0001
 1   
 2   
 3   
 4   
 5   
 6         DEPARTMENT OF HEALTH AND HUMAN SERVICES
 7            U.S. FOOD AND DRUG ADMINISTRATION
 8   CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)
 9   
10          SAFETY OF FRESH PRODUCE PUBLIC HEARING
11   
12            Ronald V. Dellums Federal Building
13                       Oakland, CA
14   
15                 Tuesday, March 20, 2007
16   
17   
18   
19   
20   
21   
22                Reporter:  Freddie Reppond
0002
 1                    A P P E A R A N C E S
 2   
 3   FDA Panelists
 4      Michael Landa, Deputy Director for Regulatory Affairs,
 5         CFSAN; Panel Chair
 6      David Acheson, M.D., Director, Office of Food Defense,
 7         Communication & Emergency Response, CFSAN, FDA
 8   Shirley Bohm, Consumer Safety Officer, Office of Food
 9         Safety, CFSAN, FDA
10   Robert Buchanan, Ph.D., Senior Science Advisor, Office
11         Of Center Director, CFSAN, FDA
12   Sherri McGarry, Acting Coordinator, Emergency
13         Coordination and Response Team, CFSAN, FDA
14   Mark Roh, Acting Regional Food and Drug Director, Office
15         Of Regulatory Affairs, FDA
16   Persons from Government Agencies Providing Comment
17         Michael Lynch, M.D.
18         Michelle Smith, Ph.D.
19         Barbara Cassens
20         Jeff Farrar, Ph.D.
21         Marion Aller, Ph.D.
22         Hank Giclas, Ph.D.
0003
 1               A P P E A R A N C E S   (C O N T) 
 2   
 3         Linda Harris, Ph.D.
 4         Elisa Odabashian
 5         Amy Green
 6   Persons Providing Public Comments
 7         Senator Dan Florez
 8         Edward Beckman
 9         James Gorny
10         Richard Ross
11         Sik-Lam Wong
12         Ron Strochlic
13         Dan Cohen
14   
15   
16   
17   
18   
19   
20   
21   
22   
0004
 1                   P R O C E E D I N G S
 2               (The hearing began at 8:56 a.m.)
 3             MR. LANDA:  My name is Michael Landa, the
 4   deputy director for regulatory affairs at the Center for
 5   Food Safety and Applied Nutrition in the Food and Drug
 6   Administration.  I welcome you to this auditorium in the
 7   Ronald V. Dellums Building for our hearing today on
 8   produce safety.  This is the first of two hearings we're
 9   holding on produce safety.  The second one will be on
10   April 13 in College Park, Maryland in the Harvey Wiley
11   Building, which is CFSAN's principal location.  Food
12   safety, of course -- and produce safety, more
13   particularly -- are among CFSAN's highest priorities.
14   Consumption of fresh fruits and vegetables -- whether
15   fresh-cut or not -- is an important part of a healthful
16   and nutritious diet.  And consumption has been
17   increasing -- and a good thing at that.  But -- and, of
18   course, it's the "but" that brings us here.
19             I want to quote now from the Federal Register
20   notice that we published announcing the hearing.  Data
21   reported to the U.S. Centers for Disease Control and
22   prevention indicate that between 1973 and 1997 reported
0005
 1   outbreaks of foodborne illness in the United States
 2   associated with fresh produce increased in absolute
 3   numbers and as a proportion of all reported foodborne
 4   outbreaks.
 5             By "outbreak," by the way, we mean the
 6   occurrence of two or more cases of similar illness
 7   resulting from the ingestion of a common food.
 8   Unpublished data compiled by FDA indicate that from 1996
 9   to 2006 there were approximately seventy-two reported
10   outbreaks of foodborne illness associated with
11   approximately twenty fresh produce commodities.
12             Of this total, twelve outbreaks were
13   associated with tomatoes; eleven with melons; and
14   twenty-four with leafy greens such as lettuce and
15   spinach.  These outbreaks involve a number of pathogens
16   -- E. coli 0157:H7 and Salmonella species -- in both
17   domestic and imported produce.  I should say these
18   totals include only those outbreaks in which FDA's
19   investigation indicated that the contamination of this
20   produce was not the result of exposure to an infected
21   food handler or other unsafe food-handling practices at
22   the place of preparation and consumption, that is, home
0006
 1   or restaurant.
 2             The purpose of today's hearing is twofold.
 3   First, it's to share information about the recent
 4   outbreaks.  Second is to solicit comments, data, and
 5   other scientific information about current agricultural
 6   and manufacturing practices in relation to fresh
 7   produce; risk factors for contamination associated with
 8   these practices; and measures FDA might take to enhance
 9   the safety of fresh produce.
10             For those who recall the hearing notice,
11   there's a docket number at the head of that notice.  The
12   docket will remain open until June 13 for comments on
13   the issues and the questions posed.  We think the
14   hearing transcript should be available in about thirty
15   days.  That will be accessible via FDA's Web site, but
16   you'll have to check back.  Sometimes thirty days proves
17   to be optimistic, sometimes not.
18             About the hearing itself:  I'm what's called
19   -- I'll put this in quotes -- the presiding officer for
20   this hearing.  It's not a very formal hearing, as you
21   can probably tell already.  It's called a Part 15
22   hearing, after the part of the Code of Federal
0007
 1   Regulations in Title 21 in which the provisions
 2   governing the hearing appear.
 3             As I said, it's not formal.  There's no direct
 4   testimony.  There's no cross-examination.  There's no
 5   redirect.  There's no recross.  There's no objections to
 6   evidence.  Indeed, there are no rules of evidence that
 7   apply to these types of hearings.
 8             The one rule that is firm, though, is that the
 9   questions are asked only by the FDA panelists.  I will
10   introduce them later.  But we do not in these
11   proceedings entertain questions from anyone other than a
12   member of the panel.
13             Before we get started, let's turn to a few
14   housekeeping issues.  One, the agenda.  I think you all
15   have agendas in your packets, so I will not go into them
16   -- the agenda -- in any great detail.
17             Two, if you need assistance, FDA staff are
18   available to help you.  They have blue name tags.  If
19   you'll stand up you can see who they are.  Two.  Do I
20   hear three?  Juanita in the back.
21             For media and press support staff, we have
22   Michael Herndon and Sebastian Cianci.  I'll ask them to
0008
 1   stand up, please.
 2             Restrooms -- through the door; and women on
 3   left and men on the right.  And there are additional
 4   restrooms through the double doors.
 5             Lunch.  There is a cafeteria on the fifth
 6   floor.  Take the elevator up there.  On that floor
 7   there's also a conference room for the press --
 8   Conference Room G.  And apparently there's a smoking
 9   area, I gather -- an outdoor patio.  We will break for
10   lunch, by the way, from twelve to one-thirty.  I have
11   what seem to be complicated directions to the cafeteria.
12    Maybe people can remember them.  Take the elevator to
13   the fifth floor.  Bear to the right as you walk through
14   the rotunda area.  Cafeteria is on your left.  Important
15   point: cash and carry.  No credit cards.  No debit
16   cards.  And there are restaurants as you leave the
17   building directly across the street.  There should be a
18   list in your folder.
19             We'll start the substance this morning with
20   five speakers -- government speakers -- who will talk
21   about, first, fresh-produce-associated outbreaks.  Then
22   good agricultural practices, good manufacturing
0009
 1   practices, and FDA's produce-safety action plan.  We
 2   will then have a talk about findings from the
 3   investigation of the outbreak of E. coli O157:H7 in
 4   spinach.  Then have a presentation of the state
 5   perspective.  And, finally, for the first batch of
 6   speakers, the perspective of the association of food and
 7   drug officials.  We will then have questions from the
 8   panel -- as I mentioned, only the panel can ask
 9   questions -- followed by perspectives from industry and
10   consumers in sort of the science and research viewpoint.
11   We will finish the morning with more questions from the
12   FDA panel.
13             In the afternoon -- and we will take a break
14   from twelve to one-thirty -- in the afternoon, Amy Green
15   from CFSAN's Office of Food Safety will give an overview
16   of the issues and questions from the hearing notice.
17             And then we'll hear, we think, from eight to
18   ten members of the public.  The number is not sure yet.
19   We're not sure who will show up.  We'll have questions
20   for those speakers, again, from the panel.
21             With that, let me introduce the panel.  On my
22   immediate right is Mark Roh, who's acting regional food
0010
 1   and drug director for the office of regulatory affairs
 2   of FDA.
 3             To his right, David Acheson, director, office
 4   of food defense communications and emergency response
 5   from CFSAN.  Dr. Acheson is also CFSAN's chief medical
 6   officer.
 7             To David's right, Sherri McGarry, acting
 8   coordinator, emergency coordination and response team in
 9   CFSAN.
10             To Sherry's right Dr. Robert Buchanan, who's
11   the senior science advisor in CFSAN.
12             And to Bob's right is Shirley Bohm, consumer
13   safety officer in the office of food safety in CFSAN.
14             Now let's turn to our first speaker, Dr.
15   Michael Lynch, who's with the enteric diseases and
16   epidemiology branch in CDC.
17             DR. LYNCH:  Good morning.  Thanks for asking
18   me to speak here today.  I am going to talk about
19   produce-related foodborne infections and give a brief
20   review of data reported to the Center for Disease
21   Control -- foodborne outbreaks.
22             But to start with, just to review the public
0011
 1   health burden of foodborne disease, each year an
 2   estimated seventy-six million cases of foodborne disease
 3   occur in the United States.  And this translates into
 4   one in four Americans who gets a foodborne illness each
 5   year.  One in a thousand Americans is hospitalized each
 6   year.  And over six billion dollars in medical and other
 7   costs are incurred due to foodborne illness.
 8             And prevention efforts to prevent foodborne
 9   illness depend on efforts from farm to table to produce
10   the contamination of food and increasingly recognize the
11   problem in fresh produce.
12             And if any of you here may have been involved
13   in some respect with recent outbreaks associated with
14   produce, in September 2006 there were over 200 E. coli
15   O157:H7 infections in multiple states due to fresh-
16   bagged spinach.  And we're going to hear more about that
17   later in the program.
