1
Docket FDA-2008-D-0058
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          5             Public Hearing:  Listeria monocytogenes 
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          7   
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          9               Date:         March 28, 2008 
         10               Time:         9:00 a.m.  5:00 p.m.
         11               Location:     FDA
         12                             51 Paint Branch Parkway
         13                             College Park, MD 20740
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          1        MR. LANDA:  Hello.  I just want to make sure it's
          2   working.  But I think we actually should get started, so
          3   if people would take their seats.  You might even
          4   consider moving up a little closer to the front of the
          5   room.  Just consider it.  You don't have to do it.
          6        UNIDENTIFIED MALE SPEAKER:  Guidance.
          7        MR. LANDA:  Yeah, guidance, right.  Any other
          8   method of complete compliance is acceptable.  I'm told
          9   we're not going to have a full house here today so I
         10   think I will get started.
         11        My name is Michael Landa.  I'm Deputy Director for
         12   Regulatory Affairs at CFSAN.  Let me welcome you to the
         13   Wiley Auditorium in the Wiley Building.  And you may, if
         14   you choose to, have lunch in the Wiley Cafe.  I'm sure
         15   you'll be most welcome there.  It's just outside the
         16   building as you come in.  It's the closest place to eat;
         17   although, I think there is a list of restaurants in your
         18   packet.
         19        We're here today, of course, for the public meeting
         20   on Listeria monocytogenes.  On February 7th, FDA issued
         21   for public comment a draft compliance policy guide
         22   directed to FDA staff.  If it's finalized, the CPG will
                                                                        3
          1   establish FDA enforcement policy regarding Listeria
          2   monocytogenes in food.  A copy of the draft CPG is in
          3   your packet.
          4        We prepared the CPG following up on a risk
          5   assessment we did.  It was conducted in collaboration
          6   with FSIS and in consultation with the Centers for
          7   Disease Control and Prevention.  The purpose for the
          8   assessment was to systemically examine available
          9   scientific data and information to estimate the relative
         10   risk of serious illness and death that may be associated
         11   with consumption of different ready-to-eat foods that
         12   may be contaminated with Listeria.  The risk assessment
         13   showed that risk consuming Listeria-contaminated food
         14   varies depending on whether the food does or does not
         15   support growth of the organism.
         16        Foods that support the growth of Listeria are
         17   relatively high risk.  Foods that don't are relatively
         18   low risk.  The draft CPG is intended to provide a clear
         19   enforcement policy and regulatory guidance about
         20   Listeria in certain foods.  In particular the policy in
         21   the draft CPG would direct FDA staff to consider legal
         22   action if high-risk RTE foods contain detectable
                                                                        4
          1   Listeria or if low-risk RTE foods contain a hundred or
          2   more cells of Listeria per gram of food.
          3        It's important to recognize that the policy in the
          4   CPG, if adopted, would not establish an acceptable level
          5   of Listeria in food and that the enforcement strategy
          6   would not supercede existing legal requirements.  For
          7   example, compliance with current good manufacturing
          8   practice requirements, in general, as reflected in 21
          9   CFR, Part 110 would still be required.  Most RTE foods
         10   don't contain detectable numbers of Listeria.  For many
         11   RTE foods, Listeria contamination can be avoided by
         12   applying current good manufacturing practice.  To
         13   complement the enforcement policy and to assist the food
         14   industry in ensuring that production procedures do not
         15   contribute contamination from any source, we also issued
         16   for public written comment a draft guidance to industry
         17   on control of Lm in refrigerated or frozen RTE foods.
         18        The draft guidance describes factors, technologies,
         19   procedures and practices that have been identified as
         20   providing control of Listeria during the manufacture,
         21   distribution, marketing and use of RTE foods.  The draft
         22   guidance recommends ways to reformulate high-risk foods
                                                                        5
          1   so that the foods become low risk.  Since the release of
          2   the risk assessment several years ago, some foods have
          3   already been reformulated to reduce their Listeria risk.
          4        The CPG clarifies which foods support Listeria
          5   growth. This will help ensure that FDA's resources are
          6   focused on these high-risk foods.  We anticipate being
          7   able to increase our periodic sampling and testing for
          8   Listeria to assess compliance with the organism limit
          9   for low-risk foods, even as we continue to focus our
         10   inspection and outreach efforts on high-risk RTE foods
         11   manufacturers.
         12        We're holding this public meeting to discuss and
         13   share information about the Listeria enforcement policy
         14   as reflected in the draft CPG.  This morning we have a
         15   number of speakers who will provide you with background
         16   in the science underlying that document.  We also have a
         17   panel of FDA staff panel members.  You may have
         18   questions for the speakers this morning.  This afternoon
         19   the panel may be available to -- will be available to
         20   answer questions about the draft CPG.
         21        Throughout the morning we'll have cards available
         22   to submit your questions about the draft CPG.  Please
                                                                        6
          1   pass these note cards to the FDA staff facilitating this
          2   meeting.  This afternoon our staff will go throughout
          3   the auditorium collecting cards to pass to me.  You may
          4   give questions to any staff helping with the meeting. 
          5   You can identify them by their blue nametags.
          6        After the afternoon's question-and-answer period,
          7   you'll have an opportunity to comment on the draft CPG. 
          8   If you wish to make comments but didn't register in
          9   advance to do so, please inform any of the staff at the
         10   registration desk outside.  We'll accommodate these
         11   additional requests to the extent time permits.
         12        The topic of today's meeting, again, is the draft
         13   CPG, so we ask that you limit your questions this
         14   afternoon to the draft CPG.  We will not be entertaining
         15   questions on the draft guidance to industry, but we do
         16   encourage written comments on that document, as we also
         17   encourage them on the draft CPG.
         18        We had several requests to extend the comment
         19   period for both the compliance document and the guidance
         20   to industry document.  There really isn't any need to
         21   extend the comment period.  The comment period for
         22   guidance documents does not close as it does for
                                                                        7
          1   informal rulemaking.  In a sense the docket's always
          2   open.  So, there isn't any need.  Nor do we extend the
          3   comment period for guidance documents, but we do
          4   recognize that today's discussion, which will be
          5   transcribed, may provide you with information that could
          6   be important in developing written comments.
          7        We'll begin considering written and oral comments
          8   soon after they're submitted and we do not expect to
          9   finalize the CPG or make a decision about it until
         10   there's been a reasonable time for the public to access
         11   the transcript. Let me just -- before we have our first
         12   speaker -- get some housekeeping details.  The schedule
         13   is fairly tight so we've got a timekeeper who will
         14   notify speakers as their time is coming to a close. 
         15   Daria Kleinmeir (ph) is on the first shift; Cynthia
         16   Leonard (ph) is on the second shift.
         17        You all by now have should have folders containing
         18   an agenda, a draft Federal Register notice, the draft
         19   CPG, and a list of area restaurants.  As I mentioned, we
         20   do have a cafe, the Wiley Cafe, just outside the
         21   building.  They have sandwiches, salads and occasional
         22   hot offerings.
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          1        Having said that, please don't bring any food or
          2   drink into the auditorium.  We try to keep it neat and
          3   tidy. It's a lot easier to do that when there isn't any
          4   food or drink here.  Restrooms:  As you exit the
          5   auditorium, you sort of hook to the left.  The restrooms
          6   are down on the right-hand side.  There are also a
          7   couple of training rooms that are available during
          8   breaks.  They are on the left-hand side of the same
          9   corridor.  Press contacts:  We have two representatives
         10   from FDA here available.  Kim Rawlins, would you stand? 
         11   And Sebastian Cianci; Seb?
         12        Transcripts, which I mentioned earlier:  We are
         13   having this meeting transcribed.  Transcripts should be
         14   available roughly 30 days after the meeting and it will
         15   be available at FDA dockets.  Written comments:  You can
         16   submit them electronically into the FDA E-Rulemaking
         17   Portal at www.regulations.gov.  Hard copies should be
         18   submitted to the address in the Federal Register Notice
         19   in your packet.
         20        Let me just thank in advance the staff,
         21   administrative and technical, for the work that's made
         22   this meeting possible.  What they do is invisible until,
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          1   I suppose, there's an IT breakdown.  But without their
          2   work, these meetings really couldn't -- they couldn't
          3   happen, much less happen as smoothly as they routinely
          4   do.
          5        With that, let's turn to our first speaker, Dr.
          6   Robert Tauxe of CDC.  Rob?
          7        DR. TAUXE:  Good morning, all.  Thank you for the
          8   invitation to come and speak here this morning and I
          9   appreciate everyone's attention to this issue.  I'm
         10   going to address some of our epidemiological
         11   observations about Listeriosis that we've gained through
         12   surveillance and outbreak investigations at CDC.
         13        Is there a magic button that needs to get pressed
         14   here?
         15        Listeriosis, of course, has been a public health
         16   concern for many years.  I'll first review some of the
         17   outlines of the illness, the clinical manifestations of
         18   this rather severe but uncommon infection and then what
         19   we've learned about its -- the foods and the conditions
         20   that are associated with it.
         21        One of the clinically unique or unusual features
         22        about
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          1   Listeria is its propensity to affect pregnant women and
          2   the children they carry.  The woman herself may have a
          3   fever or really very little defined illness at the time,
          4   but it's the spread to the fetus that's the problem
          5   which can lead to sepsis, miscarriage and stillbirth or,
          6   if the infection occurs right around the time of
          7   delivery, spread to the newborn baby who can develop
          8   meningitis.
          9        Most infections, however, occur outside of the
         10        setting
         11   of pregnancy.  In compromised hosts, people have
         12   underlying illnesses like malignancy or organ transplant
         13   or other immunosuppressive medication or HIV/AIDS or
         14   this increasingly important-to-me category of the
         15   elderly, who may have less functioning immune system
         16   than some of the younger folks.  In these folks it often
         17   produces an invasive disease where -- manifested by
         18   bloodstream infection or sepsis, meningitis or
         19   encephalitis.
         20        In a non-elderly and non-pregnant normal host,
         21   infection is most often asymptomatic.  A high very dose
         22   appears to produce diarrheal illness with fever and in
                                                                       11
          1   rare cases, it also can lead to invasive disease.  What
          2   we track in our surveillance systems is almost entirely
          3   invasive illness.
          4        Here's a -- in a recent case control investigation
          5   that we conducted through our collaborative surveillance
          6   network, FoodNet, here is just a breakout of the
          7   different -- to show you the proportion of the different
          8   types of cases.  In that study that included the 169
          9   cases of Listeriosis, 28 of them, or 17 percent of the
         10   total, were pregnancy associated.  Those were often
         11   significant, severe.  Eighteen were hospitalized and 7
         12   were associated with stillbirth.  Eighty-three percent
         13   of the cases were non-pregnancy associated.  Of those,
         14   108, that's 64 percent of the total, reported an
         15   immunosuppressive condition. Thirty-three of them or 20
         16   percent did not report an immunosuppressive condition or
         17   treatment but the majority of those were elderly.  And
         18   of those 141, nearly all of were hospitalized and 22
         19   died.  The overall mortality rate out of this was 17
         20   percent, which is close to our current - - what we
         21   anticipate of being about 20 percent.
         22        The major public health concern was -- began in
                                                                       12
          1        1985
          2   with a very large outbreak in California.  One hundred
          3   forty-two cases with 40 fatalities traced to a Mexican-
          4   style soft cheese, the queso fresco, where it was not
          5   entirely appropriately pasteurized.  And the following
          6   year active surveillance began at sentinel locations. 
          7   Active surveillance, Listeria was not nationally
          8   notifiable but an active surveillance public health
          9   representative calls all the diagnosing laboratories in
         10   an area to collect reports and make sure that anything
         11   that's diagnosed gets tracked.
         12        In 1996 this was expanded to other foodborne
         13   infections and became the FoodNet network, we're glad to
         14   say, with the collaboration and support of the U.S.
         15   Department of Agriculture and the FDA as well as the ten
         16   state health departments that participate.  In 1998,
         17   PulseNet began subtyping isolets of Listeria, and I'll
         18   show you the difference that made and what we began to
         19   detect and learn.
         20        In 2001 Listeria was made nationally notifiable and
         21   reports from all states at that point began to be
         22   collected.  And in 2004 the Listeria -- the National
                                                                       13
          1   Listeria Initiative was launched.  The CDC portion of
          2   that was to amplify surveillance in a particular way. 
          3   Under the initiative all isolets put now in the
          4   certification of public health laboratories promoted
          5   this.  All isolets of Listeria mono from clinical
          6   sources are fingerprinted now in PulseNet and we
          7   encourage all the states to use this rather lengthy
          8   standard case in interview form and use the same form
          9   across all states.
         10        We monitor for clusters.  If there is a cluster
         11   detected by PulseNet, then those interviews allow us to
         12   do an immediate analysis of matching up the cases who
         13   are in the cluster with other persons with Listeria that
         14   have  non matching isolets.  And since this was
         15   launched, we've had one deli turkey outbreak identified
         16   and investigated by this means.  So, it does achieve
         17   that purpose.
         18        This curve shows how the incidents of reported
         19   Listeriosis has gone in the United States between 1986
         20   and 2006.  Both with the active surveillance, which
         21   began in '86 and was sustained since '89 and then in
         22   1996 it becomes the FoodNet involving most of the same
                                                                       14
          1   sites.  You can see that the incidents, that is the
          2   number of cases per million population, was 7 to 8 back
          3   around '89, '90.  Eight or so cases per million.  At
          4   that point there was a rather well-known case of a woman
          5   with cancer who developed Listeriosis and a turkey frank
          6   was implicated and associated.  At that point, a rather
          7   -- new regulatory policies were instituted and there was
          8   a lot of industry efforts to reduce contamination and
          9   you can see that the incidents drops down to about five
         10   per million where it is stable and more or less
         11   oscillates throughout the 1990s.
         12        Some significant outbreaks happened in '98, '99. 
         13        And,
         14   again, there was a second cycle of targeted focused
         15   efforts to improve ready-to-eat processed meats. 
         16   Largely, another queso fresco outbreak or two.  And that
         17   brings us to our sort of to our current state where
         18   we're down running around 3 per million.
         19        Now, FoodNet is -- since 1996, is a collaborative
         20   effort now involving these ten state health department
         21   sites, representing 15 percent of the U.S. population a
         22   collaborative public health surveillance effort
                                                                       15
          1   involving, as I said, those sites, USDA and FDA
          2   coordinated from CDC.
          3        And this is now a slightly different version of
          4        that
          5   same graph that I showed you before.  This shows the
          6   relative rate for Listeriosis, the laboratory diagnosed
          7   cases using 1996, '98 as a baseline period and then
          8   tracking as new sites -- that started with -- FoodNet
          9   started with five sites and we've added five since, one
         10   by one and to account for that change in the
         11   surveillance population, this model tracks the changes
         12   with accounting for that and you can see that -- here is
         13   that decline in the early part of this decade down to a
         14   low in 2002 and then -- that's the best we've gotten and
         15   since then, it's been a little higher and with really
         16   relative little change.
         17        Total as of 2006, a 32 percent decrease, compared
         18        to
         19   our baseline in '96, '98.  A significant decline, one I
         20   think many people should look at and say that they feel
         21   they had a hand in -- a contribution.  But we're not to
         22   our national goal, which was to reduce it to 2.5 per
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          1   million and there's bit -- there's further to go to
          2   reach or exceed that goal.
          3        Now, among other things that we learned is that
          4   invasive Listeriosis is a little different rate in
          5   different population groups and this is some data from
          6   the earlier part of FoodNet at which time it was 4 per
          7   million in the general population and that in general
          8   the group with the highest rate was the Hispanic
          9   population.  It was 7 per million among Hispanics
         10   compared to 2 per million among non-Hispanics and that
         11   if we looked among infants, who might be susceptible to
         12   the perinatal phase, the incidence rate was 12-fold
         13   higher among Hispanics than among non-Hispanics.  Or if
         14   we looked among women of child-bearing age, the
         15   incidence rate was 11-fold higher among Hispanics than
         16   non-Hispanics.
         17        And this has been a rather constant feature of
         18   Listeria and I think it may well be related to the
         19   recurrent observation of the problems with the soft
         20   cheeses and perhaps other traditional Mexican style
         21   foods.
         22        There have been three major case control
                                                                       17
          1   investigations to look at, Epidemiologic associations of
          2   food exposures with sporadic, that is non-outbreak-
          3   associated Listeriosis.  Most cases are sporadic and
          4   these -- two of these occurred back in the late 1980s
          5   and one of them occurred earlier in this decade.
          6        In the early ones, the association was with
          7        uncooked
          8   or non-reheated hot dogs or undercooked chicken, between
          9   '86 and '87; '88 to '90 a second study implicated soft
         10   cheeses.  And a general one, food purchased at a deli,
         11   which is -- that's a really general sort of category
         12   that's a little hard to get specific with commodities
         13   with but it's an interesting location.
         14        In 2000 to 2003 FoodNet conducted a large case
         15        control
         16   study and identified as the core robust associations
         17   with illness, hummus and sliced melons, which had been
         18   prepared in some type of commercial food establishment. 
         19   And that could be a restaurant, it could be a deli, it
         20   could be number of different locations.  But that was a
         21   finding there.  And that's -- now, that's in the era
         22   where the rate has come down substantially from where it
                                                                       18
          1   was back in the late '80s.
          2        I had mentioned PulseNet.  PulseNet of course is
          3        our
          4   molecular fingerprinting network across the country.
          5   Participating laboratories, actually in all 50 states,
          6   collect isolets and perform pulse-field gel
          7   electrophoresis, molecular fingerprinting on the DNA
          8   from those strains and with the joint software can look
          9   at their own patterns, compare them with other patterns,
         10   match them up and communicate with the database at CDC. 
         11   And either states or CDC may identify that there's a
         12   pattern that has appeared, a cluster that may be related
         13   and it needs to be investigated.
         14        PulseNet, as I said, began in 1988, late 1988. 
         15        There
         16   is a -- this graph shows -- each block is an outbreak
         17   that had been detected and you can see back in 1979 is
         18   the first one on this graph and that there was about one
         19   every five years or so.  Every four or five years there
         20   would be another outbreak.  And then when PulseNet turns
         21   on, all of the sudden there's a considerable number of
         22   more outbreaks. This increased our ability to detect
                                                                       19
          1   clusters and identify them and investigate them as
          2   outbreaks.
          3        The darker-colored ones, the orange ones, are the
          4   multi-state outbreaks.  And you can see that before
          5   PulseNet we were simply not identifying any multi-state
          6   outbreaks.  Since PulseNet turned on, we have identified
          7   five major ones as well as a considerable larger number
          8   of single-state outbreaks.
          9        Now, I've here superimposed that curve of the
         10   incidents just to show you this interesting irony, which
         11   is actually true for most foodborne disease
         12   surveillance, that when you increase the surveillance
         13   and increase the number of outbreaks and increase the
         14   amount of information you have about where outbreaks are
         15   coming from and how control measures can be targeted,
         16   often the result is:  Although that would look like
         17   that's a bad thing, that looks like more outbreaks means
         18   more disease, more trouble, more pain; at the same time
         19   you can see that's when the cases began this later
         20   descent and began declining.
         21        The overall incidents began declining and as you
         22        can
                                                                       20
          1   see here, I've put the healthy people, 2005 goal of 2.5
          2   in. We came very close essentially in 2002 and have been
          3   above that since.  But that's the irony that the better
          4   the surveillance, the more outbreaks, the worse the
          5   problem looks, but in fact the prevention is actually
          6   improving as a result.
          7        Here's a list that's pretty hard to read but this
          8        is
          9   those same outbreaks spread out showing you a
         10   distribution of serotypes and foods involved.  And just
         11   to summarize, this is 21 outbreaks and of those 4 -- it
         12   was a food but the nature of food -- the nature of the
         13   food was not reported but for the others, the most
         14   commonly identified vehicles were sliced meat or deli
         15   items.  In seven outbreaks, cheese, most often the queso
         16   fresco, Mexican styled soft cheese; and four, hot dogs;
         17   and two, a pate in one; and one, in a nacho salad; taco
         18   salad thing in one; a grilled chicken in one; and
         19   pasteurized milk in one.
         20        So, this shows that the foods that have been
         21   implicated in the outbreaks are really the high-risk
         22   ready-to-eat food items that have been flagged I think
                                                                       21
          1   also in the risk assessment.
          2        Just to briefly walk through a couple of these
          3   outbreaks and give you a little more information about
          4   them, a very large one in 1988, '99; 101 cases in 22
          5   states; 84 non-pregnant adults; 15 deaths and 6
          6   miscarriages.  This was one epidemiologic investigation
          7   implicated eating hot dogs from one particular plant. 
          8   Here is the epi curve of those cases.
          9        You can see that the epi curve is increasing and
         10   increasing over a number of weeks at the point at which
         11   the plant was -- implicated a recall and then a very
         12   rapid fall off of cases at that point of the infections
         13   showing a control had been achieved.
         14        Another outbreak, a smaller one, North Carolina
         15   2000-2001.  This is a single-state outbreak but an
         16   interesting one.  Twelve cases, all Hispanic; ten were
         17   in pregnant women; five stillbirths.  Epidemiologic
         18   investigation identified queso fresco as the vehicle of
         19   interest.  This was purchased from door-to-door vendors,
         20   not a formal distribution system.  It was homemade queso
         21   fresco made using a local raw milk.  A very informal
         22   sort of production and distribution system.
                                                                       22
          1        Strains of serotype 4B with a single PulseNet
          2        pattern
          3   came from patients from the cheeses and from the raw
          4   milk. And as a result of this, North Carolina banned the
          5   sale of raw milk and launched an education program.
          6        Multi-state outbreak in 2002.  This was a large
          7        one,
          8   54 patients in 9 states; 42 non-pregnant adults; 8
          9   deaths; 3 miscarriages or stillbirth; again, serotype
         10   4B.  This outbreak was linked to turkey deli meat and
         11   led to a great deal of investigation and a concern
         12   within the -- both the production at the implicated
         13   locations as well as throughout the entire industry. 
         14   USDA/FSIS issued new microbial sampling policy,
         15   increased environmental testing, and now -- and began to
         16   base recalls on environmental test results.
         17        So, let me say that for the last two outbreaks,
         18        what
         19   we know about the sources of Listeriosis from our
         20   epidemiologic investigations is that the outbreaks are
         21   most often caused by -- have been most-often caused by
         22   processed, ready-to-eat meats, especially turkey and hot
                                                                       23
          1   dogs, and that was particularly true in the earlier time
          2   period before the recent decline in cases.  Typically
          3   contaminated after initial processing with a local
          4   locus of contamination in the processing plan.  But
          5   there's also been this recurrent issue of fresh soft
          6   cheeses made with raw milk.
          7        There have been sporadic cases, many of them, and
          8        the
          9   epidemiologic associations in the earlier period was
         10   un-reheated hot dogs, undercooked poultry, foods from a
         11   deli or soft cheeses; and in the most recent one, hummus
         12   and sliced melons were implicated.  And all of these I
         13   would know are foods that I believe support the growth
         14   of Listeria.
         15        So our general conclusions, I would just say that
         16        the
         17   overall incidents has declined from 8 per million to 3.1
         18   million in the last decade with little change since
         19   2002. We are not below the goal of 2.5 per million;
         20   although, perhaps we could be.  Mortality is high. 
         21   Generally the estimate of 20 percent is reasonable. 
         22   With PulseNet our ability to detect and investigate
                                                                       24
          1   Listeria outbreaks has improved and it's clear to us
          2   that investigating the outbreaks provides information
          3   that leads to immediate and longer-term control measures
          4   and that targeted efforts to reduce contamination have
          5   been followed by declines in the incidents of human
          6   illness.  Thank you very much.
          7        MR. LANDA:  Thanks, Rob.  Our next speaker is
          8   Michael Doyle, University of Georgia.  Mike.
          9        DR. DOYLE:  Well, good morning.  Do I just go ahead
         10   with. . .
         11        Well, thank you.  I'm going to bore down a little
         12        bit
         13   more.  Rob has given us an excellent overview of some of
         14   the risk factors that CDC has found to be associated
         15   with Listeriosis and I'm going to bore down a little bit
         16   more in terms of focusing what I believe, based on my
         17   experiences, as well as those of an expert panel that
         18   was organized as part of an International Life Sciences
         19   Institute Risk Science Institute within the ILSI program
         20   group that was brought together to address this topic of
         21   Listeriosis and what can be done to have the greatest
         22   impact on reducing the incidents of Listeriosis. And
                                                                       25
          1   basically an important part of this is to reduce the
          2   availability of foods that support the growth of
          3   Listeria.
          4        And I'm going to bore down on several of these
          5   different topics to share with you the thinking of this
          6   expert panel of more than 30 international experts in
          7   the area of Listeriosis in foods.  And the first is
          8   high-risk foods.  There are certain foods that are of
          9   greater risk in terms of transmitting Listeria and
         10   acquiring Listeriosis and others.  I talk about the
         11   types of foods that support the growth of Listeria.  The
         12   control strategies for these high foods, some of the
         13   factors that will limit the growth of Listeria, talk
         14   about hurdle technology and then finally the need for
         15   validating that the foods don't support the growth of
         16   Listeria.
         17        So, the panel first determined that there are
         18        certain
         19   foods that pose a substantially greater risk of causing
         20   Listeriosis and these were then described as, in quotes,
         21   high-risk foods.  And they came to this conclusion based
         22   on information from outbreak in sporadic case studies as
                                                                       26
          1   well as risk assessments.  And also looking at those
          2   response relationships.  There was a lot of discussion
          3   about what should be the criteria for defining a high-
          4   risk food and essentially it came up with these five
          5   criteria.
          6        First, the food has to have the potential for
          7   contamination with Listeria monocytogenes.  Secondly, it
          8   has to support the growth of Listeria to high numbers.
          9   Thirdly, these foods are ready to eat, they're not
         10   further processed, they're cooked.  Fourth, they require
         11   refrigeration.  And lastly, they are usually stored for
         12   an extended period of time that would enable the growth
         13   of Listeria in these types of products.
         14        Now, I commend Bob Buchanan and Dick Whiting and
         15        the
         16   risk assessment team here at FDA as well as USDA and I
         17   know CDC was involved in putting together what I
         18   consider to be one of the best risk assessments done on
         19   a pathogen in foods and that is the Listeria risk
         20   assessment which was published, I believe, in 2003.
         21        And basically what this risk assessment did was
         22        enable
                                                                       27
          1   us to better focus on those types of foods that are of
          2   greater risk of acquiring Listeriosis.  And the bottom
          3   -- the X axis shows the acronyms for the various types
          4   of foods, the top two being deli meats and frankfurters;
          5   and just to give you a list of some of the highest-risk
          6   foods that were identified by the FDA, certain deli
          7   meats, including sliced turkey or chicken and
          8   frankfurters that are not reheated before serving,
          9   pates, meats, meat spreads, cold smoked seafood, cooked
         10   ready-to-eat crustaceans, and soft unripened cheeses,
         11   such as the queso fresco.
         12        Some of this was not news or a surprise to me
         13        because
         14   back in the early to mid '80s, we were asked to do a
         15   study by the meat industry looking at the growth of
         16   Listeria monocytogenes in freshly made deli meats.  And
         17   holding these meats, we inoculated it with a very low
         18   level.  My colleague, Kathy Glass, and I did this study
         19   back when I was at the University of Wisconsin.  We
         20   inoculated with very low levels of Listeria in sliced
         21   chicken and sliced turkey and frankfurters and roast
         22   beef and summer sausage, put on the surface of these
                                                                       28
          1   freshly made products at levels of less than a hundred
          2   per gram or per package in most cases.  And then stored
          3   these packages of meat, which were vacuumed packaged, at
          4   4 degrees -- 4.4 degrees centigrade for up to 12 weeks. 
          5   And you can see how well Listeria grows in some of these
          6   products.  In sliced chicken, for example, we had --
          7   what is that? -- about 40 billion Listeria within four
          8   weeks at refrigeration temperature and with turkey meat
          9   within six weeks, the same numbers.  And frankfurters
         10   even -- about 30 billion within 12 weeks.
         11        Now, these were spoiled products by the time the
         12   organisms had grown to that level but the point is you
         13   can see that the bacteria grow very well in these types
         14   of products.
         15        And then a very nice study that was done through
         16        the
         17   National Food Processors Association, with the
         18   leadership of Dave Gombas, addressed the prevalence and
         19   numbers of Listeria in a variety of different types of
         20   products of which many could be considered high-risk and
         21   you can see from these data, especially in this last
         22   column, there were these three of these different types
                                                                       29
          1   of products, the deli salads, the luncheon meats and the
          2   smoked seafood that had very large populations of
          3   Listeria monocytogenes within these retail products. 
          4   And the percentages of contaminated products -- you can
          5   see the deli sandwich about 2 and a half percent and 1
          6   percent in luncheon meats and so on -- indicate the
          7   prevalence of Listeria in these products and hence --
          8   especially these that are higher risk probably need to
          9   be addressed better in terms of reducing the incidents
         10   of Listeriosis.
         11        So, this panel decided that to have the greatest
         12   impact on reducing the incidents of Listeriosis, there
         13   should be a focus to reduce the number of servings of
         14   high-risk foods, and to do that we can prevent
         15   contamination -- which there is a major effort for it
         16   being put forward, but we know that it's nearly
         17   impossible to entirely prevent contamination -- so the
         18   next thing is to prevent the growth of Listeria in the
         19   high-risk foods.  In the second part of the equation is
         20   to educate these high-risk populations about foods that
         21   may be high-risk and how to better treat or avoid those
         22   should they be at risk.
