, we're going to use this as a starting point to look at further areas of cooperation of alignment and resource sharing. 

Last conclusions.  It's not for everyone.  Requires a high level of pre-existing alignment and experience.  Is very comprehensive and resource intense.  As I say, must result in future resource savings and efficiencies.  Will result in much higher levels of assurance than achieved from port of entry inspections and commercial assurance.  Commercial assurances don't even come close.  Must result in improved conditions of trade.  Some things, of course, are hard to compare.  Thank you.

(Pause.)

CARLOS ALVAREZ ANTOLINEZ:  Thank you very much.  Good afternoon.  My name is Carlos Alvarez.  I work with the delegation of the European Union, and I represent the Commission services in the U.S. in the areas of food safety, health and consumer affairs.  And I have to say I'm not very happy to have to make my presentation after Bill Jolly.  So please, Camille, if I have to -- I mean, next time, let me know.  He should be the last one. 

I have been asked to speak about the experience of the EU in the current exercise of comparability stroke equivalence between the EU and the U.S. in the area of bivalve molluscs.  And I have been given ten minutes.  So I'm sorry that you cannot see the (inaudible: 1:31:40). 

Before speaking out with this, let me say maybe a couple of words about our legal framework.  I wanted to say that the concept of equivalence is well-defined, well established, in the EU legislation.  The main piece of EU legislation on food safety regulation 178 of 2002, which is also known as the General Food Law.  And in Article 11, it establishes that food and feed imported into the community of the Union should comply with the relevant requirements of food law, or conditions recognized by the community to be at least equivalent, or where specific agreements exist between the community and exporting country, with their requirements of the agreement.

Another important piece of legislation in our system is Regulation 882, 2004, official controls, and its Article 49 addresses equivalence and also provides that following the implementation of an equivalence agreement or a satisfactory audit, a decision may be taken recognizing that measures taken that all the regions apply in a specific areas, offer guarantees equivalent to those applied in the community.

We have a number of what we call veterinary agreements, or veterinary equivalence agreements, notably with Canada, with New Zealand and certainly with the United States, this one since 1998.  And I think it's probably worth remembering, what it says, that the Article 1 defines the objective of the agreement, asks to facilitate trade in live animals and animal products between the two parties by establishing mechanisms, or a mechanism for the recognition of equivalence of sanitary measures maintained by a party consistent with the protection of public and animal health, et cetera.  So the objective of the agreements are very clear.

A couple of points I wanted to make about our system is that there is a substantial, a very significant difference between in the EU legal system, between food of animal origin and food of non-animal origin.  I think I will have tomorrow the opportunity to speak a little about imports -- again, preferably not after Bill -- but we will see.  I will say that the requirements are very different.  Imports of food of animal origins require the (inauidlbe: 1:34:39) of a country, the listing of establishments, certificates, and prior notification; whereas for food of non-animal origin, none of this is applicable, none of this is relevant. And this was brought out by the questions from Mac Lumpkin of this morning, were very interesting.

Finally, I would like to mention as well that more food safety legislation in our system takes the form of regulations, particularly after our big reforms in the early 2000s.  And in these regulations, and contrary to previous directives which were very detailed, the Competent Authorities, both in member states and in third countries, have some room for maneuver as to how to achieve the objectives, the safety objectives, and standards defined in legislation.  So I think that's interesting point, and maybe we'll see later why.

Now, on the questions that I was asked to address, our experience in this particular exercise.  In terms of bivalve molluscs, I think it has already been mentioned, imports of bivalve molluscs from the U.S. into member states have been taking place or had been taking place for a long time, but this was a decision of temporary regime that ended at some point, for legal requirements, and it was taken place on the basis of bilateral -- it was a bilateral basis with members states.  It was not something that was harmonized while accepted at the EU level. 

Now, in order for us to have U.S. accepted such for the whole of EU, we would have needed a satisfactory audit.  The results of our audits in 2009 revealed that there were very significant differences between the two systems and that in some areas, the U.S. system was not aligned with our requirements.  So that was -- this prevented us from formally listing the U.S. in this particular sector.  But, at the same time, because we have this veterinary equivalence agreement, the logical approach would be, okay, let's examine our systems.  We cannot say that you are in compliance with my requirements, but let's sit together and try to see whether our system and your systems can be considered equivalent.  Now with the new terminology, maybe it's -- I'm not sure whether we are speaking about an equivalence exercise -- maybe a little more as a hybrid; some of you mentioned this.

The processes are still ongoing, and for this reason we are not yet in a position to make an assessment of the whole exercise; however, we can make a few comments.  We think that overall, the main advantage is probably that the overall approach, which in our view combines the comparative assessment of systems on the one hand, and the assessment of also comparative of measures on the other.  And we believe that this is an approach which has more flexibility and therefore, we can focus better the resources, and overall it leads to some savings and some more efficiency I would say.

At the same time, from our perspective, we acknowledge that this is -- it is being challenging.  It is a very long process.  There are still some uncertainties about procedures, what's going to happen afterwards.  Both systems are complex, and there are differences both in the standards as well as in levels of prescription, and this makes the whole exercise challenging.  Differences in the standards, for instance, microbiology, water vessels, flesh -- this has been addressed through technical discussions, which are very intricate and very complicated.  As well -- at the same time, I think I have to say that there is, as we said, even if the legislation in this area is fully harmonized, as far as we are concerned, there is some room for maneuver for member states in the way they implement measures.  So insofar as you want to carry out a very detailed analysis of the measures that are taken by every single member state, then the process becomes more complicated.

At the same time, I have to say, for us, differences between member states within the room for maneuver, which is established by the legislation -- that's acceptable.  We wouldn't accept that there are differences in outcome; otherwise, it would mean that some member states would not be compliant with our legislation, and this is something that we are not prepared to tolerate.  This is why we have an oversight system, which evaluates the performance of the different member states. 

Now, as far as the outcome, well, again, we are very confident about the level of protection that our system provides, and in principle, I would say we don't have any reason to believe that the U.S. system does not provide similar level of protection.  So in principle we are optimistic, but we have to go through this process.  As to the ICAT, the ICAT, well, we think that this is a useful instrument.  It represents a logical and comprehensive framework for gathering relevant information.  The range of questions is very broad.  In some cases they are very detailed, in others, broader.  We have experienced some difficulties from our side in the sense that both the European Commission has to provide the information; the same for the member states involved in this process, and some place it's not clear who has to say what, and therefore this has made the exercise from this perspective also challenging.  I concur with Jolly over the whole issue of Excel, that it was impossible to print anything from ICAT.  It's really a challenge. 

Now, on this basis, our preliminary use of comparability without reservations, benefits and disadvantages.  Obviously, the main benefit, the main potential benefit from our side, we think it would be flexibility and efficiency.  It might be useful in the case of sectors which are highly regulated -- it is the case, as I said, for food of animal origin in the EU system.  And a good example is the bivalve mollusc case, where we had a system which is different.  From a legal perspective, you cannot compare, so we need to go through an exercise which allows it to compare let's say the outcome of these systems.  At the same time, it remains to be seen, I think, whether this approach is justified or it is useful in the case of less regulated sectors or commodities.  For me that's a question mark. 