18             Then in November 2006 there were over a
19   hundred Salmonella-type Typhimurium infections
20   associated with tomatoes served in restaurants.
21             In December 2006 there were dozens of E. coli
22   O157:H7 infections that were due to shredded iceberg
0012
 1   lettuce served at fast-food restaurants.
 2             Foodborne illness involves infection with
 3   pathogens -- a variety of different pathogens; and each
 4   pathogen has a characteristic reservoir, or place where
 5   it resides most of the time.  Some of these have a human
 6   reservoir, such as Shigella; hepatitis A; or Norwalk
 7   virus, now called norovirus.  And some have an animal
 8   reservoir, such as Salmonella, Campylobacter, E. coli,
 9   and others.  And these pathogens can be transmitted by
10   several pathways.  We're going to talk a lot about how
11   they're transmitted by food today, but they can also be
12   transmitted by water, contact with animals, or contact
13   with infected humans.
14             So at CDC we conduct surveillance for
15   foodborne outbreaks; and most of the outbreaks that
16   occur in the United States are detected or investigated
17   or controlled by local and state health departments.  At
18   CDC we collect reports of outbreaks that are
19   investigated.  This report is voluntary and admittedly
20   incomplete.
21             Our definition of an outbreak is two or more
22   cases of a similar illness resulting from ingestion of a
0013
 1   common food.  We collect a lot of different information
 2   on these outbreaks, including the number of cases that
 3   occur; the implicated food, if that was determined; and
 4   etiology of the outbreak.
 5             We received reports of four to six hundred
 6   outbreaks per year before 1988.  And then in 1998 we
 7   made a few changes to our system that affected the
 8   number of outbreaks that we heard about.  This graph
 9   shows the number of outbreaks reported to CDC from 1990
10   to 2004.  And as I mentioned, 1998 was somewhat of a
11   watershed year.  That's when we implemented enhanced
12   surveillance; and we increased our communication with
13   the states and also initiated a formal closeout
14   procedures at the end of every year.  And this
15   dramatically increased the number of reports that we
16   received from state and local health departments; and
17   the number of reports we received more than doubled in
18   1998 and remained at that same elevated level since.
19             And the other change to the system is that in
20   2000-2001, we implemented a Web-based reporting system,
21   where before we had collected paper forms and entered
22   them into the system at CDC.  Now the state and local
0014
 1   health departments have the ability to report their
 2   findings through a Web-based interface.  And with that
 3   we actually changed the -- we refined the way that we
 4   collected some of the information and we're able to get
 5   more detailed information on several aspects of the
 6   outbreak investigation, including more information on
 7   the foods that might have been involved.
 8             So, as was mentioned, there was a recent
 9   review that was published recently in the Journal of
10   Food Protection of our data on foodborne outbreaks
11   related to fresh produce from '73 to 1997.  And here
12   fresh produce was defined as uncooked produce items or
13   salads that did not include eggs, cheese, seafood, or
14   meats.  In that time period, '73 to '97, there were one
15   hundred ninety foodborne outbreaks related to fresh
16   produce.  And these involved over sixteen thousand
17   illnesses, nearly six hundred hospitalizations, and
18   eight deaths.  And this represented three percent of all
19   outbreaks of a determined source, meaning that outbreaks
20   for which if the implicated food was determined -- that
21   happens about -- roughly about half the time.  And this
22   also represents six percent of those outbreaks
0015
 1   associated, or cases associated in those outbreaks.
 2             And there are a few interesting trends, as was
 3   mentioned in the introduction.  One is that, comparing
 4   the 1970s to the 1990s, the number of outbreaks per year
 5   increased from two to sixteen; and the median cases in
 6   these outbreaks, or the average number of cases in these
 7   outbreaks, related to fresh produce increased from
 8   twenty-one to forty-three.  And the percent of outbreaks
 9   of known vehicle that were determined to be due to
10   fresh-produce items increased from less than one percent
11   to six percent; and the percent of outbreaks --
12   associated cases in these outbreaks -- increased from
13   less than one percent to twelve percent.
14             So the foods that were implicated in these one
15   hundred ninety outbreaks could be broken down into two
16   main categories.  More than half of the foods actually
17   that were reported could be classified as generic, or
18   those that included multiple produce items, such as a
19   salad with no further description; or, if it was a fruit
20   salad, no description of the individual fruits that
21   might have been involved; or there were several
22   different fruits reported.  But in eighty-five outbreaks
0016
 1   there was one specific vehicle food vehicle that was
 2   reported; and the top individual foods are listed here
 3   --lettuce, melon, sprouts, juice, berries, tomatoes,
 4   onions.  And these seven items accounted for eighty-
 5   eight percent of outbreaks for which one specific food
 6   vehicle was reported.
 7             And etiologies were identified in over half of
 8   these one hundred ninety outbreaks.  Bacterial pathogens
 9   were the most common category of pathogens identified;
10   and Salmonella was the most common bacterial etiology,
11   although those also included -- etiologies also included
12   E. coli 157, Shigella, Campylobacter, and others.  And
13   these pathogens represent -- those that have an animal
14   reservoir represented forty-eight of the outbreaks
15   reported; and pathogens that had a human reservoir
16   represented thirty-four of the outbreaks.  In twenty-one
17   of the outbreaks the pathogen, or the agent involved,
18   has an uncertain reservoir.
19             I'm now going to talk about the more recent
20   data.  And I'm just showing this slide one more time to
21   remind you that in 1998 we did make some refinements to
22   the system in the way we collect the data from the
0017
 1   states and so that you'll see that the number of
 2   outbreaks reported is going to increase.  But I'm going
 3   to continue to talk about the proportion of outbreaks
 4   that were reported that were due to fresh produce.
 5             So for this time period, 1998 to 2004, produce
 6   was defined in a similar fashion -- those that were
 7   classified as either fruits or vegetables.  And during
 8   this time period we had three hundred eighty-four
 9   outbreaks linked to produce items; and in twenty-eight
10   of these outbreaks infections occurred in multiple
11   states.  And there's just one piece of evidence to
12   indicate, as was mentioned, that the produce was likely
13   -- in those outbreaks, at least -- is likely to be
14   contaminated before it gets to the restaurant or home. 
15   These outbreaks included fifteen thousand illnesses,
16   seven hundred hospitalizations, and fifteen deaths.  And
17   during this time period this represented outbreaks --
18   due to produce -- represented seven percent of all
19   outbreaks of a determined source and fourteen percent of
20   those outbreak-associated cases.  So this looks very
21   similar to what we saw in the 1990s.  And even though we
22   did make some refinements to the way we collected the
0018
 1   data, at least in this analysis it actually looks like
 2   we had similar findings during this time period.
 3             As I mentioned, we did gather more information
 4   on the foods that were reported by the state and local
 5   investigators; and this allowed us to categorize these
 6   foods in different ways.  And one of the ways that we
 7   can categorize produce items is by these broad produce
 8   categories, which include leafy greens, fruits, root
 9   vegetables, vine-grown items, sprouts, and fungi.
10             And the two points to make for this slide: One
11   is that the proportion of outbreaks of known vehicle due
12   to produce -- those vary somewhat from year to year,
13   although it does hover around the seven-percent average
14   for this time period.  And, also, within each year
15   there's a range of produce items that are responsible
16   for the outbreaks that are reported.
17             We did a similar analysis during this -- for
18   outbreaks reported during this time period of food
19   vehicles that were reported in these three hundred
20   eighty-four outbreaks.  Again, more than half were
21   generic or included mixed or multiple different produced
22   items.  But in one hundred sixty-eight outbreaks there
0019
 1   was one specific food identified as the cause of the
 2   outbreak.  Again, you'll see the same list of foods --
 3   produce items that were involved in these outbreaks.
 4             And in these outbreaks the etiology was
 5   reported in nearly half of these three hundred eighty-
 6   four outbreaks.  And, again, the bacterial pathogens
 7   account for the most outbreaks for which an etiology was
 8   determined.  And, again, Salmonella was the most common
 9   bacterial pathogen that is reported.  These pathogens,
10   again, include those with animal and with human
11   reservoirs.  The other, I think, interesting point to
12   make is that the number of outbreaks that were reported
13   due to norovirus infection increased dramatically.  This
14   is similar to what we saw in outbreaks -- in all
15   outbreaks -- reported during this time period; and we
16   think that is due to the increased availability of
17   norovirus diagnostic testing in state public health
18   laboratories.
19             So, in conclusion, the outbreaks due to
20   produce represented a greater proportion of the burden
21   of outbreaks than in the past.  And most recently they
22   represent fourteen percent of outbreak-associated cases;
0020
 1   and the outbreaks are larger.  And there's a larger
 2   number of outbreaks, if you look over the thirty-year
 3   time period.  And a variety of fruits and vegetables are
 4   involved; and the spectrum of pathogens that we see in
 5   these outbreaks reflects contamination with human and
 6   with animal feces.  And the contamination amplification
 7   of pathogens in produce items appears to occur from
 8   several points from farm to table; and, consequently,
 9   our control efforts will be focused, I think, on several
10   points along that continuum.
11             Thank you.
12             MR. LANDA:  Thank you, Michael.
13             Our next speaker will be Dr. Michelle Smith,
14   who is with the Office of Food Safety.  Dr. Smith will
15   speak about good agricultural practices, good
16   manufacturing practices, and the produce-safety action
17   plan opportunities and challenges.
18             DR. SMITH:  Good morning.  It's a pleasure to
19   be here.  I'm seeing faces in the audience that I didn't
20   see earlier before we started, so hello.  I hope we have
21   a chance to talk.
22             As Mike Landa said, I am going to talk about
0021
 1   the good agricultural practices, produce-safety action
 2   plan; opportunities and challenges.  There are copies of
 3   FDA's guidance on the table out there.  Because I've
 4   only got fifteen minutes, I'm going to call it the "GAPs
 5   guide" for short.  That should save about three to five
 6   minutes through the whole talk.
 7             And he also did a very good job covering the
 8   purpose of the hearing.  I'll just make a few more
 9   points as we go along and talk a little bit about where
10   we are now and close maybe with a few thoughts on where
11   we can go from here.