                                                                       30
          1        Okay.  Now, what we can do in the food industry to
          2   help reduce the number of servings of high-risk foods,
          3   the panel came up with three ideas that could be
          4   helpful.  One is to reformulate foods to include
          5   antimicrobials that would prevent or retard the growth
          6   of Listeria to large numbers.  Secondly, there could be
          7   a post-packaging treatment that would destroy Listeria
          8   on the product.  An example is using hot water
          9   treatments of packaged deli meats.  The weakness of this
         10   is that if someone were to contaminate this product
         11   after it had been opened, whether it be at the deli or
         12   in the home and then keep it in the refrigerator at home
         13   for an extended period of time, Listeria can grow
         14   because there's nothing in there to prevent these
         15   Listeria from growing in the high-risk product.  And the
         16   third possibility could be to put time temperature
         17   controls throughout the entire distribution chain and
         18   have an appropriate storage time that would be
         19   validated.
         20        Well, if we're going to control Listeria, we need
         21        to
         22   know what are some of the growth parameters that would
                                                                       31
          1   control it and we do know that Listeria is a
          2   psychotrope. It will grow at temperatures as low as .4
          3   degrees centigrade, it's been reported; although, we
          4   know that when it's at that temperature, it grows very,
          5   very slowly.  It will not grow below pH 4.4, 4.39 to be
          6   exact, and it's not known to grow well below a water
          7   activity of .92 as defined by the International
          8   Commission on Microbiological Specifications for Foods.
          9        Now the USDA has taken this information and has
         10   applied to it the concept of fertile technology, which
         11   is a good approach as well, and basically had set up
         12   some specifications for controlling the growth of
         13   Listeria in meats by -- if one -- if a processor was to
         14   have a product that was below pH 4.5, Listeria would not
         15   grow.  If the pH of the product was at 5 but they
         16   included refrigeration and controlled refrigeration then
         17   that should be a controlling factor.  If the product was
         18   below an aw of .9, the Listeria is not going to grow but
         19   it were a .92 and included refrigeration -- that's the
         20   hurdle there -- the hurdle concept -- then Listeria
         21   should be controlled.  And you can go up as high as an
         22   water activity of .95 and have a pH of less than 5.5. 
                                                                       32
          1   And that combined hurdle effect would control the growth
          2   of Listeria.
          3        Also, there are known anti-Listerial preservatives
          4   that can be applied to foods.  A list of these are here,
          5   not in its entirety, but those that are available: 
          6   sodium benzoate, potassium sorbate, potassium lactate,
          7   potassium propionate, sodium diacetate, glucono delta
          8   lactone, liquid smoke; and there's more to this list but
          9   these are some examples of what might be applied to
         10   meats and other types of foods.
         11        Now, once you've identified a way of reformulating
         12   products, it's important to validate that Listeria will
         13   not grow in these products and this must be done on a
         14   product-by-product basis because not all products are
         15   necessarily created equal.  Listeria should be
         16   inoculated at least 10 to the 2 per gram or square
         17   centimeter on the product. These validation studies
         18   should go on for at least 1.3 times the shelf life of
         19   the product and we know that there's often some degree
         20   of temperature abuse, slight temperature abuse, that
         21   occurs somewhere in the food chain, and so it's
         22   important to do these studies at a slightly elevated
                                                                       33
          1   temperature such as 7 to 10 degrees for refrigerated
          2   foods such as soft cheese and deli meats.
          3        I want to share with you an example of a study that
          4   was done by John Sofos' group at Colorado State
          5   University, which was published in Food and Microbiology
          6   in 2007, where they took uncured turkey breast meat and
          7   this meat had either 1.5 percent potassium lactate and
          8   sodium diacetate at .05 percent or it didn't have
          9   either.  And they sliced this meat and they inoculated
         10   it with Listeria at about a hundred per square
         11   centimeters and then after five days it was vacuum
         12   packaged 4 degrees and then held at 7 degrees centigrade
         13   for up to 12 days.  And this was to simulate what might
         14   go on at retail or in home.
         15        And these are some of the results of this study and
         16   you can see, the recontamination or -- the contamination
         17   occurred.  And five days later the package hadn't been
         18   stored at -- in the refrigerator at 7 degrees for up to
         19   12 days and you can see from the solid circles that's
         20   when no lactate-diacetate was added and with the open
         21   circles that's when the lactate-diacetate was added.
         22        So, to me this was good validation that this
                                                                       34
          1   combination of lactate-diacetate controlled the growth
          2   of Listeria and did exactly what I had hoped it would do
          3   in terms of preventing Listeria to growing to large
          4   numbers in the home.  So bottom line here is:  The
          5   lactate diacetate provides a high level of public health
          6   protection by mitigating the growth of Listeria
          7   monocytogenes on high-risk deli meats during retail, in-
          8   home use.
          9        A few concluding comments.  This expert panel
         10        believes
         11   that the key risk factors for acquiring Listeriosis are
         12   being in an exquisitely sensitive or at-risk -- at high-
         13   risk person and consuming a high-risk food and because
         14   certain foods pose a high-risk of contributing to
         15   Listeriosis among exquisitely sensitive and at increased
         16   individual, that it would be prudent to focus our
         17   resources on reducing the risks associated with these
         18   high-risk foods rather than treating all foods as
         19   equally risky.
         20        And the most impactful interventions for achieving
         21   these continuous reductions in foodborne Listeriosis
         22   include reducing the number of servings of risk foods
                                                                       35
          1   and educating the at-risk populations' ineffective
          2   approaches to prevent Listeriosis.  And, finally, the
          3   high-risk foods can be reformulated to prevent the
          4   growth of Listeria and must be validated to ensure that
          5   no minimum growth occurs.
          6        And if you're interested in learning more about the
          7   findings of this expert panel, I encourage you to go to
          8   this Journal of Food Protection article.  It was
          9   published in 2005 and there's a whole lot more detail
         10   for this than what I have presented.  So, I thank you
         11   for your interest and attention.
         12        MR. LANDA:  Thank you very much, Mike.  Our next
         13   speaker is Robert Buchanan of CFSAN.  Bob.
         14        DR. BUCHANAN:  Thank you and just minute while we
         15   switch slides.
         16        Okay.  Thank you.  I've been asked today to
         17        summarize
         18   the risk assessments that have been done in relation to
         19   Listeria monocytogenes and I'm going to jump right into
         20   it since I have a fair amount of material to get through
         21   in a small amount of time and I see the timekeeper here.
         22    I guess if I move over, I can't see you.
                                                                       36
          1        And to put this in the right context in terms of
          2        what
          3   we know about Listeria, Listeria monocytogenes is
          4   perhaps one of the most intensely studied microorganisms
          5   that we have, particularly, and certainly in terms of
          6   foodborne pathogens, one of the most intensely studied,
          7   both in terms of foodborne disease immunological
          8   studies, genetics, virulents, food processing, etc.  And
          9   I know just from the files that we have here in CFSAN,
         10   we've got well over 4000 individual studies on record
         11   that we were able to draw from and study when we studied
         12   this problem.
         13        Also, it is the most intensely assessed
         14        microorganism
         15   that we've had in terms of risk.  These are some of the
         16   risk assessments that have been done, going back to an
         17   original short one by ICMSF in 1987.  There at the
         18   bottom you see the 2003 FDA/FSIS risk assessment, the
         19   FAO/WHAO risk assessment, and in fact there are several
         20   risk assessments that are currently underway.  I know
         21   we're heavily involved in doing two of them right now to
         22   learn more about the risks associated with specific food
                                                                       37
          1   products.
          2        In terms of the CPG in our discussion today, the
          3        two
          4   risk assessments that I'm going to be focusing on are
          5   the FDA/FSIS risk assessment for ready-to-eat foods. 
          6   And this was a quantitative risk ranking.  It was
          7   released in 2003. And then I'll also be talking about
          8   the FAO/WHAO risk assessment for Listeria and ready-to-
          9   eat food, which was a quantitative risk comparison and
         10   that was released in 2004.
         11        I might note that while these two risk assessments
         12   have a lot in common and they have similar approaches,
         13   they essentially used a lot of the same data.  They are
         14   somewhat different in their design because of the
         15   questions they were asked to address.  The FDA/FSIS was
         16   designed primarily to determine the relative risks among
         17   the 23 categories of foods it considered.  And this was
         18   primarily for the purposes of priority setting in terms
         19   of where we should be focusing our effort.  It was also
         20   additionally designed to evaluate the key factors
         21   contributing to the differences in relative risks.
         22        The FAO/WHAO risk assessment was designed very
                                                                       38
          1   specifically to address some questions that the Codex
          2   Committee on Food Hygiene had in developing its new
          3   international code of hygienic practice for Listeria
          4   monocytogenes, in particular, the effective growth on
          5   risk, the differences in risks among different
          6   subpopulations and the effect of microbial limits on
          7   risk.
          8        They only considered four foods:  milk, ice cream,
          9   smoked seafood and fermented meat.  And these were
         10   selected for specific characteristics that I'll talk
         11   about in a minute.  I might note that this risk
         12   assessment was largely based on the draft FDA/FSIS risk
         13   assessment and the data was available in it from the
         14   2001.
         15        The two risk assessments, however, do have a number
         16        of
         17   things in common.  They are both problematic in their
         18   approaches.  They both used conservative non-threshold
         19   models for dose-response relationships where each cell
         20   is assumed to have some small but finite probability of
         21   causing infection.  It's based largely on U.S. public
         22   health statistics.  The focus is from point of sale
                                                                       39
          1   onward and the potential growth of the organism from
          2   point of sale to the point of consumption was
          3   considered.  The exposure data was consumption and
          4   contamination data collected for - - by FDA and FSIS for
          5   the risk assessments, either the draft one in 2001 or
          6   the final one in 2003.  And both of them considered
          7   increased susceptibility populations.
          8        So, real quickly, the FDA/FSIS risk assessment,
          9        these
         10   are the 23 categories of foods that were considered in
         11   evaluating these, somewhere in excess of a half a
         12   million data points were examined.  So, we had a quite
         13   robust database that we drew upon in terms of the
         14   studies that have been looked at.
         15        This is a summary of the exposure for the ready-
         16        to-eat
         17   foods that were considered and in many ways mimics what
         18   you saw from Dave Gombas's work where we broke up the
         19   foods into categories or groups based on the level of
         20   exposure that a consumer would like -- likely to have in
         21   a serving going from less than one per serving, which
         22   the majority of foods were in that category, up to a
                                                                       40
          1   more than a billion. And they range all the way up to
          2   maybe 1300 exposures at the lowest end all the up to
          3   about once every three years someone is going -- the
          4   average person will have consumed a product that gets
          5   you up over a billion per serving.
          6        I might note that this is considering all the
          7        servings
          8   that we're talking about here even at the billion per
          9   serving.  That's a total number of somewhere in excess
         10   of ten million servings per year are anticipated to be
         11   at that high level.  That's important because as we do a
         12   risk assessment, you then have to match that with the
         13   incidents of disease that we see in the actual
         14   population and this is the breakdown of the cases of
         15   Listeriosis that have been anchored against the CDC
         16   statistics that we that we had at that time.
         17        I might note you'll see slight variations in the
         18        CDC
         19   statistics for baseline levels from 2078 in this. 
         20   There'll be another one where it's 2100, etc.  This is
         21   the way that the program iterates in the rounding errors
         22   that we're seeing here.
                                                                       41
          1        We use the exposure data and the data from the
          2        cases
          3   to develop dose-response models for three populations
          4   here: The neonatal cases, the elderly cases and then
          5   what we refer to as intermediate age.  That was everyone
          6   from one month onwards to 60 years, which -- 60 years
          7   was the definition that CDC uses for elderly.
          8        I need to talk to you about that, Rob.
          9        And you can see that there are substantial
         10   differences.  I might note in the intermediate age,
         11   which appears to be the least susceptible, most of the
         12   cases of Listeriosis in that group are actually people
         13   within that age group that immunocompromised.  This is a
         14   breakdown of the predicted relationship between dose and
         15   incidents taking into account the contamination rates
         16   that we see and you will note there on your left this is
         17   the level of Lm at consumption in terms of serving and
         18   on the right the percentage of cases that are
         19   attributable to that based on the exposure data and the
         20   dose response.  You can see that almost all of the cases
         21   are associated with a high end -- the types of food that
         22   Mike was talking about in his presentation.
                                                                       42
          1        I might note we did look at two different types of
          2   risks associated with this and the risk assessment, the
          3   risk per serving, and the risk per annum.  The risk per
          4   serving is the risk that an individual consumer faces
          5   when they pick up a serving of food and consume it.  The
          6   risk per annum then weights that against the total
          7   number of servings that are consumed during a year and
          8   that we refer to as the risk to the country.  It's the
          9   overall burden.
         10        Mike already showed this.  I do want to point this
         11        out
         12   to you again.  This is the 23 food categories as
         13   captured when this risk assessment was published.  I do
         14   want to note that, you know, at some point we're going
         15   to need to do this risk assessment again because
         16   certainly the changes in the industry have probably
         17   changed these priorities.  But I do note and I ask you
         18   to look at the different colors.  The colors here are --
         19   the blue are foods that support the group of Listeria
         20   monocytogenes.  The black are the foods that some do,
         21   some don't within that category, so, for example,
         22   certain vegetables or fruit support growth whereas
                                                                       43
          1   others do not and that's also where you see the most
          2   uncertainty.  And then finally the yellow are the foods
          3   that are -- that do not support the growth of Listeria
          4   monocytogenes.  And it's important to keep these numbers
          5   in perspective because they are in a log scale.  So,
          6   effectively between the highest and the lowest is a 10
          7   million-fold differential in the relative risk.  It's a
          8   very large differential.
          9        This is a dissimilar showing the 23 categories on a
         10   per annum basis and, again, to put it in context on a
         11   per annum basis at the upper end this was an estimate of
         12   approximately a thousand cases per year.  At the other
         13   end of the scale it's an approximate one case every
         14   20,000 years.  So, again, you want to keep these kinds
         15   of values in mind because they have very large
         16   differentials.
         17        I might note when we combine the two into a --
         18        using a
         19   cluster analysis-type of approach and we then did rank
         20   out in terms of hopefully messages to the industry and
         21   to the consumer the areas with the highest and the
         22   lowest risks. And this a cluster analysis of risk per
                                                                       44
          1   serving versus risk per annum.
          2        So, the conclusions of this was it reinforced
          3        certain
          4   things that we had already known, that this disease
          5   primarily impacts specific at-risk subpopulations, that
          6   the disease is rare but severe, and that there are
          7   substantial differences in risks among different food
          8   categories. Other major factors that came out and were
          9   explored through a series of what-if scenarios was that
         10   in major factors that affect risk are the amount and
         11   frequency of consumption, the frequency and levels of
         12   contamination, the ability of food to support growth and
         13   then the temperature and the duration of refrigerated
         14   storage.
         15        Now, quickly, for the FAO/WHAO risk assessment.
         16   Again, this was in response to the need for Codex
         17   Committee on Food Hygiene to reach decisions about the
         18   international codes that they were developing, including
         19   the development of microbiological criteria.  The three
         20   questions were: The impact of varying criteria between
         21   the absence in 25 grams to a thousand CFUs per gram on
         22   the risk of Listeriosis.  The differences in risk
                                                                       45
          1   associated with foods that do and do not support growth
          2   of Listeria monocytogenes, and the relative risk of
          3   Listeriosis among different subpopulations as compared
          4   to the general population.  This was -- also a purpose
          5   of this risk assessment was one of the first ones that
          6   the FAO JEMRA Group had done.  It was also -- it was an
          7   example of how to design, conduct, use and interpret
          8   microbiological risk assessment, and it is still used
          9   today.
         10        I might note, as I indicated before, that there
         11        were
         12   only four of the foods that were actually looked at. 
         13   This was done on purpose to limit the size of the risk
         14   assessment that was being done and the four foods were
         15   milk, ice cream, smoked seafood and fermented meats. 
         16   And they had the following characteristics.  They had --
         17   for milk, it was a high-volume consumption, low-
         18   contamination rate in product that supports growth.  Its
         19   paired food was ice cream, which is high-volume, low-
         20   contamination rate and does not support growth.
         21        The other set or pairs were smoked seafood.  It has
         22        a
                                                                       46
          1   low-volume consumption.  It's consumed -- I mean,
          2   there's a lot of it consumed but nowhere close to what
          3   milk is.  It's a high-contamination rate as Mike pointed
          4   out in some of the data that we had.  And it supports
          5   growth.  And its paired one with fermented meats which
          6   is a low-volume consumption, high-contamination rate in
          7   a product that does not support growth.
          8        In putting this one they used a somewhat simplified
          9   dose-response model.  It gave a reasonable match to the
         10   FDA/FSIS dose-response model.  Actually, it took all of
         11   their dose-response response model and refit it to a
         12   different more simple curve.  There are also was a lot
         13   of work in the hazard characterization of that risk
         14   assessment exploring the uncertainties of the models and
         15   factors that influenced it.  So, it considered both a
         16   most likely dose-response model, which is basically
         17   equivalent to the dose-response model of FDA, and then a
         18   worst model that was basically 300 times -- 300-fold
         19   more stringent.
         20        (Addressing timekeeper)  Ah, she can find me.
         21        Again, look at both the incidents per serving and
         22        the
                                                                       47
          1   risks per annum and then they answer the CCFH question
          2   through a series of what-if scenarios. This is one of
          3        them.  This is for the impact of
          4   different microbiological criteria.  And what they
          5   looked at is that if you had -- if you had a hundred
          6   percent compliance, what would be the expected rate of
          7   Listeria based on the dose-response curve if you had a
          8   microbiological criteria at the different values there
          9   on the left.  And it's important to note here that in
         10   doing this, the estimated cases at the current standard,
         11   the .04, the estimated standard was that you should have
         12   one case every three years and this is across all the
         13   ready-to-eat foods.
         14        And going all the way up to a thousand CFUs per
         15        gram,
         16   the anticipated case rate was basically 22 cases per
         17   year. So, this is a very big disconnect between that and
         18   the baseline data -- baseline value, which was, in this
         19   case, again rounding errors, it was 2133 and -- running
         20   this scenario -- so, this had the risk assessment team
         21   spending a lot of time talking about compliance.  And
         22   they examined the effect of compliance using a what-if
                                                                       48
          1   scenario where they looked at defect rates and what they
          2   said -- they simplified it -- they said:  What happens
          3   if you had a certain percentage of samples that had a
          4   million CFUs per gram?  What would be the impact varying
          5   the rates of compliance?  And so basically you see that
          6   with a criterion of .04 CFUs per gram or 100 CFUs per
          7   gram, if you had absolute compliance to those standards,
          8   you would predict one case every two years for .04 CFUs
          9   per gram and approximately six cases per year if you
         10   were looking at 100 CFUs per gram.
         11        And then the what-if scenarios looked at different
         12   defect rates and I might note the baseline level
         13   indicates that we have a failure rate based on this
         14   scenario of about .02 percent in terms of defects.  This
         15   also allowed the evaluation of what would happen if you
         16   could -- if changing a standard, if you were able to
         17   achieve levels of control by other means.  And so I just
         18   throw these out -- if you look at the yellow one,
         19   assuming that if you had a defect rate of .01 percent
         20   and you could achieve a 90 percent reformulation of
         21   ready-to-eat foods, the, you know, back to the envelope,
         22   what-if scenario here is that you would reduce the
                                                                       49
          1   incidents of Listeriosis by 90 percent if you were
          2   capable of doing that.
          3        Okay.  Question 2 was the increase in the risk of
          4        --
          5   due to growth.  This is where we used our pair of foods.
          6   This is both the cases, predictive cases, per hundred
          7   thousand and the cases per million servings.  And
          8   basically the end result was depending on the class of
          9   food you had, its contamination rate, etc., you got
         10   approximately a 500-to 10,000-fold differential in
         11   relative risk that was attributable to growth.  And you
         12   can see that between milk and ice cream it's about a
         13   500-fold differential; and between smoked fish and
         14   fermented meat it's about a 10,000-fold differential.
         15        And finally the last question, we were lucky to
         16        have a
         17   bunch of data when this was put together that this came
         18   from France and actually were able to make risk
         19   estimates or relative susceptibility estimates on a
         20   relative risk basis for a large number of different
         21   diseases.  I might note that these are largely people
         22   that -- some of these groups are people that are under
                                                                       50
          1   medical care and actually are undergoing treatment.  So,
          2   for example, the most susceptible population were
          3   transplant patients while they were in the hospital.
          4        I might note that after transplant patients --
          5        after
          6   they get out and they wean them down on the
          7   immunosuppressive drugs, their risk drops substantially.
          8   And most of the cancer patients that you're seeing high
          9   rates they're people that are undergoing chemotherapy. 
         10   So, again, these are the most sensitive of the
         11   population. But, again, there is a substantial
         12   difference between these populations with people less
         13   than 65 years of age with no underlying condition being
         14   a baseline of 1.
         15        Okay.  Key factors identified by the -- this risk
         16   assessment that was most risk was associated with high
         17   numbers of Listeria in foods that support growth.  Most
         18   cases associate it with the failure to meet existing
         19   standards by a substantial margin, that the greatest
         20   improvement in public health is by decreasing the
         21   percentage of servings with high numbers -- and this is
         22   primarily enhanced compliance against any of the
                                                                       51
          1   proposed standards.  And then preventing growth was one
          2   of the most effective means for mitigating the risk. 
          3   And I think that's it.
          4        MR. LANDA:  Thanks, Bob.  Our next speaker is
          5   Rebecca Buckner, also of CFSAN.
          6        MS. BUCKNER:  Good morning.  I'm going to talk to
          7   you this morning about international guidelines for
          8   Listeria monocytogenes and basically I'm going to give
          9   you some information on what some other countries' Lm
         10   requirements are and this will not be an exhaustive list
         11   of other countries' Lm requirements.  I'm concentrating
         12   on countries that have similar regulatory systems to the
         13   United States and so I'll give you information on Lm
         14   requirements in Japan, Australia/New Zealand, the
         15   European community and Canada.  And then I will finish
         16   up with information on recommendations on Listeria
         17   monocytogenes being -- some that have been adopted by
         18   the Codex Alimentarius Commission and then some that are
         19   under consideration in the Codex Committee on Food
         20   Hygiene.
         21        I'll start with Japan -- and the countries are in
         22   no particular order -- and I'm also going to concentrate
                                                                       52
          1   in the information I give you on the microbiological
          2   criteria that these countries use and not go details
          3   about any HACCP requirements they have or SSOPs.  Japan
          4   has very simple requirements.  They have microbiological
          5   criteria of an absence in 25 grams for two types of
          6   food, soft and semisoft cheeses and uncooked meat
          7   products.  Pretty straightforward, otherwise, they have
          8   no criteria.
          9        Move to Australia/New Zealand.  In this case
         10   Australia and New Zealand have harmonized standards. 
         11   They have a Food Standards Code that covers certain
         12   products of Listeria and they have a requirement for
         13   absence in 25 grams for the following foods:  Butter,
         14   soft cheeses again, all raw milk cheese, unpasteurized
         15   milk, packaged cooked and salted meat, and heat-treated
         16   meat paste and pates, and also bivalve mollusks.
         17        They also have separate criteria for fin fish which
         18   allows one sample out of five to have zero to one
         19   hundred CFU per gram.  The follow-up actions to a
         20   finding of Lm in any food, not just foods on the list,
         21   but any food, depends on whether or not the food
         22   supports growth.  New Zealand also has sector-specific
                                                                       53
          1   guidance for seafood and dairy which reinforces their --
          2   the Food Standards Code requirements.  I do know from
          3   New Zealand that they are re-considering their big list
          4   over here on this page and are thinking of going to
          5   risk-based standards, which they hope to possibly have
          6   in place within the year, actually.  So they are re-
          7   considering this list and may move to separating foods
          8   by category whether they do and don't support growth.  I
          9   don't know what Australia will do if New Zealand does
         10   that; presumably, possibly the same thing.
         11        Moving to the European community.  This -- the
         12   European community is the first one I'm going to talk
         13   about that has risk-based standards instead of a big
         14   list.  In September of 1999 the Scientific Committee on
         15   Veterinary Measures related to public health issued an
         16   opinion that Lm should be kept below a concentration of
         17   100 CFU per gram. And that opinion was the basis for the
         18   E.U.'s requirements.
         19   The E.U. has three categories.  They have ready-to-
         20   eat foods intended for infants and special medical
         21   purposes.  And the requirement there is absence in 25
         22   grams during the shelf life of the product.  They also
                                                                       54
          1   have other than those foods for infants and medical
          2   purposes, RTE foods are able to support growth.  For
          3   those foods they have two criteria.  They have 100 CFU
          4   per gram.  During the shelf life of the product, you
          5   have to be able to demonstrate that during the shelf
          6   life of the product -- this is the food that will
          7   support growth -- the concentration will never go above
          8   100 or -- well, not "or"; it's actually "and" -- while
          9   the food is in control of the manufacturer, the criteria
         10   is absent in 25 grams.  For foods not able to support
         11   growth, the criteria is 100 CFU per gram during the
         12   shelf life of the product.
         13        Moving to Canada.  Oh, I should go back and mention
         14   here on the E.U.  In December 2007, the European Food
         15   Safety Authority issued an opinion -- they were asked to
         16   issue a new opinion to update the 1999 opinion.  They
         17   issued an opinion -- they were asked to update the
         18   science and issue an opinion on Lm recommendations. 
         19   They actually issued an opinion on a Codex
         20   recommendation that I'm going to talk about later but
         21   it's applicable to this E.U. standard of the 100 CFU per
         22   gram during the shelf life of the product.  And what the
                                                                       55
          1   FSIS said and I'm quoting, "It is impossible to predict
          2   with a high degree of certainty that the level will or
          3   will not exceed 100 CFU per gram during the shelf life
          4   of these products."  They're talking about products that
          5   will support the growth of Listeria.
          6        So, that was the E.U. community's scientific body's
          7   opinion of the fact the 100 CFU per gram during shelf
          8   life for foods that are able to support the growth. 
          9   Basically the committee said that it's really sort of
         10   impossible to guarantee that, so it might be a risky
         11   food safety move.
         12        As I said, they're actually talking about a Codex
         13   opinion that I'm going to talk about in a minute.  But
         14   I'll quickly move to Canada.  Canada issued their Lm
         15   policy in July of 2004.  It applies to all ready-to-eat
         16   foods and places them in three categories based on
         17   health risks and their policy is a combination of
         18   inspection of environmental sampling and end-product
         19   testing.
         20        And these are the micro criteria for the end-
         21   product testing.  Canada also, like I said, has three
         22   categories and it starts with a list.  In category 1,
                                                                       56
          1   which is the highest health risk are products that have
          2   been associated in the past with outbreaks.  And that's
          3   soft cheese, pate, unacidified jellied pork tongue, hot
          4   dogs, cold, smoked rainbow trout and deli turkey meat. 
          5   And the action level there is detection in 50 grams.
          6        Category 2 is all other ready-to-eat foods that
          7   support growth with a shelf life of less than ten days.
          8   Canada throws in shelf life as a factor.  The action
          9   level for those foods is detected in 25 grams.  And
         10   category 3, which has the least health risk associated
         11   with it, is RTE foods supporting -- supporting growth
         12   with a shelf life less than or equal to ten days and all
         13   other RTE foods that don't support growth.  And the
         14   action level for those is less than or equal to 100 CFUs
         15   per gram.
         16        And now I will move to recommendations of the Codex
         17   Alimentarius.  If you don't know, Codex is an
         18   international standards setting body that offers
         19   recommendations on food safety and suitability.  The
         20   committees within Codex develop standards and then those
         21   standards go to the commission for adoption when they're
         22   final.  And in 2007, the commission adopted guidelines
                                                                       57
          1   put forth by the Codex Committee on Food Hygiene.  The
          2   document is entitled Guidelines and the Application of
          3   General Principles of Food Hygiene to the Control of Lm
          4   in RTE Foods.
          5        This document contains general recommendations on
          6   controlling Lm during primary production and production
          7   facilities, equipment during processing and transport. 
          8   It also has issues about personnel, hygiene and training
          9   and consumer education.  It follows the standard outline
         10   of code of hygienic practice by Codex.  So it's a very
         11   broad document.  And the recommendations contained in
         12   that are very similar to the recommendations that you'll
         13   hear Dr. Zink talk about in the text presentation that
         14   are FDA's recommendations for processing.
         15        At present the guidelines document has one annex
         16   that is final.  It contains recommendations for
         17   environmental monitoring and if you would like to read
         18   the document, it's available on the Codex Web site. 
         19   Another annex is still under discussion.  What
         20   occasionally happens in Codex is when one part of a
         21   document is far enough advanced that it's ready for
         22   final adoption, that part moves forward and is adopted
                                                                       58
          1   and if there's some part of that's maybe not quite
          2   ready, that part kind of lags behind.  And that's what
          3   happened in this case.  There's another annex to the
          4   Codex' main document that contains microbiological
          5   criteria and that document is still under development in
          6   the Codex Committee on Food Hygiene.  That is Draft
          7   Annex II which contains micro criteria for ready-to-eat
          8   foods and it is a work in process led by Germany and the
          9   United States is part of the working group.  And the
         10   criteria is being developed based on the risk
         11   assessments.