Incentives.  Well, it is obvious that a favorable outcome should facilitate bilateral trade, and it is I think logical to assume that if the outcome is positive, it would be very easy to move to other sectors.  I'm speaking from the perspective that we are doing this on one particular sector, so again, I think that there would be some advantages on this.

And of course, the costs, this is all related to resources.  Obviously it's very demanding, but I think that overall the advantages, once the process has been completed, certainly would outweigh the cost.  About the terminology, the word.  Well, again, equivalence is well-defined in international treaties, international law.  It is established in new legislation where comparability as we have seen, it is a new term.  We don't have in the EU the same kind of say, difficulties with the term equivalence that probably are more common this side of the Atlantic.  But in any case, we were asked, all the terms that can be used, we have heard some of this, equivalence of systems, mutual acceptance of systems -- this is at the end of the day, something similar.  But from our perspective, I think it would be interesting and worth probably exploring the possibility of harmonizing the term and consolidating the term at an international level -- not for tomorrow, obviously.

Regarding implications vis-à-vis import provisions.  Well, I think it has already been said by Don and others, and I'm happy to see that our expectations coincide more or less with your views.  We think that once comparability has been established in relation to a particular sector or other sectors, this should facilitate in general the implementation of the import provisions.  The foreign supplier verification would rely or should rely on the national Office of Controls -- that's avoiding duplication of work.  The same would apply to inspections.  Maybe there should be some impact on the level of inspections.  And regarding regulatory systems, I think that if the Competent Authorities, in our case, from member states, were interested, it would be very easy to recognize the authorities in these member states as accrediting bodies or accrediting or say, accredited agent.

And the last question that we were asked here, about maintaining the status.  From our perspective, we think that the status has to be maintained until there is a very significant change in the legal framework.  So we think that it's important to make the distinction between the systems itself and the implementation, because mistakes may happen, but not because you have found a consignment which is not in compliance.  It doesn't mean that the whole exercise of comparability equivalence has to be reviewed.

Visits.  They should be organized on a risk basis.  I don't think it's from our perspective, possible to establish a particular frequency.  And the last question, communication.  Of course, we would agree that fluent communication is absolutely necessary, because at the end of the day, this is an exercise of reciprocal confidence.  And that's the end.  Thank you for listening.

MARY ANN GREEN:  Thank you very much.  Again, I too, don't always appreciate the blarney, comparable to the Irish man who preceded us in Natal, Brazil.  So cut from the same cloth. 

Anyways, I'm coming from a very much more theoretical perspective than the two previous speakers.  I had the privilege to work with Camille's group in working through some of the discussions, and very much bringing in an exporter perspective into the discussion.  So this very much is a Canadian perspective on the U.S. initiative.  With regard to titles, I prefer the concept of systems recognition, because that's the ultimate goal.  You're looking at a systems recognition.  Comparability is a tool to do so.  There are other tools available. 

We really have to look at the context, and fundamentally, what you're starting out to do is with a very clear objective, and one you started with an objective-based approach, then you can very clearly set out your parameters.  So if the objective is to protect your public from food-borne illnesses, then fundamental to that protection is that the product would meet regulatory requirements. 

Countries -- and it doesn't matter which country -- they're in very different stages and in very many different ways, different legislative approaches -- they put in place processes.  Those processes can be robust or less robust.  In the domestic concept, very much it's evolved from simply product evaluation, and some of you will have probably seen all the walls around here and looked at some of the history of FDA.  And there was an awful lot that just started from simply doing a product analysis.       We moved into facility inspection and/or process assessment as it became clear that that was the better way to actually protect and ensure that the processes being used to produce food actually met the objective. 

We've also moved in as imports became greater and greater and more complex and in different forms into border inspections and foreign facility inspections.  But when you look at the entire number of countries which export to any importing country and the number of facilities that might be eligible, you actually get a cost-prohibitive factor that comes in, and it is greatly beyond the means of most countries, to actually inspect each facility.  We're not quite as small as New Zealand, but even at 30 million people, we don't have the resources to go out and look at every single country and every facility.

So then you're looking at, trying to find a much more effective means of ensuring that food safety.  One of the means that you can look at is really looking at import controls, where you put the requirements on your importers -- licensing supplier, quality assurance.  And one of the key principles underlying this is that the industry have to be responsible for importing the product that meets the requirements, coming back to our objective.  The key is, that food cannot be just seen as any other commodity.  If we are truly saying that one of the critical issues is to protect the public from food-borne illness, then you must see that food is a very specific commodity, and the importers must understand the requirements for that food that they are importing.  But even then, the sheer number of importers -- there has to be oversight, there has to be processes -- and the sheer number of importers and the number of audits or inspections you would have to do of those importers often, again, makes it cost-prohibitive.  And so you move into, how do we look at other arrangements, and government, offshore type of processes, where we can look at arrangement to recognize foreign systems. 

To me, where we come into the comparability or systems recognition, is that it has a very structured process.  It has a preventative approach in which it focuses on processing the safe food and not the border inspection.  And the key in this area from our perspective, is that the food and the process, safety parameters that are put in place, provide for residual risk, and rather than just looking at the inherent risk.

The concept of systems-based, that you're evaluating a system that works in that country within its legislative framework, its cultural framework, is very important.  There's starting to be a common understanding of what a system might apply.  Similar, though not identical; it has similar elements covering the same requirements, and confidence that there's going to be a level of public health protection -- again, coming back to your key objective, which is to protect the public. 

And then there has to be clear processes, and you heard me this morning say very similar.  The process is with the ICAT that Julie outlined, looking at compliance history.  Looking at the comparability tool and the in-country assessment really outlined the steps that countries have to meet.  And it does provide a clearly defined reference standard, not a moving target -- again, something that's very important. 

I once heard one of my colleagues say about drug approvals, that the drug industry had the right to know what barriers they had to meet.  They might be this high, might be this high, but they couldn’t go up this high in the middle of the approval process.  And by having very clear defined processes, it's not a moving target.  You're not changing the height of the barrier halfway through the process.

The benefits from our perspective in terms of looking at seeking comparability is that it does allow for such a flexibility assessment.  It can be commodity based; it can be country based; and you can exclude issues, such as labeling.  There are fundamental requirements for labeling in a particular country, nutritional labeling, and those might just have to be meats.  We have bilingual labeling, any product coming in, meets.  And it may be the importer's responsibility to ensure that that label is perhaps put on a sticky. 

It can maintain or enhance access to a market and minimize the trade disruptions, and it can provide access in a bilateral way as well.  It can provide an efficient use of resources, replacing the foreign facility inspections with a systems assessment.  And again, it can enhance collaboration in the sense that its process supports ongoing communication, not just of the actual processes for comparability, but also on the ongoing basis as you find new problems, as you exchange information on issues and as you're discussing things that you may have found in other countries as well. Again, the objective being the key to protect consumers and ensure safety.