12             Now, the purpose of the hearing is for the
13   invited speakers to share information; but most
14   importantly it's for us to solicit comments, data, and
15   other information that can help us to decide what's the
16   appropriate direction to go from here.  So your interest
17   and participation is very much appreciated in this
18   effort.
19             Some of this may look familiar to people that
20   have seen FDA produce presentations before.  We like to
21   make the point that fresh produce is a concern for a
22   variety of reasons.  It's grown in a nonsterile
0022
 1   environment.  There are opportunities for contamination.
 2   And, finally, by definition it's likely to be consumed
 3   raw.  The point that I would like to make is that FDA
 4   does not expect fresh produce to be a sterile item.
 5   However, the presence of pathogens on fresh produce is
 6   not the natural state of fresh produce.  If it was,
 7   there would be an awful lot more sick people in this
 8   country.  There are practices that producers and
 9   everyone along the chain can adopt to minimize those
10   opportunities for contamination that exist.
11             Mike Lynch did a very good job talking about
12   the outbreak history.  I'm not going to spend a lot of
13   time on this, but I did want to make the point that the
14   significant increase in outbreaks associated with fresh
15   produce between 1973 and 1997 were the driving force
16   behind FDA's good agricultural practices guidance and a
17   number of other programs.
18             Between release of our guidance in 2006, there
19   have been a number of continued outbreaks associated
20   with twenty fresh-produce commodities.
21             There are couple of errors on this slide and
22   the next one.  That should read "seventy-two reported
0023
 1   outbreaks."  This should read "seventy-two reported
 2   outbreaks," and the numbers for the individual
 3   commodities should be different also.
 4             I had put this slide in here to make the point
 5   that people are often confused when they see the numbers
 6   because the numbers differ from agency to agency, group
 7   to group.  I have to admit whatever I pulled the numbers
 8   out of made a difference within agencies, also.  I'll
 9   make the corrections for the record.
10             What I did want to point out is that we are
11   concerned about all fresh produce and opportunities for
12   contamination.  At the same time, there are a number of
13   commodities that tend to show up a lot more frequently
14   than others.  For simplicity, I chose three commodities
15   that total more than half of the outbreaks.  I could
16   have chosen four or five or six, like Mike's list.
17             A few words about the good agricultural
18   practices guidance.  This guide is a broad-scope
19   document.  We were charged with outlining opportunities
20   for contamination and making recommendations to cover
21   the field and packing facility for all fresh produce
22   consumed in the U.S., whether it's produced domestically
0024
 1   or abroad.
 2             The guide is focused on risk reduction not
 3   elimination.  The guide is voluntary.  It's not a
 4   regulation.  And this is one of the issues that we're
 5   here to talk about today.  The advantage of the good
 6   agricultural practices guide, particularly back in 1998
 7   -- its first goal was to raise awareness about the
 8   potential sources of contamination and provide
 9   recommendations for practices that could minimize that
10   contamination at a time when this was a relatively new
11   way of thinking.
12             A few points that I would like to make about
13   what we have learned in our foodborne illness outbreak
14   investigations:  First of all, many times investigators
15   go to a farm, packing facility, or even fresh-cut
16   operation; and they see either conditions or practices
17   that cause concern.  These may include things like
18   insanitary conditions, lack of adequate handwashing
19   facilities.
20             I want to make the point that those potential
21   sources of contamination are preventable.  So even
22   though the second bullet talks about how investigators
0025
 1   are not always able to identify a specific route of
 2   contamination, for context, don't forget about the
 3   things that we know you can do and we know need to be
 4   done to produce a safe product.
 5             Having said that, investigations by their very
 6   nature occur after the contamination event.  Sometimes a
 7   significant amount of time passes between the
 8   contamination event and investigators' being able to
 9   identify the likely location and can go back and take a
10   look.  Under those conditions particularly, it may be
11   difficult to identify what has been referred to as the
12   cause of contamination, or the smoking gun.  We are
13   continuing to rely on our investigators, giving them the
14   best possible tools, working with researchers in other
15   areas of expertise to try and drill down and get better
16   answers to those remaining questions.
17             The Produce Safety Action Plan:  This was an
18   action plan that FDA put together in 2004 with input at
19   a public meeting similar to this and written comments.
20   What we did with the action plan is we took a look at
21   where are we now, what have we learned, what do we need
22   to do to go from here.  The action plan built on
0026
 1   existing programs and expertise.  It expanded to cover
 2   fresh fruits and vegetables from farm to table.  The
 3   overarching goal of the action plan is to minimize
 4   foodborne illness associated with the consumption of
 5   fresh produce.  And it has four general objectives.
 6             Now, FDA realized that an action plan is just
 7   that.  It's a plan.  It's a start.  To be truly
 8   effective requires implementation.  One of the things
 9   that we built into the action plan was measurable goals
10   and outcomes for each of the individual objectives.  For
11   example, for Objective 1, "Measurable Goals and
12   Outcomes," it would be the issuance of guidance,
13   regulations, or other tools to help people prevent
14   contamination from happening in the first place.
15             To achieve Objective 2, "Minimizing Public
16   Health Impacts when Contamination Occurs," we identified
17   measures such as the speed and accuracy of
18   investigations and the information gained.
19             We have accomplished many things under the
20   Produce Safety Action Plan.  I've pulled out just a few
21   examples.
22             On March 12th, 2007, FDA released the draft
0027
 1   final guidance for fresh-cut produce.  This guidance is
 2   designed to complement use of the CGMPs in Part 110 at
 3   fresh-cut processing facilities.
 4             In August 2006 FDA launched, in collaboration
 5   with California Department of Health Services and
 6   California Department of Food and Agriculture, the
 7   leafy-greens safety initiative.  This proactive
 8   initiative was designed to give investigators an
 9   opportunity to be on the ground and observe conditions
10   and practices in advance of an outbreak occurring.  That
11   gets us a lot closer to actual production conditions
12   rather than going in after the fact and trying to figure
13   out what happened.
14             There was another important component of this
15   initiative and that was to establish a plan for rapid
16   communication with consumers and others in the event
17   that an outbreak did occur, which, in fact, is what
18   happened.
19             One of our other accomplishments -- in 2006,
20   also -- was to finalize guidance for farm investigations
21   and to conduct training for FDA investigators, state
22   investigators, and support counterparts.  These actions
0028
 1   were designed to provide the best possible tools to the
 2   investigators that are going out and looking for
 3   answers, to give them the tools to ask the right
 4   questions, and get as close to the answer as possible.
 5             Some of the opportunities that we have had in
 6   implementing the action plan:  Increased communication
 7   with research, academia, federal, state, and industry
 8   partners.  An example of this is the industry-led
 9   commodities-specific supply-chain guidance that has come
10   out fairly recently.  Public and private partners are
11   also joining together to form coalitions to address
12   specific research issues associated with the commodities
13   and regions that show up most often in produce-
14   associated outbreaks.
15             One of the things that is both a challenge and
16   an opportunity is our 1998 GAPs guidance.  As I had
17   mentioned, this is broad-scope.  It needed to apply to
18   everyone involved in producing and packing fresh produce
19   consumed in the U.S.  I think it did a very good job of
20   that, but we understand that one size does not fit all.
21   We said in the guidance that it would be most effective
22   if the individual operations took those recommendations
0029
 1   and tailored them to their specific needs.  But that
 2   could be a challenge to take broad recommendations and
 3   come up with the appropriate fit for an individual
 4   operation.  We understand the risk of microbial
 5   contamination results from the interaction of several
 6   factors, including characteristics of the commodity, the
 7   production environment, and the practices used.
 8             Now, the industry-led commodity-specific
 9   supply-chain guidance is an effort to do a number of
10   things, including provide more specific recommendations.
11   Guidance is available now for melon, lettuce, and leafy-
12   greens and tomatoes at the links shown here.  It was
13   also an opportunity to incorporate information based on
14   advances in science since the 1998 guidance was
15   released.
16             What we didn't anticipate when these guidance
17   documents were finalized was what the last six months
18   would be like and the additional experiences that we
19   would have to add to this.  The lettuce and leafy greens
20   has a section that is being added to the production part
21   of that guidance; and the tomatoes guidance document is
22   also in the process of being reopened to try to make
0030
 1   certain sections more robust based on what continues to
 2   be a fairly steep learning curve.
 3             Among the challenges, I think the biggest
 4   challenge we face is the fresh-produce outbreaks
 5   continue.  Some of the things that contribute to this
 6   challenge are issues like globalization, the complexity
 7   of distribution for fresh produce, and the variety of
 8   products available.  There's a growing high-risk
 9   population in the United States.  There are certainly
10   practical limitations to investigations and the
11   information gained.
12             Traceback is an area of significant concern.
13   We can do better with traceback.  This is also an area
14   where there are great opportunities for collaboration to
15   improve the record and improve the systems to facilitate
16   actually getting back to the source of the problem; and
17   finally -- and very significantly -- the challenge of
18   identifying and promoting risk-based preventive
19   controls.
20             Now, I think our starting point is that the
21   measures outlined in the Produce-Safety Action Plan, the
22   good agricultural practices guide, and other public and
0031
 1   private guidelines have or can be effective when
 2   properly implemented.  However, the continuing outbreaks
 3   that we have seen associated with fresh produce lead us
 4   to ask several questions:
 5             What is the extent of implementation of the
 6   existing recommendations?
 7             What is the effectiveness of these
 8   recommendations when they're implemented properly?
 9             And what additional or different interventions
10   might be appropriate to reduce future outbreaks?
11             Which path should we take when we're looking
12   for input at this public hearing and at the hearing in
13   College Park and written comments?  Guidance?
14   Regulations?  Or should it be different or additional
15   mechanisms?
16             The Federal Register notice for this public
17   hearing contained half a dozen examples of the approach
18   that FDA has taken with foods other than fresh produce.
19   I've pulled out juice -- the regulations are in 21 CFR,
20   Part 120 -- not because I think HACCP is appropriate for
21   the farm and not because I think FDA should mandate a
22   five-log pathogen reduction for fresh produce.  I don't
0032
 1   think we have those options at this point in time.