         12        Currently the draft annex defines three categories
         13   for foods:  Foods for which no criteria are needed,
         14   ready-to-eat foods in which growth will not occur, and
         15   ready-to-eat foods in which growth can occur.  It
         16   defines microbiological criteria for the latter two
         17   categories, foods that -- in which growth will not occur
         18   and foods in which it can occur.  The first category,
         19   foods in which no criteria are needed, is basically a
         20   list.  That contains things like:  Dried cereals, some
         21   beverages, baked goods -- sorry I don't have the list in
         22   front of me.
                                                                       59
          1        But I'll move now to the criteria for the other two
          2   -- for the two categories.  Ready-to-eat foods in which
          3   growth of L mono will not occur the proposed criteria
          4   for that category is less than or equal to 100 CFU per
          5   gram throughout the shelf life of the product.  The
          6   micro criteria under consideration for ready-to-eat
          7   foods in which growth of L mono can occur -- again,
          8   there are two. One is less than or equal to 0.4 CFU per
          9   gram or less than or equal to 100 CFU per gram,
         10   applicable only if the manufacturer is able to
         11   demonstrate to the competent authority that the product
         12   will not exceed this limit throughout its shelf life.
         13        The draft annex also outlines actions to be taken
         14   when criteria are exceeded and it describes other
         15   microbiological matrix that may be used by competent
         16   authorities.  These would include environment monitoring
         17   and process control testing.
         18        I will note that this annex is a draft, and what I
         19   described to you is how it stood at the end of the
         20   working group in 2007 and the plenary session in 2007. 
         21   We have another working group coming up on it in late
         22   May of this year.  And we're in the process of preparing
                                                                       60
          1   for that.  The draft -- the recommendations -- these
          2   recommendations didn't change much after the last
          3   plenary session at Codex because there wasn't really
          4   time to discuss the document. Basically the committee
          5   merely agreed -- we all agreed that it was important to
          6   have criteria.
          7        I suspect our comments going into this working
          8   group meeting will be very similar to the comments that
          9   we submitted when this document was considered in
         10   December of 2007 by the plenary.  Those comments are a
         11   matter of public record and that is -- and I will
         12   briefly tell you that in those comments the United
         13   States did not support this idea of three criteria.  We
         14   like the idea -- we like two criteria.  We were not in
         15   support of the list because foods either fall into: 
         16   They will not support growth or they can support growth.
         17    And so our feeling was a list sometimes takes on a life
         18   of its own and may not be a great idea or helpful in
         19   this case.
         20        We also did not support the second criteria for RTE
         21   foods in which growth of L mono can occur.  The
         22   microbiological criteria that allows less than a 100 CFU
                                                                       61
          1   per gram during the shelf life of the product, for
          2   products where L mono can grow, this is actually what
          3   the European Food Safety Authority was rendering an
          4   opinion on, their opinion that said this is not a
          5   practical approach.  It's also equally applicable to the
          6   E.U.'s own standard but this is actually what they were
          7   talking about.
          8        So, we don't know -- going into this working group
          9   meeting we now have that opinion to think about -- for
         10   the group to think about.  And finally our comments were
         11   very much in support of the annex containing the
         12   information of other microbiological metrics that might
         13   be useful that the environmental monitoring and the
         14   process control testing.
         15        And so the outcome of the May working group will be
         16   considered in December at the plenary meeting of Codex
         17   Committee on Food Hygiene and the annex technically
         18   should be completed this year.  I don't know if that
         19   will happen but if it does, we will then have final
         20   international recommendations for micro criteria for Lm,
         21   but right now they're just drafts.  So, stay tuned.  And
         22   that's it.
                                                                       62
          1        MR. LANDA:  Thanks Rebecca.  Our final speaker this
          2   morning, before the break at least, is Donald Zink from
          3   CFSAN.  Don.
          4        DR. ZINK:  We're publishing this guidance document
          5   at the same time as the compliance policy guide because
          6   it's a document that we believe that supports the
          7   compliance policy guide to the extent that what it is,
          8   is a how-to manual for the food industry to control
          9   Listeria contamination in food products.  It is a
         10   guidance document. There is nothing in this document
         11   that carries the force of law and in this presentation I
         12   don't always use the words "should" or "we recommend." 
         13   There's already a great many words on these slides
         14   without having that but everything in here that I'm
         15   going to discuss is merely the agency's recommendation
         16   and guidance.
         17        The document addresses two broad categories of ways
         18   to control Listeria monocytogenes.  One of these, of
         19   course, is to, if you can, formulate the refrigerated
         20   food to prevent the growth of Listeria monocytogenes. 
         21   You've already seen the tremendous reduction in risk you
         22   get from having a no-growth food versus a growth food. 
                                                                       63
          1   And finally the document addresses all of the steps
          2   necessary for the prevention of contamination during
          3   manufacturing.  And I should say these are particularly
          4   important for foods that support growth but it's also
          5   important for foods that do not support growth.  I think
          6   anyone would agree any food that has less Listeria is
          7   better than a food that has more Listeria in it.
          8        In general, the document is organized along the
          9   topics listed here.  I won't go over all of them and
         10   what I want to do in this presentation is just briefly
         11   hit the high points of the document.  I know a great
         12   many of you have already read the document.  It's some
         13   46 pages in length and by no means am I going to try to
         14   tell you everything that's important in it.
         15        Who should use the guidance?  Obviously, processors
         16   of refrigerated ready-to-eat foods should use it,
         17   whether it's a growth or no-growth foods.  Processors of
         18   fresh-cut fruits and vegetables; many of these fresh-
         19   cut fruits and vegetables will be growth foods, some
         20   will not.  And also processors of frozen foods and other
         21   such non-growth foods.
         22        Again, the guidance does not establish legally
                                                                       64
          1   enforceable responsibilities in its reflection of our
          2   current thinking and indeed much of the document is
          3   drawn from many publications in the scientific
          4   literature and by trade associations on this topic.
          5        First, formulating foods to prevent the growth of
          6   Listeria monocytogenes.  You can do some of these things
          7   by pH alone or water activity alone, obviously freezing.
          8    The organism does not grow in a food that's frozen and
          9   marketed as a frozen food.  More commonly, combinations
         10   of reductions in pH and water activity will be effective
         11   in preventing the growth of the organisms.  In many
         12   foods pH is higher than 4.4 and water activity is higher
         13   than .92, as you saw in Dr. Doyle's presentation, can
         14   effect actively inhibit the growth.  Also, there's a
         15   variety of antimicrobial substances that can be used and
         16   added to food.  We often call this the "hurdle concept"
         17   when you're using a number of factors, intrinsic
         18   factors, to inhibit microorganisms, no single one of
         19   which is entirely effective.
         20        The important message is that if you use the hurdle
         21   concept, you need to understand it, validate it and have
         22   appropriate controls in manufacturing to ensure that you
                                                                       65
          1   are in fact consistently manufacturing foods that don't
          2   support growth.
          3        Listeriacidal Measures.  There's a lot of
          4   literature -- scientific literature on the effectiveness
          5   of various treatments for the destruction of Listeria,
          6   everything from heat treatments to high pressure
          7   treatments.  You can reference these scientific studies
          8   as a basis for a Listeriacidal process you use, you can
          9   conduct your own scientifically valid experimental
         10   trials, and you could even use mathematical modeling. 
         11   There are some pretty good mathematical models available
         12   for use to establish the Listeriacidal effects of
         13   various treatments and certainly you're free to approach
         14   it in any of these measures.  But regardless of what you
         15   do, you need to ensure that you establish and implement
         16   controls that are consistently applied during
         17   manufacturing.
         18        Raw ingredient controls.  In many cases Listeria
         19   gets into a food product or a food processing
         20   environment through raw materials.  It's desirable to
         21   list and identify -- identify and list these ingredients
         22   and -- where possible treat these ingredients with a
                                                                       66
          1   Listeriacidal control measure.  There is also value, I
          2   think, in purchasing ingredients from suppliers that
          3   have also implemented this guidance and have similar
          4   levels of control.
          5        Food storage controls.  You've seen from the
          6   presentations of Dr. Doyle, Dr. Buchanan that the time
          7   at which a product is stored refrigerated can be a
          8   significant factor.  It's desirable to keep foods fresh
          9   and moving through the distribution system using
         10   something like a first-in/first-out inventory control. 
         11   Temperature is also a very effective means of limiting
         12   the growth rate of Listeria.  It does grow at
         13   refrigeration temperatures but of course the lower that
         14   temperature, the lower its growth rate.
         15        Personnel.  Personnel can be a significant factor
         16   in the contamination of food products during
         17   manufacturing and it's essential, we believe, that
         18   training and health and hygienic practices should be
         19   adopted for all employees who enter production and
         20   storage areas even though these employees might not
         21   actually work there.  Even workers such as office
         22   workers and maintenance workers, anyone who goes through
                                                                       67
          1   a production area, should have training and awareness
          2   about sanitation.  If you have employees who are
          3   obviously ill, they should be excluded from the
          4   production area until their illness is resolved. 
          5   Maintenance personnel in our experience are key.  They
          6   contaminate a food production line with their tools are
          7   coming from contaminated of the plant and they too
          8   should be educated. Appropriate use of other controls
          9   such as footwear, gloves, smocks, uniforms, these are
         10   often very valuable.
         11        How you design a facility and construct it often
         12   determines how easy or difficult the job of controlling
         13   Listeria is going to be and in the document we list some
         14   key things that you can look for:  Things that relate to
         15   the flow of raw materials and finished products, traffic
         16   patterns, all sorts of cleanability aspects of a
         17   facility. Equipment in that facility is also a factor. 
         18   Many of you heard stories over the years of the -- how
         19   undesirable it is to have things like hollow bodies and
         20   nooks and crannies and crevices where this organism can
         21   establish a harborage and consistently contaminate
         22   production.  In the history of outbreaks related to
                                                                       68
          1   Listeriosis where products became contaminated during
          2   manufacturing, they are often traceable to this form of
          3   systematic from equipment that was difficult to clean. 
          4   Certainly food contact surfaces need to be smooth and
          5   nonabsorbent and cleanable.  Again, I emphasize the
          6   importance of tools of maintenance workers can be a
          7   source of contamination and I think there are many good
          8   suggestions along these lines in the guidance document.
          9        Sanitation controls.  We think that it's important
         10   that you establish and use a sanitation program that
         11   includes written standard operating procedures for areas
         12   where refrigerated ready-to-eat foods are processed or
         13   exposed.  And these sanitation standard operating
         14   procedures should address what is the end result
         15   desired. How effective must the cleaning be and they
         16   ought to be specifically focused on the riskiest areas
         17   such as food contact surfaces, equipment, utensils,
         18   gloves, outer garments and prevention of cross-
         19   contamination.  And my own experience, and I think that
         20   of many here, is that you have to consider how equipment
         21   is disassembled, the frequency at which cleaning must be
         22   done, and the type and concentration of chemicals used. 
                                                                       69
          1   These are also important steps in effective sanitation.
          2        Environmental monitoring.  Environmental monitoring
          3   is key to the effective control of Listeria in a food
          4   plant environment.  Despite your best efforts at design
          5   and sanitation there can very well be niche environments
          6   that go undetected and it's through environmental
          7   monitoring that you discover where these are and allow
          8   you to take corrective action and address this.
          9        We do say in the guidance document that it's our
         10   opinion that even a small facility should sample a
         11   minimum of five sites of food contact surfaces in a
         12   refrigerated ready-to-eat production line.  That --
         13   there's no magic number, in our opinion, of the correct
         14   number of samples to take.  It depends on the complexity
         15   of the facility, the quality of the sanitary design and
         16   operation; but, you know, nonetheless we felt that it
         17   would be useful if we could come up with some kind of
         18   minimum number recommendation.
         19        Finished-product testing can also be valuable.  I
         20   would like to emphasize that we do not see finished-
         21   product testing as a useful tool for lot-by-lot release
         22   of product. Finished-product testing, you should have a
                                                                       70
          1   written plan that spells out the frequency at which
          2   you're going to collect samples and how you're going to
          3   test these samples. And the purpose of this testing in
          4   our view as is an ongoing validation of the adequacy of
          5   your other controls. It's a disaster check if you will. 
          6   And while the amount of finished-product testing may not
          7   be statistically useful for releasing a lot of product
          8   or releasing product on a lot-by-lot basis, over a
          9   period of time you accumulate a great deal of data which
         10   tells you how the facility is operating over time and
         11   how your controls are working.  If you consistently and
         12   periodically see finished-product positives, it's
         13   telling you that the adequacy of your controls needs to
         14   be re-examined and modified.
         15        Corrective actions.  Again, we believe that you
         16   should have corrective action plans and that these
         17   should be written and you should conceive these plans at
         18   a time well before you're faced with a crisis and you
         19   should be able to then follow this corrective action
         20   plan that will outline how you react to finding Listeria
         21   species or Listeria monocytogenes on critical surfaces
         22   or in foods.  Certain records are desirable to be kept. 
                                                                       71
          1   For example, you might want to document Listeriostatic
          2   control measures that are applied in the formulation of
          3   your product, Listeriacidal control measures that you
          4   might be using for kill steps. It's useful to have this
          5   list of ingredients reasonably likely to be contaminated
          6   with Listeria monocytogenes; retention of certificates
          7   of analysis or conformance from suppliers; your written
          8   plans for sampling and testing the environment and
          9   finished products; also, you should have analytical
         10   methods and some knowledge of the sensitivity of the
         11   method to be sure it does what you intend it to do; and,
         12   finally, retain the results of tests that you conduct to
         13   enumerate Listeria species or Listeria monocytogenes.
         14   With that I'll conclude.
         15        MR. LANDA:  Thanks, Don.  Well, we're running a
         16   little ahead of schedule.  So, why don't we pick up at
         17   five after 11:00, please.  Thank you.
         18        (Break taken.)
         19        MR. LANDA:  Why don't we get started again.  Our
         20   next speaker is Joseph Corby with AFDA.  Joe
         21        MR. CORBY:  Thank you.  Thank you for the
         22   invitation. As an organization that represents state and
                                                                       72
          1   local regulatory officials and one that is very, very
          2   close to state food safety program managers, Listeria
          3   has been a big issue to AFDA.  Not only have we
          4   conducted a few seminars on Listeria, we put together
          5   model response plans based on models from Wisconsin,
          6   Florida, and New York.  But we also have put together
          7   educational materials for the retail industry
          8   particularly small businesses.  We did that with the
          9   assistance of FSIS and FMI and Penn State University.
         10   And we also collected data a few years ago from states
         11   that are conducting surveillance and with FSIS analyzed
         12   some of the data that was submitted by states.
         13        Not all states are active in the surveillance of
         14   Listeria.  The ones that are, however, are clearly those
         15   states that have specific industries within their
         16   borders, such as, smoked fish or the soft, ripened
         17   cheeses being manufactured in those states.  You know,
         18   regulators are always being slammed for being reactive
         19   and we believe that having an active surveillance
         20   program with an inspection program is important and a
         21   way of being more proactive. Please understand that
         22   state and local regulators are also the individuals that
                                                                       73
          1   regulate the retail industry and many of the things that
          2   might seem easily to control in whole sale environment
          3   it's sometimes a different ball game with retailers, but
          4   we do an awful lot of outreach with the retail food
          5   industry.  And clearly because we're right there at the
          6   forefront when illnesses occur with our health agencies
          7   and health officials, it is a public health issue and
          8   one that we are very active.  And here's the states that
          9   we have collected data from in the project that we had a
         10   few years ago and as you can see those states that you
         11   would expect to have a Mexican-style soft cheeses --
         12   California, Texas and New York -- have an active
         13   surveillance program and of course those states that
         14   have a lot of smoked fish manufacturing -- Wisconsin,
         15   Alaska, Washington, Florida, Minnesota, Michigan and New
         16   York. Again, they all have very active surveillance
         17   programs there.
         18        The data we collected was a five-year period from
         19   those states and we were able to look at 34,000 -- over
         20   34,000 samples of food products for Listeria of which
         21   758 of those samples were found positive for Listeria. 
         22   And that resulted in an additional followup which
                                                                       74
          1   included over 6000 environmental surface swabs that were
          2   taken.
          3        This is the order that of those violative where
          4   violations existed.  And the number to us was
          5   sandwiches. And these would be sandwiches that would be
          6   under FDA jurisdiction.  As you know it's an open-faced
          7   sandwich, it's regulated by USDA.  If it's a closed
          8   sandwich, it's regulated by the states and FDA.  But
          9   that's where we found most of our problems was with
         10   sandwiches, also with deli meats and retail food stores,
         11   salads.  Fermented sausages was surprisingly a big one
         12   for us.  I'll talk a little bit more about that in a
         13   second.  Smoked fish, the soft, ripened cheeses and
         14   frankfurters.
         15        We also taught the states about the common issues
         16   that were associated with these positive samples and it
         17   all seemed to be consistent in these three areas, that
         18   there was a persistence of Listeria, that after finding
         19   positive samples they would go back and do environmental
         20   swabs and they would find positive swabs and then they'd
         21   go back again and they'd still find it and there seemed
         22   to be a persistence that existed.
                                                                       75
          1        One that I can relate to you in New York is about
          2   the deli case that had Listeria in it and it got down
          3   into those coils and into those areas which are
          4   difficult to clean, and they simply could not get the
          5   Listeria out and had to get rid of the deli case.  And
          6   when they disposed of the deli case, they disposed of
          7   the Listeria.  Very persistent.
          8        Sanitation concerns.  Again, we go back with the
          9   swabs and the samples, and the swabs were ribotyped and
         10   we were able in some circumstances to match the ribotype
         11   with of the finished product with the piece of equipment
         12   or some environment within the establishment.  But the
         13   other thing was the methods of processing.  One reason
         14   for the fermented sausages, a lot of the small retail
         15   shops in some of the larger cities will do natural
         16   fermentation where they do not use starter culture and
         17   they simply use salt in the mixture that is going to be
         18   fermented and that will set in a refrigerator anywhere
         19   from 20 to 40 days.  And where most other pathogens may
         20   be controlled during this period, as you know Listeria
         21   will grow under refrigeration.  So we found that the
         22   fermented sausages that were naturally fermented was
                                                                       76
          1   indeed a problem.
          2        And for those products where there was multiple
          3   handling, you think of a loaf of ham that sits in a deli
          4   and then when you get down to the end cut after several
          5   days, what happens to that?  Sometimes it goes or it is
          6   mixed into a ham salad or something like that.  You
          7   think of a smoked fish plant that trims their smoked
          8   products, the bellies, and they take -- they don't throw
          9   that trimming away.  That is left under storage for a
         10   period of time and then it may be produced into a smoked
         11   fish salad. Where there was multiple handling of
         12   products, it seemed to be a much, much higher risk for
         13   Listeria.
         14        The messages from the data we looked at is that the
         15   organism is very persistent.  We did find however that
         16   those establishments that employed a specific Listeria
         17   action plan -- and we've seen this with some of the
         18   large smoked fish manufacturers, they employ a specific
         19   plan, specifically for them -- we did see a reduction in
         20   a number of positive samples, both environmental and
         21   product samples in those establishments.  The use of
         22   starter cultures where they don't have to do natural
                                                                       77
          1   fermentation, they can put a starter culture in this
          2   mix, reduce the pH almost immediately and you don't have
          3   to go through such a long storage period was another
          4   indication where -- where you could reduce Listeria in
          5   fermented sausage.  And, again, a multiple handling of
          6   products that I mentioned and probably the biggest thing
          7   is the trained employees and particularly in small
          8   businesses.
          9        Our enforcement actions in most -- and this is for
         10   most states -- was assessments of penalties where
         11   Listeria was found in products.  If we believe the
         12   products may remain in the consumer's home, there would
         13   be a recall and a press release.  Where they could not
         14   get the Listeria out, we would suspend their food
         15   processing license and not allow them to slice cold cuts
         16   or manufacture until they could demonstrate that they've
         17   got the Listeria out of there.  In worst case scenarios
         18   we'd get a court injunction which would close them down
         19   unless they operated with a consultant and in many cases
         20   a hold in test program.
         21        One particular project what was conducted in my
         22   state in New York was a collaborative project with
                                                                       78
          1   Cornell University, which we did with the retail food
          2   industry to try to get a better understanding of the
          3   transmission and sources of Listeria.
          4        There were three phases of this project.  We are
          5   currently working on the third phase but the first one
          6   was a 12-month project where our inspectors would go
          7   into ten stores each month.  We did 120 stores.  We
          8   would collect samples of sliced deli meats and store-
          9   made salads and additionally we would collect the intact
         10   samples directly from the manufacturer and directly from
         11   USDA inspected facilities.  We would do 8 to 10
         12   environmental swabs within the store and we would
         13   ribotype all of the isolets.
         14        Very quickly, we went into 121 establishments,
         15   actually, and 60 percent of them -- 73 of those retail
         16   stores -- we found Listeria; however, we only found four
         17   positive products during that entire sampling and I
         18   believe one or two of them were intact products that
         19   were directly from the wholesale manufacturer.
         20        And, quickly, where did we find the environmental
         21   positives?  To no one's surprise just about all of the
         22   drains in the floors were positive.  A couple of things
                                                                       79
          1   that surprised us is the second one, the dairy case,
          2   where you go and select your milk.  For some reason
          3   there was a lot of Listeria in that case, which
          4   surprised us during this one.  And the other one was the
          5   deli sink. Unfortunately deli sinks are not only used
          6   for cleaning and disinfecting equipment.  They're used
          7   for thawing turkeys, chicken wings and actually for
          8   preparing ready-to-eat foods.  And we found that to be a
          9   real easy source of transmitting Listeria.
         10        The messages there is that retail chains in our
         11   view appear to have effective sanitation programs. 
         12   Understand in phase one, these are the large
         13   supermarkets that are generally dealing with educated
         14   employees that have access to resources like sanitariums
         15   or are active in FMI and generally have good sanitation.
         16        And, again, because of environmental sampling, we
         17   found that it's commonly found but we believe through
         18   sanitation it could be controlled and we began to think
         19   the surveillance by states would probably be best
         20   supplied in establishments where sanitation was poor. 
         21   Rather than just going out and trying to get a hit, to
         22   focus our resources in those establishments which had
                                                                       80
          1   bad sanitation histories.
          2        So, we went to phase two.  We said, well let's go
          3   into smaller stores.  These are stores that slice cold
          4   cuts, make salads, but they are not those that have
          5   access to sanitariums.  These are very, very small
          6   retail food stores.  And we did 60 stores.  Again, we
          7   collected product samples, intact samples if available. 
          8   Again, eight to ten environmental swabs and ribotyped
          9   all of the isolets.  A little bit surprising is that the
         10   smaller stores were a little bit better than the bigger
         11   stores.  Fifty-three percent of those stores, a little
         12   bit more than half of them, we found Listeria.  We only
         13   found one product that was positive, that was a salad
         14   product.  So, again, most of these were environmental
         15   and it appeared to us that at least these people were
         16   apparently doing a fairly good job on sanitation.
         17        Here's our environmental samples.  I'll point out a
         18   couple.  We had more here that we found on a slicers and
         19   utensils but again the dairy case, there was quite a few
         20   hits but then we took it a step farther and we looked at
         21   the milk crates that the milk come in and we see that
         22   milk crates also were fairly high in this phase.
                                                                       81
          1        So, we began to think and you start looking in
          2   inner cities and you see the milk being delivered and
          3   put on the outside of the store on the street and then
          4   it's carted into the store from these crates and then
          5   it's put into the milk crates and it just appears to be
          6   just a way of transmitting Listeria through that
          7   process.
          8        Our messages there was although there were less
          9   small stores implicated than the larger supermarkets, we
         10   did find that when they had Listeria in these small
         11   stores, it wasn't just one environmental sample, it was
         12   in several areas of those small stores with the same
         13   ribotype.  And again, there seemed to be a much more
         14   widespread distribution of the organism in certain
         15   stores; whereas, in the large supermarkets we may get
         16   lucky and hit the -- the floor mat or the shopping cart
         17   was positive.  That would be the only positive.  In
         18   these smaller stores we'd find it not only on the mat
         19   but we would find it in several areas of the grocery
         20   store.
         21        But, again, we began to think that our surveillance
         22   would be best applied in establishments where sanitation
                                                                       82
          1   is poor.  So, we decided we'd better do phase three. 
          2   And phase three is to go into our establishments, retail
          3   establishments, which have the poorest of histories. 
          4   And we decided to go into places that we are about ready
          5   to close because they have failed four consecutive food
          6   safety inspections.  And so we are up to our first nine
          7   stores have been completed and I can tell you that we
          8   are a hundred percent in most stores now.  Every store
          9   we have been in -- and we've been in nine, we're going
         10   to do 60 -- every one of those we have found
         11   environmental positive Listeria in those dirty stores.
         12        So, that's one thing we'll be sharing with
         13   everybody and sharing with all the states.  The other
         14   thing I think the states are doing because we believe
         15   that education is so important here, particularly with
         16   the small businesses, is preparing booklets and
         17   educational materials, working with academia to have
         18   programs for small businesses.  We actually in New York
         19   will go out and put on seminars specifically for deli
         20   operators.  We have a program we put together.  It's
         21   made available through AFDO on its Web site, where we
         22   will give a program to any industry, any retail business
                                                                       83
          1   that they can use to help educate their deli workers or
          2   their food handlers dealing with ready-to-eat foods.
          3        And I think you will see not only from what we've
          4   shown in New York and other states but I think with the
          5   changes that are about to occur with FDA and these
          6   guidance documents, I think you will see a change in
          7   surveillance approach conducted by state and regulatory
          8   officials.
          9        Very quickly on inspection focus, I was asked to
         10   talk about what do we do when we inspect.  Those places
         11   where we've had hits, those places which have had a
         12   history of Listeria, state and local agencies up the
         13   frequency of inspections in those establishments.  A
         14   smoked fish plant will get inspected a minimum of 3 to 5
         15   times a year, for instance.  The things we are trying to
         16   promote is specific sanitation and GMP controls.  That's
         17   why I think this guidance document will be very, very
         18   helpful.  We have fully endorsed the Listeria action
         19   plan that was put together for the smoked fish industry
         20   because it is specific to that industry and we believe
         21   all of these industries need to have specific sanitation
         22   and GMP controls.
                                                                       84
          1        We strongly support the sanitary zone concept,
          2   which is really useful in retail where you try to make
          3   sure the zone where there is ready-to-eat foods are --
          4   is protected as possible.  There seems to be an interest
          5   nowadays with certain large retailers to bring their
          6   delis out into the middle of the store so that they have
          7   more access to consumers.  We frankly do not like that. 
          8   We like them back up along the corner, against the wall,
          9   with a dropped ceiling so they can have the sanitary
         10   zone concept because it's much, much easier to control
         11   Listeria.
         12        And dedicated equipment in washing areas, we like
         13   to see that.  This goes back to the sink issue.  That
         14   should be used for washing and not thawing turkeys and
         15   clearly not for opening cold cuts and preparing salads. 
         16   The use of sanitizer to experiment with that.  We've
         17   seen some of the success with the acid-based sanitizers.
         18    And the big one is employee education and training. 
         19   And I thank you again for the invitation.
         20        MR. LANDA:  Thanks, Joe.  Our next speaker is Sarah
         21   Klein with CSPI.
         22        MS. KLEIN:  Hello.  Okay.  I'm going to talk a
                                                                       85
          1   little bit about the consumer understanding of Listeria.
          2    The first thing we know is that the at-risk populations
          3   are comprised mostly of pregnant women and infants,
          4   immunocompromised individuals and the elderly.  My
          5   presentation will focus largely on pregnant women.  I
          6   myself am a pregnant woman and thus I am personally
          7   seeing the lack of information and the misinformation
          8   that abounds among pregnant women about Listeria.
          9        First, some little anecdotes.  It's very difficult
         10   to introduce information about Listeria or about any
         11   hazard to pregnant women.  We, they, are inundated with
         12   information and can become defensive when we are
         13   presented with new information about something that is
         14   very common.  For example, feeding a sandwich with deli
         15   meat, something that we may have already done.  This, I
         16   think, is one of the difficulties with educating
         17   consumers about Listeria is because it is so common, so
         18   prevalent that when you try to explain to pregnant
         19   women, they are terrified that they may have already
         20   done grave damage.
         21        Over the last couple of months my personal attempts
         22   to educate pregnant women have been met with surprising
                                                                       86
          1   resistance.  I participate in some online message boards
          2   for pregnant women and whenever I see somebody asking a
          3   question:  What's the deal with deli meat?  Can I eat
          4   soft cheeses?  Things like that I will generally post a
          5   response and say:  I work in food safety and this is
          6   what the issue is.
          7        Among the responses that I can share with you that
          8   are appropriate for -- I have received the following
          9   responses. You are a fear mongerer; my obstetrician says
         10   he doesn't know where these old wives' tales come from;
         11   and my favorite, oh, right, like I would trust a food
         12   safety professional over my OB.
         13        So, you can see that there are issues with
         14   educating consumers.  The message that is basically
         15   getting out to pregnant women seems to be everything in
         16   moderation.  This runs the gamut from tuna to deli meat,
         17   soft cheese, in some cases even alcohol.  In my
         18   discussions, it's become clear to me that many pregnant
         19   women view the foods that carry Listeria, such as deli
         20   meats and soft cheeses, as categorically similar in risk
         21   to foods like tuna, which is if you eat it every once in
         22   a while you won't have an issue, that it's a cumulative
                                                                       87
          1   effect issue similar to mercury.