But there are challenges and considerations that have to be done, and many of these were mentioned.  Is there sufficient trade or industry support for a resource-intensive process?  One of the failures could be that the industry says, yes, we're going to get comparability, and when they realize all of the issues that are facing them or they decide they found better markets and no longer are interested, you could use that support, and therefore, it may not be cost-effective for small volumes of exports. 

Clear understanding of the food safety program in the two countries -- the legislative, the programming, the compliance and enforcement.  Some of the things that we've learned over many years is when you're negotiating, international negotiating team is not absolutely clear on what your program does, they may go negotiating requirements that you can't meet, come back and hand it on the table and say, oh, what do you mean you can't implement it?  You have to have a really clear understanding on both sides of the food safety program.  And I think Bill mentioned this as well, importance.

Clear understanding of the ICAT reference standards, demonstrating that element in the exporting country and how these elements although different, meet the food safety objectives.  There has been discussion over a number of different presentations on performance measures.  One of the key areas that may be of interest in the longer term is, how do you continue to demonstrate that you maintain that?  And that may be coming through performance measures.

And fundamentally, one of the key considerations is ongoing commitments.  Communications will be key in maintaining that recognition, that you continually have those discussions, but it also allows for continuous improvement of the food safety systems.  When you're looking at your own system, because you're trying to find ways to demonstrate or put in words, what you're doing and how it actually contributes, it allows for a continuous improvement of that system.

And so I guess with a conclusion is, comparability or systems recognition is one approach for the importing country to seek assurance of imported food safety.  It does require good communications, clear processes, and transparent reference standards.  It can be resource effective for both partners, and it also can help in terms of import verification processes with opportunities for enhanced trade. 

It can also fall within a broader government initiative and processes.  When you start looking at free trade arrangements or other types of international arrangements, one of the points is you don't want to have these negotiation happen and then everybody say, okay, we're going to get X point, and we end up having to have problems because we can't negotiate out a lot of the comparability elements or understanding of the systems.  And so having a good process may assist us in moving forward. 

One of the things that they say is imitation is the sincerest form of flattery.  The other question in resources is recognize that countries are going to be looking for bilateral arrangements, and that needs to be forecast into the resource requirements.  Thank you.

CAMILLE BREWER:  All right.  Thank you, all.  Could I ask the panelists, Carlos, Bill, Mary Ann, to come forward, and if the Inquiry Team could reassemble?

(Pause.)

Mr. Chair, would you like a qualifying questions for the FDA panelists?

STEVEN SOLOMON:  I think it would be valuable if we had the FDA folks also maybe want to weigh in on a question.

CAMILLE BREWER:  Yes, sir.  And we have them all here.  To you, Dr. Solomon.

DR. STEVEN SOLOMON:  Thank you.  That was an excellent discussion, and really appreciate it. 

So I've got a number of questions, but maybe I'll kind of start with, there was a lot of discussions about what to call this.  We had the comparability and comparability, but beyond that we had systems evaluations and other pieces of it. 

Part of the discussion was that we're trying to compare public health outcomes.  Yet, when I listen to the presentations and the way they've been done so far, they were all evaluating the systems that oversee that.  So I'm interested in trying to get, should there be public health outcomes that are actually the metrics to deem how successful this is being, or is it simply the overriding system that's being looked at?  And I think everyone seems to be very comfortable that the system is what's important to give us long-term assurances, but I remain somewhat confused about how we're actually doing the comparable public health outcomes. 

ANN GREEN:  I think the ultimate objective would always be if you could, find the magic bullet that said, this performance metric is comparable.  I don't think anybody's found it, so we're still struggling with, if you don't have a magic bullet, then what do you do?  You clearly have to have an objective, and you have to measure that, and it has to be clear, transparent and consistent.  So this is the next best way. 

I think as we all struggle towards a performance measurement approach, that may change in the future, but we're not there yet.  Twenty years ago we didn't have this process.  We've moved forward, we've improved, and that's my view is that we will get there, but we're nowhere near there yet.  And it may be a magic bullet that we'd never get to for awhile, or at least not in my lifetime.

BILL JOLLY:  Mac Lumpkin and I discussed this at lunchtime, and we're one of the few public health agencies around the world that have put in our performance parameters for government that we will reduce foodborne disease in humans by defined percentages.  And we've quantified that both from a point of view of number of cases.  We've quantified it from an economic impact. 

But when you look at the starting point, when we look to -- one of those was reduction of campylobacteriosis by 50 percent -- and those are important.  New Zealand had one of the higher rates of campylobacteriosis, campy infections in the world.  And you can say, well, is that inherently because New Zealand has a high risk there, or did we just have some of the best statistics?  And the answer is we had some of the best statistics.  We had a number of PhD students doing lots of studies on it. 

And so to compare maybe our rates with the U.S., is that appropriate?  Comparing our rates three years ago with what they are now, which is 50 percent, we've already achieved that target.  Is that appropriate?  Or is the fact that we were identifying, quantifying, and putting appropriate control measures in place to actually impact that reduction, is that the sort of ethos that you're looking for?

There's very few defined metrics as far as what people would consider their ALOP, their appropriate level of protection.  So we tend to compare objectives and what the objectives of the public health agencies are, and what are the mechanisms there they bring to bear to make those objectives.  And that's the thing that gives you the confidence, and over the long-term, that will reduce all the differences. 

CARLOS ALVAREZ ANTOLINEZ:  Just to express my agreement with what has just been said, ideally just probably to have outcomes, that will be, but it is not -- it's not really feasible.  It is practically challenging in our case, because we have 27 member states, and when it comes to the issue of public health surveillance and reporting -- it is much more difficult to handle all this information and to make sure that we really have a good metrics.

The issue of -- more generally, the issue of the effectiveness of our systems, there is already a requirement legislation for every member state to have in their own plans as part of the control systems, elements and instruments to measure the effectiveness of the systems.  I can tell you, this is already a very big challenge.  We are working on this, but we don’t have harmonized tools to measure the effectiveness of the control systems in general.

MAC LUMPKIN:  Could I just follow up on that?  I think we all know that on a routine basis, we go to Europe, we go to Canada, we go to New Zealand, we eat; you don't think twice about it. There are other places in the world we go, you do think twice when you go out to eat and do these things.

So each of us in our own way, kind of make these assessments when we travel around the world and when we make our own personal decisions.  I think what we struggle with here trying to look at this process is saying, okay, when that day comes that -- and we know it will -- that something goes wrong, that there's an imported product from one of your countries that causes a public health problem here -- or vice versa; there's one from our country that causes a problem for you guys.  And whether it is somebody on the Hill or whether it is our consumers or whether it's our own selves, we ask, somebody's going to say, why did you trust that other country?  That's going to be the ultimate question that comes to us.  Why did you trust their assessment?