 2   However, this regulation has significantly contributed
 3   to a reduction in outbreaks associated with juice
 4   products.  And for that reason I think this is a good
 5   place to look for things that may be useful for fresh
 6   produce.
 7             There are a number of aspects.  Some of the
 8   ones that I've pulled out include training and other
 9   requirements for specific functions to make sure that
10   the person doing that function is actually qualified to
11   do the function appropriately.  There are options for
12   importers to verify that the product they're importing
13   into the U.S. is consistent with the requirements in
14   this regulation.  There are also requirements in the
15   regulations that can help both the firm and
16   investigators verify that the regulation is being
17   followed consistently over time.  This regulation, in
18   addition, is augmented with a hazards-and-controls guide
19   and recognized training curriculum, both of which can
20   help assist its implementation.
21             FDA's mission is ensuring the safety of all
22   domestic and imported fresh and fresh-cut fruits and
0033
 1   vegetables consumed in the U.S.  Continuing themes
 2   throughout these efforts -- and Mike started off the
 3   hearing today with these themes -- are increasing
 4   American's consumption of fruits and vegetables to
 5   achieve a healthier diet and improving the safety of
 6   fresh fruits and vegetables.  We can't do one without
 7   the other.
 8             And I thank you.
 9             MR. LANDA:  Our next speaker is Barbara
10   Cassens, who is director of the FDA's San Francisco
11   district office, where she oversees an office of about
12   one hundred forty-five professionals.  That district
13   office, by the way, covers Northern California, Nevada,
14   Hawaii, and the Pacific Islands.
15             MS. CASSENS:  Thank you and good morning,
16   everyone.  I think the beginning of any successful
17   presentation is making it up the stairs without tripping
18   as you get to the podium here.
19             And Michelle did an amazing job of summarizing
20   a huge amount of information.  It's just incredible.
21             I'm going to take some time this morning to go
22   through a few things.  I'm not going to go through the
0034
 1   history.  I'm really going to talk about the spinach
 2   outbreak of 2006; a synopsis of that; and slides
 3   provided by our sister agency, CDC, which I greatly
 4   appreciate; talk about some of our initial findings; and
 5   then end with some conclusions.
 6             As you heard the history, we had a number of
 7   outbreaks associated with leafy greens; and twelve of
 8   those -- at least -- have been traced to a California
 9   source.  Many of them are related to the Salinas Valley,
10   which is our concern.
11             What happened with the spinach outbreak of
12   2006 is basically CDC called FDA to alert us of matching
13   E. coli O157:H7 and PFGEs in two states.  These are
14   clinical isolates.  The State of Wisconsin called the
15   FDA to alert them of an outbreak in Wisconsin; and the
16   FDA alerted the California Department of Health
17   Services.  The next day what was being reported by CDC
18   were thirteen states and forty-five cases of illnesses,
19   eight of them with hemolytic urine syndrome (HUS) and
20   with one death.  A high percentage of these people had
21   reported exposure to fresh bagged spinach.
22             There were a number of brands associated.  But
0035
 1   multiple brands identified by individuals were Dole Baby
 2   Spinach.  At that point FDA did advise consumers not to
 3   eat the bagged fresh spinach; and we did initiate a call
 4   to Natural Selections, who was the packer and the
 5   processor of the Dole Baby Spinach.  At that point we
 6   dispatched a couple of our CalFERT investigators --
 7   which I'll talk about in a minute -- to Natural
 8   Selections to begin our investigation.
 9             Now, CalFERT is something which we started in
10   2003 and was actually a brainchild for sometime.  It is
11   taking investigators from our Los Angeles and San
12   Francisco FDA districts and California Department of
13   Health Services, Food and Drug branch, and then training
14   them together to respond to outbreak investigations.
15             Why we did this was because basically we heard
16   from the industry that in the past the only way of doing
17   business was to conduct parallel investigations, write
18   parallel reports; and we know that was a burden on many;
19   and many times had conflicting information.  So we've
20   done this.  We're very happy with it and we think this
21   is a good way to approach future outbreaks.
22             So our CalFERT staff was deployed.  They were
0036
 1   already in the process of doing some assessments under
 2   the leafy-green initiatives, so we were lucky to have
 3   them in the area and we could just direct them from one
 4   activity to the next.  The following day, of course,
 5   twenty states now reported -- ninety-five cases, where
 6   forty-four were hospitalized and fourteen with HUS and
 7   one death, still.  These ill individuals reported
 8   exposure to fresh spinach -- bag and clamshells --
 9   containing spinach; and FDA did advise citizens not to
10   eat packaged fresh spinach.
11             A concern we were starting to have here were
12   packaged spinach was actually used in restaurants, is
13   open, and a consumer may not know if it was packaged
14   spinach.
15             At that point, Natural Selections announced a
16   voluntary recall of all spinach-containing products,
17   after much discussion with my office and with Health
18   Services.  And we also had calls with the other firms
19   that was -- brands that were coming up during this
20   investigation -- to talk about what could be possible
21   relationships with these products.
22             September 16th, we were looking at nineteen
0037
 1   states; and we were up to one hundred and two cases.
 2   This was climbing rapidly; and we didn't know when the
 3   stop was going to be.  Again, ill individuals were
 4   reporting fresh spinach consumption related to the
 5   products.  We were interested in how big this universe
 6   would be.  We continued to advise the public not to eat
 7   spinach.  We did tell them, however, that eating canned
 8   spinach, frozen spinach -- that would be acceptable.
 9             Again, September 21st -- you can see days are
10   increasing -- we have twenty-three states now, with one
11   hundred fifty-seven cases -- eighty-three hospitalized
12   and twenty-seven HUS.  At this point we are doing
13   traceback at the producer, trying to determine where the
14   spinach may have come from; and we are starting to
15   narrow this down to three counties within California.
16             We identified a number of branches that could
17   be associated with this, but there was a positive
18   spinach sample.  This is a product that was recovered in
19   New Mexico and analyzed; and it was Dole Baby Spinach of
20   Lot Code P-227, which many of you have probably heard
21   about in the press; and that was best used by August
22   30th date.  This helped us narrow in on the product
0038
 1   because it did test positive for the 0157:H7 where the
 2   two enzymes matched.  So it matched the clinical
 3   isolate; therefore, our investigators focused in on this
 4   particular code, working with Natural Selections.  And I
 5   must commend the firm for being extremely cooperative
 6   for providing documents rapidly so we could get to the
 7   point of where we need to be.
 8             So at this point we were able to -- October
 9   12th -- to really narrow in to four ranches in two
10   counties.  And that was down from just several days
11   before of nine in three counties, supplying this Lot
12   Code 227.
13             We'll talk more about environmental samples
14   that we took and the different product samples.  Just to
15   give you an idea, these were the states that were
16   affected -- one in four cases all the way up to fifteen
17   and more.  A very large percentage of people were
18   hospitalized -- out of two hundred and four cases about
19   fifty-one percent -- and numerous with HUS.
20   Predominantly females that were impacted by this.  And
21   this is compliments of CDC, just talking about the
22   spread of the symptom onset date and the cases and where
0039
 1   they peaked.
 2             I believe our -- right now, our belief is that
 3   the actual outbreak started on August 20th, with the
 4   PFGE involved a matching case on that date.  And the
 5   ones prior to August 20th are felt to be public
 6   background information.
 7             So just to get -- those who were interviewed,
 8   those exposed to any spinach versus bagged fresh spinach
 9   -- those are the percentages that we were able to
10   recover with that.
11             Leftover product testing.  Yes, there was
12   some.  These were open bags and thirteen out of
13   seventeen with a lot code of 227 were tested positive,
14   again with a two-enzyme match.
15             So where did this take us?  We collected eight
16   hundred fifty environmental samples during this
17   outbreak, which is pretty huge for us, but what we've
18   learned from past outbreaks is twenty samples won't need
19   it.  We need to get a large volume.  We are talking
20   about ranches here -- a lot of area; and you're looking
21   at observations and trying to take the best samples you
22   can based on what you're seeing at that time.  I think
0040
 1   the fact that we were able to get out there rapidly
 2   during the outbreak helped us quite tremendously.  These
 3   samples were water, soil sediment, cows, wild pig feces,
 4   any residual lettuce or spinach waste in the field, and
 5   any other environmental samples from the processor
 6   themselves.
 7             What we did learn on those four ranches is
 8   that E. coli O157:H7 was found on all four ranches and
 9   there were cattle feces near the ranch in three of the
10   four.  Now, not terribly surprising, we know that the
11   organism was in the environment.  One particular ranch,
12   however, there were twenty-one isolates that matched the
13   outbreak strain.  This is a PFGE match of two enzymes to
14   the clinical isolates.  Those samples were two stream
15   water sediments; dust and dirt from a pasture; seven
16   wild pig feces; and indented, although it doesn't need
17   to be, are eleven cow feces.
18             What I can tell you about this ranch is that
19   basically it was a beef-cattle operation, at least a
20   small amount of land for crop production.  We had cattle
21   feces, feral pig feces, and stream water tested positive
22   for the outbreak strain.  And the stream runs through
0041
 1   the property and includes riparian areas that are great
 2   wildlife habitat.  And there was a large population of
 3   feral pigs in and around the ranch.  Our investigators
 4   did observe that.  The well water used for irrigation --
 5   the well was in the center of the field in a slightly
 6   depressed area.  And having our CDC water expert looking
 7   at the situation, there is a possibility that stream
 8   water may be populated in the underground water source
 9   that may potentially be getting into the well.  These
10   are all possibilities.
11             Although the investigation does no longer
12   continue -- we are completed at this point and we are
13   finishing up our report.
14             Findings:  Basically, to summarize, preharvest
15   phases of production are the most likely opportunity for
16   introduction of contamination.  But post-harvest the
17   cooling and processing and shipping really stand the
18   possibility to spread this contamination over thousands
19   of bags, particularly in the fresh-cut arena.
20             We focus heavily on environmental and farm
21   investigations, with distributors and processors to the
22   specific lot codes that have been identified.  We know
0042
 1   that traceability would help us tremendously; and that's
 2   an area of focus.
 3             New sampling.  Higher through-put of samples
 4   would greatly speed the investigation process.
 5             And testing to determine to see if manure is
 6   applied to the field; what kind; how is that treated.