          2        So, in the past couple of weeks CSPI decided to do
          3   a very brief survey of consumers to find out what they
          4   know about the risks of Listeria.  We received over 500
          5   responses and I can tell you that we sent -- we posted
          6   the survey in two places.  First, we sent it to people
          7   who have contacted CSPI in the past and asked to receive
          8   information.  These consumers tend to be consumers who
          9   know more about food safety, about nutrition.  We also
         10   posted it on several of my pregnancy message boards. 
         11   What's interesting is that if you take in combination
         12   the fact that both these groups should be very
         13   knowledgeable about Listeria compared to the general
         14   population -- people who self-identify as interested in
         15   food safety and people who theoretically are getting
         16   important food safety messages about Listeria right now
         17   -- the responses are really interesting.
         18        And I do apologize in advance.  I don't have the
         19   survey result numbers up here because I had to turn in
         20   my slides a couple of days ago and I wanted to keep
         21   calculating the survey results up until last night.
         22        So, we asked a couple of threshold questions just
                                                                       88
          1   to see what the environment was like in consumers'
          2   homes. Over 70 percent of consumers report that they
          3   clean their refrigerators every six months at the most. 
          4   Forty-four percent are cleaning once every six months
          5   and 27 percent once a year.  That's at the most.  I
          6   received several e-mails saying you should have put
          7   "never" on the survey.
          8        In terms of proper temperature, 35 percent of
          9   consumers do not know that their refrigerators should be
         10   set at 40 degrees to restrict the growth of harmful
         11   bacteria.  The other options ranged from 42 to 46
         12   degrees.
         13        In terms of recognizing hazard, there was some good
         14   news.  We mixed in -- we didn't use all Listeria
         15   products because I didn't want it to be obvious that
         16   that's the answer we were looking for -- so we asked for
         17   other things. The good news about swordfish is that 93
         18   percent of consumers correctly identified mercury as a
         19   particular hazard associated with sword fish.  And for
         20   raw milk 43 percent know that raw milk can carry E.
         21   coli.  Thirty percent are more concerned about
         22   salmonella.  And another 30 seem to know that Listeria
                                                                       89
          1   is an option in raw milk. So, that's fairly good news.
          2        Now we get to the bad news.  In soft cheeses, only
          3   50 percent know that Listeria is a grave risk from these
          4   soft cheeses.  The other 50 percent didn't know whether
          5   it was salmonella, E. coli, or nitrates.  In deli meats,
          6   over 50 percent believe that nitrates are the biggest
          7   hazard. Eighteen percent know that deli meats can be
          8   contaminated with Listeria and another 18 percent are
          9   worried about E. coli.  In deli salads 50 percent of
         10   consumers believe salmonella is the biggest risk.  From
         11   deli salads, fewer than 10 percent identified Listeria
         12   as a hazard.  Forty percent believe it's E. coli by the
         13   way.  In smoked cold seafood, consumers have no idea
         14   what the risk is.  They were all over the board. 
         15   Thirty-three percent think it's nitrates, 25 percent
         16   think it's mercury, 20 percent salmonella and only 13
         17   percent said it was Listeria, which is alarming since we
         18   have seen some research that suggest that smoked seafood
         19   may in fact be one of the greatest carriers of Listeria
         20   of all of these foods.
         21        Our next question focused specifically on pregnant
         22   women.  We asked people to self-identify if they were
                                                                       90
          1   currently pregnant, had been pregnant within the last
          2   year, or were the spouse or immediate family member of
          3   someone who it was pregnant or had been pregnant within
          4   the last year.  And then the question went on to ask
          5   what information have you received from your
          6   obstetrician or health care provider.  Some of the
          7   results were for me not particularly surprising but
          8   certainly distressing.  The good news is that pregnant
          9   women are being told to avoid sword fish.  At least 63
         10   percent of them are. Unfortunately almost 18 percent are
         11   being given no information.  Another 20 are being told
         12   to enjoy it in moderation.  Seventy-five percent of
         13   pregnant women are being told to avoid raw milk
         14   completely.  Twenty percent are being given no
         15   information.
         16        The bad news.  Less than 50 percent of pregnant
         17   women are being told to avoid soft cheeses.  The other
         18   50 percent are either being told to eat it in
         19   moderation, 33 percent; or are being given no
         20   information, 18 percent.  Over 40 percent of women are
         21   told to eat deli meat in moderation. Thirty-six percent
         22   are told to avoid it, the remaining 20 percent are given
                                                                       91
          1   no information.
          2        I think that in the absence of no information we
          3   can safely assume that many pregnant women are going to
          4   go ahead and give in to that craving for a Subway
          5   sandwich. It's not a particularly unusual food item for
          6   people to eat.  So, in the absence of no information I
          7   think we can assume they're going ahead and eating it as
          8   opposed to not. Interestingly, 42 percent of pregnant
          9   women say they've been told to avoid smoked seafood but
         10   as we saw in the previous results, they don't know why. 
         11   Thirty percent are being told to eat in moderation and
         12   28 percent are being given no information.
         13        Why are pregnant women being given so little
         14   correct information?  It's really unclear and also
         15   unfortunate. From the comments I mentioned receiving at
         16   the beginning of this talk, it's very clear that
         17   pregnant women rely on their obstetricians almost to the
         18   exclusion of everyone else and thus the failure to be
         19   told something directly by your OB is a serious problem.
         20        Next, we asked what are the effects of Listeria or
         21   Listeriosis.  We allowed consumers to select more than
         22   one potential problem rather than just a single one.
                                                                       92
          1   Encouragingly, over 65 percent recognize the two big
          2   risks: fetal abnormalities and infant death and 60
          3   percent identified miscarriage as a possible risk. 
          4   Interestingly equal amounts thought that there was
          5   either no risk to the fetus or maternal death.  So,
          6   people were really unclear whether this was something
          7   that was a really big deal or not a bill deal at all.
          8        Clearly, more education is needed to help these
          9   consumers, particularly these consumers, understand
         10   Listeria and the risks associated with it.  Although
         11   this survey was brief, I think it does illustrate fairly
         12   clearly that consumers are not well informed about these
         13   risks and that the most vulnerable among us might be
         14   making hazardous choices as a result.
         15        So, what should be done to improve consumer
         16   education? The first is improved labeling.  Labeling on
         17   risky products should be clear and concise.  Consumers
         18   may not understand the current labeling, which when used
         19   is unnecessarily wordy and uses some scientific jargon. 
         20   Labelings on risky products should simply state, "If you
         21   are pregnant or immunocompromised, heat this product
         22   thoroughly before eating," in the case of deli meat or
                                                                       93
          1   hot dogs.  Or in the case of products that should be
          2   just avoided they should just say, "Pregnant or
          3   immunocompromised consumers should either avoid this
          4   product or check with their health care provider before
          5   consuming."
          6        Secondly, we need to see some improvements in
          7   retail. Retailers should be more closely scrutinized to
          8   make sure they're routinely cleaning and sanitizing deli
          9   and cheese counters to prevent the environmental
         10   contamination that we just heard about.  FDA should also
         11   consider requiring labeling at those counters with
         12   informational warnings similar to what we're starting to
         13   see out mercury that says, "If you are part of this at-
         14   risk population, you may want to consider whether you
         15   should be seating at the deli counter."
         16        There should be a recognition and a focus that the
         17   greatest area of risk does occur in the retail setting
         18   and at the deli counter, that the foods that carry
         19   Listeria into that environment can seed the environment
         20   and create an entire condition that supports growth and
         21   it doesn't have to be just the food itself that supports
         22   growth.
                                                                       94
          1        We'd also like to see FDA partnering with the AMA
          2   or College of Obstetrics to improve the provision of
          3   this important information to pregnant women at the
          4   doctor's office.  As I've stated, obstetricians have to
          5   be providing that information for women to take it
          6   seriously.  FDA should take on the greater
          7   responsibility of getting the message to doctors about
          8   Listeria and then making sure that those doctors are
          9   passing along the message.
         10        We'd like to see a greater focus on fightbac.org as
         11   well.  There has not been enough done by Fight Bac! on
         12   Listeria and we understand that that may be a funding
         13   issue but we'd really like to see some more done there. 
         14   Of course the drawback with something like Fight Bac! is
         15   that once again it relies on consumers to educate
         16   themselves. It kind of puts a little bit of a burden on
         17   consumers and that's a drawback.
         18        Kind of following on from education is the question
         19   of:  Given that this is the current state of education,
         20   where do we go from here?  One of the questions is
         21   whether it's the right time to do anything about
         22   Listeria other than make it more challenging for it to
                                                                       95
          1   get into the environment.  CSPI obviously believes that
          2   now is not the time, that it's clear that consumers are
          3   not getting the message about the risks and thus
          4   allowing an even greater risk is not appropriate.  The
          5   time to loosen standards is not when the problem still
          6   exists, and from the results that I just spoke about, I
          7   think it's clear that the problem of getting the message
          8   to consumers is definitely still out there.
          9        We're further not convinced that the evidence
         10   really supports the looser standard and I can talk about
         11   that more later, but we don't believe that consumers
         12   understand the difference between shelf life and
         13   consumption and thus maybe there should be some work
         14   done on clarifying that point.
         15        Further, since we heard about some of the
         16   international practices, I just wanted to touch on that,
         17   that there is -- there has been attempt by Codex and
         18   also here to harmonize the standards between the U.S.
         19   and some of the E.U. members and what becomes difficult
         20   is that we're facing different challenges.  The E.U. as
         21   we heard has a lot of specialty products that require a
         22   greater tolerance for Listeria in order to be produced. 
                                                                       96
          1   We don't have that here in the U.S. and so we shouldn't
          2   necessarily be allowing that greater tolerance.
          3        Further, we have some concerns about -- as we
          4   talked about the deli counter and all the different
          5   products that exist there, both USDA-and FDA-regulated
          6   products, we have some concerns about dual
          7   jurisdictional issues there and how that protects
          8   consumers when you have some products that are under a
          9   zero tolerance policy and other products that are not
         10   that can seed that environment as we talked about
         11   before.
         12        It conclusion, CSPI feels strongly that consumer
         13   education around Listeria is inadequate and that the
         14   consumers most at risk are getting inaccurate,
         15   misleading or incomplete information and so we're urging
         16   FDA to take a stronger role in educating consumers both
         17   through its own educational tools like Fight Bac!,
         18   through cooperation with the medical profession, and
         19   stronger regulatory standards such as better labeling. 
         20   Until consumers understand the risks it seems foolhardy
         21   to consider exposing them to even greater level and so
         22   we're very concerned based on the results of the study
                                                                       97
          1   we just conducted.  If we conducted an even larger one,
          2   I'm very concerned about what we would see that people
          3   don't know about this bacteria.  Thank you.
          4        MR. LANDA:  Thanks, Sarah.  Our next speaker is
          5   Jenny Scott with GMA.
          6        MS. SCOTT:  Thank you.  I've been asked to talk
          7   about industry programs that are successful in
          8   controlling Listeria monocytogenes.  You are obviously
          9   going to get a very condensed view of this because there
         10   are many publication on this and there are workshops
         11   that take a couple of days to go through some of this
         12   material.  So, we're going to high-top it here.  As you
         13   saw from Rob Tauxe's presentation, Listeriosis has
         14   decreased significantly over the years but it has
         15   plateaued at this level of about three cases per million
         16   population.
         17        The data from FSIS shows that Listeria
         18   monocytogenes in ready-to-eat meat and poultry products
         19   has also been reduced significantly over the years but,
         20   again, it seems to have leveled off.  Looking at FDA
         21   recalls for Listeria monocytogenes focusing on two
         22   products there, milk and ice cream, you can see that
                                                                       98
          1   back in the mid '80s there are a significant number of
          2   recalls but they have dropped off significantly with the
          3   dairy initiatives projects.
          4        So, what industry programs have been put into place
          5   to achieve these reductions in Listeria monocytogenes? 
          6   First of all, there is the validation of lethality steps
          7   or those steps that remove Listeria from products that
          8   don't get a lethal treatment.  There is the development
          9   of new interventions.  There are good manufacturing
         10   practices that involve stringent personal hygiene and
         11   appropriate traffic patterns.  There is sanitation and
         12   there's been a big focus on sanitation efforts directed
         13   specifically at Listeria control and of course there are
         14   environmental monitoring programs.
         15        These programs and their components do vary by
         16   company and by product.  There is no one-size-fits-all
         17   approach. Also, inherent in these industry programs that
         18   have achieved a reduction in Listeria monocytogenes has
         19   been the sharing of food safety knowledge and practices,
         20   where the harborage sites are, what are appropriate
         21   inhibitors or interventions for Listeria monocytogenes,
         22   and what practices can prevent recontamination of this? 
                                                                       99
          1   This information has been shared through trade
          2   association meetings through workshops, the development
          3   of videos and publications.
          4        The American Meat Institute has a number of task
          5   forces to look at various issues and two of particular
          6   importance are related to equipment design and facility
          7   design.  Their task force on equipment design came out
          8   with ten principles of sanitary design for ready-to-eat
          9   processing equipment and the facility design one came up
         10   with 11 principles for sanitary design for facilities. 
         11   Now while they were targeting the meat and poultry
         12   industry, most of what they have in these design
         13   criteria are applicable to all ready-to-eat production
         14   facilities.  I'm not going to go through their
         15   principles but I just wanted to highlight a couple that
         16   I think are quite specific to Listeria control and one
         17   of these deals with hollow areas.
         18        We all know that hollow areas in food processing
         19   equipment can lead to harborage sites and they should be
         20   avoided where they can be and where they can't be they
         21   need to be hermetically sealed so they don't serve as a
         22   point where Listeria can grow.
                                                                      100
          1        Another principle of sanitary design focused on
          2   Listeria control is to not have niches where Listeria
          3   can get in with the moisture and with nutrients and grow
          4   to high levels and then serve as a means of seeding
          5   product. Also the hygiene design of maintenance
          6   enclosures is something that was developed as a result
          7   of Listeria problems.  And just an example here:  You
          8   can see on the far left, the outside of the equipment
          9   where the supply lines are connected, if you look on the
         10   back side of that old designs involved the lines not
         11   being shielded.  You can see that the lines are all
         12   clustered together; makes a very good environment for
         13   Listeria to get in between those lines.  You cannot
         14   clean those areas.  You cannot sanitize them and so the
         15   new design involves enclosing those so that the Listeria
         16   and the nutrients can't get into that environment and
         17   they don't become a harborage site.
         18        AMI's sanitary design principles for facilities
         19   focused on three broad themes.  First of all, providing
         20   zones of control, then keeping these zones cold and
         21   controlling moisture, and then designing to facilitate
         22   sanitation.  A lot of this is not really new, not really
                                                                      101
          1   specific to Listeria but they're all good practices for
          2   Listeria control.
          3        Some of the things that were specific to Listeria
          4   control include having distinct hygienic zones in the
          5   facility; controlling personnel and material flows to
          6   reduce Listeria transfer them throughout the facility,
          7   in particular, water accumulation being controlled.  We
          8   have learned that water is not always your friend in
          9   these operations and your mid-shift cleanup may be doing
         10   more harm than good.
         11        I won't go through these others.  They're there for
         12   the records and I'm sure the slides will be made
         13   available. Looking at strategies for control of Listeria
         14   monocytogenes in very broad terms.  It's very important
         15   to minimize the potential for the presence of Listeria
         16   monocytogenes in the ready-to-eat area.  So programs
         17   dealing with implementing stringent hygiene and
         18   sanitation practices and implementing personnel and
         19   traffic controls are part of minimizing the presence.
         20        Minimizing the potential for growth of Listeria
         21   monocytogenes in the plant environment, particularly in
         22   a niche, is another major strategy and this involves
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          1   designing out the niches or designing in cleanability
          2   and then keeping the environment dry.  These are control
          3   strategies that can apply to every operation producing
          4   the ready-to-eat product.
          5        In strategies for control of Listeria that may be
          6   specific to certain products involved in developing
          7   formulations that don't support the growth of Listeria
          8   monocytogenes and developing in package lethality
          9   treatments, such as, heat treatments or high pressure
         10   processing.
         11        And once these programs are in place, it's
         12   important to have an environmental monitoring program to
         13   verify the effectiveness of the Listeria monocytogenes
         14   control program and to assess the need for additional
         15   control measures. This program should be written,
         16   results should be documented, and they should be
         17   evaluated over time.  There are many effective
         18   variations on these programs.  Again, I have to
         19   emphasize that having reviewed a number of these
         20   effective programs, I don't see a lot of the same
         21   programs in different operations.  Everybody has their
         22   twists and they all work very nicely.
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          1        Some things that they have this common.  Pretty
          2   much all of these programs involve using Listeria
          3   species or Listeria-like organisms as the target
          4   organism for the program.  It's a conservative approach
          5   because all Listeria monocytogenes are Listeria species
          6   but the reverse is not always the case.  We also don't
          7   use a statistical sampling program but we use a biased
          8   and intensive sampling during or at the end of
          9   production.  By doing it during production or at the end
         10   of production you have given the opportunity for the
         11   harborage sites to be opened up and the organisms to be
         12   released from those sites and possibly contaminating the
         13   equipment or the product.
         14        Many people use the zone concept with respect areas
         15   to sample and I'll come back to that in a minute.  But
         16   determining what areas to sample has been based on
         17   industry knowledge and experience as well as the
         18   complexity of operation.  Generally, these programs
         19   involve sampling areas as large as possible. We have
         20   gotten away doing a one square foot sampling site to: 
         21   Let's look at as big an area as we can to find the
         22   organism.
                                                                      104
          1        Although we recognize that there are these little
          2   cracks and crevices and niches that are small areas and
          3   in that case swabs are necessary to get into those. 
          4   These programs generally involve both testing the food
          5   contact surfaces and non-food contact surfaces and every
          6   production line gets sampled.  It may not be every time
          7   but there is a time frame which in every production line
          8   will get sampled. So, looking at the sanitary zones
          9   concept, it generally involves starting with a zone one,
         10   which is the product contact surfaces, the area of most
         11   concern and focusing much of the effort there and then
         12   working out from this with maybe lesser effort on the
         13   exterior of the equipment and the framework and floors
         14   right around the area where the product is exposed to
         15   the environment and then working away from to phones,
         16   forklifts, walls and drains in the ready-to-eat area and
         17   then moving out of the ready-to-eat area into the locker
         18   rooms, the cafeterias and halls.  I have to emphasize
         19   though that not everybody uses the zone concepts, there
         20   are other approaches that work equally well.
         21        With respect to the environmental monitoring
         22   programs the sampling plans need to be flexible and
                                                                      105
          1   tailored to each specific line and facility.  Things we
          2   have seen that have differed among these programs
          3   include the number of sampling sites, whether or not all
          4   of the sites are fixed sites, or whether they were
          5   variable sites or there's a combination of fixed and
          6   variable sites with the rotation of sampling sites.
          7        Which sampling sites fall within which zone may
          8   differ for different companies and the frequency of
          9   testing can vary by zone, by site, by product type, etc.
         10    Most of these programs use a randomized testing
         11   approach with respect to the day of testing and the
         12   shift of testing so the plant doesn't always know when
         13   someone is coming in to take the samples.  Not that they
         14   could really clean up if there's a harborage site but
         15   still surprise is good.
         16        The programs are generally based on the risk of the
         17   product with the programs being more aggressive, that is
         18   more samples being taken and taken with a greater
         19   frequency with respect to products that support the
         20   growth of Listeria monocytogenes and have a longer shelf
         21   life.
         22        The emphasis on all of these programs is on test to
                                                                      106
          1   find and reacting to all of the positives.  Now the
          2   actions that are taken with respect to the positives
          3   will differ depending upon the significance of the
          4   positives. Corrective actions are taken based on the
          5   plan and they are developed in advance.  What we're
          6   trying to do here is find these harborage sites, the
          7   growth niches where the organism will persist even after
          8   the sanitation operations.  For example, the industry
          9   learned a long time ago that hollow rollers not only can
         10   become a growth niche but they will become a growth
         11   niche unless they are dissembled, cleaned and sanitized
         12   or heat treated in a manner that will eliminate
         13   contaminating organisms and most people have found that
         14   the growth where hollow rollers had been replaced over
         15   time.
         16        Most of the programs involve triggers and
         17   escalating corrective actions as part of the
         18   environmental monitoring program.  This is based on the
         19   significance of the finding. For example, a sporadic
         20   positive, which indicates a transient strain is less
         21   significant than a repeat positive that occurs after
         22   you've taken a corrective action.  Food contact surfaces
                                                                      107
          1   are clearly more significant than non-food contact
          2   surfaces.  Increased positives in one area of the
          3   facility may be a red flag that something is going on.
          4   Likewise, the trend of increased positives over time,
          5   even though positives in the plant in general may be
          6   low, if the trend is increasing over time it may suggest
          7   that something is changing and warrants additional
          8   attention.
          9        The escalating approach to corrective actions often
         10   get to a root cause analysis when there's a harborage
         11   site. If the original sample was a composite, then the
         12   first step is to go back and test the individual sites. 
         13   Sites are generally resampled after sanitation program
         14   and usually sanitation has occurred between when you've
         15   taken the initial positives and when you go back to
         16   resample but rather than waiting for the next weekly
         17   sampling site, companies may go in right after they
         18   learn that they had a positive in the site and resample
         19   that.
         20        If additional corrective actions are not effective
         21   then intensified environmental sampling takes place. 
         22   There are more sites sampled more frequently sampled,
                                                                      108
          1   sometimes as frequently as every day for a while.  Then
          2   enhanced corrective actions may involve disassembling
          3   the equipment and then cleaning it, scrubbing it,
          4   sanitizing, reassembling it, resanitizing it.  And then
          5   finally applying heat is another corrective action that
          6   occurs with enhanced need to look for Listeria.
          7        The industry discovered a long time ago that
          8   steaming equipment can be very effective.  The
          9   electronics are shielded by plastic and the equipment is
         10   placed under a tarp and steam is pumped in to get the
         11   temperature up to 160 degrees Fahrenheit for 30 minutes.
         12    Some people only use this when they have detected a
         13   problem. Other people have their equipment using this on
         14   a rotating basis where the equipment lines get steamed
         15   once a month or something along those lines.
         16        Corrective actions may also include the evaluation
         17   of personnel and procedures such as the action
         18   production sanitation and maintenance employees.  They
         19   may involve looking at the frequency of sanitation and
         20   the types and the strength of the sanitizers as well as
         21   specific sanitation techniques.
         22        It may involve looking at maintenance procedures. 
                                                                      109
          1   Are the maintenance procedures designed to prevent
          2   breakdowns and formation of harborage sites and are the
          3   maintenance procedures such that they don't contribute
          4   to contamination of the environment?  With respect to
          5   product testing, the industry recognizes that product
          6   testing is a verification measure but is not a lot
          7   release program.  The reasons for doing product testing
          8   by industry often are because an environmental
          9   monitoring positive suggests that there is food contact
         10   surface contamination coming from a harborage site that
         11   will lead people right into product testing and hole and
         12   test procedures.
         13        But also product testing can be done as periodic
         14   routine verification to look at process control over
         15   time and of course industry often does product testing
         16   as a customer requirement.  Most industry programs also
         17   recognize the importance of controlling special
         18   situations such as activities that result in temperature
         19   increases with, for example, the HVAC being maintained. 
         20   Moving and modifying processing and packaging lines that
         21   can expose harborage sites and release Listeria into the
         22   environment. Installing pre-owned equipment, you may be
                                                                      110
          1   moving someone else's harborage site into your facility.
          2    Equipment breakdown where maintenance has to go in
          3   during production can be a problem.  And construction
          4   activities.  Also new employees in the ready-to-eat
          5   area.  They may not be familiar with the Listeria
          6   control program.
          7        These programs have resulted in successes.  For
          8   example a typical processor implementing these types of
          9   programs has reduced Listeria in the environment from
         10   about 5 percent to less than .5 percent.  And food
         11   contact surface positives have been reduced from about 2
         12   percent to about .2 percent.  We haven't got a whole lot
         13   of information on the level of Listeria on surfaces when
         14   they are contaminated but the limited data we have
         15   suggests that we have for the most part the numbers are
         16   less than ten unless we're talking about something like
         17   a floor or a drain.
         18        The key elements to the success of these industry
         19   environmental monitoring programs has been the
         20   flexibility to design the program to meet the needs of
         21   the facility. No fixed number of samples.  No set
         22   frequency of sampling, etc.  Also inherent in this is
                                                                      111
          1   there will be no penalty for finding Listeria species at
          2   least initially on a food contact surface.  Having the
          3   ability to take corrective action and determine if
          4   there's a harborage site.
          5        Also, there'd be no requirement for product holding
          6   test when a food contact surface is initially tested. 
          7   The logic behind this is that the success of these
          8   programs depends on locating Listeria, finding positive
          9   results and taking proper action.  You have to remember
         10   that a positive is a data point and is not necessarily a
         11   failure.  Even with effective control the environment
         12   will not be completely Listeria negative.  And programs
         13   that punish positive results are destined to failure.
         14        The goal of industry Listeria monocytogenes
         15   programs is to keep transient strains from become
         16   resident strains, to find Listeria monocytogenes if it's
         17   present in the environment, to prevent product
         18   contamination and to protect the consumer.  Thank you.
         19        MR. LANDA:  Thanks Jenny, our final speaker this
         20   morning is Bob Buchanan from CFSAN.
         21        MR. BUCHANAN:  Hi there, again.  My job now is to
         22   introduce this draft compliance policy guide and
                                                                      112
          1   summarize what's in it and set the final stage for the
          2   discussion that will take place this afternoon.  And I
          3   would recommend if you haven't already looked at it and
          4   I assume you have since you're here, in your package is
          5   the draft compliance policy guide for FDA staff and also
          6   the Federal Register Notice is a second document that is
          7   worth looking at because it goes into some of the detail
          8   behind the rationale behind the policy guide.  And both
          9   of those are available and we hope you take the
         10   opportunity to take a look at them and study them in
         11   detail.
         12        To provide a little bit of a background on why
         13        we're
         14   here and some of the issues that we're facing as a
         15   regulatory agency, we have noticed that the data that is
         16   coming out of CDC that after initial improvements the
         17   incidents of foodborne Listeriosis in the last four
         18   years from 2002 to 2006 has essentially plateaued and
         19   certainly that's interpreted by us as a need to focus on
         20   potential new approaches and to get to the areas that
         21   represent the barriers to making further successes.
         22        Also in terms of background, FDA did receive an
                                                                      113
          1   industry petition that stated quite strongly that the
          2   numbers-based approach would encourage the industry to
          3   reformulate their product, increase their testing.  It's
          4   also and always is critically important that FDA is
          5   viewed nationally and internationally as a science-
          6   driven, risk-based food safety agency.  This has been a
          7   key to our success over the last hundred years.
          8        It's also increasingly important for our food
          9        safety
         10   requirements and whenever appropriate be harmonized with
         11   international standards and then finally the risk
         12   assessment, scientific evaluations and extensive
         13   research you heard about summarized quickly are --
         14   certainly provides us with a very strong scientific base
         15   in terms of the factors that influence the risk of
         16   foodborne Listeria. So, our goal in bringing you-all
         17   here today and seeking public comment is that within our
         18   legal framework the goal of the CPG is, number one, to
         19   enhance public health.  It's to focus our efforts where
         20   there is going to be the greatest risks so that we get
         21   the greatest improvement in public health, to base our
         22   actions on science and risk, to encourage industry to
                                                                      114
          1   develop innovations that enhance safety through things
          2   such as product reformulation, post-packaging treatments
          3   and effective testing programs.  And then finally to
          4   harmonize where appropriate our guidelines with those
          5   that are accepted internationally.
          6        Now, I want to -- one of those things in all of our
          7   documents that appear in a text box at the front that
          8   people -- most people don't read I did want to put this
          9   slide up and make sure we talk about it here that this
         10   is draft guidance.  It is guidance to our inspectors. 
         11   So this is primarily guidance to ourselves.  Of course
         12   we understand that this has an impact on industry.  But
         13   I did want to look at that disclaimer.  It is guidance. 
         14   We want to emphasize that it's guidance.  It does not
         15   create or confer any rights for or on any person and
         16   does not operate to bind FDA or the public.  You can use
         17   this -- use an alternate approach if the approach
         18   satisfies the requirements of the applicable statutes
         19   and regulations. If you want to discuss an alternative
         20   approach, contact FDA staff responsible for implementing
         21   this guidance.  So I've gotten that out of the way.  And
         22   this is true.  This is guidance and it's to be used in
                                                                      115
          1   that respect and we will continue to be looking for
          2   comments on this approach.
          3        Okay.  A little bit about the scope of the draft
          4        CPG.
          5   It is about ready-to-eat foods.  These are foods that
          6   consumed without further cooking by the consumer or
          7   foods that reasonably appear to be suitable for
          8   consumption without cooking.  I might note that also
          9   included in there is the discussion that foods may be
         10   considered ready-to-eat if consumers are likely to use
         11   the product without cooking despite cooking instructions
         12   provided on the label and as with the rest of the CPG,
         13   we are interested in public comment on this.
         14        The CPG establishes two levels for foods to be
         15   considered adulterated under our statutes 402A1, based
         16   on their ability to support growth of Listeria
         17   monocytogenes over the course of the food's shelf life. 