And I think at some level, you've lived with your own system and you know its good points and its bad points, and no matter what, you kind of have a history of what it gives you and a certain comfort level with what that system that you're familiar with gives you.  But when you're having to rely now on somebody else and somebody's saying, why did you trust them, we can't just say, because we go to London and eat and don't think about it; or because we go to Wellington and eat and don't think about it.  I mean, we're looking for something tangible that will make the case that even when things might not go as we wish in the future, that it was rational and that it was reasonable to make the assessment that we made. 

And I guess my question to you is, have you had that happened?  Those of you that have been in this kind of process in the past, when something has gone wrong -- say in Europe, with one of your imports -- have you been able to make that case, that yes, this is part of what happens; it's okay, and have your consumers and have your Parliament and have your -- the people that look over your shoulder, have they been willing to accept the fact of looking at a system upfront as opposed to not having the magic bullet that says, this is the metric for an outcome.  Are they willing to accept this kind of upfront look at a system as adequate and acceptable for establishing trust?

CARLOS ALVAREZ ANTOLINEZ:  I think I'm going to make a habit of speaking before Bill.  That's my purpose in life now.  But honestly, on this then, I think that we need to understand and to accept that the same principle which applies domestically applies when it comes to food imported.  You cannot have 100 percent safety.  There are problems, and this happens here or wherever. 

So what you cannot expect this to have except that you have to deal with food incidents from time to time in your own domestic production, and then to try to establish a system which provides you is going to bring you 100 percent certainty from imports.  This is not going to happen.

So I think that in this regard, it is undebatable.  It has to be accepted.  It has to be understood.  Now, in our system, and coming back to what I said earlier, we have a very different approach, animal products, non-animal products.  In the case of animal products, we need to audit the countries; we need to establish a list of establishments, ones the country has been listed, and also certificate. 

So the authorities also define that everything in line with our requirements, so this provides a very robust normally system of guarantees.  If something goes wrong, we will examine why this happened, and we may need to take measures.  In some cases, if this denotes or represents a systematic failure of system, then we need to take what we call emergency measures. 

Now, it is completely different in the case of plant products or products of plant origin, where we don't have this system of approval in the countries.  So require the listing of the established source.  So it's a much more flexible, super-loose system, if you want.  The responsibilities with importers, they have to make sure that things are right.  And of course, if something happens, we will go through the systems, we will channel through the chain, and we will investigate whether there is a systematic governance.  But it's a completely different world.

ANN GREEN:  I'm just going to go down the table.  You have the same situation now under a border protection.  You have a product come through.  How do you react differently? 

I think the question has to be, is the assurance provided by the government with potentially even enough communications for advance notice, that they found something in telling you, going to give you more protection or less?  I think it's not, how do you react if it's going to fail in the assurance process.  It's really a question of, which one are you better under to meet your objective of public health?  If you're better under a system where you have assurance and communication and ongoing assessment that there's a responsive system on the other end, looking for those same products and same problems, and we'll tell you as soon as possible, not wait for you to find it, your public's probably better off in meeting your objective.

BILL JOLLY:  I'd like to bring three wise men to the table.  And I can't remember who it is --

ANN GREEN:  You mean, I have to leave?

BILL JOLLY:  You might like to interpret it as that.  There's an Arab saying, trust in God, but tie up your camel.     And one of your presidents also said, trust, but verify.  And the wisest of all, of course, is Murphy, who said, despite what you do the proverbial happens.  And I think we're all going to have instances at our border or associated with imported foods, just as we have in domestic systems. 

And the question's really in a hierarchical order.  Was it something that the importer should have foreseen and controlled, first and foremost?  Secondly, as a government, why were you confident that that commodity or imports from that country was unlikely to cause undue risk?  And are they more likely than your own system? 

And then but more importantly, when those things happen, and to take up Murphy's point, is what are you doing about them, and if all you're doing about them is putting pressure on a single importer, to put pressure on a single exporter, that's not a very good answer.  If you can actually say that you're cooperating with the other country, to find out the problem and to learn from it and put protections in place, et cetera, then that's a far more politically acceptable situation.

Now, we've been in that situation on numerous times in animal health issues.  To give one particular example, we had a threatened release of an animal disease, and we went into full emergency response.  We went and told all the countries we had this.  We said, we didn't think it was likely, but we went out and told them.  And ultimately, it hadn't been released.  It was one of those sort of situations.  But the fact that the regulators around the world could say to their politicians, the New Zealand regulators have been in touch with us; they've told us of this threat; they are monitoring; they are doing this, this, and this.  I mean, that issue never got out of hand.  And I think that's important when you're dealing with Competent Authority, Competent Authority. 

MARY STANLEY:  Mary Stanley with FSIS.  And Bill, I was going to pick up on the point in regard in your comments, the design prototypes for both the ICAT as well as the tool that we use, recognizing that Excel is just a pilot-type program.

But I was curious, do you have any ideas, recognizing -- and this is speaking to other comments that Mary Ann and Carlos also said -- the ideas, this approach may go global; other countries may want to pick up on this process.  Hopefully they will, and so if each designs a different tool, then we are going to be instead of entertaining people coming into the countries, they would be filling out the tools.  So I was just wondering if you've given any thought to that and have any suggestions. 

BILL JOLLY:  Okay.  The Excel comments, of course, is really just a logistics issue, and that can be solved by a different program.  The work we're doing in quads and UK, looking at taking what is in the self-reporting or self-assisting tool for the FSIS, taking what's in the ICAT and taking what's in some other country systems, the EU, particularly, and putting them into a much more conceptual basis, will allow that to be a much more universally applied system.      Now, it will still be populated to some extent with your own statutes and regulations, but at least there will be that commonality of elements -- maybe just a hierarchy of what you're trying to achieve above and beyond your statutes.

So I think that's an important thing, and that's why we're doing that work, and that's where the quads and the EU cooperation, just as it has been in the equivalence field, is just so, so important.

ANN GREEN:  I think what Bill said is absolutely true.  We're going to be working through, but again, coming back to a lot of the comments that were stated this morning and the statements in FSMA -- the Food Safety Modernization Act, around using international standards,.  I would see that some of the work that CCFICS does and may do in the future around the control systems, how we look at elements, what are key areas of national food control systems, and perhaps even future works may come into how we look at systems recognition -- is it at the level of maturity that we are all on the same page and moving forward? 

I can't answer that.  That's a theory esoteric question at this point, but looking into a crystal ball, that's where I'd say it would go.

CARLOS ALVAREZ ANTOLINEZ:  I just want to say, I think it has some potential. It should be explored.  The one thing I'm sure is that if it is successful in our case, we will speak very positively all day, so you can count on this -- and this is a joke, of course.