 7             These are all areas that we believe need to be
 8   looked at.
 9             Again, there are possibilities that I will
10   cover later in the conclusion.  I don't think there's
11   one smoking gun, there's one answer to this outbreak.
12             From this outbreak of 2006, it is estimated
13   that approximately four thousand cases of infection were
14   associated with this one bag lot; and that's based on
15   CDC's belief that for every twenty that are reported
16   another two hundred go unreported.  The quick actions
17   that we were able to take, I think, probably averted
18   additional cases in this particular outbreak.  We did
19   expend a larger number of resources to the investigation
20   and the communications regarding the outbreak and during
21   the process of the investigation.
22             CalFERT does have a report.  I will tell you
0043
 1   it's coming soon.  It's been going through a number of
 2   reviews with management at all different levels; and
 3   you'll be seeing it soon.  We believe this is the
 4   twenty-second outbreak of the O157:H7 to leafy greens.
 5   We'll have to coordinate with Michelle to make sure we
 6   have the exact numbers.
 7             I want to acknowledge my colleagues here and
 8   everyone who worked on this and just go over a few
 9   concluding remarks for you.
10             The presence of in E. coli O157:H7 is in the
11   agricultural environment.  That's just the knowledge
12   that we are aware of.  In fact, how do we prevent these
13   pathogens from getting into products?  I think we are
14   looking at the eight-hundred-plus environmental samples,
15   the cattle feces, wild pig feces, the soil associated
16   with the cattle area, and the surface water in the
17   vicinity of one ranch that matched the outbreak strain
18   is really significant.  These observations are a place
19   to start -- these are places to start and things and
20   practices can be changed at the farm level.
21             You know, we believe that this outbreak with
22   leafy greens is very complex; and I want to stress that
0044
 1   the fixing of one thing identified won't be appropriate
 2   assurances that future outbreaks will not occur.  A
 3   comprehensive science-based plan is needed.  And
 4   voluntary programs may be very good and they may help.
 5             I think the question has to be asked if the
 6   entire industry does not participate, what does that
 7   mean?  Because we all know the outbreak itself can
 8   impact the entire industry and not just the spinach
 9   outbreak.
10             I believe this is an industry-wide issue. It's
11   one that needs a comprehensive -- needs an integrated
12   research plan to address as many elements that we don't
13   quite understand, because minimizing contamination in
14   the field of the product is essential, but there are
15   complicated relationships, I think, between the animals
16   -- the cows, the wild pigs, the water, and how they all
17   relate into infecting the product.  Is it direct onto
18   the lettuce or perhaps indirect through the water
19   source?  We can't answer that.  We can just tell you
20   what matched the particular outbreak strain.
21             I think continued prior testing is one means
22   of verifying that current good agricultural practices
0045
 1   are working; however, I'm not sure that testing alone is
 2   right to assure a totally safe product and is something
 3   to consider.  I think as we learn the specific analytic
 4   methodology it is important.  We need to take advantage
 5   of new changes in that methodology to make sure that we
 6   are detecting the pathogen that is there.
 7             There are other food-safety programs. Michelle
 8   mentioned the juice HACCP.  There's ready-to-eat deli
 9   meats.  There are other programs to look to that leafy
10   greens could use as a model.  One of the challenges, of
11   course, is the product is meant to be eaten raw.  You
12   destroy the sensory attributes by cooking, so it's not
13   the same product.
14             And my final comment to you, very sincerely,
15   that FDA and California Department of Health Services,
16   Food and Drug branch, are committed to assuring the
17   safety of fruits and vegetables; and it's our goal to
18   continue to work with industry, as we have, but we can't
19   stand by when the foodborne illness outbreaks associated
20   with leafy greens occur each year.  And the consuming
21   public has been demanding action from us, so it's time
22   for a change.  It's time for a change in policy --
0046
 1   perhaps regulation or an industry practice or a
 2   combination of all three of those.
 3             I thank you for the time today.
 4             MR. LANDA:  Thank you, Barbara.
 5             Our next speaker is Dr. Jeff Farrar.  Jeff is
 6   the branch chief of the food and drug branch with the
 7   Department of Health Services (DHS) since joining that
 8   organization in 1994.  He's led numerous environmental
 9   investigations of foodborne illness in California,
10   including Salmonella associated with eggs, sprouts and
11   cantaloupe; E. coli O157:H7 illnesses from unpasteurized
12   apple juice and sprouts; and cyclosporiasis from
13   berries.
14             DR. FARRAR:  Thank you, Bob.  I appreciate the
15   opportunity to present here today.
16             During this discussion today, there are likely
17   to be numerous issues that we may have different
18   opinions on.  There are many facts that are still
19   unclear regarding contamination of produce.  However, I
20   do believe there is broad consensus that twenty-two
21   leafy-greens outbreaks in twelve years is too many.  And
22   that broad, industry-wide changes need to be made
0047
 1   immediately.
 2             The questions then turn to the more specific
 3   issues, such as what are the specific causes of leafy-
 4   green contamination?  And, unfortunately, as you've
 5   heard from several of the speakers before, despite very
 6   aggressive investigation by state and federal agencies,
 7   the specific cause remains unclear how the patch came
 8   into contact with the leafy-greens product.
 9             We do, however, find in our outbreak
10   investigations that the most likely opportunities for
11   introduction of the pathogen are at the preharvest and
12   harvest levels, basically, in the field.  And as Barbara
13   and others have mentioned, the four predominant risk
14   factors that we do identify in these very extensive
15   investigations come back to water, manure, workers, and
16   wildlife.
17             If we assume that the most likely opportunity
18   for contamination is at the farm level, then the
19   questions turn to what are the current structures that
20   exist at the farm level.  There are no current
21   requirements for food-safety inspection of growers in
22   California nor in many other states.  However, food
0048
 1   processors are extensively regulated in California and
 2   are extensively inspected by state and federal agencies.
 3   The voluntary GAPs, as Dr. Smith mentioned earlier in
 4   her presentation, were developed some years ago for very
 5   specific purposes -- to increase awareness, provide a
 6   broad, overarching set of recommendations and guidelines
 7   for ensuring the safety of these products.  These GAPs
 8   have been very helpful and have had an impact.  However,
 9   at the same time the GAPs are recognized as being
10   extremely broad and lacking specificity to deal with the
11   unique issues that many of commodities have to deal
12   with.
13             If we accept that we do not know the specific
14   causes of these outbreaks at this time, the questions
15   then turn to what changes can be made now -- this month,
16   this year -- to reduce the risk of illness.
17             The recent industry-proposed marketing
18   agreement and marketing order under the statutory
19   authorities of California Department of Food and
20   Agriculture is the fastest way to make changes this
21   year.  As part of this effort, industry is finalizing a
22   list of specific, measurable good agricultural
0049
 1   practices, which you'll likely hear more about today,
 2   currently referred to as the "GAPs metrics," if you
 3   will.  These metrics precision fill in some of the
 4   needed specificity in the FDA good agricultural
 5   practices, specifically for leafy greens to focus on
 6   quantifiable verifiable parameters, such as the
 7   frequency of testing irrigation water and the specific
 8   limits for bacteria in that water, among other things.
 9   Farm Health Services and FDA have provided technical
10   input and review into a couple of those versions of the
11   GAP metrics.
12             If the marketing agreement and marketing order
13   as proposed by the industry includes a requirement for
14   the specific GAP metric, as we have reviewed in the
15   latest draft along with each of the following parameters
16   then we do believe that the risk of future leafy-green-
17   associated illnesses and outbreaks will be reduced. 
18   Those parameters include immediate extensive and ongoing
19   grower education outreach and training, incorporation of
20   the GAP metrics on all leafy-green farms one hundred
21   percent of the time, inspection and verification of
22   compliance with the GAP metrics on all leafy-green
0050
 1   farms, and immediate enforcement steps taken when a farm
 2   is determined not to be in compliance.  If all of those
 3   parameters are met, we believe that the risk will be
 4   reduced substantially.
 5             Having said that, it is important to remind
 6   ourselves that there is no such thing as zero risk,
 7   especially with a ready-to-eat commodity lacking a kill
 8   step.  The goal is sustained risk reduction.  We will
 9   not achieve zero risk in the near future for this
10   commodity.  Clearly, if the marketing-agreement/market-
11   order approach is not successful in the long term, then
12   other options will have to be evaluated.  But we do
13   believe that this represents an immediate opportunity to
14   decrease the risk.
15             Extensive, numerous data gaps, scientific
16   understanding -- lack of understanding -- exists.  These
17   data gaps have been identified by working groups of
18   industry, academia, state and federal regulators; and
19   they have been prioritized.  Now the challenge turns to
20   finding sufficient short- and long-term funding to begin
21   to answer some of the unanswered questions.  The
22   governor's budget has $500,000 in research funding in
0051
 1   the budget this year, along with additional resources
 2   for outbreak investigations.  We appreciate that 500,000
 3   is not enough funding; however, we hope that those
 4   funding gaps can be addressed at the federal level and
 5   within the industry as well.
 6             Although California is clearly the largest
 7   leafy-green producer, other states do produce leafy
 8   greens.  Therefore, we understand it is important to
 9   ensure that we make every effort to avoid a patchwork of
10   conflicting efforts in different states for reducing the
11   risk of illness from leafy greens.  The hearing today
12   hopefully will provide FDA and state regulators with
13   more information to access what additional actions may
14   be needed.  Efforts are under way within the Association
15   of Food and Drug Officials.  Dr. Marion Aller from that
16   association is here and will tell you more about efforts
17   in the Association of Food and Drug Officials to provide
18   some assistance and possible recommendations to FDA in
19   this area.
20             With that, I'll include.  Thank you, Michael.
21             MR. LANDA:  Thanks, Jeff.
22             We're a little ahead of schedule.  Why don't
0052
 1   we reconvene at twenty after ten.
 2             (Break from 10:02 a.m. to 10:20 a.m.)
 3             MR. LANDA:  Our next speaker is Dr. Marion
 4   Aller, who will give us a perspective of food and drug
 5   officials.