         18   And I might note -- I want to emphasize that's over the
         19   entire course of the food's shelf life.  This is --
         20   basically divides them into -- for foods that support
         21   growth, the requirement would be less than .04 CFUs per
         22   gram or this is absence in 25 grams I might note and
                                                                      116
          1   emphasize because sometimes people forget that this is
          2   our current requirement.  This is the level to which we
          3   now look at foods because it's limited by the sampling
          4   that we actually do.  The second would be for ready-to-
          5   eat foods that do not support growth. It would be a
          6   level of less than 100 CFUs per gram.
          7        Okay.  The draft CPG also provides a general
          8        framework
          9   on how our inspectors will distinguish foods in terms of
         10   those that do and do not support growth.  For foods that
         11   have a water activity of less than .92, a pH of less
         12   than or equal to .44 or a product that is frozen until
         13   consumed. That is it remains frozen up until the point
         14   it actually goes into the consumer's mouth.  These will
         15   be considered to be foods that do not support growth.
         16        We also provide options to our inspectors to look
         17        at
         18   other validated controls, things like the use of hurdle
         19   technology, antimicrobials, pH water activity
         20   combinations that prevent growth over the course of the
         21   ready-to-eat food's entire shelf life.
         22        I might note in our request for public comments we
                                                                      117
          1        are
          2   asking for comments related to our draft guidance to
          3   industry on how one should go about validating that a
          4   food does not support the growth of Listeria
          5   monocytogenes and the types of documentation that would
          6   be needed by our inspectors to feel confident that in
          7   fact that product would not support the growth.
          8        So, we are looking at part of the written comments
          9   we're asking for the guidance to industry document,
         10   comments on the validation requirements particularly the
         11   duration of the test period.  For example, does the 1.3
         12   times the shelf life of the product, is that an
         13   appropriate value to be used?  Certainly it's one that's
         14   well-recognized within the food industry.  The
         15   temperature at which we could conduct these trials.  For
         16   example, should it be at ideal refrigeration
         17   temperatures or should it be at marginally abusive
         18   temperatures?  And also the difference of the levels of
         19   Listeria monocytogenes that can be -- that it can
         20   increase and still not be considered indicative of
         21   growth.
         22        Traditionally microbiologists like to use no more
                                                                      118
          1   increase in numbers more than one log cycle.  Should it
          2   be one log cycle or half a log cycle, etc.?  So, we are
          3   interested in comments on all of those validation
          4   questions.  The draft CPG also provides guidance on the
          5   standard methods to be used by FDA laboratories for
          6   analyzing samples and again the methods will be
          7   different for the two classes of foods.  For foods that
          8   support growth, we will continue to use the
          9   bacteriological analytical manual approach.  This has
         10   served us well and continues to serve us well.  And for
         11   any of you that are not familiar with it, this is the
         12   Web site where that method can be found.
         13        For foods that do not support growth, we did not
         14        want
         15   to get into a situation where we would have to require
         16   ambient-type testing if we could avoid it and so we've
         17   selected the ISO method.  I might note that the FDA labs
         18   are now all ISO certified so they like to use ISO
         19   methods. This is a plate count method and it is
         20   recognized internationally.  I might note that the
         21   confirmation for both of those methods are the methods
         22   that are employed in the BAM.
                                                                      119
          1        Just a little bit more about the -- for those of
          2        you
          3   who are not familiar with the ISO method, it is a
          4   direct-plating method.  The lower limit of sensitivity
          5   is appropriate for use with a standard with 100 CFUs per
          6   gram. And it's a simplified test that provides both
          7   sensitivity and the ruggedness that is needed for this
          8   class of foods.
          9        Okay.  A couple of other general comments.  The CPG
         10        is
         11   to be applied on a case-by-case basis.  This is an
         12   individual evaluation of an individual finding.  It is
         13   not and does not establish an acceptable level of
         14   Listeria monocytogenes in food and I might note that FDA
         15   does not expect to see a decrease in the general level
         16   of control of Listeria monocytogenes now achieved in
         17   ready-to-eat foods that do not support the growth of
         18   Listeria monocytogenes.
         19        We do note and are quite familiar with the type of
         20   testing we do and the degree to which industry would be
         21   even more rigorous and conservative and we don't expect
         22   to see that to changed.  And then finally the CPG does
                                                                      120
          1   not excuse GMP violations, CGMP violations, nor does it
          2   preclude an action being taken by FDA under 402A4.
          3        And then finally summarizing by proposing this
          4        draft
          5   CPG, we do expect that it will, one, encourage industry
          6   to reformulate ready-to-eat foods and implement other
          7   control measures.  We anticipate that it will allow FDA
          8   to focus more of its resources on the highest-risk foods
          9   and then finally it will allow FDA to harmonize its
         10   programs with international guidance being developed by
         11   Codex Alimentarius.
         12        And then finally I remind all of you that we are
         13   seeking comment on this.  We are looking for comment,
         14   you know, rigorous comment coming in to us and this is
         15   just a reminder of where you can send the comments to. 
         16   And that is short and sweet and I'm well ahead of even
         17   your five-minute presentation.
         18        MR. LANDA:  Thanks, Bob.  Before we break for lunch
         19   just a couple of reminders.  The first is:  If you have
         20   questions for the panel to please give them to FDA
         21   staff, the folks with the blue tags, blue nametags. 
         22   Second, if you would like to make comments in the public
                                                                      121
          1   comment period this afternoon but haven't registered
          2   please do so. That's at registration desk just outside
          3   the corridor.  To the extent we have time we'll
          4   accommodate late registrants. The third thing is just if
          5   you haven't had a chance it's worth look taking a look
          6   at the exhibit in the corridors out there.  It was
          7   assembled for the hundredth anniversary of the agency. 
          8   It starts as you enter the building on the left, late
          9   19th, early 20th Century and continues up through the
         10   latter part of the 20th Century through the food safety
         11   initiative and maybe a little bit beyond.
         12        Why don't we -- we were scheduled to return at
         13        1:30.
         14   Why don't we stick to that schedule.  So, we'll see you
         15   then.  Thanks. (Break taken.)
         16        MR. LANDA:  Why don't we get started.  We've
         17   managed to stay on schedule most of the day.  Let's see
         18   if we can continue on that path.  Following the agenda
         19   this is the time for the FDA panel for questions.  The
         20   panel is Dick Whiting, Don Zink, Bob Buchanan and I'm
         21   Mike Landa.  We did get some questions on cards and
         22   we'll go through them and then see if any more come in.
                                                                      122
          1        MR. WHITING:  Hello.
          2        MR. LANDA:  The first question:  Dr. Buchanan
          3   mentioned that a number of risk assessments have been
          4   conducted.  Are there significant differences and
          5   conclusions from various risk assessments, for example,
          6   with respect to the conclusion that low levels of
          7   Listeria monocytogenes equal low risk?
          8        DR. BUCHANAN:  None that I know of.
          9        MR. WHITING:  No.  I would agree.  I think they're
         10   all working off the same general idea that you have a
         11   linear response leaving one Listeria as a potential of
         12   causing illness but when you're at that level, if you
         13   have a ten-fold increase in the number of Listeria the
         14   risk goes up about ten-fold.  This is, you know, you saw
         15   the linear lines on that one graph that Bob has
         16   presented.  And I think when you look at the large
         17   number of cases that we had ten to the 11th ready-to-
         18   eat servings a year and it was ten to the 7th with high
         19   numbers of Listeria with only 2000 cases, you have
         20   looked at the probabilities of this and you are going to
         21   expect that almost all of the cases will have to come
         22   from the very high doses.  This is what's basically the
                                                                      123
          1   logic underlying all the models.
          2        MR. LANDA:  Next question is sort of three parts. 
          3   I'm going to start with the last part because it's the
          4   one I'm reasonably confident we can answer.  How would
          5   the deployment of FDA inspectors, inspectional personnel
          6   be impacted by this policy change?  I'll take a stab at
          7   that and then see if anyone wants to add or for that
          8   matter subtract what I'm going to say.
          9        It seems to me the effect would be that we would be
         10   devoting more inspectional resources to high-risk, to
         11   the growth -- of the foods that support growth and fewer
         12   resources to foods that don't, and in each case I would
         13   hope in a more focused fashion.
         14        MR. LANDA:  How many FDA regulated food
         15   establishments would be affected by this policy change?
         16        DR. BUCHANAN:  Let me make a stab at this and what
         17   -- which one was it?
         18        MR. LANDA:  How many FDA regulated food
         19   establishments would be affected by this policy change? 
         20      DR. BUCHANAN: A lot.  It's really hard to tell, you
         21   know, we could go over to our registration database and
         22   I could make a simple answer and say it's about 300,000
                                                                      124
          1   establishments that we are responsible for regulating.
          2        MR. LANDA:  That's foreign and domestic.
          3        DR. BUCHANAN:  Foreign and domestic.  But
          4   specifically which of them have ready-to-eat foods is
          5   harder to tell so I would sum it up as a lot.
          6        MR. LANDA:  Next question:  How many dual FDA/FSIS
          7   regulated food establishments would be affected by this
          8   policy change?
          9        DR. BUCHANAN:  All of them that make ready-to-eat
         10   foods.  Let me emphasize that's one of the areas that
         11   we're particularly interested in receiving public
         12   comments on is public comments on particularly the
         13   guidance to industry document and the differences
         14   between the requirements that are outlined in the
         15   guidance document or the guidance that's in the guidance
         16   document and then that's what you're receiving in the
         17   dual jurisdiction from FSIS because certainly we see
         18   that an area where there needs to be a -- as much
         19   harmonizing of the approaches that we do have. Even now
         20   we have differences in our approaches to some degree.
         21        MR. LANDA:  Don, did you want to add anything or
         22   Dick?
                                                                      125
          1        DR. ZINK:  No.  I was thinking all the -- virtually
          2   all of the frozen food manufacturers would probably be
          3   dual jurisdiction and would be affected and virtually
          4   all of the deli salad manufacturers would be affected so
          5   I think the number is substantial.  And I believe in our
          6   guidance, if memory serves, that we had pointed out that
          7   if you are in a situation where there is dual
          8   jurisdiction and the other jurisdiction has more
          9   stringent requirements for the product, even though you
         10   may be, for example, using an FDA regulated non-growth
         11   product to make a USDA growth product, then you have to
         12   have a degree of control that will be adequate for the
         13   most stringent requirement.
         14        MR. LANDA:  Thanks.  We have some questions about
         15   application of the guidance in the retail context.  One
         16   is what to do about states that only test for presence
         17   or absence and do not enumerate.
         18        I think from our standpoint if you look at the CPG
         19        as
         20   an enforcement document providing guidance to staff, FDA
         21   staff, for ready-to-eat that supports growth, we don't
         22   need enumeration.  If it doesn't support the absence of
                                                                      126
          1   enumeration could be a problem from the standpoint of
          2   proceeding under that guidance.  And of course that is
          3   the change in our own -- or proposes, if you will, a
          4   change in our own policy.
          5        DR. ZINK:  I think this will have the effect -- we
          6   mentioned the effect it would have on our own
          7   investigators to focus on ready-to-eat products that
          8   support growth.  I think it's going to have the same
          9   effect on our state and local partners.  I think that
         10   will cause them to also focus much more on these higher-
         11   risk products.
         12        DR. BUCHANAN:  The only other suggestion I can
         13   offer is that you can manipulate the sensitivity of any
         14   microbiological testing program by altering the size of
         15   have sample that is taken and if someone else wants to
         16   propose an alternative method that provides
         17   approximately the same level of sensitivity as what we
         18   would need to have a high degree of confidence that more
         19   than 100 CFUs per gram has not been exceeded, I'm sure
         20   that we could sit down and discuss those alternate
         21   methodologies but I think certainly from our standpoint
         22   or my personal standard probably the most cost effective
                                                                      127
          1   approach would be the one that we recommended.
          2        MR. LANDA:  Two other questions also in the context
          3   of FDA working with states.  First, is how to identify
          4   foods that do not support growth beyond what we --
          5   presumably the question means -- beyond what we said in
          6   the document.
          7        DR. ZINK:  If you run into a food that obviously
          8   has a pH or water activity that falls outside the limits
          9   that support growth of Listeria, that's an easy one.  A
         10   food that's acidic or something like a granola bar, you
         11   know, that's so dehydrated that you're not going to get
         12   the organism to grow or frozen foods, that would be easy
         13   to exclude.  I'll admit there are probably a category of
         14   foods -- most of the questions I see seem to be in the
         15   area of deli salads where these foods have higher pHs
         16   and higher water activities than those limits alone will
         17   inhibit but may have interactive effects that inhibit
         18   the growth of Listeria and in such cases unless you can
         19   use a growth modeling program or draw upon some
         20   previously published data, it is hard just by looking at
         21   pH and water activity to tell whether or not a
         22   particular food will support the growth of Listeria and
                                                                      128
          1   in some of these cases it may have to just be determined
          2   by testing.
          3        I think what I'm hoping is that manufacturers will
          4   look at this guidance and for themselves determine and
          5   document which of their products are growth products and
          6   which are no-growth products and that's relatively easy
          7   to do with a challenge study.
          8        DR. BUCHANAN:  Yeah, I'd like to emphasize that if
          9   we're talking about the retail the separation of
         10   products that are formulated and made within the retail
         11   environment and those that are actually just sold in the
         12   retail environment and would suggest that if a retail
         13   company has faith in their manufacturers that are
         14   supplying them with material, then they might rely on,
         15   you know, verification done by the person providing the
         16   product.  On the other hand if they're producing a
         17   product within their store, they're either going to have
         18   to provide documentation or I think our inspectors would
         19   have to assume that it was a growth food unless it was
         20   something like beef jerky or something like that that
         21   was obviously dried to the consistency of shoe leather.
         22        MR. LANDA:  And about as tasty.  Last question in
                                                                      129
          1   this retail context is:  What about contact surface
          2   samples?
          3        DR. ZINK:  In the guidance we recommend that as
          4   part of environmental sampling, food contact testing --
          5   food contact surface sampling should take place.  I
          6   think that with Listeria that has to be or should be a
          7   portion of any environmental sampling plan that gives
          8   you an indication of what the food is exposed to.  It's
          9   really the most critical area.  If you have some sort of
         10   defective sanitary design or some defective application
         11   of your sanitation program with respect to these
         12   critical surfaces, testing them is really the only way
         13   you're going to detect that.
         14        MR. LANDA:  I know I said this morning that we
         15   wanted questions on cards and we did get some but we've
         16   gone through the ones we got.  We can certainly take
         17   more questions if people have them and we do have some
         18   microphones here so -- are there. . .
         19        MR. POWELL:  Question for Bob Buchanan.  I'm Mark
         20   Powell with the USDA Office of Risk Assessment and Cost
         21   Benefit Analysis.  It seems to me that the JEMRA study
         22   may have been somewhat mischaracterized in terms of
                                                                      130
          1   compliance. It's really about the proportion that the
          2   defective product at the point of consumption.  If there
          3   is some proportion of products where the control measure
          4   fails to inhibit growth, then the product could be
          5   compliant at the point of testing but a small proportion
          6   could nevertheless be in excess of 100 grams -- 100 CFU
          7   per gram at the point of consumption if the validations
          8   don't take into consideration not only the average
          9   performance of the control measures but the reliability
         10   and the consistency of those measures.
         11        How can that be taken into account in the challenge
         12   studies that will validate the performance of the
         13   measures?
         14        MS. YATES:  Would you. . .
         15        MR. POWELL:  Mark Powell of the USDA Office of Risk
         16   Assessment and Cost Benefit Analysis.
         17        DR. BUCHANAN:  Yeah, I know Mark.  I'll try and
         18   make an answer and then turn it over Dick and Don to
         19   give their thoughts on this.  And the question was
         20   primarily focused on validating that a product does not
         21   support growth over its entire shelf life and certainly
         22   that was an area that in my presentation of the CPG we
                                                                      131
          1   were specifically looking for advice on how to conduct
          2   those validations.
          3        My presumption as a microbiologist would be that in
          4   conducting these studies you would expect a certain
          5   confidence -- degree of confidence in evaluating these
          6   studies so that you could say that you should not get
          7   growth or growth will not exceed such and a such a point
          8   over this time frame and then you put the confidence
          9   interval around it in looking at that.
         10        Certainly the issue has been for some of the
         11   products the number of these antimicrobials that are
         12   used in conjunction with the products only last for a
         13   period of the total shelf life of the product and
         14   currently as a CPG, at least my understanding of the
         15   CPG, is that that type of product if it did not last the
         16   full shelf life of the product will be classified as a
         17   product that supports growth and therefore fall under
         18   the more stringent requirement.  It would not have the
         19   100 CFU or less limit. So that's one of issues I think
         20   in learning how to use these is that the CPG
         21   specifically says over the entire shelf life.
         22        I don't know if that helps to answer the question.
                                                                      132
          1   But we're looking for that because also when you're
          2   looking at any of these, for example, traditionally
          3   microbiologists are allowed one log of growth or one log
          4   increase.  They don't call it "growth."  They call it
          5   the "errors of the methodology."  Okay.  And I'm going
          6   to -- the question is: Is that the true error of
          7   methodology or should there be half a log would be
          8   sufficient, etc.?
          9        MR. POWELL:  That a log is the average over
         10   replicates?  Is that 95 percent confidence that the
         11   growth is less than one log taking into account the
         12   measure of an error?  I think there's a whole host of
         13   issues that are going to confront the food safety
         14   agencies as you look to validate the measures that will
         15   inhibit or prevent the outgrowth.
         16        DR. BUCHANAN:  Well, we'd certainly like your
         17   comments, Mark, on that in terms of the underlying
         18   statistics that should be put into a validation trial.
         19        DR. ZINK:  I'll kind of address that.  At one point
         20   in my career, I was responsible for salad dressings --
         21   the microbiological stability of salad dressings and I
         22   think that you can address the inhibitory qualities of
                                                                      133
          1   the food fairly easily with challenge studies.  Let's
          2   say that you're concerned about a .01 percent defect
          3   rate. Obviously if you tried to handle that in a
          4   challenge study that was designed to challenge the
          5   product with real world likely contamination levels,
          6   then you'd have to have such a tremendous number, tens
          7   of thousands of numbers to replicate, and even that
          8   wouldn't be satisfactory because you's have to account
          9   for manufacturing and batch-to-batch variation.  Okay?
         10   But this is no different than many segments of the food
         11   industry and particularly the salad dressing industry,
         12   refrigerated salad dressings, have had to deal with for
         13   decades.
         14        Challenge studies are as much art as science and we
         15   see challenge studies submitted to us for evaluation all
         16   the time and certainly they fall into the category of
         17   the good, the bad and the ugly.  But a good challenge
         18   study can still be very reasonably run and can still
         19   give you an enormously high confidence that you're going
         20   to have a Listeriostatic product throughout its shelf
         21   life and how is that?  Well, quite simply put, you
         22   challenge it with a much larger dose than what it's ever
                                                                      134
          1   going to see in the real world.
          2        It's pretty typical to use something like a ten-
          3   strain mix and you might challenge the product with a
          4   hundred cells per gram and maybe a hundred thousand or a
          5   million cells per gram and you might run your study
          6   under expected conditions of storage as well as somewhat
          7   abusive conditions of storage.  And you might run it for
          8   one and a half to two times the expected shelf life. 
          9   And so what you get out of that -- if you have a product
         10   that truly holds up under a high-dose challenge run for
         11   one and a half or more times its shelf life under even
         12   slightly abusive conditions, you could have a very high
         13   confidence that, you know, in the real world where
         14   contamination rates are likely low and likely involving
         15   only one strain and likely not every container sees that
         16   kind of abuse or that kind of storage life, that there's
         17   a very high probability that you're not going to have
         18   significant failures or the kinds of failures that would
         19   cause you a problem.
         20        And the industry does those kinds of challenge
         21   studies now in a number of product areas.  It may be new
         22   to some categories of products in the types of products
                                                                      135
          1   that we're talking about here, but it's not difficult to
          2   do that study and to have a pretty high confidence in
          3   the result.
          4        DR. BUCHANAN:  Can I make one more comment -- and
          5   then ask for additional comments from the people in the
          6   audience.  It's important that the two documents that
          7   are being discussed today are looked at in terms of
          8   their interaction and their relationship because as part
          9   of a guidance to industry, one of things that we are
         10   recommending is the ongoing testing of the environment,
         11   the product, etc.  And what you're effectively doing, if
         12   you're doing that type of process control testing,
         13   you're periodically testing your system is that you're
         14   continuing your validation study as part of your
         15   routine.
         16        So, if you began to get situations where, you know,
         17   that on the tells that you're concerned about they would
         18   start showing up as part of your testing program and
         19   then you could go back and revalidate your original
         20   process if you started to go out of what your
         21   expectations were if they were starting to show up.
         22        MR. WHITING:  I would also say from a practical
                                                                      136
          1   matter, I think issues like selecting the best strains
          2   to use in your challenge study and probably deciding
          3   what temperature your food should withstanding, there
          4   are probably bigger issues than, you know, some of the
          5   things you were thinking of.
          6        MR. LANDA:  We have one more written question.  Can
          7   imported frozen vegetables, mushrooms in industrial
          8   packaging, which will be reprocessed by thermal
          9   processing be exempted from the guidance limit of
         10   absence in the 25-gram sample?
         11        DR. ZINK:  Did you say frozen mushrooms?
         12        MS. LEE:  Yeah, frozen.  Is it being allowed to
         13   come in and then --
         14        MR. LANDA:  Reprocessed by thermal processing.
         15        MS. LEE:  Definitely for reprocessing with thermal.
         16   . .
         17        DR. ZINK:  But they're manufactured as frozen
         18   mushrooms --
         19        MS. YATES:  Excuse me.  Before you proceed for
         20   purposes of our translator --
         21        MS. LEE:  Yeah.
         22        MS. YATES:  -- would you give your name?
                                                                      137
          1        MS. LEE:  This is Helena Lee.  I'm from an
          2   importing -- importing food company in New Jersey.
          3        DR. ZINK:  If it's -- if you're talking about
          4   mushrooms that are brought in as a frozen item --
          5   shipped frozen, distributed frozen, and they go to
          6   manufacturers that take them from the frozen state into
          7   some over reprocessing -- a frozen item is a no-growth
          8   food.  So, it would not be subject to the negative and
          9   25-gram requirement.  Is that correct?
         10        DR. BUCHANAN:  Yeah, I would -- if this is a --
         11   from the description that you gave of this product, if
         12   -- basically it's an ingredient of a product that's
         13   going to be further processed and then it would be an
         14   ingredient. It's not a ready-to-eat food as such.  Now,
         15   if you're unable to differentiate whether some of that
         16   product is going to go to a further process product and
         17   some of it's going to go directly for use as a frozen
         18   component, for example, of salads or thawed and put on a
         19   salad, then that would be a ready-to-eat food and would
         20   have to be treated as such.
         21        So, I think part of it is going to be of the
         22   consignment coming in, do you have control of it such
                                                                      138
          1   that we can consider it only as an ingredient for
          2   further processing?
          3        MS. LEE:  And would it be necessary for, say, this
          4   kind of shipment, would it help that -- if we put a
          5   certain kind of label on import packaging saying that
          6   this is for further processing -- ingredients for
          7   further processing.
          8        DR. ZINK:  The question you're asking is:  Would it
          9   be -- would you get assurance that you wouldn't fall
         10   under this negative and 25-gram requirement simply by
         11   labeling the product to say that it was an ingredient
         12   intended only for further processing; is that correct?
         13        MS. LEE:  A little different, because, you know,
         14   our concern is that occasional -- when the product comes
         15   in from different port branches of FDA, okay, and
         16   occasionally the FDA officers say, "Okay.  We have to
         17   inspect the product for microbes.  And then in a case
         18   where they found more than, you know, 20 -- absent in 25
         19   grams.  Okay.  And then they say, "Okay.  Stand by over
         20   there.  We have to do further sampling."
         21        That's what I was going to say.  You know, would it
         22   help to get over this kind of inspection.  I mean. . .
                                                                      139
          1        DR. ZINK:  Well, I think I understand what you're
          2   saying.  You're saying would it help you avoid that kind
          3   of detention or further inspection.  And I would say
          4   that anyone can label anything any way.  I think while
          5   we certainly give some consideration to how something is
          6   labeled, we're certainly also going to give
          7   consideration to how it really is used.  Okay?  So what
          8   I'm saying to you is if someone said, you know, this is
          9   not ready to eat; it's intended to be further
         10   manufactured or cooked, that's well and good but if it
         11   happens to be a food item that is customarily eaten as
         12   it is, you know, as a ready-to-eat food, then, no, that
         13   sort of labeling wouldn't deter us from further
         14   investigation or enforcement.
         15        MS. LEE:  Okay.  And here I have another question
         16   that is marginal.  It's very marginal but we have to
         17   discuss it because this is an actual situation that we
         18   are running into.
         19        MR. LANDA:  I think this question fills about half
         20   page.  I think it's a little complicated for this forum,
         21   particularly, handwritten.  Maybe we can take it up at
         22   some other time.  Unless you want to try to explain it.
                                                                      140
          1        MS. LEE:  Yeah, I will.  In the guidance that was
          2   written by Dr. Buchanan saying that on the, you know,
          3   consumer label that cooking is recommended.  Okay. 
          4   Somehow people can still consume the product without
          5   further cooking.  And this is my question because we are
          6   really running into this kind of situation.  The
          7   mushrooms that we're importing and then definitely is
          8   for ingredient usage; however, somehow, you know, like
          9   at the point of reprocessing some of them are not really
         10   instantaneous reprocessing.  They put it onto the
         11   surface of the pizza, of frozen pizza and they are in
         12   the frozen stage when it is in the store but when it
         13   gets to somebody's household and when they take it out
         14   for cooking and there are people who pick on the
         15   mushroom and pop it into their mouth.  So my question
         16   is:  Does this count as a ready-to-eat food?  But this
         17   is the actual case that we're running into.
         18        DR. BUCHANAN:  There's always someone in
         19   distribution that go really far out.  In the comments
         20   that we provided in the information I provided in the
         21   CPG, we raise the issue that there are changing patterns
         22   of people consuming things.  And I'm sure I can look
                                                                      141
          1   around the audience and anticipate at least one public
          2   comment is going to focus on this.  Where we find that
          3   despite products being put out into the marketplace with
          4   cooking instructions that a significant amount of the
          5   portion of the population just thaw the product and eat
          6   it.  And so the issue that we have and we're raising
          7   this as not definitive but you remember the word that I
          8   used was "may consider."  If we know that a substantial
          9   portion of the population -- and I'm not sure picking it
         10   off the pizza counts -- but if you sent around a bag of
         11   frozen mushrooms that said, "This is for putting on top
         12   of pizzas and further cooking on the pizza," and you
         13   knew that half the population that bought your product
         14   was not putting it on the pizza, they were just throwing
         15   it on top of their salad, then I think we would have a
         16   concern that that is a food that is ready -- is not --
         17   is capable of growth and we would consider it as a
         18   ready-to-eat product.
         19        DR. ZINK:  The example we've cited was fully-
         20   cooked, frozen crab meat.  It may have cooking
         21   instructions on it but we know that a lot of people
         22   simply thaw that fully cooked crab meat and make crab
                                                                      142
          1   salad out of it.  You know, that's a very common usage
          2   of it as opposed to somebody that has an unusual food
          3   habit, you know, where they like to eat their food as a
          4   popsicle right out of a box.
          5        MR. WHITING:  We have the same sort of issues with
          6   cooked food like the frankfurters, which I think most of
          7   us say that should be heated but we know that a
          8   significant number of people will just take frankfurters
          9   directly out and consume them.  So, you know these are
         10   uses that you have to look at and say what's the
         11   likelihood and there is, I guess, a dividing line
         12   someplace that's kind of hard to define where you say,
         13   "This is now a common practice that this is now a ready-
         14   to-eat food versus a food that will be cooked in the
         15   home or handled in the home."
         16        MS. LEE:  Yeah, this is one that we have been
         17   discussing about the eating habits of people in this
         18   country has been changing, because in the past when I
         19   was a young girl and everybody re-cooked the frozen
         20   vegetables. But now these days I'm always seeing, you
         21   know, salad bar or whatever in cafeteria they rip open a
         22   frozen bag vegetable and just put right on to the
                                                                      143
          1   counter and people eat it.
          2        DR. BUCHANAN:  We've noticed the same thing.
          3        MS. PETKER:  Judith Petker, Maple Leaf Consumer
          4   Foods and the timing of the previous question couldn't
          5   be better because mine is along similar lines.  Talking
          6   about frozen, fully cooked meat pies.  That would be a
          7   product I would suggest would not be eaten from its
          8   thawed state.  It would have to be reheated.  Does that
          9   not or would that not put it into a less risk category
         10   or is it still considered a risk?
         11        DR. ZINK:  Well, you mentioned an example of like a
         12   frozen meat pie?
         13        MS. PETKER:  Yes.
         14        DR. ZINK:  Mercifully, we don't regulate those but.
         15   . .
         16        MS. PETKER:  Okay.  All right.  I'll change my
         17   example.  Let's talk about --
         18        DR. ZINK:  Let's assume you've got a vegetarian.
         19        MS. PETKER:  Let's talk about fully-baked, non-meat
         20   quiche products.  There's a product that you would
         21   regulate.