MERTON SMITH:  I have a question for all of you.  Julie mentioned that her dream, her ultimate dream, I guess one of them, is that we would find comparability of the comparability assessments.  I'm just wondering, we know that the EU audits a lot of countries shipping to the EU and within the EU, and the rest of us have been auditing and looking at the comparability, or beginning to look at it.  How much are we studying these assessments done by other countries, the U.S. and all of you at the table?  How much do you look at each other's assessments to help you determine whether you have more confidence in food coming from that country?

BILL JOLLY:  I'm going to start this one.  We worked out a long time ago, we couldn't go and visit every country and every single premises, and so we've been looking to partner with the likes of EU and the U.S. and Canada and Australia on when they do an assessment.

Now, on the food safety side of things, it's much easier than animal health or plant health.  But some of our standards now -- I'll take an example.  The EU, we have this sanitary agreement, which is a full treaty status, and under that sanitary agreement we've got multiple equivalence determinations.  Now, these are system equivalence determinations -- comparability system determinations, whatever you'd like to call them.  And on the basis of that, when another country meets the EU's requirements, then we will triangulate that and say they also meet ours. Because we've already assessed, if it is one of those commodities or systems, that the EU meets ours, and it's safe.

So we're working that way, and we've actually extended it much further in our free trade agreement negotiations, so that we're looking at linking up and triangulating all these type of systems. And it's just another way of harmonization.  International standards is one, but this sort of not trying to reinvent the wheel and utilize each other's assessments, is a great way of doing it.

One caveat.  We look for the positive, because different countries do different assessments for different reasons, and sometimes what's important for one country may not be important for another.  It might be a peculiarity of law.  And so you've got to be careful when you read audit reports.  I've never read a good audit report yet, except for maybe ours.  And so you've got to actually look behind that and actually, what is the outcome and what's being achieved. 

ANN GREEN:  I think we all to a certain extent where there's publication of audit reports, go in with interest.  Whether or not they're good, bad or indifferent, you still tend to look at them and read them to get an indication.

I think one of the things with the system recognition, you can build into it as part of your process.  Would you be interested, how do you work on it.  You can work on that comparability as part of that review.  We've done joint audits with other countries.  Sometimes there's same audit reports; sometimes they're different audit reports.  There are logistical problems in the sense of, you have to be very clear on what you're doing, how you're doing it.  But it's one tool you can use.  With regard to, if you've got confidence and you're moving with, in through a process, you can say, this is how we're going to be approaching it.

Other areas, as Bill said, you just say, a friend of a friend is a friend.  I know that we, Canada works very closely with regard to the shellfish, and in fact, lists all the plants or only allows certain plants that are on the shellfish list into Canada.  We don't audit them all.  So again, it really is a flexible tool, and I think it needs to be built into the process if that's where we want to go.

CARLOS ALVAREZ ANTOLINEZ:  I would agree, if your reports are normally very good, but some are better than others.  No, I think that this is an area which has a lot of potential, actually.  I think that it happens in other sectors, pharmaceuticals.  There is a level of cooperation as regards inspections between the U.S. and the EU, which works very well.  There is no objective reason why this could not be extrapolated, but there are some challenges and difficulties.

And we would be interested, because actually we carry out the inspections all over the world, 200 or 250 countries, export into the EU, plus all the inspections or all the audits we conduct within the EU. And we have 90 inspectors, and they conduct about 200, 250 inspections or audits per year.  That's all we do.  So I think that we could also benefit from some synergies with other countries.

DR. STEVEN SOLOMON:  Camille, I'm checking with you, sensitive to our time.  Where are we at?

CAMILLE BREWER:  One quick question.

STEVEN SOLOMON:  I'll take the last one, then.  The resource issue, you all touched on it, and what I thought I heard clear from your presentations is, there's a big upfront investment in the resources that are necessary.  But on the benefits side, what I thought I heard was, it's anticipated where the program will not be successful unless there are these resource benefits in the long run.  Either on comparability or on equivalence, does anyone have any data to be able to support that long-term resource saving?

ANN GREEN:  I'm not sure it's hard data that I could pull out and use, but in terms of some of the programs that we worked on where we had arrangements where we were doing 100 percent inspection and we put the investment in with a country that was exporting to us, to that they would cover off with their systems.  And we did check.  We did verify.  We're not completely naïve, and we ended up with 100 percent compliance of the product coming in, and we completely switched those resources that were an ongoing drain.  And laboratory analyses are excessively expensive. 

The industry wasn't as happy with us, because there were still delays and problems, but we did get some kudos for shortening it, from our lab analysis to something pre-border.      So  anecdotal, agreed, but it does take upfront resources, and not all of the skill sets may be readily available for those resources to be put upfront.

BILL JOLLY:  I can give just one export R&D example.  The reason why we all got into sanitary agreements or veterinary agreements, depending on the agreement, with the EU, was they introduced a new better law which said for these high-risk or high regulatory interest products, that we're going to go to a I think, 25 percent inspection at the border, unless you had an agreement of some sort. 

And the success of those assessments and those agreements for the high-risk products, the meat products and the like, has been that I think we're down to about either half or one percent inspection and that's a bit like an FSIS inspection.  Most of those are actually just a documentary check.  And similarly, the FVO now comes to New Zealand much less frequently and comes and audits our systems as a whole.

And so there's been cost savings both ways, and yet there has not been any identified increase in foodborne illness associated with imports either way.  And we we've removed a redundancy or a façade out of the system while still maintaining a level of confidence, and the consumers on both sides seem to be pretty happy.

CARLOS ALVAREZ ANTOLINEZ:  Just let me say it from our perspective.  Veterinary agreements, (inaudible: 2:23:46) -- this is generally a good investment.  It provides the framework for further work, which will probably be done at the level of domestic approach in some public health sectors.  So it is -- we don't have that many.  We have Canada, New Zealand.  We know that they work very well.  We have the one with the United States.  I think we cannot be very, very positive about the outcome of this agreement so far, but we still think that it has potential, and we are optimistic.  That's all I can say

STEVEN SOLOMON:  Thank you, all for your insights.

CAMILLE BREWER:  I have about ten of.  Why don't we come back at 4:05.  Thank you, panelists, thank you inquiry team.

(Whereupon, a brief recess was had at 3:50 p.m.)

CAMILLE BREWER:  Could we have the folks that will be supplying testimony up front, please?  Could you please come down, Mr. Robert Bauer, Patience Eke, Anthony Corbo, Linda Rheinstein, Darryl Sullivan, Pat Waldo, and David Plunkett?

(Pause.)

CAMILLE BREWER:  Okay, shall we begin?  The first presenter -- the first presenter -- may I have your attention, please?  The first presenter will be Robert Bauer from the Association of Food Industries.

ROBERT BAUER:  Hi, my name is Bob Bauer.  I'm the President of the Association of Food Industries.  AFI was formed in 1906 and we are a trade association of approximately 850 companies that are involved in the food import business.  I want to thank FDA for putting this on today.  And everything I've heard today totally changed what I had come prepared to say, so I'm kind of winging it.  Very encouraged by what I've heard, and talking with other people, it's the same thing. 