 6             DR. ALLER:  Thank you.  I'm Dr. Marian Aller;
 7   and I am here representing the Association for Food and
 8   Drug Officials.  For those of you who are not familiar
 9   with our organization, we were established in 1896.  We
10   are a bunch of gray-hairs.  And our mission is to foster
11   uniformity in the adoption and enforcement of food-and-
12   drug-safety laws, rules, and regulations.
13             A little bit of background as to why AFDO is
14   perhaps here:  We were approached by the tomato industry
15   during a tomato industry safety forum that was held in
16   Florida in late November of last year.  During that
17   forum, as the issues of foodborne illness outbreaks
18   associated with tomatoes, those issues were discussed.
19             Industry raised a number of concerns that have
20   been touched upon already here today.  And that is what
21   do we do?  Where do we go?  And their very real concern
22   for the potential, as Jeff alluded to earlier, of the
0053
 1   patchwork of regulatory responses that state and local
 2   officials may adopt in response to these outbreaks,
 3   particularly in the absence of any federal regulation or
 4   additional or different federal guidelines.
 5             They approached AFDO and asked if AFDO would
 6   look at the potential to develop a model code for
 7   consideration, or guidelines.  I'll talk a little bit
 8   about that in just a moment.
 9             I think we -- I'm not going to reiterate.
10   We've touched on already the general recognition that
11   the size and scope of foodborne illness outbreaks
12   associated with fresh produce is unacceptable.  There
13   are existing guidances; and, as has been alluded to,
14   many of these are very broad and lack specific criteria
15   or metrics for growers and producers.  And I'm speaking
16   across the broad spectrum of fresh produce.  And along
17   with that absence, with some exceptions -- obviously,
18   the work that's been done here in California with the
19   leafy greens -- the absence of those metrics are always
20   an absence of response.  What do you do if you meet an
21   excedence?  If you're trying to meet certain criteria
22   and a grower fails to meet them, what's the impact of
0054
 1   that?  What does the grower do?  And what are the
 2   appropriate responses?
 3             I think there is also a general recognition as
 4   others have alluded to already of the need for
 5   additional research.  And while I think a lot of that
 6   work has been identified and prioritized, funding will
 7   remain an issue.  I think we all have to recognize that
 8   we cannot stand still.  We must move forward, even in
 9   the absence where science is not yet to the point where
10   we have all of the answers.  It's important and, I
11   think, imperative that in those instances we use best
12   professional judgment.  And we do that carefully and
13   judiciously and with the knowledge that the answers are
14   not there and that the guidance is developed at one
15   point in time today may not be appropriate as science --
16   as we learn more and our science progresses.
17             So it's with those sort of broad background
18   points in mind that AFDO appointed me to chair an ad hoc
19   committee, or working group, as was asked by the tomato
20   industry.  But they have charged me to look -- and this
21   working group -- to look a little more broadly, not just
22   at tomatoes, but at the issue of fresh-produce safety in
0055
 1   a broader spectrum.
 2             Why AFDO?  And let me spend a few minutes and
 3   iterate or identify what I think are some strong points
 4   for us and may serve, at least as a starting point, to
 5   answer some of the questions of where do we go from
 6   here, regulation, guidelines, what AFDO might be able to
 7   offer to bring to the table.
 8             First and foremost, as I've alluded to, we
 9   foster strong partnerships with our federal, industry,
10   and local counterparts.  This is the foundation of this
11   association and we do have some prior experience with
12   the development of model codes.
13             A couple of those that I alluded to -- there
14   are others -- are the GNPs that have been developed for
15   cured, salted, and smoked fish establishments; model
16   consumers salvage code; control of Listeria
17   monocytogenes; and retail food establishment custom
18   slaughter guidelines.  These are all products that have
19   been developed in very close cooperation and
20   collaboration both, again, with our federal partners,
21   with industry, with consumer interests, and with
22   academia.
0056
 1             AFDO is, in developing these model guidelines,
 2   we offer something that I think is a quicker process
 3   than perhaps federal rule-making, if that were the
 4   choice to be taken.  And I just say, to state a fact,
 5   states can go a little more quickly, but we're not
 6   always the quickest either.  So it's with full
 7   appreciation of the constructions that our federal
 8   partners have to operate within.
 9             Similarly, guidelines and codes that AFDO
10   adopts are more readily modified for the same similar
11   reasons.  I also believe that this is a more open
12   process.  And I want to be careful in how I use that.
13   I'm not suggesting that this process is not an open
14   process.  It certainly is.  What I'm pointing to, if our
15   federal partners -- if FDA -- were to go into rule-
16   making mode, there is a point at which they are no
17   longer able to discuss where they are in their current
18   thinking when that public comment period has closed. And
19   that's just a constriction under which they are bound.
20             AFDO does not have those kinds of
21   constrictions and so the development of the codes that
22   we have worked on previously and anything that we
0057
 1   undertake in the future is that iterative, open
 2   collaborative process.  Because of that ongoing
 3   iterative process, we believe that this retains and
 4   encourages continued discussion and participation by all
 5   the stakeholders and especially for what I consider to
 6   be the ground-truthing of products as they are being
 7   developed; and that is simply that the participants,
 8   because it is an open process, can take that back to
 9   their constituents and do some ground-truthing:  Is this
10   going to work?  Is this something that is viable?  Is
11   this an opportunity?  Is this a problem?  And, more
12   importantly, if it is a barrier, if it is a problem,
13   what are the avenues to work within or around that?
14             It's through this process I believe, too, that
15   the product -- work product -- that comes out at the
16   other end is generally viewed, again, as a very
17   collaborative effort and tends to have a fairly wide
18   acceptance -- certainly within state and local
19   regulatory bodies -- and I believe lends itself to more
20   rapid adoption, embracing -- and more importantly -- a
21   more uniform implementation.  And I think that that's
22   probably of very considerable importance, as we look at
0058
 1   this very broad and very serious issue, that we do need
 2   consistency across our regulatory bodies -- across
 3   states and local authorities -- and consistent with the
 4   direction and needs that our federal partners identify.
 5             Having said that, so we are charged to put
 6   together a work group and where do we go and who are you
 7   and what are you going to do with it?  And, being very
 8   naive, I thought at first that a work group would be
 9   ideal if it was very small and agile and mobile and able
10   to adapt.  Then I realized, Well, this is a little bit
11   bigger and a little more complex than a small group
12   might be able to undertake.  So my wings were clipped in
13   a heartbeat there.
14             Currently, our membership includes several --
15   five -- states:  California, Florida, Virginia, Ohio,
16   and North Carolina.  We have representatives from both
17   FDA, USDA; and I thank both federal agencies for
18   agreeing to participate.  AFVISA -- which for those of
19   you who are not familiar with -- is the Association of
20   Fruit and Vegetable Inspection Standardization Agencies.
21   For industry representation we have the Western Growers
22   Association, United Fresh Produce, Food Products
0059
 1   Association; and I have also made contact with the
 2   National Restaurant Association.  We're playing
 3   telephone tag at the moment.
 4             We have identified tomato growers, since this
 5   industry is the initiator of this effort, who had the
 6   operation on both the East and West Coast.  Again, we
 7   believe that it's an important aspect to ground-truth;
 8   and we have a representative from academia.
 9             I am not here to suggest that this is the end-
10   all and be-all.  I anticipate that this membership will
11   probably grow and we will bring people and experts in
12   for specific issues.  As I said, the plan is to sort of
13   pick up where all other -- where the rest of the current
14   guidances and documents out there leave off.
15             We have been asked, again, to look at this
16   from a very broad perspective.  I can't claim to know
17   that we'll be absolutely successful, but we do feel we
18   owe it to ourselves and to industry to make this effort,
19   to extract those -- from the documents in existence --
20   those practices and guidances and criteria that do cross
21   commodity lines; to identify those; and then recognize
22   that there are commodity-specific issues that must be
0060
 1   addressed; metrics to be dealt with; and, as I have
 2   mentioned before, responses that will vary according to
 3   the crop, the production methods, the geographical
 4   locations, and other factors already alluded to.
 5             Is this the end-all and be-all?  I don't have
 6   any crystal ball.  I do envision that this could go grow
 7   into something quite different.  AFDO is open to that.
 8   We are open to suggestions.  We don't believe we hold
 9   all the answers.  We believe we are a good place to
10   start and offer that as an option to FDA, USDA, and CDC,
11   and kind of bring forth, again, this collaborative
12   effort.  We do fully support FDA leadership in guiding
13   research efforts and encourage both FDA and USDA -- to
14   use a word that we are all learning to grow and love and
15   it has a lot to do with decreased funding -- and that's
16   leveraging our sources to get the biggest bang for the
17   proverbial research buck that we can to stress the need
18   to emphasize -- direct those dollars to the areas of
19   greatest risk.
20             We, again, appreciate FDA's expertise and
21   participation in our effort.  We also will pledge to
22   work very closely with FDA as they move forward in this
0061
 1   process and offer any assistance that we're able in any
 2   -- as I said -- any outgrowth of these efforts that can
 3   work together rather than at cross purposes.
 4             And, with that, I will close and close my
 5   remarks.  Again, thank you for the opportunity to be
 6   here.  And if I can answer questions, I would be very
 7   happy to do so.
 8             MR. LANDA:  Thank you, Dr. Aller.
 9             We're now going to have questions from the
10   panel.  And I think, given the configuration here, we
11   will start with Dr. Lynch.  And we ask each speaker to
12   step up to the podium and we will pose several
13   questions.
14             I'm going to take the prerogative of the chair
15   I guess I'm functioning as today and ask the first
16   question, which is, how if at all does CDC take into
17   account not outbreaks -- I guess what I'm after --
18   individual cases -- so how do they figure into the data,
19   generally?
20             DR. LYNCH:  All the data that I've presented
21   includes data on outbreaks; and we know that outbreaks
22   are really a small fraction of the cases and outbreaks
0062
 1   represent a small fraction of all the cases of foodborne
 2   illness in the country.  We think that, though, that
 3   outbreaks do represent in some degree the range of foods
 4   and pathogens that you would see in sporadic cases as
 5   well.