         22        DR. ZINK:  I would have to agree with you that it's
                                                                      144
          1   very -- I mean as the woman said, there is always
          2   somebody out that that's probably cutting that on a band
          3   saw and eating it frozen but. . .
          4        MS. PETKER:  Only if they have no taste buds.
          5        DR. ZINK:  I would agree with you that that product
          6   would probably customarily be cooked before it was
          7   consumed.
          8        MS. PETKER:  Absolutely.
          9        DR. ZINK:  You could get into discussion about the
         10   adequacy of the cooking instructions on it but generally
         11   I would say that that would be viewed as a non-growth
         12   food.
         13        MS. PETKER:  All right.  Thank you very much.
         14        UNIDENTIFIED MALE SPEAKER:  Let me -- let me just
         15   --
         16        MR. WHITING:  A non-ready-to-eat food--
         17        MS. PETKER:  Yes.
         18        Mr. WHITING: -- wouldn't fall under this whole
         19   program.
         20        DR. ZINK:  Well, if it was fully cooked before it
         21   was frozen.
         22        MS. PETKER:  That's the problem.  Because it's
                                                                      145
          1   fully cooked before it's frozen, technically it is
          2   classified as ready-to-eat and I guess this is where I
          3   have -- I see that as a real gray area because if a
          4   product is going to be fully heated and the cooking
          5   instructions or heating directions specify an internal
          6   of at least 165, does that not technically take it out
          7   of the ready-to-eat category. But because it's fully
          8   cooked before it's frozen, we've got a real catch-22.
          9        DR. ZINK:  It gets into how people handle it. 
         10   Let's say if that is sold to the consumer and the
         11   directions and customary usage is for them to take it
         12   right out of the freezer, put it right into the oven for
         13   heating, then, yes, it's probably ready-to-eat but I
         14   would consider that no-growth but if that same thing was
         15   sold in a food service pack to a store that thawed them
         16   and displayed them refrigerated for people to buy then
         17   that's a different story.  Then it's a ready-to-eat
         18   refrigerated food and it would seem to be a growth food
         19   in that scenario.
         20        MS. PETKER:  Yes.  Okay.  Thank you.
         21        DR. ZINK:  We're probably making it even more
         22   confusing.
                                                                      146
          1        MS. PETKER:  Just a bit.
          2        DR. BUCHANAN:  If it's being marketed as a ready-
          3   to-eat food, particularly if it says on the label that
          4   this is a fully-cooked product, despite the fact that it
          5   has heating instructions, particularly if the heating
          6   instructions say for best enjoyment cook to such and
          7   such a temperature, that you don't infer that it
          8   requires cooking, then we've got a ready-to-eat product;
          9   particularly if you have any portion of the population
         10   that just sits and thaws it, puts it in the refrigerator
         11   for a while and then consume it.  That would be a ready-
         12   to-eat product.
         13        MS. PETKER:  But if the instructions are
         14   specifically instructing the consumer that it must be
         15   heated to an internal of 165, does that not imply that
         16   it needs to be fully reheated before it can be consumed?
         17        DR. BUCHANAN:  I guess it goes back to the second
         18   bullet is that if it has the appearance of being a
         19   ready-to-eat product, a fully-cooked ready-to-eat
         20   product then you get into this Never Neverland of how
         21   it's conceived of -- how the consumer views that product
         22   becomes on issue in terms of safety.
                                                                      147
          1        MS. PETKER:  If it's sold in a boxed meat store or
          2   boxed food store where all the products in the store are
          3   frozen and that's how they are marketed. . .
          4        DR. BUCHANAN:  That's why we said "may."
          5        MS. PETKER:  Okay.  Thank you very much.
          6        MS. YATES:  There's a questioner and I'm going to.
          7   . .
          8        MR. LANDA:  Let me just add a point to Bob's
          9   reference to the word "may."  There are at several
         10   points in the statute the language "such use" -- along
         11   the lines of "such use as is customary or usual," and
         12   that's typically sort of in contradistinction to
         13   labeling.  So for a long, long time Congress has
         14   recognized that people don't always use products
         15   following label directions.  There is such thing as
         16   customary or usual use notwithstanding labeling
         17   directions or instructions and we have to take that into
         18   account how that will come out, you know.
         19        In any given case I think it's not something we can
         20   predict which is -- which gets back to Bob's reference
         21   to the use of the word "may."  But there's a statutory
         22   basis for it as well as a basis grounded in sort of
                                                                      148
          1   consumer perception if you will.
          2        MR. WALDROP:  Hi.  Chris Waldrop, Consumer
          3   Federation of America and in the -- in the materials
          4   that FDA sent out there was reference to the E.U. and
          5   the Canadian criteria for determining -- for regulating
          6   ready-to-eat products. And in both of those I believe it
          7   specifically made considerations for susceptible
          8   populations so it said that this applied except when it
          9   was marketed to infants or when it was sold to pregnant
         10   women or something like that.  And the FDA doesn't seem
         11   to make those same considerations in its guidance and I
         12   was wondering if somebody could comment about that
         13   decision or if that was even a consideration in
         14   comparing the two?
         15        DR. BUCHANAN:  I'll take a shot at it.  For the
         16   most part -- and I'm not going to say that this is
         17   absolutely absolute -- but our regulations are written
         18   for the susceptible population.  Our guidance are
         19   written for the susceptible population and this CPG
         20   really takes into account the -- all of those portions
         21   of the population that we're concerned about.  It's our
         22   estimates from our partners at CDC that at any one time
                                                                      149
          1   20 percent of the population may be at increased risk
          2   due to any of a variety of underlying factors.  So, we
          3   try to take those into account so the CPG and the
          4   guidance documents are based on dealing with the
          5   population that Rob earlier identified as being at-
          6   risk.
          7        Now, there are certain instances where the
          8   practicality, for example, of someone who has just come
          9   out from a transplant operation that's in a hospital at
         10   that moment they may require additional safety
         11   assurances provided by the medical staff that is above
         12   and beyond what anyone could achieve in a food but the
         13   rest of the time, this is for everybody.
         14        MR. WHITING:  I should make clear here that we
         15   don't children as a susceptible group.  So, it's quite
         16   different than salmonella or E. coli 015787.  I mean,
         17   once you're past the neonate stage of a month or two,
         18   children are not particularly susceptible to Listeria.
         19        The other, as Bob was saying, is we do see in
         20   almost all of the cases coming from very high doses. 
         21   So, there's quite a few logs in range between the 100
         22   per gram to where we think the cases are coming from. 
                                                                      150
          1   So, allows for, you know, that very sensitive person
          2   that a lot of the cancer, diabetics and some of those
          3   that were maybe 50 to a couple of hundred times more
          4   sensitive than the background population.  There's still
          5   a range in between here that we hope -- that it should
          6   be protecting them too.
          7        MR. WALDROP:  Then just to follow-up.  This is
          8   Chris Waldrop again with Consumer Federation of America.
          9    In your understanding of the -- those other
         10   regulations, do they not -- can the Canadians and the
         11   European union, do they not -- are they not as
         12   protective of the susceptible population as you say the
         13   FDA guidance is?  Is that why they have made specific
         14   exceptions within their criteria or are they just doing
         15   that as. . .
         16        DR. BUCHANAN:  Let me clarify that.  This is the --
         17   both the European regulation the current and the
         18   Canadian referred to a group of products called special
         19   medical products.  These are products that are made for
         20   specific use in a hospital and for in some instances for
         21   -- I guess powdered infant formula would fall under that
         22   same requirement.  I might note that -- I don't think --
                                                                      151
          1   we just don't see Listeria in powdered infant formula. 
          2   It's because of the way it's manufactured and processed.
          3    And we have similar stringencies built into our medical
          4   foods that go above and beyond the normal but if what
          5   we're talking now is straight foods, there's no
          6   difference between the European regulation or the
          7   Canadian regulation in terms of the products we were
          8   talking about today.
          9        MR. LANDA:  Well, it's a little early to start with
         10   people providing public comments but we could certainly
         11   start and I'd like to start with Randy Huffman from the
         12   American Meat Institute Foundation.
         13        DR. BUCHANAN:  We have one left.
         14        MR. LANDA:  Oh, one more?  Okay.
         15        MR. POWELL:  Mark Powell again, USDA Office of Risk
         16   Assessment and Cost Benefit Analysis.  Bob I would like
         17   you to quickly put on your U.S. delegate hat to the
         18   CCFH.  Can you give us an update on the status of the
         19   Codex standard that's under development and specifically
         20   is this -- is it being entertained as a no-appreciable
         21   risk standard?
         22        DR. BUCHANAN:  No.  I don't think it's being
                                                                      152
          1   approached as a no-appreciable risk standard.  I don't
          2   think that we've even had that phrase come up in our
          3   discussions.  It's certainly a document that's based on
          4   risk analysis concepts as now associated with all of
          5   Codex's approaches.  I am hesitant to say anything about
          6   the annex on microbiological criteria.  While there are
          7   active discussions going on, the last official document
          8   was the one that Rebecca referred to today and until the
          9   working group has actually made its recommendations,
         10   which will take place in a meeting in May, and then
         11   presents it to the committee, I can't really say
         12   anything beyond --
         13        MR. POWELL:  How many steps is it at in the
         14   process?
         15        DR. BUCHANAN:  Three.
         16        MR. POWELL:  It got kicked back to three.
         17        DR. BUCHANAN:  No.  It never -- it was at -- it
         18   never went beyond three.  It was at four and -- it goes
         19   to four. Because it wasn't moved forward it went to
         20   three.
         21        And for those of you who are not familiar with
         22   Codex Alimentarius, it's an arcane process by which
                                                                      153
          1   these are approved and it's another language and I'd be
          2   happy to give you a lesson later on codices if you'd
          3   like.
          4        MR. LANDA:  Randy:
          5        MR. HUFFMAN:  Hope it's okay that I closed the
          6   computer.  I won't be using it.  Thank you very much for
          7   having me here today.  My name is Randy Huffman with the
          8   American Meat Institute Foundation and I appreciate the
          9   opportunity to be here to comment on the draft
         10   compliance policy guide that addresses the presence of
         11   Lm in ready-to-eat foods.
         12        AMIF is the research, education, and information
         13        arm
         14   of the American Meat Institute or AMI.  We're the oldest
         15   and largest trade association representing U.S. meat and
         16   poultry producers.  In the U.S. over 90 percent of the
         17   meat products and over 70 percent of the turkey products
         18   produced in the U.S. are made by AMI member companies. 
         19   AMI has been a long -- has long supported science-based
         20   regulatory policies.  Our previous comments on the
         21   record to both FDA, CFSAN as well as FSIS at USDA
         22   demonstrate a strong support of using concepts of risk
                                                                      154
          1   assessment as a foundation for regulatory policy.  AMI
          2   has been a member of the alliance for Listeriosis
          3   prevention and has supported the position of the
          4   alliance for more than a decade.  We represent hundreds
          5   of companies that produce ready-to-eat foods from small
          6   family-owned companies to some of the largest food
          7   processing firms in the world.
          8        Our positions are based on consensus of the
          9        majority
         10   of our diverse membership but it should be pointed out
         11   that our policy position does not require unanimous
         12   support by every AMI member company.  AMI is in support
         13   of a data-driven non-prescriptive approach to achieving
         14   science-based regulatory standards.
         15        We support science-based regulatory standards for
         16        Lm
         17   in ready-to-eat foods that recognize the risk is very
         18   different between foods that have been scientifically
         19   proven to not support the growth of the organism during
         20   the shelf life of the product.  Along these lines and
         21   following up with a comment made by Dr. Buchanan earlier
         22   today, CFSAN should consider updating the risk
                                                                      155
          1   assessment soon to recognize the changes in product
          2   categories such as reformulation of products and also
          3   new data that exists on the prevalence of Lm in certain
          4   ready-to-eat foods.
          5        AMI recognizes that the global scientific community
          6   has embraced the concept of these foods that support the
          7   growth of the Listeria monocytogenes to high numbers
          8   during life of the product present the greatest risk to
          9   at-risk populations.  This concept is supported of
         10   course by several risk assessments that we've heard
         11   about today and also Dr. Doyle described earlier the
         12   global expert panel that was convened to discuss this
         13   issue and I didn't realize that Dr. Doyle was going to
         14   cover this in his comments today but I guess I can
         15   reiterate some of the points that were made in this
         16   peer-review publication that was published in 2005.
         17        And I'm going to quote directly from the document
         18        to
         19   reiterate some of the points that Dr. Doyle mentioned
         20   earlier and I quote, "Three main strategies were
         21   identified by the expert panel for ensuring continuous
         22   improvement introducing foodborne Listeriosis.  One,
                                                                      156
          1   preventing contamination of foods with Lm or eliminating
          2   the pathogen after contamination.  Two, preventing
          3   growth of Lm to high numbers in contaminated foods and,
          4   three, science-based education messages targeted to
          5   susceptible populations and their caregivers.  Focusing
          6   on all three strategies were most effective for
          7   preventing Listeria but the expert panel concluded that
          8   preventing growth of Lm to high numbers will have the
          9   greatest impact on reducing cases of Listeria." Closed
         10   quote.
         11        We're not aware of any new data since the
         12        publication
         13   of this report that would contradict this conclusion. 
         14   As presented earlier during the program many countries
         15   already have a regulatory tolerance for Lm in ready-to-
         16   eat foods that do not support the growth of the
         17   organism.  Codex, as we just mentioned, is also
         18   considering such a tolerance. Some of our most important
         19   trading partners have these policies in place and it is
         20   imperative that U.S. government agencies are consistent
         21   and equivalent with regard to the regulatory policies
         22   with our key trading partners.
                                                                      157
          1        Food safety in our industry is recognized as a
          2   noncompetitive issue and we have multiple forums where
          3   companies can actively share critical food safety
          4   knowledge and information about enhancing Listeria
          5   control.  AMI and our industry partners have long been
          6   committed to enhancing safety of our products through
          7   research.  The industry has worked cooperatively with
          8   academic, government, and private researchers and we've
          9   invested hundreds of millions of dollars in Listeria
         10   research to find new and efficacious means to make
         11   ready-to-eat meat and poultry products safer.
         12        We have developed sanitary practices for facility
         13        and
         14   equipment design that have been widely adopted.  Jenny
         15   Scott spoke of those earlier today.  Facility
         16   engineering and processing equipment firms have made
         17   significant changes in facility and equipment design and
         18   these companies should be complimented for their
         19   contributions to this effort.
         20        Implementation of these principles facilitates good
         21   sanitary practice within the processing plant.  The meat
         22   and poultry industry has worked also with allied
                                                                      158
          1   supplier firms to identify and implement new processes
          2   and new ingredients that reduce or eliminate Lm in the
          3   finished product.
          4        Meat and poultry companies aggressively sample the
          5   processing environment on a routine basis as was
          6   discussed by Jenny earlier.  Every year the companies
          7   take hundreds of thousands of Listeria samples to
          8   provide critical monitoring information that supplies
          9   the frontline workers and the food safety managers with
         10   the data that they need to control Listeria in the
         11   ready-to-eat environment.
         12        Process control and prevention have been shown by
         13        meat
         14   and poultry to reduce the incidents of Lm in finished
         15   products.  The industry and CFSAN should assume that
         16   every ready-to-eat food plant may have Listeria present
         17   in the environment at some point during processing. 
         18   Using the concepts of process control, this assumption
         19   leads to the conclusion that finding a positive sample
         20   for Listeria as part of an aggressive and environmental
         21   testing program must be treated as a success.  If
         22   positives are treated as a failure by the company or by
                                                                      159
          1   CFSAN of the regulatory agency and punitive actions
          2   follow, the regulatory control program will fail.
          3        The trigger for regulatory actions must be
          4        appropriate
          5   for the risk of the product and based on scientific
          6   data. Continuing to encourage plants to adopt aggressive
          7   environmental testing programs, it is essential.  The
          8   key driver behind the success of these programs is the
          9   use of environmental monitoring of Listeria to detect a
         10   change in the sanitary conditions of the processing line
         11   and to prevent exposure of the finished product.
         12        We believe that CFSAN as well as FSIS should have
         13   consistent policy and guidance on control of Lm in
         14   ready-to-eat foods.  In situations where different
         15   regulatory policies exist the reason for the differences
         16   in these policies should be clearly articulated and
         17   supported by science.  AMI and our industry partners
         18   have worked with FSIS to implement science-based
         19   regulatory standards for ready-to-eat meat processing
         20   facilities that recognize that not all products present
         21   the same level of public health risk.  Industry-
         22   implemented process control programs and not simply the
                                                                      160
          1   regulatory standard of zero tolerance have led to
          2   remarkable improvements in the level of Lm on ready-to-
          3   eat meat and poultry products.
          4        The prevalence of Lm on RTE meat and poultry has
          5   dropped dramatically from an instance of 4.61 in 1990 to
          6   .2 percent in 2007.  That's over a 95 percent decline.
          7   Importantly in 2006 FSIS began to quantitatively assess
          8   the number of organisms present in positive samples. 
          9   And out of 72 samples that have been quantitatively
         10   measured by using the most prevalent number techniques,
         11   62 of those samples or 86 percent were less than 1 MPM
         12   per gram per product.  That's remarkably low.  None of
         13   the samples measured from the domestic federally
         14   inspected establishments had a quantitative value of
         15   greater than 46 MPM per gram.
         16        FSIS also reports that they have not had a reason
         17        to
         18   conduct an illness investigation involving Lm in ready-
         19   to-eat meat and poultry products since 2005.  These data
         20   represent remarkable improvements, not simply because
         21   there was regulatory policy of zero tolerance but
         22   because a total regulatory approach was in place that
                                                                      161
          1   encouraged industry to implement science-based
          2   solutions.
          3        In summary AMI encourages CFSAN to focus regulatory
          4   efforts on the following key issues:  a risk-based --
          5   regulatory approach that targeting product categories
          6   that support the growth of Lm and have been associated
          7   with Listeria monocytogenes.  Two, provide incentives to
          8   manufacturers that implement effective and verifiable
          9   environmental control programs aimed at identifying and
         10   eliminating Listeria from the environment.  Three,
         11   develop regulatory guidance that encourages industry to
         12   adopt aggressive environmental sampling plans for
         13   Listeria and to recognize that finding positives should
         14   be treated as a success since the goal is to find and
         15   eliminate niches and harborage sites within the
         16   processing line that lead to product contamination.
         17        And finally recognize that every plant is unique
         18        and
         19   environmental control programs must be designed and
         20   implemented accordion.  AMI will submit more detailed
         21   written comments to CFSAN regarding the guidance to
         22   industry document.  CFSAN has acknowledged that
                                                                      162
          1   stakeholders will have -- should take into consideration
          2   testimony from today's meeting in those comments and we
          3   understand that they will be in a reasonable period of
          4   acceptance of those written comments beyond this date.
          5        With this in mind I'd like to be on the record
          6        stating
          7   that the success of any new regulatory standard for Lm
          8   will be inextricably linked to having a regulatory
          9   approach to controlling Listeria in the processing
         10   environment.  One that encourages industry to implement
         11   the aggressive programs needed to control the pathogen,
         12   thank you very much.
         13        MR. LANDA:  Our next speaker is Robert Garfield
         14   from the American frozen food institute.
         15        MR. GARFIELD:  Thank you very much.  The American
         16   Frozen Food Institute or AFFI appreciates the
         17   opportunity to express our views concerning the agency's
         18   draft compliance policy guide that addresses the
         19   presence of Listeria monocytogenes in ready-to-eat
         20   foods.  I'm Robert Garfield, Senior Vice President of
         21   Public Policy International Affairs for the American
         22   Frozen Food Institute and I'm joined by Gary Kushner who
                                                                      163
          1   is a partner in Hogan & Hartson and serves as AFFI's
          2   legal counsel.  And by the way Gary was very
          3   instrumental in working with the alliance for
          4   Listeriosis prevention in developing the petition which
          5   we submitted to FDA and I thought it would be
          6   appropriate to bring him here today to answer any
          7   potential questions that might be available.
          8        AFFI is the national trade association that
          9        represents
         10   the interests of the frozen food processors and their
         11   suppliers.  Since 1995 AFFI and several allied industry
         12   trade associations, some of which are represented here
         13   today, have recommended that FDA adopt a sound risk-
         14   based, regulatory policy concerning the presence of
         15   Listeria monocytogenes in ready-to-eat foods.  AFFI was
         16   and continues to be part of the alliance for Listeria
         17   prevention, a coalition that supported that effort.
         18        We applaud FDA's effort to modernize regulatory
         19        policy
         20   to ensure that FDA resources are focused on foods that
         21   present relatively higher risk by establishing a
         22   science-based standard for the regulation and control of
                                                                      164
          1   Listeria monocytogenes.  AFFI believes there is a
          2   compelling case for the policy change.  The
          3   international scientific and regulatory evidence clearly
          4   indicates and concludes that potential risks presented
          5   by Listeria monocytogenes is a function of the organism
          6   cell numbers in food and not its mere presence.  The
          7   policy if finalized would permit FDA and industry to
          8   distinguish products for which increased scrutiny is
          9   prudent from which those for which greater attention
         10   will not yield any corresponding benefit to public
         11   health.
         12        AFFI believes that such a distinction will
         13        encourage
         14   sampling in application of interventions to minimize the
         15   risk of contamination.  To meet the definition of low-
         16   risk ready-to-eat foods, the policy change will also
         17   encourage new control measures to inhibit growth of the
         18   organisms. We will focus our oral comments on the CPG. 
         19   We plan to submit comprehensive written comments on the
         20   entire Listeria monocytogenes notice included in the
         21   guidance to industry -- including the guidance to
         22   industry published by the agency on February 7th.
                                                                      165
          1        FDA has acknowledged that stakeholders will want to
          2   take into consideration testimony from today's public
          3   meeting and preparing the written comments; therefore,
          4   we understand that the agency will accept comments for a
          5   reasonable period of time after the transcript -- and I
          6   need get together with you -- after the transcript of
          7   this meeting has been released irrespective of the
          8   comment deadline to allow for thoughtful and meaningful
          9   responses to the agency's initiative.
         10        Although AFFI concurs conceptually with the CPG's
         11   direction, we have two reservations.  The CPG suggests
         12   that FDA may consider a food to be suitable for
         13   consumption and hence ready-to-eat without cooking even
         14   though the cooking instructions are provided on the
         15   label.  The examples listed in CPG on refrigerated and
         16   frozen crab meat and individually quick-frozen peas and
         17   corn.  There are major differences between these
         18   products.  Crab meat is normally pasteurized and based
         19   on my quick review and very informal review at a local
         20   supermarket none contained cooking instructions.  On the
         21   other hand frozen peas and corn do not receive lethality
         22   treatments during processing but contain full cooking
                                                                      166
          1   instructions on the package so consumers know how to
          2   cook the product before consuming it.
          3        In a typical frozen vegetable plant raw produce is
          4   washed, trimmed, and subsequently blanched to inactivate
          5   enzymes.  The product is then inspected and further
          6   trimmed, often by hand, prior to being packaged and
          7   frozen. Frozen vegetable plants are clean operations
          8   which follow strict internal controls and supplier
          9   requirements, although, these operations are not
         10   aseptic.  Blanching is not a kill step.  The blanching
         11   of vegetables is not the same as pasteurization of crab
         12   meat, nor are the equipment design, distribution of
         13   heat, and end product comparable. Blanching destroys or
         14   partially destroys enzymes that can cause deterioration
         15   in flavor and texture during long-term storage. 
         16   Blanching will reduce but not eliminate microbial lobes.
         17        The equipment is fairly open in design and
         18        typically
         19   the product travels on a wide motorized belt through a
         20   steam chamber where temperatures can fluctuate.  FDA and
         21   the frozen vegetable industry discussed the regulatory
         22   status of frozen vegetables about 12 years ago.  At that
                                                                      167
          1   time it was not uncommon for frozen vegetable processors
          2   to include thawing instructions on the product
          3   packaging.  FDA informally observed that because thawing
          4   instructions might invite consumers to use the products
          5   without cooking them, such products could be construed
          6   as ready-to-eat.  AFFI received ensurances from the
          7   agencies that if thawing instructions were removed from
          8   the label so that consumers were only provided cooking
          9   instructions the agency would consider these products
         10   ready to cook.  In response most frozen vegetable
         11   processors voluntarily removed thawing instructions from
         12   the paneling.
         13        Through issuance of this proposed CPG, FDA is now
         14   suggesting a drastic change in regulatory policy with
         15   potentially far broad implications.  Although the agency
         16   emphasizes that the CPG is binding neither on industry
         17   or on FDA, it nonetheless renders uncertainty from the
         18   regulatory standpoint a long-standing industry labeling
         19   practice designed for assumer protection that FDA itself
         20   effectively fostered.  What FDA is suggesting in the CPG
         21   is that cooking instructions currently considered the
         22   final kill step for any number of processed foods
                                                                      168
          1   containing raw ingredients may become irrelevant. 
          2   Because the potential of off label use of a food
          3   product, AFFI believes this precedent could undermine
          4   rather than enhance food safety.
          5        Frozen vegetables have an exemplary safety record,
          6   whether they are cooked or eaten raw.  We understand
          7   that the agency may be concerned about how these
          8   products are used in food service such as on salad bars
          9   and restaurants and supermarkets.  These foods are
         10   generally regulated under the food code.  If FDA
         11   believes that frozen products are being used without
         12   cooking at food service, perhaps the food code could
         13   then encourage end users to follow label instructions on
         14   packages and discourage off label use of products that
         15   are not intended for that purpose.
         16        Consumers on the other hand are told how to use
         17        frozen
         18   vegetables.  FDA expects validated cooking directions on
         19   consumer packaging that is explicit and effective at
         20   ensuring the food's safe use.  It is simply neither
         21   feasible nor realistic to make these products aseptic.
         22   They must be cooked. In my remaining time I would like
                                                                      169
          1        to draw your
          2   attention to the apparent contradiction between the
          3   language in 2003 quantitative risk assessment on
          4   Listeria monocytogenes and the CPG.  In that assessment
          5   foods estimate -- and I quote, "Foods estimated to pose
          6   the lowest risk of being associated with Listeriosis are
          7   foods that because of intrinsic factors, extrinsic
          8   factors and/or processing factors do not support the
          9   growth of Listeria monocytogenes."
         10        As an example the agency uses the food is frozen. 
         11        Yet
         12   in section C of the CPG ready-to-eat foods that do not
         13   support the growth of Listeria monocytogenes the agency
         14   states, "A ready-to-eat food does not support the growth
         15   of Listeria monocytogenes if the food is customarily
         16   held and consumed in a frozen state."
         17        I suspect that the only food that would meet that
         18   criteria is ice cream.  AFFI recommends that FDA
         19   consider a change in that statement that reflects the
         20   benefits of freezing to control the growth of Lm.  AFFI
         21   would recommend is customarily held and consumed in or
         22   from a frozen state.
                                                                      170
          1        In summary AFFI commends the agency for issuing the
          2   CPG and supports the adoption of risk-based regulatory
          3   policy.  We are concerned however about the indication
          4   that some vegetables may be considered ready-to-eat even
          5   though their labels bear cooking instructions.  We also
          6   disagree with the criteria determining that a product
          7   will not support growth of Listeria monocytogenes.  We
          8   ask that the agency revise the CPG to address these
          9   concerns.  And as I mentioned AFFI will submit
         10   comprehensive comments outlining our concerns about the
         11   guidance document.  Thank you for your time and
         12   attention and I'll entertain any questions.
         13        DR. BUCHANAN:  Yeah, I have a question, Bob.  If a
         14   product has a cooking instruction, it's traditionally
         15   not considered to be a ready-to-eat food.  On the other
         16   hand you're making a case based on the designation of a
         17   product that has specific cooking instructions.  If it's
         18   not a ready-to-eat food then it would automatically be
         19   dropped back to the standard for overtalk --
         20        MR. GARFIELD:  How to cook.
         21        DR. BUCHANAN:  -- that supports growth.  You have a
         22   product that is frozen but it has cooking instructions.
                                                                      171
          1        MR. GARFIELD:  It has cooking instructions.
          2        DR. BUCHANAN:  So, by definition that is not a food
          3   that is ready to eat --
          4        MR. GARFIELD:  Right.
          5        DR. BUCHANAN:  -- it requires cooking.
          6        MR. GARFIELD:  It's a ready-to-cook product.
          7        DR. BUCHANAN:  It's a ready-to-cook product
          8   therefore it would fall under the criteria of .04 CFUs
          9   per gram.
         10        MR. GARFIELD:  I wasn't aware that ready-to-cook
         11   products were under the zero tolerance.
         12        DR. BUCHANAN:  They're not under -- as far as I
         13   know they're not under any.  That wouldn't apply.  This
         14   is a ready-to-eat food.
         15        UNIDENTIFIED MALE SPEAKER:  The CPG would not apply
         16   to a product that is not a read-to-eat product.
         17        MR. GARFIELD:  Ready-to-eat food.
         18        UNIDENTIFIED MALE SPEAKER:   And, furthermore, I
         19   suspect that a product also wouldnt support the growth
         20   in any event.
         21        DR. BUCHANAN:  Right.  And then my second question
         22   is: Do you have any information at all about the extent
                                                                      172
          1   of off-label use of frozen vegetables in particular?  I
          2   know that's the one that you're referring to.  And what
          3   is the duration -- what's the growth characteristics of
          4   Listeria in those products once thawed?
          5        MR. GARFIELD:  I don't have that information.  I
          6   don't.  And I would ask you since you've made the
          7   characterization about peas and corns, do you have
          8   information on that?