Time is one thing we wanted to bring up.  As been mentioned, there's so much involved in what it is that we're talking about today.  But there will be times when it becomes a competitive advantage, with one country already having either a leg up or already being approved and that sort of thing, so there could be some issues there with timing factors.  So we think there needs to be accountability for FDA and accountability for the other countries.  Maybe accountability's not the right word, but some sort of parameters where we realize, too, that the scope of what's being looked at can vary from country to country.  But there has to be some sort of idea and some sort of roadmap planned out so that the expectation can be there as to what should happen.

Tangible benefits was another subject that was mentioned, and if people are going to go through all the effort that's involved here, yes, there definitely should be some tangible benefits.  But also as was mentioned before, if a company in a less developed country or a company or the example used this morning, of searching the world for a new and unique product coming from a country that's not in this process, there needs to be a lot of coordination between all the various components of FSMA to make sure that that company has the opportunity to still get the benefits of complying with FSMA.

And then another point that we were thinking we might have to make a little stronger before today, but it's great to hear that equivalent is not meaning identical, because we've seen some issues over the years where that has been a problem.  So we're grateful to hear that that is not an issue there.  And then, one thing that wasn't brought up.  It triggered our mind when we saw that there was going to be some Codex discussion here.  It's a somewhat related matter.  Speaking with people involved in exporting food to the United States, one recurrent theme is the need for standards of identity for more food products.  This would help improve food safety, because it would spell out in black and white what is allotted a particular product, and it would also have the added benefit of combating economic adulteration.

Frustration level is even greater when there's a Codex standard for the product in question and the U.S. has supported adoption of that particular standard.  Why, people ask, does the United States spend the time and money to participate in Codex activities but never seek to adopt a Codex standard as a U.S. standard of identity?  In cases in which there's widespread industry support to create a standard of identity for a product, particularly in cases in which a pro standard is identical or nearly identical to a Codex standard.  Supported by the U.S., the process should be fairly cut and dry.  So in the interest of time, we'll wrap it up then, but I thank you again.

CAMILLE BREWER:  Thank you, sir.  The next speaker will be Patience Eke from Tastee Limited.

PATIENCE EKE:  Good afternoon, everyone.  I am talking from a different point, as a developing country, where we're really been bombarded by EU, USA, Canada, other countries with different regulation.  And we're at the point where actually we're confused.  We do not know which way to go.  I'm hoping by the time I leave here today, I will get a good answer on which way to go. 

Usually, food safety in Jamaica is governed by different laws, acts and regulations.  We have the food handling establishment regulation that is manned by the Ministry of Health.  We have Food Storage and Prevention of Infestation Act by the Ministry of Commerce.  We have Bureau standard manned by Ministry of Commerce, animal and animal products, that's Veterinary Division of the Ministry of Agriculture.

How does this regulation affect Tastee?  I just chose one of the largest food processing company in Jamaica.  Inter-Shores or Tastee Limited, is a food processing company located in Jamaica, West Indies.  They have product or pattie that consists of crust -- that is dough, and a small quantity of cooked meat.  Where do they get their meat from?  Currently, they import beef trimmings from Australia and United States.  Other ingredients, like dry seasoning, mill, imported from the U.S.  But we pause here, while we put (inaudible: 09:48) -- maybe I really got a little bit answer from Mary this afternoon, where dough, the meat sauce comes from U.S. and Australia, yet are we being restricted from, or we're being prevented from exporting these products to United States.

Jamaica food safety requirement.  Import and export permit is authorized by the Ministry of Agriculture.  That's listed on our comparability.  The permission to process food for exports and local market is the responsibility of Bureau standard.  Food handling establishment regulation is enforced by the Ministry of Health, and the infestation is monitored by the Ministry of Commerce, as I said.  Though we have these different agencies, we still corroborate in achieving food safety.

This slide is samples of what we have.  This comes from the certification from the Ministry of Health on that food-handling establishment license.  And we have the food storage and prevention of infestation from Ministry of Commerce.  We have Bureau of Standards for the exports and food processing plants. 

We can see FDA certificates, too that (inaudible 11:10).  This just a picture of the products that has been produced.  Now, we have food for thought, and we are saying with all these stringent food safety measures in Jamaica, why do we still have barriers in exporting food products to USA?  Thank you.

CAMILLE BREWER: Thank you, Ms. Eke.  Next we have Anthony Corbo from Food and Water Watch.

ANTHONY CORBO:  Thank you very much.  I'm Tony Corbo, lobbyist for the food program at Food and Water Watch.  We're a nonprofit consumer organization, and we have offices in Washington, D.C., San Francisco, Brussels, and after hearing today's presentation I think the next office is going to be in Wellington.  Just to keep an eye on you, Bill.

I also want to thank FDA for holding this meeting and allowing me speak today.  Both the Deputy Commissioner for Foods and I are avid baseball fans, and I accosted him a couple weeks ago, and asked him how dare he hold this conference where it interfered with the opening day of baseball season, which is tomorrow.  And he told me that I should get my priorities straightened out, and I won't tell you what he suggested that I do. 

The Food and Water Watch has been very active in looking at the issue of imported food safety.  On the FDA side, we did three reports over the last five years that focused on what FDA was in fact doing to determine whether imported food was safe, and focused on seafood and also produce, and you can find those reports on the Web site.  But we've also been very active on the FSIS side, much to the chagrin of some of the folks at FSIS.  But we do actively participate in the equivalency determinations when they post those for public comment. 

And I do want to complement Mary Stanley, because I think she did an excellent job in laying out the program at FSIS.  It is a transparent system.  The fact that they do post the audits; they also post the establishments that are eligible to export to the United States, and even will post those establishments that have been de-listed.  The Web site is just chockfull of information.  I'm usually looking at those audit reports or the establishment page a couple of times a month; sometimes several times a week.  But it's just chock-full of information.  And the fact that the process is open, that you have a regulatory process where the public can comment, also adds to the transparency of the equivalency process there. 

And so I wanted, highly recommend to FDA that you look at what FSIS has done in terms of providing the public information.  When the Federal Register Notice came out regarding this meeting, the whole concept of comparability was something that took a lot of us by surprise.  And you heard presentations today from folks indicating, where did this concept come from, and where does it fit with equivalence.  And so I hope that -- this is the first meeting, and I hope that there's going to be additional meetings as you flush this concept out. 

We learned that they're pilots.  This is the first time we've heard about pilots.  You all had a pilot dealing with third party certification for shrimp -- don't know where that is.  So we hope that as this process evolves, as you start implementing the law, that more information comes out in terms of what the thinking is of the Agency.

I want to address one issue that I think Dr. Solomon raised about revoking equivalency.  This has been one of the sore points with our organization, as far as the FSIS process.  I won't name the country, but there's one country that has a meltdown.  You can set your clock to it, every two years.  FSIS will do an audit and find a complete system breakdown, and they'll send their audit teams two and three times the same year to try to fix the problem.  And the system is okay for the next year, and then when the third year comes, there's another meltdown. 