 6             MR. LANDA:  Just one thought and then I'll
 7   defer to my colleagues.  Are there rules of thumb for
 8   the number of -- I'm guess I'm looking for a multiplier
 9   -- say, if you take the number of outbreaks, or the
10   number of cases in outbreaks, is there some rule of
11   thumb as to what they might represent if you had a
12   report where you knew of all the individual cases?
13             DR. LYNCH:  Well, I don't that we've developed
14   a strict multiplier for outbreak cases -- what
15   proportion of outbreak cases that they represent.  For
16   sporadic cases we do know that even the ones that are
17   reported to us as confirmed cases, they represent
18   anywhere from twenty to forty other cases, because not
19   everyone who becomes ill seeks care or gets tested or
20   their case gets reported.
21             MR. LANDA:  Thank you.
22             DR. ACHESON:  Mike, one of the questions that
0063
 1   we constantly get and I know you do too, is what's the
 2   attribution.  You presented basically, you know, the key
 3   facts as we have it.  What do you think it's going to
 4   take for us to really get to the bottom of attribution
 5   so not only are we interested in the vehicle but where
 6   it got contaminated?  Clearly, we are not there yet; but
 7   from the CDC perspective, what's it going to take to get
 8   there?
 9             DR. LYNCH:  So the attribution comparing
10   different food items and what proportion of illness they
11   might cause?  Or where in the production chain that
12   might occur?
13             DR. ACHESON:  Yeah.
14             DR. LYNCH:  They're both -- we do get asked
15   that question.  They're both difficult questions to
16   answer.  I think, to get a better idea of what
17   proportion of illnesses might be attributable to a
18   particular food, you have to take into account the
19   burden of the illness caused by that food.  And we
20   usually, when we look at that, we look at that by
21   particular pathogens, because the outbreak data
22   represents illness due to specific pathogens to varying
0064
 1   degrees.  There are some pathogens that are well
 2   represented in the outbreak data and some that are not.
 3   So that's one factor that we have to consider.
 4             And then we have to consider what the
 5   consumption of different foods are.  There are some
 6   foods that end up in the outbreak -- that are
 7   represented in the outbreak data -- such as
 8   unpasteurized milk, which we know is probably not a very
 9   commonly consumed item.  So if we're trying to figure
10   out what proportion of all illnesses are attributable to
11   a particular food, we have to take that information into
12   account.
13             Determining where in the production or chain
14   the contamination occurs is even more difficult, I
15   think, because we really only can start to understand
16   that when we identify a particular outbreak and identify
17   the food and start tracing back where it was prepared
18   and the produce site and where it was grown.  And I
19   think that those, as you heard from the folks in
20   California, are very, very intensive investigation; and
21   we get few opportunities actually to do that and even
22   when we do it's difficult to actually find out exactly
0065
 1   what happened.
 2             MR. ROH:  Dr. Lynch, thank you for coming and
 3   representing the CDC today.
 4             Just one question for the record:  It has been
 5   argued by many industry as well as some regulators that
 6   it's difficult to identify whether or not the actual
 7   incidence of outbreaks has indeed increased or whether
 8   or not it's because of the improved reporting procedures
 9   and techniques.  Does CDC have an official perspective
10   on that and does CDC indeed believe the outbreaks have
11   increased?
12             DR. LYNCH:  I think that there are both things
13   at play.  I think there probably has been an increase --
14   you're talking about outbreaks due to produce items?
15             I think that there has been an increased
16   recognition of produce items as vehicles for foodborne
17   outbreaks.  I think they were considered in the past.
18   And talking to people who have been studying foodborne
19   illness for longer than I have, they tell me that these
20   produce items were often considered.
21             I think that once you recognize a new food
22   vehicle is causing an outbreak then you're more apt to
0066
 1   think about it as a potential cause in the future; and
 2   there probably is some component of just recognizing
 3   that produce items can be causes of outbreaks.  But I
 4   think it's -- I don't think it's just increased
 5   recognition of produce items.  I think there probably is
 6   a real component to it and it's hard to quantify how
 7   much of is due to -- it's true, you know, but I think
 8   there is -- part of it is there is more illness and
 9   outbreaks related to produce not just increased
10   recognition.
11             For one thing, you would think that if we
12   identified more outbreaks due to produce one thing you
13   might see is that the average size of outbreaks might
14   get smaller because you're detecting more, smaller
15   outbreaks and you're considering for all outbreaks not
16   just large outbreaks.  And that's not what we're seeing.
17   We're actually seeing that the outbreaks are actually
18   getting larger, so that tells us that's one reason it's
19   probably a true phenomenon.
20             MR. ROH:  Thank you very much.
21             MR. LANDA:  Dr. Buchanan?
22             DR. BUCHANAN:  Mike, I'd like to follow that
0067
 1   question up a little bit.  Based on the data that you
 2   did provide us, which basically indicates that the
 3   number of outbreaks is actually remaining relatively
 4   constant.  But you didn't get down far enough into the
 5   attribution.  Is hidden in that apparent plateau the
 6   fact that we've had outbreaks associated with different
 7   commodities we've solved some of those problems and then
 8   we've seen the emergency of new produce commodities
 9   being associated with outbreaks?
10             DR. LYNCH:  Well, it's possible.  If you look
11   at individual items -- we actually didn't get into that
12   detail -- but if you look at individual produce items,
13   there are some where it appears that you are seeing
14   fewer outbreaks; and I think that the situation with
15   juice was mentioned.  But I think there are -- at the
16   same time we are seeing new items that are being
17   identified as causes of outbreaks.  So I think it --
18   maybe it's just possible the plateaus are because there
19   are new problems that we hadn't recognized before that
20   are counteracting any success we might be having with
21   other individual items.
22             MR. LANDA:  Ms. McGarry?
0068
 1             MS. MCGARRY:  Thank you, Dr. Lynch.  Again, we
 2   really appreciate your being here today.  It's very
 3   helpful to have the information provided.
 4             Looking at whether the bacterial (inaudible)
 5   that are attributable to the outbreak, can you elaborate
 6   a little more as to whether the (inaudible) viral
 7   outbreaks are associated -- I'm just going to go from
 8   here.  It works.  Whether the viral outbreaks where the
 9   contamination appears to be occurring more at the retail
10   end or point-of-service end versus the bacterial
11   outbreaks, which do appear to be more at the source end?
12   Do you have information about where you can attribute
13   the viral versus bacterial agents in the outbreaks?
14             DR. LYNCH:  Well, we have some.  Partly it's
15   just the nature of the pathogens themselves.  The viral
16   pathogens tend to have human reservoirs; and the source,
17   therefore, is ultimately human.  And where there's a
18   human source, it is more often likely to be introducing
19   contamination closer to the point of consumption -- so
20   sometime during preparation.
21             And for bacterial pathogens we see outbreaks
22   where the contamination was likely introduced at either
0069
 1   close to preparation or further back in the chain.
 2             I don't know that we know enough about the
 3   sources of all the viral outbreaks to know that we can
 4   rule out the possibility that some of those outbreaks
 5   may be due to contamination that occurs further back in
 6   the chain.  We have some -- a few -- examples where that
 7   occurred -- the outbreaks of hepatitis A in onions a few
 8   years ago.  And so we think that probably occurs.  But
 9   in general, yes, I think that the viral outbreaks are
10   more likely to be due to contamination that's introduced
11   during preparation; and the bacterial contamination
12   could be introduced at any point.
13             MR. LANDA:  We have time for one more.
14             Ms. Bohm?
15             MS. BOHM:  As you compiled your statistics
16   that you shared with us today and others, do you have
17   any -- can you give us any indication of what -- I guess
18   "advice" would be a nice way to be put it -- you have to
19   improve the investigations that are done on produce
20   outbreaks on traceback?  You have the report and you've
21   reviewed and compiled those statistics, so can you give
22   us some indication what would make those investigations
0070
 1   better?  What data or what areas of an investigation
 2   would make it a better result so that we could take that
 3   information and put it back into the system that correct
 4   those issues that were identified?
 5             DR. LYNCH:  Well, I think we can always do
 6   better.  And certainly our ability to detect outbreaks,
 7   I think, is improving with the subtyping techniques that
 8   the laboratories are using.  And then -- but I think
 9   that laboratories are always strapped for resources; and
10   I think that if they were better supported we could
11   identify more outbreaks and investigate them.
12             And during the investigation I think that the
13   -- like I mentioned -- most of the outbreaks are
14   investigated at the state and local level.  We get
15   involved in ten or fifteen outbreaks each year, but the
16   vast majority are investigated locally.  But I think
17   those departments also are under-resourced; and I think
18   that just having more people with more time to put into
19   investigation would be helpful, because that really --
20   these investigations take a lot of time, as you saw.
21             MR. LANDA:  Thank you, Mr. Lynch.
22             Dr. Smith?
0071
 1             Ms. McGarry.
 2             MS. MCGARRY:  I'll try this again.
 3             Dr. Smith, in one of your slides you mentioned
 4   that over half the outbreaks were associated with a few
 5   of the commodities.  And from that perspective do you
 6   think -- or based on your experience -- that the focus
 7   should be just on those particular produce items; or is
 8   it a broader problem?
 9             DR. SMITH:  That's a really good question.
10             I think that what I'm looking at is that we
11   have a concern for all fresh produce in general just
12   because there are many factors that make produce
13   susceptible to contamination.  So our concern is across
14   the board.  But we also have to acknowledge that it's a
15   handful of commodities that are most often associated
16   with the outbreaks.  Some of those may be because those
17   commodities are high-consumption-volume products -- not
18   everything on the list.  There are very likely also
19   environmental factors, production factors, other things
20   that play into the frequency at which some of these
21   commodities are showing up.  We need to go where the
22   problems are.  And to some extent you could associate
0072
 1   the items on the short list that show up most often as
 2   the biggest current problem.
 3             MR. LANDA:  Dr. Buchanan.
 4             DR. BUCHANAN:  Dr. Smith.
 5             DR. SMITH:  Dr. Buchanan.
 6             DR. BUCHANAN:  Considering that the United
 7   States is a net importer of produce and that an
 8   increasing percentage of the produce consumed here in
 9   the United States is imported, how does the GAPs that
10   are currently recommended by FDA compared to the GAPs
11   documents, the international code of hygienic practice
12   that is promulgated under the auspices of CODEX compare?