          9        DR. BUCHANAN:  No.  We have a great deal of
         10   anecdotal.
         11        MR. GARFIELD:  We do likewise and that's why we
         12   know that they're used in food service and that's why
         13   we're suggesting that recommendation and I think it's
         14   something simple that the agency can do to stop that
         15   practice.
         16        MR. LANDA:  What was your note to both of Bob's
         17   questions?  The first one had to do with information
         18   about what you call in your presentation "off-label
         19   use"?  Do you have any information about the extent of
         20   such use?
         21        MR. GARFIELD:  Of off-label use?
         22        MR. LANDA:  Yes.
                                                                      173
          1        MR. GARFIELD:  No.  Just anecdotal.
          2        MR. LANDA:  Thank you.
          3        MR. WHITING:  For the risk assessment your comment
          4   on frozen food it, was ice cream that we pretty much had
          5   in mind as the food in that category.  I might also say
          6   when we're looking at recommendations for frozen we had
          7   that in mind with maybe like a product like smoked
          8   seafood or smoked salmon which very often is kept frozen
          9   during the retail part of its distribution then thawed
         10   out.
         11        And we would recommend this as a way of controlling
         12   Listeria, you know, the more a food can be kept frozen.
         13   But that does not mean it would become, you know -- it
         14   would still be a supporting-growth food because it is
         15   then thawed out and kept in a thawed state in the home
         16   but in the risk assessment, though, and in subsequent
         17   thinking, we were trying to encourage maybe foods that
         18   could be kept frozen during part of their distribution
         19   phase to be kept frozen as a way of, you know, reducing
         20   that time when Listeria has the opportunity to grow.
         21        MR. GARFIELD:  Well in response, I was aware and
         22   I'm interested to hear that you're talking about ice
                                                                      174
          1   cream because I was involved in many of the dairy
          2   initiative back in the late '80s where ice cream was
          3   implicated and after several hundred million dollars of
          4   recalls and it was discovered that this wasn't an
          5   associated problem; however, it took about 20 years to
          6   even get to a point where we're rectifying the problem. 
          7   What I don't want to see happen is ten years from now
          8   we're sitting at the same table trying to rectify the
          9   problem associated with off-label use of frozen products
         10   that have cooking instructions on them and trying to
         11   resolve how we're going to quantify which products we're
         12   talking about and which we're not.
         13        I think it could develop into a very, very serious
         14   problem and I don't see the necessity of it especially
         15   when you consider these products really don't generate
         16   growth of the organism.
         17        DR. BUCHANAN:  Well, I guess that's the second part
         18   of the question I have is that I don't have much
         19   scientific information available on what are the growth
         20   characteristics of these products once thawed and then,
         21   for example, mixed as part of a salad.  So, if any is
         22   available we would certainly like to see it.
                                                                      175
          1        MR. GARFIELD:  We'll take a look at that.
          2        DR. BUCHANAN:  Okay.
          3        MR. LANDA:  Thank you.  Why don't we take a break
          4   now and come back at 3:10.
          5        (Break taken.)
          6        MR. LANDA:  Why don't we get started again.  Our
          7   next speaker is David Gombas with United Fresh Produce
          8   Association.
          9        DR. GOMBAS:  Thank you, Mike.  Good day.  I am Dr.
         10   David Gombas, Senior Vice President, Food Safety and
         11   Technology for United Fresh Produce Association.  United
         12   Fresh Produce Association is the industry's leading
         13   trade association committed to driving the growth and
         14   success of produce companies and their partners.  United
         15   Fresh represents the interests of member companies
         16   throughout the global fresh produce supply chain,
         17   including family-owned, private and publicly-traded
         18   businesses as well as regional, national and
         19   international companies.
         20        The association was founded in 1904 to represent
         21        the
         22   produce industry and it recently took the name United
                                                                      176
          1   Fresh as a result of the 2006 merger of the United Fresh
          2   Fruit and Vegetable Association and the International
          3   Fresh Cut Produce Association.  Among other activities
          4   supporting produce food safety members of the
          5   International Fresh Cut Produce Association offered a
          6   food safety manual for fresh cut processors in 2001 that
          7   considered the potential for and control of pathogen
          8   contamination in fresh cut products.  Members of both
          9   United Fresh Fruit and Vegetable Association and the
         10   International Fresh Cut Produce Association served as
         11   technical resources and editors of the commodity food
         12   safety guidelines for the lettuce and leafy greens
         13   supply chain.  Published in 2006.  The United Fresh is
         14   currently working with others on the second edition of
         15   commodity specific food safety guidelines for the fresh
         16   tomato supply chain.
         17        I want to thank FDA for the opportunity today to
         18   comment on the guidelines for controllable Listeria
         19   monocytogenes in refrigerated and frozen ready-to-eat
         20   processed foods, which I'll hereafter refer to as the
         21   "Guidance."  United Fresh applauds FDA on the change in
         22   regulatory policy applied in Guidance which better
                                                                      177
          1   reflects current scientific understanding of the
          2   relative risk of Listeriosis from exposure to low levels
          3   of the pathogen. Further much of the Guidance reflects
          4   practices already in use for a number of process
          5   commodities to ensure control of Listeria monocytogenes
          6   and others have spoken and will speak on the
          7   applicability of this guidance to their particular
          8   commodity.  I'm going to limit my comments to the
          9   Guidance's impact on fresh and fresh-cut fruits and
         10   vegetables.
         11        Unfortunately, the broad-brush approach of applying
         12   these guidelines all FDA regulated ready-to-eat
         13   processed foods will have dire and I assume unconsidered
         14   consequences to fresh produce.  While Dr. Zink has
         15   already emphasized the non-mandatory nature of the
         16   Guidance, reality is that it will be interpreted by many
         17   as mandatory.
         18        But first I'd like to speak to the apparent level
         19        of
         20   risks of fresh and fresh cut produce as a vehicle for L
         21   monocytogenes and Listeriosis.  The Guidance states
         22   twice that fresh raw produce is a potential source of L
                                                                      178
          1   monocytogenes.  While we agree that any raw agricultural
          2   commodity is a potential source of L monocytogenes, we
          3   are unaware of any systematic surveys of commercially
          4   grown raw fruits and vegetables that demonstrate L
          5   monocytogenes detection to be anything but rare or
          6   occasional.
          7        Indeed if FDA considers raw agricultural
          8        commodities
          9   to be a significant source of L monocytogenes, why does
         10   the guidance exempt the raw agricultural commodities
         11   referring control to the 1998 good agricultural
         12   practices guidance which in turn does not even mention L
         13   monocytogenes as a significant pathogen of concern.  In
         14   the 2003 edition of USDA FDA Listeria risk assessment
         15   table 7-1 describes raw fruits and vegetables as a
         16   moderate risk and we saw the same thing on slides
         17   earlier today.  Based primarily on reports of detection
         18   of L monocytogenes not on linkages to illness.  We note
         19   the assessment is silent on how many, if any, of these
         20   detections were from commercially fresh cut processed
         21   fruits and vegetables.
         22        In 2000 the FDA helped to fund a survey of retail
                                                                      179
          1   foods in order to better understand the prevalence of L
          2   monocytogenes in certain ready-to-eat foods.  That
          3   survey was referred to earlier today.  Fresh cut leafy
          4   green bagged salads, the most common form of
          5   commercially fresh cut produce, were included in that
          6   study.  By the end of that study almost 3000 retail
          7   fresh cut salad samples had been tested for L
          8   monocytogenes.  Less than 1 percent of those samples had
          9   detectable L monocytogenes.  It was the second lowest in
         10   prevalence among 8 ready-to-eat foods tested.  On one of
         11   the 3000 samples had a level greater than 100 CFU per
         12   gram and none had greater than 1000 colony forming units
         13   per gram.  These samples collected over two years
         14   include a retail package at all levels of commercial
         15   shelf life.  Now, we consider these data as evidence
         16   that L monocytogenes is a hazard not reasonably likely
         17   to occur in fresh-cut produce at levels likely to cause
         18   illness.
         19        Even in the absence of many controls recommended in
         20   the Guidance.  We're therefore surprised that FDA
         21   thought it important to specify in the Guidelines that
         22   these guidelines should be followed by processors of
                                                                      180
          1   fresh-cut fruits and vegetables.  In spite of the survey
          2   data, in spite of spite of the fact that many fresh-cut
          3   products, particularly fruits, are too acidic to support
          4   the growth of L monocytogenes and that many fresh-cut
          5   fruits and vegetables have never been reported to test
          6   positive for Listeria monocytogenes.
          7        For further evidence of the level of risk, we turn
          8        to
          9   past outbreaks of Listeriosis link to foods.  In that
         10   same 2003 USDA FDA Listeria risk assessment table 2-4
         11   indicates no report of Listeriosis outbreaks in the U.S.
         12   with a possible linkage to raw -- of vegetables since
         13   1979.  Table 2-5 indicates no reports of Listeriosis
         14   outside the U.S. with a confirmed linkage to raw
         15   vegetables since 1981. Neither table includes any
         16   outbreaks linked to commercially-prepared fresh-cut
         17   products.
         18        If you wanted to look at outbreak data over just
         19        the
         20   last 25 years instead of going back to 1970 as the
         21   tables do, fresh fruits and vegetables or commercially
         22   prepared fresh fruits and vegetables would not even
                                                                      181
          1   appear on the list.  A further note from Dr. Buchanan's
          2   presentation on relative risk earlier today that fruits
          3   and vegetable are predicted to be responsible for less
          4   than one illness per year total population.
          5        Okay.  So, again we confess surprise at FDA which
          6        has
          7   cited salmonella outbreaks linked to tomatoes and melons
          8   and E. coli in 5-7 outbreaks linked to leafy greens as
          9   reasons for the fresh produce commodities to be
         10   considered high risk has forgone epidemiological
         11   evidence and simply declared fresh-cut produce to be at
         12   risk simply because L monocytogenes can be detected on
         13   some raw produce and it can made to grow in some fresh
         14   cut products.
         15        In the interest of time I'm going to skip through
         16        some
         17   more of my written comments.  I'll submit those to you
         18   later.  I'd like to turn now to the unconsidered
         19   sequences of these guidelines.  The Guidelines state in
         20   section 9, correctly, that testing a single lot of food
         21   product for L monocytogenes is of limited value in
         22   establishing the acceptability of that lot.  But the
                                                                      182
          1   same section recommends if a processor's raw materials
          2   may be a source of L monocytogenes that the processor
          3   either obtain a certificate of analysis, that is test
          4   results, from the supplier or performance its own
          5   testing of every lot of that ingredient.  Since FDA has
          6   said in its guide that while produce is a likely source
          7   of L monocytogenes and there's no process step in good
          8   agricultural practices where otherwise I will guarantee
          9   an absence of L monocytogenes and harvested raw produce,
         10   let alone a six log Listeriacidal treatment, we can only
         11   conclude, as will others, that FDA intends for all lots
         12   of incoming wild produce to be tested for L
         13   monocytogenes.
         14        The guides also recommends that food contact
         15        surfaces
         16   be tested weekly for L monocytogenes.  We note in
         17   section 20 that FDA agrees with us in our recommendation
         18   that whenever an ingredient, finished-product or food
         19   contact surface is tested for pathogen or other food
         20   safety hazard, all lots of material impacted by that
         21   test should be segregated and held from use or
         22   distribution until cleared by result of "not detected,"
                                                                      183
          1        Now, please be aware that such materials much be
          2        must
          3   be segregated and held regardless of an expectation of
          4   the test result of "not detected" will be found time
          5   after time.  If a positive is reported real or false, if
          6   the affected product has been shipped, it will likely be
          7   subject to a class one recall with all of its
          8   consequences. Now the FDA's ban method for all L
          9   monocytogenes requires two days for initial negative
         10   result and up to five days if the sample tests
         11   presumptively positive.  This means that if the
         12   processor has -- this means that a processor has to be
         13   prepared for them.  They need to hold all raw produce
         14   ingredients and many finished product lots up to seven
         15   days each before release.  Given that some produce items
         16   have a shelf life of two weeks or less, such a test and
         17   hold process could effectively eliminate those products
         18   from commercial viability.
         19        Now, even if the ingredients product has sufficient
         20   shelf life that could survive such testing the capital
         21   costs for storing these tested materials in a
         22   refrigerated secure environment until the results are
                                                                      184
          1   known and the loss of nutritional or organoleptic
          2   quality during that whole period may eliminate fresh-
          3   cut products from commercial viability.
          4        Now, let me be clear, no one in the produce
          5        industry
          6   wants to sell products that may pose a health risk to
          7   consumers and these would be important considerations if
          8   evidence demonstrated that L monocytogenes and
          9   Listeriosis were significant risks in fresh-cut produce.
         10    However, at this time and since the commercial
         11   inception of these products in the 1980s, the types of
         12   controls and testing protocols described in this
         13   Guidance have not been generally implemented by the
         14   fresh-cut industry yet there's to epidemiologic evidence
         15   of Listeriosis link to these products.  If the fresh-
         16   cut produce industry were to implement the testing
         17   protocols described in this Guidance, the category may
         18   disappear.  Now, I'm reminded of the old but too
         19   relevant joke.  "Doctor, the operation was a success but
         20   the patient died."  We respectfully submit to the FDA
         21   that while the treatments recommended in this Guidance
         22   may be appropriate for some ready-to-eat processed
                                                                      185
          1   foods, they could kill the commercialization of fresh-
          2   cut products.
          3        I'm going to again forego the description of what
          4        we
          5   would recommend as process controls for fresh-cut
          6   operations.  Much of them are the same as described by
          7   Jenny Scott earlier today as far as environmental
          8   controls, and the fresh-cut industry and the produce
          9   industry stands ready to work with FDA in -- for further
         10   developing those types of controls as guidance for the
         11   control of Listeria monocytogenes.  Thank you for your
         12   attention.
         13        DR. BUCHANAN:  David, you're not getting off that
         14   easy.  Actually, I have two questions.  I'm going to
         15   take them in the order that they came to mind.  The
         16   first one is that:  Do you have any data that's
         17   currently available for fresh-cut produce that can
         18   inform us of the impact of the controls that you put
         19   into place to control salmonella and E. coli 0157 have
         20   on the potential incidents of Listeria and the growth of
         21   Listeria in fresh-cut products.  I'm very familiar with
         22   your industry and I know ostensibly that essential any
                                                                      186
          1   product that goes that on the market has been treated to
          2   both extend shelf life, because of the normal microflor,
          3   and also you have a series of quite dramatic controls to
          4   control enteric bacteria.
          5        So, that would be my first question.  Do you have
          6   information on how those controls impact the presence,
          7   the prevalence and the incidents of Listeria in these
          8   products and particularly their shelf life.
          9        DR. ZINK:  I'd like to add one thing on the end of
         10   that.  The one thing I want to add on the end of his
         11   list of things that the industry does, do you have any
         12   information on how high a number Listeria can grow to in
         13   produce?  I'm wondering if competitive organisms don't
         14   limit the extent to which Listeria can grow in this
         15   product or not.
         16        DR. GOMBAS:  Well, again, one of the things I want
         17   to stress on here is we refer to -- or the guidance
         18   refers to fresh-cut -- fresh and fresh-cut fruits as an
         19   entity.  And of course, Bob, as you mentioned earlier
         20   today, there's a diverse type of -- diverse number of
         21   produce items within that ranging anything from
         22   strawberries to cherries to cabbage to onions.  And so
                                                                      187
          1   it would be dependent on each one of those entities and
          2   how they're prepared and how they're stored and what the
          3   intention for their use would be.
          4        But, Bob, getting back to your question about the
          5   current programs that are in place of control of
          6   pathogens like 0157 salmonella.  There hasn't been a
          7   systematic assessment to my knowledge of the
          8   effectiveness of those treatments against Listeria;
          9   again, because the industry has does not consider
         10   Listeria as a pathogen of concern. But we certainly have
         11   information on what those controls are, how they're
         12   monitored and controlled, what kind of action limits
         13   they have, and then we can compare that information
         14   against resistance data of Listeria to come to some
         15   preliminary assessment as to whether or not they are
         16   sufficient.  So, that could be done.
         17        As to anecdotal information, I to know that a
         18   number of -- many of our fresh-cut operations do
         19   environmental monitoring and finished-product testing
         20   for Listeria monocytogenes.  I've not heard anyone tell
         21   me that they found a finished -- that they in their own
         22   facility found Listeria in their finished product. 
                                                                      188
          1   Several of them do find transient Listeria but none that
          2   recur and the conclusion that we have, again based on
          3   anecdotal information, is that the types of niches
          4   entrenched Listeria that you can find in other
          5   facilities -- and that's really been the focus of much
          6   of the discussion today -- simply don't occur in fresh-
          7   cut operations.
          8        DR. BUCHANAN:  Second question -- and I think I'm
          9   going to make it of three -- in differentiating produce
         10   items -- in differentiating fresh produce items, would
         11   the ability to differentiate them on the basis of pH
         12   allow us to effectively separate those that would and
         13   would not support the growth of Listeria monocytogenes?
         14        DR. GOMBAS:  It would be a start.  I mean, as the
         15   Guidance points out anything that's below pH 4.4 is not
         16   going to support the growth of monocytogenes anyway and
         17   that does constitute quite a few of the fruits and some
         18   on the vegetables.  So, that would be a good first step.
         19   Beyond that, it would take a little more effort.  They
         20   do not have -- obviously don't add Listeriostatic or
         21   Listeriacidal ingredients to fresh fruits and vegetables
         22   so it would have to be inherently Listeriacidal,
                                                                      189
          1   something like carrots for example, but it would take a
          2   it on a commodity basis.
          3        DR. BUCHANAN:  And then a final just real quick
          4   question:  Is there any reason why FDA should ignore the
          5   past epidemiology of Listeria associated with cabbage --
          6        DR. GOMBAS:  Other than it was --
          7        DR. BUCHANAN: -- in considering this a food that
          8   does or does not support the growth of Listeria to high
          9   levels?
         10        DR. GOMBAS:  Other than the fact that it was over
         11   20 years ago, we know what caused that and we can stop
         12   that practice now.  Thank you.
         13        MR. LANDA:  Our next speaker is Kevin Myers with
         14   Hormel Foods.
         15        MR. MYERS:  Thank you.  We appreciate the
         16   opportunity to comment today.  Hormel Foods certainly
         17   supports a science-based approach to Listeria
         18   monocytogenes control. However, after reviewing the FDA
         19   risk assessment documents Hormel does not support the
         20   change in zero tolerance policy for Listeria
         21   monocytogenes in any ready-to-eat food.  There are three
         22   points which I will briefly comment on today and we will
                                                                      190
          1   expand on these as part of our written comments.
          2        First, the amount of Listeria monocytogenes that
          3   could be unsafe, especially for those with compromised
          4   immune systems, is unknown.  The proposed 100 CFU per
          5   gram tolerance is based on assumptions that this amount
          6   is below the minimum infectious dose for Lm for anyone
          7   who consumes it.  The minimum infectious dose of any
          8   pathogenic microorganism is dependent upon the
          9   susceptibility of the host and the virulence of the
         10   organism.  The incubation period for Listeriosis is
         11   documented to range from 1 to 91 days.  With an
         12   incubation period this long and variable makes it very
         13   difficult to determine the source of the infection as
         14   well as the level of contamination in the food at the
         15   time of consumption.
         16        There is no dispute that higher levels of Lm are
         17   more likely to cause disease than lower levels.  Indeed
         18   the level of contamination of Lm in foods responsible
         19   for outbreaks often may be more than 100 CFU per gram
         20   but at least four documented Lm outbreaks have been
         21   reported from foods with Lm counts below the proposed
         22   100 CFU per gram tolerance.
                                                                      191
          1        Secondly, any proposed tolerance level ignores the
          2   possibility of cross-contamination.  Even if the level
          3   of Lm in a product that does not support its growth is
          4   low enough so that it would not cause Listeriosis for
          5   the general population, there's a very real risk in
          6   retail or food service environments of Lm being
          7   introduced from these safe foods to foods that do
          8   support the growth of Lm.  Once introduced into a food
          9   that will support its growth, Lm could grow quickly to
         10   levels sufficient to cause sickness.
         11        And third, many food safety interventions being
         12   used today are interventions that were put in place in
         13   response to the zero tolerance policy.  Because the
         14   scientific data are insufficient to establish a reliable
         15   tolerance level, several countries, including the United
         16   States, have established this zero tolerance policy. 
         17   There is no reason to relieve manufacturers of their
         18   responsible of continued vigilance because some of these
         19   programs have not get achieved complete success.
         20        The risk assessments argue that shift in focus from
         21   achieving zero tolerance for contamination of foods to
         22   reducing the number of servings on which large numbers
                                                                      192
          1   of Lm are allowed to grow will actually lower the
          2   incidents of Listeria.  There is a real danger however
          3   that a tolerance for the presence of Lm on ready-to-eat
          4   foods will have a negative effect on the operation and
          5   efficacy of a manufacturer's food safety system.  Indeed
          6   it appears that this potential effect was not addressed
          7   by the risk assessments.
          8        In conclusion we applaud the general focus of the
          9   draft compliance policy guide and draft guidance on safe
         10   product formulation, sanitation and testing to improve
         11   the safety of ready-to-eat products and reduce Lm
         12   contamination.  We do not, however, believe that the
         13   proposed change to the zero tolerance -- the current
         14   zero tolerance to accept an increase in tolerance of any
         15   level of Lm contamination on any food product is the
         16   right direction for the agencies, manufacturers or
         17   consumers. Thanks again for the opportunity to comment.
         18        MR. LANDA:  We have another question for you.
         19        DR. BUCHANAN:  Question:  In asking for public
         20   comment on our CPG, we're asking for comment on both our
         21   standards. And you referred to the zero tolerance when
         22   in fact it is a numerical standard based on a testing
                                                                      193
          1   method.  It's 0.04 CFUs per gram.  From the comments
          2   that you are -- that you've provided, are you advising
          3   us to further make that standard more stringent.
          4        For example, before Codex now there's a
          5   recommendation to move in 1 in 125 grams.  Other
          6   countries require -- for example, South Korea was moving
          7   towards 1 in 375 grams. Are you recommending that we
          8   further tighten the requirements so we get closer to the
          9   zero that you're referring to?
         10        MR. MYERS:  We're recommending no change at this
         11   time. We're recommending that certainly expanding on the
         12   higher levels and emphasizing those are important so we
         13   would not want to take our eye off the zero or the
         14   current 0.4 per 25 that you referred to.
         15        DR. BUCHANAN:  So, you're stating that the current
         16   2000 cases per year is an acceptable level of risk?
         17        MR. MYERS:  No.  That's not what we're saying. 
         18   We're saying that we need to continue to vigilance that
         19   we're doing now in order to continue to drive that level
         20   lower.
         21        DR. BUCHANAN:  Okay.
         22        MR. LANDA:  Our next speaker is Jenny Scott from
                                                                      194
          1   the Grocery Manufacturers Association.
          2        MS. SCOTT:  Good afternoon.  My name is Jenny Scott
          3   I'm vice president of food safety programs for the
          4   grocery manufacturers association.  GMA represents the
          5   world's leading food, beverage and consumer products
          6   companies. The association promotes sound public policy,
          7   champions initiatives that increase productivity and
          8   growth, and helps to protect the safety and security of
          9   the food supply through scientific excellence.
         10        GMA is a diverse organization and as such it's to
         11        be
         12   expected that not all our members fully support all our
         13   positions; however, our position on Listeria
         14   monocytogenes has been developed through broad consensus
         15   over many years. Let me make it clear from the outset
         16   that GMA fully agrees that Listeriosis is a serious
         17   foodborne illness and that industry must take steps to
         18   minimize the potential for contamination for ready-to-
         19   eat foods and reduce the risk to consumers.
         20        Let me start with a little bit of background.  In
         21        1991
         22   The National Food Processors Association, which recently
                                                                      195
          1   merged with GMA, established a written position on L
          2   monocytogenes in foods urging a reevaluation of the
          3   regulatory policy and calling for a change in monitoring
          4   focus and compliance criteria.  We outlined existing
          5   evidence that low members of this organism were unlikely
          6   to cause Listeriosis even in susceptible individuals. 
          7   We recommended that regulatory agencies focus on foods
          8   previously implicated in Listeriosis cases and foods
          9   that have the greatest potential for contamination with
         10   L monocytogenes at high levels at the time of
         11   consumption, those that support growth of the organism.
         12        FDA held many discussions with scientists and
         13   regulators on how to best minimize the risk of
         14   Listeriosis. We recognized that the way forward was
         15   through science, specifically, through quantitative
         16   microbial risk assessment; however, in spite of almost
         17   two decades of research we had a major data gap for
         18   conducting risk assessments.  Because a policy required
         19   absence of the organism in ready-to-eat foods we had a
         20   lot of data on prevalence of L monocytogenes in specific
         21   foods but very little enumeration data.  1998 and '99
         22   several forward thinking NFPA member companies provided
                                                                      196
          1   funding to initiate a product to develop data on
          2   prevalence and numbers of L monocytogenes in ready-to-
          3   eat foods at retail.
          4        With additional funding through grants from CSR,
          5        EES
          6   and FDA, we obtained data in 2000 and 2001 from over
          7   31,000 samples of ready-to-eat foods, data that were
          8   provided to FDA and FSIS for the inclusion in the risk
          9   assessment of L monocytogenes in ready-to-eat foods. 
         10   NFPA also used the data from the study combined with CDC
         11   Listeriosis data from two sampling sites to develop a
         12   risk assessment from which we concluded that low levels
         13   of L monocytogenes equal low risk.
         14        Data from the NFPA risk assessment from the
         15        FDA/FSIS
         16   risk assessment and from a FAO/WHAO risk assessment
         17   formed the basis in part for a petition from the
         18   Alliance for Listeriosis Prevention to FDA in December
         19   2003 to establish a regulatory limit of 100 Listeria
         20   monocytogenes per gram in foods that did not support
         21   growth.
         22        So, a process that began for us in 1991 has
                                                                      197
          1        culminated
          2   in FDA's development of this compliance policy guide. 
          3   GMA commends FDA in the thoughtful approach and thorough
          4   consideration of the science to develop the CPG.  It
          5   clearly was not a decision made in haste.  We strongly
          6   support FDA's use of microbial risk assessment to
          7   develop risk management strategies for control of
          8   Listeria monocytogenes.  We also support the focus of
          9   the CPG on foods where the number of L monocytogenes per
         10   serving can reasonably be expected to increase to a dose
         11   that's likely to cause illness.  And we believe that the
         12   science supports the foods containing 100 L
         13   monocytogenes per gram present a minimal risk even to
         14   highly susceptible consumers.
         15        It is entirely appropriate to focus FDA resources
         16   where the greatest benefit to public health can be made
         17   in addressing the risk of L monocytogenes in foods.  The
         18   CPG allows FDA to do this by applying more resources to
         19   foods that support the growth of L monocytogenes to
         20   levels that could cause Listeria.  Let me briefly
         21   outline why GMA believes that a policy that allows 100
         22   Lm per gram in foods that do not support growth does not
                                                                      198
          1   present an increased risk to public health compared to
          2   the current policy.  I will try to simplify my comments
          3   on this leaving the highly technical evidence to our
          4   written comments.
          5        Based on the dose response model and the exposure
          6   assessment in the FDA FSIS risk assessment it can be
          7   determined that the vast majority of cases of the annual
          8   incidents of Listeriosis in the U.S. can be attributed
          9   to the consumption of doses at or above 10 to the 6th or
         10   one million L monocytogenes per gram.  This is true even
         11   for at-risk sub populations.  Essentially no cases of
         12   Listeriosis were attributed to all the servings
         13   contaminated at or below 100 CFUs per gram.  The FDA
         14   FSIS risk assessment estimated that the risk of
         15   Listeriosis was extremely small for RTE foods that do
         16   not support growth both in terms of risk per serving and
         17   risk per annum.
         18        The FAO/WHAO risk assessment also concluded that
         19   nearly all cases of Listeriosis result from the
         20   consumption of high numbers of L monocytogenes and that
         21   the consumption of low numbers has a low probably of
         22   causing illness. FAO/WHAO concluded that the vast
                                                                      199
          1   majority of Listeriosis cases were associated with
          2   consumption of foods that did not meet current standards
          3   for L monocytogenes in various countries whether that
          4   standard is 100 CFUs per gram or 0.04 CFUs per gram or 1
          5   in 25 grams, the current U.S. standard.
          6        The NFPA risk assessment show that reducing the
          7        number
          8   of servings contaminated at high levels can have a
          9   greater impact on reducing cases of Listeriosis and
         10   relying solely on reducing the prevalence of the
         11   organism in all ready-to-eat foods.  The available
         12   evidence indicates that foods that do not support growth
         13   are rarely contaminated at high levels.  In fact the
         14   FDA/FSIS risk assessment indicates the frequency of
         15   contamination of hard cheese, ice cream and cultured
         16   dairy products at numbers exceeding 100 per gram is
         17   effectively zero percent, with more than 99 percent of
         18   servings containing less than one CFU.