And so at what point are we spending money to prop up a system that's not sending safe food to the United States and is not complying with our standards?  At what point do we revoke that equivalency and make that country go back, go to the end of the queue to country number 35 that is waiting for equivalence to be determined.  And so that is an issue that I think if you look at the concept of comparability, what's the standard?  And we may supply comments on this -- what is the standard to revoke the comparability? 

The last point is that -- I want to reiterate what Caroline Smith DeWaal said earlier.  From a consumer perspective, our preference is to have the FDA do the inspections.  If you wind up enlisting the help of other federal agencies that are abroad, that will be the second tier.  The third tier is to have the foreign governments do the certification.  We do -- my organization, in particular, has a problem with certifying private third party entities.  And I think that we're going to be probably supplying a lot of comments in terms of that aspect of the law.  So with that, I want to thank you very much.

CAMILLE BREWER:  Thank you, Mr. Corbo.  Next, we have Linda Rheinstein from the iDoggiebag Foundation.

LINDA RHEINSTEIN:  Hello.  Thank you, ladies and gentlemen of the FDA.  A picture is worth a thousand words, and borrowing from Billy Joel -- Jolly.

(Pause.)

LINDA RHEINSTEIN:  Murphy's law does come into effect all the time.  I'd like to help us with Murphy's law.  So without further adieu. 

(Pause.)

LINDA RHEINSTEIN:  I'm sorry; the statistics are a little outdated; I apologize.  I didn't get your most recent ones.

(Video playing:)

LINDA RHEINSTEIN:  Hello, my name is Linda Rheinstein.  I'm a multiple Emmy-award winning sports producer, nerd, and the founder of iDoggiebag Foundation, where 100 percent of our proceeds go to the food safety for people and pets in the cure and care of cancer.  The reason you are hearing my story today is both complicated and bizarre.  I fed my healthy pet cat Nipper Procter & Gamble's Iams pet food in December of 2006.  Shortly thereafter, Nipper went into kidney failure.  Turns out the food I gave him was part of the March 2007 mass recall of the melamine-tainted pet food from China.  However, to the detriment of thousands and thousands of pets, in November 2006, the food was already known to have been contaminated -- four months prior to the actual recall. 

And this is why it really matters to me.  Nipper had a seizure due to his food-induced kidney failure in May 2007.  Unfortunately, inadvertently, Nipper bit me on my forearm.  I was sent to the ER as the infection from the bite moved up from my right arm towards my heart.  As you can imagine, it was a very scary time, and Nipper died.  .

Flash forward to August 2007.  I go for my annual mammogram, and the doctor sees something abnormal.  My host of doctors ask the same question.  Have you had a trauma to your right side?  I mention the cat bite.  The long and short of it is, my small, slow-growing stage 1 cancer was spread by Nipper's bite to a fast-growing stage 2 lymph-node involved breast cancer.  What that means in terms of treatment is, from a simple surgery and maybe a little radiation, I am here today after five surgeries, 16 weeks of chemo, followed by eight weeks of radiation, and I'm on oral chemo for five to ten years.  I'm here, my hairs is back.  My passion to help protect people and pet's food has only grown.

We all know food safety and foodborne illness is truly now a global issue that affects tens of thousands of people, and pet's lives, along with some very negative economic impact.  It is not about scaring people or hurting the economy, in my humble opinion.  It's about making all of us more aware and learned about our and our pet's food supply.  One of the iDoggiebag Foundation's missions is what we call the Nipper Alert -- a two-way global contaminated food and feed alert, an all-clear for people and pets.  Think Amber Alert for food.  Looking for advice on how best to get the Nipper Alert activated, I call one of my sports friends, who put me in touch with Steve Largent, from the Amber Alert.  Steve's simple advice was two-part:  get the media.  So we enlisted the support of Betty White, Shari Belafonte, a few professional sports leagues and broadcasters, and one key partner -- the National Association of Broadcasters, NAB, has agreed to send Nipper Alerts and PSAs to all their thousands of TV, cable, and radio stations.  We are working with programmers in academia to create applications for Smartphones, pads and RSS feeds for the Web, allowing us not only to alert the public, but also help us to be alerted by the public, helping to spot possible local trends of contamination, which can then be activated as a local alert.

Second piece of advice from Mr. Largent was, get the government involved.  So we started with Congressman Waxman, moved on to Senator Boxer and Feinstein, Secretary Sebelius and President Obama.  Hence, why iDoggiebag has supported the efforts, giving the FDA more control over our food safety.  So that, ladies and gentlemen, is why I'm here today -- go find out how we work together.  We do not want to create scare tactics, but reliable alerts, and just as important, we feel, is a reliable all clear.  It's okay to eat the food again.  An all-clear, we feel, also has to come from the FDA. 

Part of the iDoggiebag Foundation's mission is to raise monies, use the power of technology, information, and the passion of a survivor to run 24-hour, 7-day a week, global to local contaminated food and feed alert and all-clear, and help educate people about the new global food chain for people and pets.  The unchecked facts about nuclear food contamination has already begun.  So how do we get started working together to save people and pet's lives, and help take some pressure off the already overwhelmed healthcare system?  Thank you, ladies and gentlemen.

Thank you.

CAMILLE BREWER:  Thank you, Ms. Rheinstein.  Next, we have Darryl Sullivan from Covance Labs.

DARRYL SULLIVAN:  Well, I can't beat that video, but thank you very much, FDA, for allowing me to make a couple of brief comments this afternoon .  I work for Covance Labs, which is an international contract testing laboratory, and I'm also on the Board of Directors of AOAC International, which is the organization that provides standards for laboratory testing methods and for laboratories. 

Industry is going to rely very heavily on my company and companies like mine for laboratory testing services in the implementation of FSMA.  And the Act itself does permit use of independent third party laboratories if they're certified.  The belief in the industry right now is that that certification is going to be based on ISO 17025 standard, and I want to make a couple of comments about that and maybe a little bit of caution.

As we look at testing being done in the U.S. and in other countries as part of the cooperative efforts in comparability, ISO 17025 is a very vague standard, and it in fact is implemented very differently in the U.S. and in other parts of the world.  So I would suggest that we probably need some additional rigor in the process to certify testing laboratories, probably both in the U.S. and in other countries, probably some more robustness.

Now, on the other side of the agency, FDA has a very, very rigorous protocol for testing the safety of drug products.  The FDA Good Laboratory Practices is used actually very effectively around the world and very consistently.  It is a highly, highly rigorous protocol.  And maybe we don't want to consider that level of standard, but there's probably some lessons to be learned there for our use in certifying laboratories in the area of food safety testing.  So I would suggest there may be some things that we want to look at there. 

As we look at laboratories that are operating in other countries, I hope we can be cognizant of the fact that all of these countries have standards and certification, agencies and bodies that will require certain levels of certification for these laboratories.  So as we look at comparability, I'm hoping that we can reach a system so that the laboratories won't need to have the FDA certification and the certifications that are required in each of these individual countries, because they are different and they are required in each of the individual countries. 