         19        The CPG does not abrogate a company's
         20        responsibility
         21   to minimize Listeria monocytogenes contamination.  In
         22   order for a manufacturer to consistently meet a limit of
                                                                      200
          1   100 L monocytogenes per gram, that manufacturer will
          2   need to follow stringent programs to minimize
          3   contamination of products with this organism.  The types
          4   of programs needed will depend upon the product, the
          5   establishment and the level of control they have
          6   achieved to date.  It can take several years of
          7   aggressive action to reduce L monocytogenes in the plant
          8   environment to levels that consistently minimize L
          9   monocytogenes contamination.  Many companies have
         10   achieved the appropriate level of control as evidenced
         11   by the low numbers of L monocytogenes that can be found
         12   in most ready-to-eat products when they're contaminated.
         13    Relaxing these programs will result in a failure to
         14   comply with the CPG.  And FDA has appropriately
         15   indicated that food manufacturers must take all
         16   reasonable precautions to not contaminate foods.
         17        GMA does have reservations about the categorization
         18        of
         19   foods with respect to whether or not they're ready-to-
         20   eat or whether they are considered to support growth. 
         21   There are a number of ready-to-eat foods for which
         22   testing to determine if they comply with the CPG would
                                                                      201
          1   have no public health benefits including dry products
          2   such as cereals, crackers and cookies.  Foods heat
          3   treated in the package, low-acid and acidified canned
          4   foods and aseptically processed products.
          5        We also strongly support extending the types of
          6        frozen
          7   food considered to not support growth to frozen foods
          8   other than those consumed frozen, for example, that are
          9   cooked from a frozen state.  We believe that the
         10   intended use of a specific product should be considered
         11   in determining whether or not a product presents a risk.
         12    For example, frozen peas and corn destined for further
         13   processing should not be considered ready-to-eat and
         14   subject to a limit of less than 1 per 25 grams. 
         15   Resources need to be focused on the riskiest products. 
         16   Those that support growth and are likely to be held
         17   refrigerated for a sufficient time that L monocytogenes
         18   can grow to high numbers.
         19        We need practical programs.  The FAO/WHAO risk
         20   assessment indicated that public health would be
         21   improved by changing the standard from less than 1 per
         22   25 grams and less than 100 per gram if this resulted in
                                                                      202
          1   a decrease in the number of servings that greatly
          2   exceeded the established limit.  For example, and I
          3   quote, "If the change encouraged manufacturers to
          4   routinely screen for L monocytogenes in the plant
          5   environment and take appropriate remedial actions."
          6        To do this FDA must encourage the types of programs
          7   that are designed to seek and remove Listeria when it's
          8   present in plant environments.  Which takes me to the
          9   FDA guidance for industry.  The guidance appears to
         10   ignore many of the concepts that have made industry
         11   control of L monocytogenes so successful in many
         12   operations.  We're concerned with several broad issues. 
         13   FDA's guidance is not the most effective approach for
         14   programs that aggressively look for Listeria in order to
         15   prevent Listeria monocytogenes contamination.
         16        Recommendations in the guidance do not appear to
         17   differ among ready-to-eat products with different risks
         18   and one-size-fits-all approach that applies the same
         19   programs regardless of product risk is unnecessarily
         20   burdensome without enhancing public health.  We commend
         21   the agency for taking a bold step forward in
         22   establishing regulatory policy based on extensive risk
                                                                      203
          1   assessments.  The CPG clearly recognizes that the most
          2   effective approach to reducing Listeriosis is to move
          3   from commerce foods that are contaminated with high
          4   numbers of L monocytogenes and that ready-to-eat foods
          5   in which the organism can grow are the ones most likely
          6   to contain these high numbers.
          7        GMA looks forward to working with the agency to
          8   develop practical, flexible approaches that will reduce
          9   L monocytogenes contamination in ready-to-eat foods,
         10   particularly, in those products that support growth of
         11   the organism.  To achieve our common goal of minimizing
         12   contamination of ready-to-eat foods with Listeria
         13   monocytogenes in order to protect the consumer.  Thank
         14   you.
         15        MR. LANDA:  One question.
         16        DR. BUCHANAN:  Thank you, Jenny.  I had a question
         17   that -- what the CPG does not address, it lays out two
         18   microbiological criteria or levels but it doesn't talk
         19   about the frequency of testing.  And while there is some
         20   mention of it in the guidance document, it doesn't go
         21   into great detail.  Do you have any feel from your
         22   experiences in industry on what the frequency of testing
                                                                      204
          1   should be both in the environment and also a finished
          2   product against these two standards that we're
          3   proposing?
          4        MS. SCOTT:  I think I probably don't have time to
          5   go into that.  We will address that in our written
          6   comments.
          7        DR. BUCHANAN:  Okay.
          8        MR. LANDA:  Our next speaker is Sarah Klein with
          9   the Center for Science and the Public Interest.
         10        MS. KLEIN:  Thank you.  I have just a few brief
         11   comments in addition to what I spoke about earlier.  The
         12   threshold question that we'd like to answer is:  Should
         13   we be entertaining a more relaxed regulatory framework
         14   at this time?  CSPI believes that the answer
         15   emphatically is no for the following three reasons. 
         16   One, we're not convinced that the evidence clearly
         17   justifies what we call the "looser standard."  The
         18   European Food Safety Authority recently published a
         19   scientific opinion that questioned some of the
         20   scientific evidence that appears to support the 100 CFU
         21   per gram standard.  That opinion stated, among other
         22   things, that the current testing that has been relied
                                                                      205
          1   upon could not predict with a high degree of certainty
          2   that allowing that 100 CFU per gram at shelf life would
          3   not result in an even higher rate at consumption.  We,
          4   therefore, believe that consumption should be the
          5   appropriate measure and not shelf life.
          6        We also have questions about the scientific basis
          7        for
          8   using foods that do or do not support growth when
          9   studying Listeria and making effective regulations about
         10   it.  CSPI had suggested to Codex and reiterates the
         11   suggestion here that the more appropriate terminology is
         12   "conditions" which do and do not support growth.  This
         13   recognizes that Listeria is an environmental contaminant
         14   and can create problems in seeded environments and not
         15   just in individual food products.
         16        Number two, further their failure to meet the
         17        healthy
         18   people 2010, changed under the Clinton administration to
         19   2005, objectives for two years in a row about Listeria
         20   that was in 2006 and 2007, calls the rationale for
         21   changing the standard now into serious question.
         22        Third, and finally, although we appreciate in
                                                                      206
          1        theory
          2   the attempt to harmonize regulations with the members of
          3   the international community, we see two major and
          4   undeniable flaws in this approach.  First, is the need
          5   by some of those countries to employ the lower standard
          6   unless they regulate themselves out of being able to
          7   produce their specialty products.  The U.S. doesn't have
          8   similar constraints and U.S. consumers should not be put
          9   at greater risk because of the decisions made by these
         10   other countries.
         11        Second, harmonizing with the international
         12        community
         13   would bring FDA far out of harmony with FSIS.  It's my
         14   understanding that FSIS is opposed to this change and
         15   has reasonable and justifiable concerns with creating a
         16   dual regulatory limit for Listeria, including first,
         17   that FDA products could contaminate USDA products at
         18   retail.  The national alliance for food safety and
         19   security report noted that while Listeria has decreased
         20   in USDA regulated meat since 2003 the levels in those
         21   meats that are then sliced at the deli are seven times
         22   higher than unopened packages. This suggests that there
                                                                      207
          1   is already a significant problem of cross-contamination
          2   at retail and the result is more Listeria brought into
          3   consumers' homes.
          4        We also face a slippery slope problem.  If FDA
          5        relaxes
          6   the standard USDA regulated industries will be impacted
          7   and may wind up moving to a lower standard as well,
          8   which we don't feel is necessary or reasonable.
          9        Finally, the FDA research shortage that we've heard
         10        so
         11   much about, particularly in the last year, prevents
         12   adequate follow-up on retail environments which will be
         13   sorely needed even more than it is now if products were
         14   carrying additional loads of Listeria into that
         15   environment.  FSIS would also be forced to devote
         16   additional resources to retail compliance testing that
         17   is now largely controlled by the current policy.
         18        FSIS would also have to do increased sampling at
         19        their
         20   facilities which may not be something that FSIS
         21   regulated commodities are looking forward to either. 
         22   So, for these reasons we are opposed to the current
                                                                      208
          1   standard that's been suggested.  Thank you.
          2        DR. BUCHANAN:  Sarah, can I ask you for a point of
          3   clarification?  I noticed in your first item that you
          4   referred to the FSIS report and I just wanted to clarify
          5   which of the standards you were referring to when they
          6   address the Codex standard.  As I read the FSIS report
          7   they were focusing on the standard that says that a
          8   product that supported growth could -- you could still
          9   let it go up to a 100 if you could justify that it did
         10   not exceed 100 over its shelf life.  And I agree totally
         11   that there was a lot of confusion in the European
         12   standard about how they were defining shelf life.  Do
         13   you have any question that we're defining shelf life in
         14   the CPG up to the point of consumption and that the
         15   products that you're referring in the FSIS report are
         16   not really on the table here?
         17        MS. KLEIN:  Well, yes, but we just wanted to
         18   clarify that we are talking about consumption and that
         19   shelf life, as you're defining it, does go all the way
         20   through.
         21        DR. BUCHANAN:  Right.
         22        MS. KLEIN:  Okay.
                                                                      209
          1        DR. BUCHANAN:  Thank you.
          2        MR. LANDA:  Our next speaker is Cary Frye with the
          3   International Dairy Foods Association.
          4        MR. FRYE:  Good afternoon.  I'm Cary Frye, Vice
          5   President of Regulatory Affairs for the International
          6   Dairy Foods Association.  IDFA and our constituent
          7   organizations, the Milk Industry Foundation, the
          8   International Ice Cream Association and the National
          9   Cheese Institute represent nearly 500 companies that
         10   manufacture and market about 85 percent of the dairy
         11   products consumed in the U.S.
         12        IDFA appreciates the opportunity to express our
         13        views
         14   concerning the agency's draft compliance guide regarding
         15   the presence of Listeria monocytogenes in ready-to-eat
         16   foods.  The dairy foods processing industry has worked
         17   closely with FDA for over two decades to help improve
         18   the safety of dairy products by enhancing efforts to
         19   control potential post-pasteurization contamination of
         20   Listeria monocytogenes.
         21        In 1986 IDFA and our members worked with FDA, state
         22   agencies, and the National Conference on Interstate Milk
                                                                      210
          1   Shipments to help develop and carry out FDA's dairy
          2   safety initiative program that you heard a little bit
          3   about this morning.  This program included inspection of
          4   facilities to ensure proper controls and maintenance of
          5   processing equipment, sanitation, and education and
          6   training of all dairy factory personnel.
          7        The program also included microbial surveillance
          8   program to detect Listeria monocytogenes and other
          9   pathogens in dairy products such as milk, cream, ice
         10   cream, butter and nonfat dried milk.  This initial
         11   surveillance program for Listeria in dairy products
         12   helped lay the foundation to understand potential
         13   contamination frequency rates for dairy products to be
         14   used in future risk assessments.  More importantly it
         15   also provided a benchmark to gauge the industry's
         16   commitment to improve and reduce Listeria contamination.
         17        In addition, in response to FDA and USDA's call for
         18   data on the frequently on L mono and ready-to-eat foods,
         19   IDFA provided detailed industry testing data on the
         20   presence -- prevalence of Listeria monocytogenes
         21   detected in ice cream, frozen desserts and cheeses.  And
         22   due to a lack of industry data on milk, IDFA conducted a
                                                                      211
          1   comprehensive survey of pasteurized fluid milk from
          2   retail stores in 2000 for also the risk assessment's
          3   use.
          4        More recently IDFA's constituent organizations, the
          5   International Ice Cream Association and the National
          6   Cheese Institute, join several other trade associations,
          7   as Bob Garfield mentioned, with the Alliance for
          8   Listeria Prevention in 2003's petition to FDA requesting
          9   the establishment of a regulatory limit of 100 Listeria
         10   monocytogenes CFU per gram in foods that do not support
         11   the growth of Lm.
         12        Thus, IDFA fully supports FDA's draft compliance
         13   policy guides and its proposed approach to regulate
         14   foods. FDA's planned policy regarding ready-to-eat feeds
         15   that do not support the growth of Lm to be adulterated
         16   when the organism is present at or above 100 colony
         17   forming units per gram is based on sound science. 
         18   There's international and regulatory evidence that
         19   public health impact of Lm is almost exclusively a
         20   function of foods that contain high numbers of the
         21   organism well in excess of 100 CFU per gram. Likewise,
         22   low levels of Lm in foods that do not support the growth
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          1   present a minimal risk to harm.
          2        We applaud the agency's risk-based approach to this
          3   issue.  This policy will enable FDA to focus its
          4   resources on those foods that are more likely to result
          5   in illness if Lm is present.  Additionally, by
          6   permitting FDA and the dairy industry to focus resources
          7   an attention on cell numbers, the approach outlined in
          8   the CPG will facilitate the adoption of targeted
          9   science-based control measures. Indeed control measures
         10   that will prevent cell numbers of Lm in foods at the
         11   point of consumption and will be most effective in
         12   reducing the incidents of Listeriosis.
         13        Therefore, in sum, we believe the proposed approach
         14        in
         15   the draft compliance policy guide will enhance food
         16   safety and result in greater public health benefit. 
         17   With specific regards to dairy foods, we applaud FDA for
         18   recognizing that many dairy foods such as ice cream,
         19   processed cheese, culture dairy products, such as yogurt
         20   and hard cheeses with a moisture content less than 39
         21   percent are ready-to-eat foods that are generally
         22   considered to not support the growth of L monocytogenes.
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          1    There is sound scientific evidence supporting these
          2   conclusions.
          3        Nonetheless the way FDA's CPG is currently written
          4   mainly to misinterpretation of some dairy products, such
          5   as cultured dairy products, yogurt and cheese, with
          6   regard to their ability to support the growth of Lm. 
          7   Specifically a hard cheese with a moisture content of
          8   less than 39 percent may have a pH greater than 4.4 and
          9   a water activity greater than 0.92.  The available
         10   sciences FDA's has recognized clearly indicates that
         11   these foods do not support the growth of Listeria
         12   monocytogenes.
         13         As FDA appropriately states in the draft guidance
         14   that the addition of added antimicrobial agencies as
         15   well as intrinsic and processing factors of the foods
         16   can have an effective Listeriostatic control; however,
         17   for foods such as dairy products, these are intrinsic
         18   factors and are not solely limited to pH and water
         19   activity.  Numerous researchers have reported the
         20   bactericidal effects of Listeria monocytogenes in hard
         21   cheese due to lactic acid production, salt, competing
         22   microflora, biochemical metabolites and naturally
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          1   produced bacteriocins.
          2        In the case of dairy products, including yogurt,
          3        the
          4   literature is replete with studies that identify
          5   intrinsic antimicrobial factors associated with the
          6   generation of lactic acid for fermentation and natural
          7   biacins (ph). Research confirms that yogurt and cultured
          8   dairy products with a pH of 4.7 or less for lactic acid
          9   will not support the growth of Listeria monocytogenes. 
         10   In fact the lactic acid and other compounds in the
         11   cheese and yogurt actually help limit the growth of
         12   Listeria monocytogenes and thus these foods should be
         13   considered under the 100 CFU per gram approach.
         14        Therefore, we ask the agency to make clear how it
         15   intends to apply the criteria in the draft CPG to
         16   regulate foods that do not support the growth of
         17   Listeria monocytogenes.  We suggest the agency clarify
         18   the fourth point of the criteria which now reads:  Is
         19   processed using an effective Listeriostatic control
         20   measure; to also include the words:  And is otherwise
         21   demonstrated through competent and reliable scientific
         22   evidence to not support the growth of Listeria
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          1   monocytogenes.
          2        IDFA also recommends additions to the parenthetical
          3   examples in this criterion to recognize inherent anti
          4   Listerial growth factors such as lactic acid from
          5   cultured dairy foods.  Such an approach would reconcile
          6   the other criteria listed with FDA's conclusion that
          7   foods such as processed cheese, yogurt, cultured milk
          8   and hard cheeses like cheddar, Colby and Swiss do not
          9   support the growth of Listeria monocytogenes.
         10        In summary, IDFA commends the agency for issuing
         11        the
         12   draft compliance guidance and supports the adoption of
         13   the approach outlined in it.  We agree with the agency
         14   that many dairy foods do not support the growth of
         15   Listeria monocytogenes and seek clarification on how FDA
         16   intends to apply the criteria outlined in the CPG to
         17   such foods such as yogurt and cheeses.
         18        IDFA does intend to file written comments
         19        discussing
         20   this issue further.  Additionally, although we
         21   understand this public meeting is not to address FDA's
         22   draft compliance guidance for industry controls of
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          1   Listeria monocytogenes in refrigerated ready-to-eat
          2   foods, we would like to express the dairy industry's
          3   concern with the prescriptive nature of the draft
          4   guidance.  And we look forward to the opportunity to
          5   working with FDA on refining the guidance and hopes to
          6   consider more performance-based outcomes.  We will also
          7   be submitting additional comments related to those
          8   points.  Again, thank you think for this opportunity and
          9   I'd be happy to answer any questions.
         10        DR. BUCHANAN:  Cary, just one question and a lot of
         11   the latter part of your comments focused on the fact
         12   that a number of your products don't meet the pH 4.4,
         13   0.92 but --
         14        MS. FRYE:  Correct.
         15        DR. BUCHANAN:  -- in the CPG there is a discussion
         16   about validation.  Do you anticipate that the dairy
         17   industry would have any difficulty in either validating
         18   and/or modeling the characteristics of your products
         19   such that you could fulfill that requirement for those
         20   products that scientific evidence suggested Listeria
         21   will not grow?
         22        MS. FRYE:  No.  I think that there is a
                                                                      217
          1   considerable amount of literature that does support
          2   this, which we've all relied on before, and there's also
          3   challenge studies that have been done in cultured dairy
          4   products.  So there is a great deal of literature
          5   available, which -- as the risk assessment -- the risk
          6   ranking saw hard cheeses were the lowest risk foods,
          7   those are some of the cheeses that we're referring to.
          8        So, I believe that the data is available and we
          9   believe that quite often it could be in modelled, it
         10   could be in challenge studies or it could already be in
         11   the literature already published.
         12        DR. BUCHANAN:  And so going back to some of the
         13   earlier presentations that we heard this morning, you
         14   would recommend that we also set some default -- we'll
         15   call them hurdle technology values similar to what are
         16   in the guidance provided by FSIS?
         17        MS. FRYE:  I'm not as familiar with FSIS but I --
         18   so I can't speak to that -- but we are suggesting that
         19   hurdle technologies are the most important factor when
         20   we're looking at these products because it's not the
         21   added antimicrobials -- although some of them are used
         22   that are Listeriostatic -- it's the combinations of the
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          1   natural effects received with the lactic acids or the
          2   organic acids that are produced.  So, in essence, it's
          3   the hurdle technologies, correct.
          4        DR. BUCHANAN:  Okay.  Thank you.
          5        MS. FRYE:  Thank you.
          6        MR. LANDA:  We have one more speaker, Chris
          7   Waldrop, with the Food Policy Institute Consumer
          8   Federation of America.
          9        MR. WALDROP:  Thank you very much.  I was a late
         10   addition, so I apologize you don't have my remarks in
         11   advance but I will make sure that you do get them.
         12        My name is Chris Waldrop.  I'm the Director of the
         13   Food Policy Institute At Consumer Federation of America.
         14   CFA is a nonprofit association of over 300 pro-consumer
         15   groups with a combined membership of 50 million
         16   Americans. And before I get to the remarks on the
         17   specific FDA proposal, I do want to register an
         18   objection for the record specifically on the agenda that
         19   was set out today.  There was a -- what we'd
         20   specifically like to object to the fact that there were
         21   certain constraints placed on the consumer perspective
         22   in this agenda.
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          1        The agenda identified the consumer perspective as
          2   addressing consumer experience and education programs to
          3   prevent L monocytogenes and Listeriosis and that title
          4   suggests that the consumer perspective is only valuable
          5   in the area of consumer education.  This is inaccurate
          6   and inappropriate.  Consumer representatives bring a
          7   very unique and important perspective to any discussion
          8   on food safety and it's unacceptable to limit that
          9   discussion to just consumer education.  So, we would
         10   strongly urge the FDA in the future to work with
         11   consumer representatives to find the most productive
         12   means of addressing agenda and not dictate the agenda to
         13   them.  Moving on from there.
         14        CFA opposes FDA's proposal to weaken its standard
         15        for
         16   Listeria for several reasons.  First, progress in
         17   reducing Listeriosis in the United States has ground to
         18   a halt.  Dr. Tauxe mentioned the national incidents of
         19   Listeria, the healthy people goal of 2.5 persons per
         20   million population. That goal as Sarah Klein said had
         21   been moved to 2005 and we have now failed to meet that
         22   goal for two years in a row. To us that says it is not
                                                                      220
          1   the right time FDA to be weakening its current standard
          2   and we think it would be very difficult to tell the
          3   American people that you're weakening the current
          4   standard when we're failing to meet the public health
          5   goals that have been set out for the Federal Government.
          6     Second, one of the goals that Dr. Buchanan's slide
          7     show
          8   showed was that one of the goals was harmonizing with
          9   international standards.  As was mentioned earlier we
         10   may be trying to harmonize with international standards
         11   but we're not harmonizing with our own domestic
         12   standards.  And FSIS does not seem to be supportive of
         13   this change and we think that that will then create a
         14   discrepancy between the two agencies responsible for
         15   ensuring the safety of the majority of the food supply
         16   which creates further confusion in an already fragmented
         17   system.
         18        In addition, there is information from the E.U.
         19        that
         20   showed in 2006 that the cases of illness of Listeria
         21   monocytogenes has reached it highest point in the past
         22   eight years and we're concerned about harmonizing to a
                                                                      221
          1   standard that may be increasing illnesses in the E.U. as
          2   well. Third, we are concerned about FDA's proposal in
          3   relation to establishments that handle both FDA and USDA
          4   regulated products including retail stores and deli
          5   services establishments, particularly the issue of
          6   cross-contamination, and how different standards could
          7   affect the different products and may increase the
          8   growth of Listeria for FSIS-related products that do not
          9   have -- that have the zero tolerant standard.
         10        In addition, FDA has not indicated it will conduct
         11   additional increased inspections and verification at
         12   retail.  FSIS does virtually no inspection at retail so
         13   we're left at a point where nobody is going to be
         14   assuring that FDA's proposal is not creating increased
         15   risk to consumers.
         16        And that brings me to the next point that FDA has
         17        not
         18   really explained how it will assure the public that
         19   their new proposal on read-to-eat foods will not impact
         20   the population.  Dr. Doyle, I think, mentioned
         21   validation studies in terms of what the industry is
         22   doing to assure that their methods are reaching the
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          1   necessary goals and I think FDA needs to do same.  We
          2   need to make sure that FDA's proposal does not make to
          3   create worse problems and present an increased risk to
          4   consumers.
          5        And finally, I want to discuss the issue of
          6        labeling
          7   as was mentioned earlier.  CFA supports labeling for
          8   ready-to-eat products specifically to direct to pregnant
          9   women and immune compromised persons that these
         10   products, particularly meat products, should be reheated
         11   before using or, in the case of some FDA regulated
         12   products, maybe these populations should not -- or
         13   should consider whether or not they should be consuming
         14   these products based on their status of pregnancy or
         15   immune compromised system.  Thank you.
         16        DR. BUCHANAN:  Quick question, Chris.
         17        MR. WALDROP:  Sure.
         18        DR. BUCHANAN:  You mentioned the situation over in
         19   Europe and I did have a question because we have noted
         20   the increases in Germany and the UK during the past year
         21   in terms of their incidents of Listeriosis and I might
         22   note pretty much over all of the countries in Europe and
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          1   the United States and Canada.  Though we have very
          2   differing regulatory approaches, the incidents of
          3   Listeriosis in the population is approximately the same.
          4        Are you aware of anything that FDA should note
          5        about
          6   those two countries and why they've had a sudden
          7   increase in their rates of Listeriosis whereas the rest
          8   of Europe, based at least on the report I saw that came
          9   out yesterday, suggests that the rest of Europe, which
         10   falls under the same regulations, has remained pretty
         11   much as we have here in the United States plateaued
         12   after improvements the, you know, over the preceding
         13   years?
         14        MR. WALDROP:  The report that I saw was not
         15   specific to those two countries.  It was more Europe-
         16   wide -- I'll have to go back and I can get that
         17   information for you and forward it along -- but it was
         18   more a Europe-wide concern and that just -- it gives us
         19   pause.
         20        DR. BUCHANAN:  Okay.  The day on the individual
         21   countries was published yesterday.
         22        MR. WALDROP:  Okay.  Thank you.
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          1        MR. LANDA:  One question for you.  You referred to
          2   the issue of cross-contamination at retail, meaning, I
          3   think, from FDA to USDA regulated products?
          4        MR. WALDROP:  Correct.
          5        MR. LANDA:  Do you have any -- do you know of any
          6   evidence that that's occurring?
          7        MR. WALDROP:  I do know that there are concerns
          8   about, one, sanitation levels at retail and making sure
          9   that everything is being done so that cross-
         10   contamination doesn't occur.  I know that that is a sort
         11   of ongoing concern.  And there's, I think, limited --
         12   the efforts that have been -- that have put in place
         13   that have tried to eliminate that have been limited and
         14   not as effective as we would have wanted them to be.
         15        DR. BUCHANAN:  Follow-up question on that one too,
         16   Chris, and I'm sorry Joe Corby isn't -- had to leave
         17   early. From his presentation I had the strong impression
         18   that the food was not the major problem in a deli
         19   environment, that there seemed to be a general problem
         20   of contamination of the environment in that part of the
         21   store and appears from multiple sources.  Did you
         22   interpret that different when he made that presentation
                                                                      225
          1   this morning?
          2        MR. WALDROP:  I have to admit I missed part of his
          3   presentation when I was coming in.  No.  I think there
          4   certainly is a problem in the environment.  We don't
          5   want to get in a situation where -- we're concerned that
          6   the situation where you have a product that has a higher
          7   -- or is allowed to have a higher CFU and a product that
          8   does support the growth and does not, if there's any
          9   sort of cross-contamination based on the equipment or
         10   the surfaces that they may become a problem for the
         11   FSIS-regulated products.
         12        DR. BUCHANAN:  Yeah, because I was just struck by
         13   his presentation on how low the incidents of
         14   contamination in the food or the direct food contact
         15   surfaces was as opposed to the general environment and
         16   the design of the equipment that was in the deli area,
         17   which is notorious for being almost impossible to clean.
         18    So I was just wondering if we're -- I'm wondering out
         19   loud and asking for your input on this one -- is if
         20   we're chasing the wrong thing in the deli, that we
         21   should be thinking about sanitation and equipment design
         22   and the ability to clean that equipment and certainly
                                                                      226
          1   the comments that Jenny provided earlier, the equipment
          2   design is a critical issue.  So I just -- if you had any
          3   offense.
          4        MR. WALDROP:  We'd agree on the sanitation side as
          5   well.  Yes, sir.
          6        DR. ZINK:  I think that it would be very helpful if
          7   you'd get a copy of his presentation and look at two
          8   things that leapt out at me.  One was the -- in their
          9   phase 2 they looked at, I believe it was 60, small
         10   delis.  In the first phase, they learned that looking at
         11   the larger delis from chain stores seemed to be -- have
         12   better sanitation.  So the theory was that smaller
         13   single-proprietor-type delis might be a different
         14   situation.  What they found was is that they failed to
         15   isolate Listeria from any of the products in any of
         16   those 60 delis.
         17        Their next theory was that it was better correlated
         18   with poorer sanitation.  And I believe he made the
         19   remark - - he didn't have a slide but he made the remark
         20   -- that they found that in their third phase that 100
         21   percent of the delis characterized as having poor or
         22   inadequate sanitation, they were able to recover
                                                                      227
          1   Listeria monocytogenes from the environment.
          2        DR. BUCHANAN:  From all over the store.
          3        DR. ZINK:  Yeah.  From all over -- I mean that
          4   struck us as strongly indicative of the role of
          5   environmental sanitation in those delis as opposed to,
          6   you know, the incoming product.
          7        As we sit here now we're not aware of any data,
          8   despite efforts to obtain such data, that shows that
          9   there is significant spread or any spread from one class
         10   of products, such as a no-growth to a growth food, or
         11   anything else in the deli.  We'd be very interested in
         12   such data if it exists.
         13        MR. WALDROP:  Okay.  Great.
         14        MR. LANDA:  Chris is our last speaker today.  So,
         15   let me close by thanking our presenters this morning and
         16   our public commenters this afternoon, the administrative
         17   and technical staff for making this go so smoothly.  Let
         18   me also encourage public comment.  We do take it
         19   seriously.  I hope prior experience teaches folks that,
         20   that public comment on the CPG and on the guidance to
         21   industry.  As I said this morning we do anticipate that
         22   the transcript will be available in about 30 days at
                                                                      228
          1   dockets.  And we will wait a reasonable period of time
          2   after that's available.
          3        At the same time let me encourage people to start
          4   drafting comments now and not to wait until the
          5   transcript's available.  That will help you get them
          6   done faster and help us see them faster.
          7        Finally, let me thank you for attending and we hope
          8   to see you here again when we have another public
          9   meeting. Thank you.
         10        (Proceedings concluded 4:20 p.m.)
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