At the same time, as we look at test data being generated in foreign countries, there's considerations that need to be given to those foreign governments.  If you're testing on their soil and you're testing food products that are manufactured in their country, they're going to have an interest in that data.  Now, typically in my world when I'm doing contract testing, the data belongs to the food company that has manufactured the food product.  In the cases of some foreign countries, they're going to be claiming some ownership of that data.  FDA's also going to have an interest in that data.  So I think it's important that we clearly define the protocol of how this data is handled and what the channels are for getting access to FDA and making sure that the food companies maintain ownership of this data.

Whatever process we consider or is looked at as the process moves ahead with the Act, as we certify laboratories for testing -- and this will apply to in-house laboratories, contract laboratories, both in the U.S. and other parts of the country -- I would suggest that we need more than just approval of their systems and their processes, but we need to look at an ongoing approval of their proficiency and their performance, something that demonstrates an ongoing successful performance to these laboratories, because frequently a snapshot of their systems and the way that they're operating isn't sufficient to maintain a level of confidence in the quality of data that's generated over any significant length of time.  So thank you very much for your time.

CAMILLE BREWER:  Thank you, sir.  Next we have Pat Waldo from Decernis.

PAT WALDO:  Thank you very much.  My name is Pat Waldo.  I'm CEO of Decernis, and I'm speaking very much from the perspective of a company very much involved in the weeds of comparing international systems.  We have been involved with a comparison of food safety control requirements in about 130 countries.  And so as a brief introduction, Decernis provides research and information systems for global compliance with product safety requirements.  And we have clients in 46 countries. 

And our information systems are updated daily and seek to meet three objectives:  first, to provide a reference information source to understand what compliance obligations must be met in a global marketplace; and second, to provide enterprise systems to analyze and support business-to-business declarations of certification and compliance; and third, to support change management to provide early warning and issue management.

So in looking at FDA's program of establishing international comparability assessments, we very much support that, and we believe that there is series of practical ways of approaching that.  But in so doing, there are two basic areas of challenge.  One is the challenge of complexity, where the legal system, the scientific approach and the cultural difference from country to country varies enormously; and second, the challenge of maintenance.

So a couple of recommendations in addressing that.  One is landscaping of program selections.  We recommend that FDA conduct a landscaping exercise of those countries and sectors where the risks and benefits of moving forward support a detailed international comparability assessment.  So we're differentiating between a broad review and a detailed information that would support an international comparability assessment.  And based on our work in conducting similar global landscaping for FDA, there is very much a need for incentives, both to the participants as well as downstream to the effects of that landscaping and participation that make it worthwhile to engage in the assessment.

A lot has been discussed about the criteria of equivalence or comparability, and I won't get into too much more detail about that.  I guess what I would comment on is that there is a great benefit to looking at the depth of the review as well as the nature of the review, whether you have decided that you wish to pursue equivalence or comparability, and however those criteria are defined.

And out of that exercise of looking at these different international programs, we believe and recommend that FDA adopt a systems approach where the information can be used for further purposes.  So to be able to take the international comparability assessments, the content, the conclusions, the methods contained in the assessment, should be actionable.  And by that I mean used by others, whether on a bilateral basis with relevant government or interoperable with enterprise systems that are in use, or to support the maintenance of auditing.

So I think that there is a tremendous benefit to the use of the information that's collected and to approach that in a highly structured way to adopt a systems approach that this would make the international comparability assessments actionable not simply in a policy perspective, but actual for the supply chain.

Finally, maintenance, just a comment there.  With regard to the challenge of maintenance, I think -- there hasn't, at least from what I heard, not been too much of a discussion there, but I believe that that is a fundamental aspect.  It is one thing to do the assessment once.  It's another to define how it will be maintained.  And so a dynamic means of updating the international comparability assessment should be considered for the use and the continuity of these kinds of assessments. 

One approach is to establish an active notification regime similar to technical barriers of trade.  But in the case here, where human health is at stake, you may want a much more dynamic principle at work, and therefore there has to be a means of communication, consultation, and reaction as part, built into the maintenance of the system.  And therefore, I guess at rock bottom I would suggest that by whatever criteria you establish, that if you develop an information resource which becomes actionable per se, as well as a system for maintaining that, that that would have this program have far-reaching effects.  Thank you very much.

CAMILLE BREWER:  Thank you, Mr. Waldo.  Our last presenter is Mr. David Plunkett from the Center for Science in the Public Interest.

DAVID PLUNKETT:  Thank you.  Thank you, FDA, for holding this meeting.  I'm David Plunkett, Center for Science in the Public Interest, and I had actually not come to anticipating comment.  I had actually come to take notes in the back and carry them back to my office for research and perhaps later comment.  But in listening to today's presentations, I was concerned to learn that one of the pilots that is being used for comparability is the Molluscan Shellfish Program, and with EU and with New Zealand. 

That's an area where I have been working for some number of years, and there's an ongoing public health issue here in the U.S. with vibrio vulnificus in Gulf Coast oysters, and it's a risk that's likely to occur, but it's a risk that's not controlled by the Seafood Hassock Program.  As U.S. consumers, we don't think the U.S. program is strong enough to support a comparability assessment.  So it's a concern that comparability may be used or may not be robust enough a system to protect the public.  It may result in decisions that bypass serious public health consequences if not properly implemented, and I wanted to raise that concern after hearing the discussion today about that particular pilot.  But thank you.

CAMILLE BREWER:  Thank you, sir.  And with that, we will conclude the public testimony portion of our program.  I'd like to turn to Dr. Solomon.  Do you have any closing remarks?

STEVEN SOLOMON:  No, we appreciate all the input from everyone today, and we've taken lots of notes.  I think there will be further information forthcoming, and you're going to talk about tomorrow' schedule. 

CAMILLE BREWER:  Yes, we invite you all back tomorrow.  We're going to conclude the comparability discussion.  We'd certainly appreciate you staying.  You are indeed the hale, hearty and steadfast, so I'm quite pleased and surprised that you're all still here, so thank you for that.  I know that there have been questions about the slide sets.  Unfortunately, we can't put them on the web, because they're not all 508 compliant.  But we'd be happy to send them to you all, so if you'd like to leave your card at the front desk or write your e-mail down, we would be pleased to send them to you. 

Now, with respect to next steps on comparability, I want to remind you that there is an open docket.  It will close June 29th.  We hope that we've given you some grist for the mill.  We hope that you will go back, think through the issues that were raised today, and send in formal comments.  Indeed, your comments will help us determine next steps.  Obviously, we have a number of decisions to make, and stakeholders, you most certainly can inform that process.  So thank you once again.  It's been a pleasure, and we'll see you tomorrow.

(Whereupon, the hearing was concluded at 4:47 p.m.)

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CERTIFICATE OF COURT REPORTER

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