13             DR. SMITH:  Okay.  That's actually a very
14   timely question.
15             We have last fall met in Ottawa as part of a
16   work under the strategic partnership for prosperity
17   comparing the U.S. GAPs guidance with the Canadian
18   system and the Mexican system.  I think that's fair to
19   say that the U.S. system came out very favorably.  We
20   were the first GAPs guidance that was developed -- that
21   was the basis for many of the international standards,
22   including the CODEX committee for food hygiene code of
0073
 1   practice document.  It doesn't mean that there aren't
 2   additional things that we could do and there are some
 3   things that are under way right now.  But we're
 4   consistent.  We compare, I think, very favorably.
 5             MR. LANDA:  Dr. Buchanan?
 6             DR. BUCHANAN:  Michelle.
 7             DR. SMITH:  Okay.
 8             DR. BUCHANAN:  Of the outbreaks that have been
 9   associated with fresh produce, do you have any idea what
10   percentage of those could be attributed to the failure
11   to follow the GAP advice and good manufacturing
12   practices?
13             DR. SMITH:  Okay.  I don't think we have any
14   kind of quantitative data to point the fingers.  We have
15   -- I'm trying to remember Marion Aller's reasoned-
16   judgment-professional-opinion kind of phrase --
17   whatever.
18             In the course of our experience, investigators
19   do come back with reports of their observations; and we
20   have put together data on qualitative observations where
21   we've done a number of investigations both in the U.S.
22   and abroad; and we have been captured practices and
0074
 1   conditions of concern that we have seen at those places.
 2   It doesn't necessarily mean that those observations were
 3   the cause of the outbreak contamination, but if someone
 4   comes back and in their report the workers are washing
 5   their hands in the bucket of water that captures water
 6   from the handwash station, then you can be pretty
 7   certain that the workers haven't had adequate training
 8   or that the handwashing system is a new one.  There are
 9   more than enough references to situations, not just in
10   foreign countries, but also in the U.S. where things
11   certainly could be done better.
12             MR. LANDA:  Dr. Acheson.
13             DR. ACHESON:  Follow-up to Dr. Buchanan's
14   question.  I think, Michelle, you said the extent of the
15   implementation gap was unknown and the effectiveness of
16   implementation are unknown.  Correct me if that is
17   incorrect.
18             My question, I think, is fairly short around
19   that -- with the introduction -- do you believe that we
20   need to address those both?
21             DR. SMITH:  This isn't as easy as a yes-or-no
22   answer.  We did do a survey with U.S. National
0075
 1   Agricultural Statistical Services maybe back in 2002 or
 2   so.  We asked extensive questions related to the
 3   recommendations in the GAPs guidance targeting ten
 4   thousand farms and packing facilities.  Now, we did not
 5   actually capture as many as we had hoped to; and there's
 6   no such thing as baseline data because some changes had
 7   started to be put in place even before our GAPs
 8   guidance.  However, that survey was never repeated, so
 9   we don't know how things have changed since 2002.  If we
10   were to do that again, I'm not sure that we would do
11   that same kind of tool.  There are a number of
12   individual efforts that have been done to try to measure
13   GAPs implementation in tomatoes in California, Florida,
14   for cantaloupe in the Southern states.
15             So the first thing that I would do would be to
16   try and catalog what information is out there.  There
17   would be value in at least cataloging what surveys have
18   been done before trying to decide if we need to launch
19   another national survey.  As far as the effectiveness of
20   recommendations, the lettuce and leafy-greens
21   initiative, for example, asked questions about
22   familiarity with the GAPs guidance and familiarity with
0076
 1   the industry's supply-chain guidance.  And I think there
 2   was also a question about -- and based on exposure to
 3   these guidances -- what kind of changes have been made.
 4   So there may be that kind of information out there to
 5   search for first.
 6             MR. LANDA:  Just one question from me:  During
 7   your presentation, you referred to growing high-risk
 8   population.  Could you elaborate a bit on that -- what
 9   you meant by that and what the implications are?
10             DR. SMITH:  Okay.  I'm not a microbiologist,
11   but one of the things that showed up in the spinach
12   outbreak was a high number of hospitalizations, a high
13   number of deaths.  And that may be specifically related
14   to the strain that was involved in that outbreak.  But
15   it is also a fact in many ways it's good.  We're living
16   longer.  But as we are living longer, there's a growing
17   elderly population.  There are a lot of drugs and other
18   medical advances that are available to people that may
19   reduce immune system, just a number of things where we
20   now have at least twenty-five percent of our population
21   in the category that we would call high risk.
22             MR. LANDA:  Thank you.  Thank you, Dr. Smith.
0077
 1             Ms. Cassens, if you would come up, please.
 2             Ms. McGarry.
 3             MS. MCGARRY:  You mentioned CalFERT team.  Can
 4   you talk a little bit about the factors that are
 5   involved in such a rapid response that we had in the
 6   spinach outbreak?  What were some factors that allowed
 7   us -- you, the CalFERT team -- to respond as quickly as
 8   you did.
 9             MS. CASSENS:  Well, there are probably several
10   things.  I'll say first we were working on a lettuce
11   assessment at the time, so we had folks in the field in
12   the area, which helped tremendously.  What was most
13   significant, I think, is that we have taken time with
14   the CalFERT group -- the state and federal group -- to
15   train them together, to get them comfortable with each
16   other and to be familiar with early response.  These
17   folks know that they're to be on call essentially, be it
18   vacation or not, to be available on an outbreak.  And
19   that was the rapid turnaround that we had.  We also had
20   some supervisors, both on the state and federal side,
21   that are very proficient in this type of investigation
22   that could provide some very specific and good guidance
0078
 1   to the field folks.
 2             MR. LANDA:  Dr. Buchanan.
 3             DR. BUCHANAN:  Barbara, of the twenty-two
 4   outbreaks that have been associated with leafy greens,
 5   this was the first time that we've ever been able to
 6   isolate the organism from the product implicated.  What
 7   was different about this time?
 8             MS. CASSENS:  Dr. Buchanan, very, very good
 9   question.
10             I would say several things were different this
11   time.  We began the investigation while outbreak was
12   still occurring.  It was a rather long time span for
13   this.  We were able to rapidly narrow down the number of
14   fields implicated, which is very key because the more
15   places you're looking it's like a needle in a haystack
16   after a while.  We had good information through the
17   processor, the harvester, the ranchers.  And we had,
18   again, staff that were highly trained that could
19   evaluate the practices they saw, the clues, the trails,
20   the tracks, and bring them into really sampling key
21   samples that turned out to be very beneficial.
22             MR. LANDA:  Ms. Bohm.
0079
 1             MS. BOHM:  Acknowledging that the CalFERT
 2   group did a faster than normal response because of some
 3   of the things that you just mentioned, are there any
 4   stumbling blocks that they encountered that could have
 5   made it even better?
 6             MS. CASSENS:  Thank you.  I sure prompted that
 7   question for you, right?
 8             Of course, there are many things.  In fact, as
 9   of next week, we are going to be doing a local lessons-
10   learned with our staff as well as celebration for their
11   excellent work.
12             I think there are a number of things we
13   learned.  I'll say first and foremost is the folks had
14   set up an incident-command center without any previous
15   either formal training together or experience in doing
16   so.  So there are things we ran across -- challenges
17   with the hotels and getting IT support and connections
18   and things everybody runs into with these outbreak
19   investigations.  Just the logistics of getting the
20   samples to and from the area -- we drove many of the
21   samples back and worked out a routine where there were
22   carriers to take the samples out of the field situation
0080
 1   back to the laboratories.  We are going to be providing
 2   incident command training.  That's one of the things
 3   we'll start with next week, because I think that is
 4   essential; and I believe that the nice thing is we had
 5   lessons learned.  We got to react on the Taco Bell/Taco
 6   John outbreak that followed shortly thereafter spinach,
 7   and we were much faster, much more efficient setting up
 8   a command center.
 9             MR. LANDA:  Dr. Acheson.
10             DR. ACHESON:  Barbara, I'd like to publicly
11   congratulate your team and the State of California for
12   CalFERT.  I think you really made a difference.
13             My question to you -- and maybe this is one
14   I'd also direct to Dr. Aller in Florida, when she's up
15   there -- do you think it's exportable?  My vision here
16   would be that we've got a great model.  Why aren't we
17   doing this in other places?  Obviously, it took a lot of
18   work setting this up ahead of time, making sure than
19   when the gun goes off, you're good to go.  But,
20   conceptually, do you think that this is a model that
21   could work in other states?
22             MS. CASSENS:  Yes, I do.  I think there are
0081
 1   some caveats though.  I think you need to consider that
 2   this was something that we dedicated resources to.  We
 3   were fortunate that we had complementary expertise on
 4   both sides that we could train with.  Maybe not all
 5   states will have that.
 6             Other avenues are having regional CalFERt
 7   teams where one state deploys to another; so there are
 8   obviously ways to work it.  I think it's valuable,
 9   extremely valuable, that state counties, Feds work
10   together on this type of investigations.  So, yes, I do.
11             MR. LANDA:  Ms. McGarry.
12             MS. MCGARRY:  In addition to the
13   collaborations with CalFERt and the State of California
14   and FDA, what other types of collaborations may have
15   been different or you see is needed in these types of
16   investigations that are tremendous assets to the
17   investigation?
18             MS. CASSENS:  I called it "the right people
19   there at the right time with the right expertise" in one
20   of the recent articles.  But we did rely heavily on
21   CDC's water expert.  We did have some Earth Center
22   people brought out.  Sherry was one that participated in
0082
 1   the onsite investigation.  It's pulling in the needed
 2   parties where we just had that lack in expertise within
 3   the CalFERT team and we wanted to enhance it.  I think
 4   that was very, very crucial.  And any ways we could
 5   reach out even further that.  We tapped into UC Davis
 6   and a wildlife expert, as just one other example.  And
 7   we were fortunate to have an expert in food safety and
 8   security at Davis who could help pull those resources
 9   and support us in many different ways as we continued
10   the investigation.
11             MR. LANDA:  Any other questions?
12             MR. ROH:  Certainly we discussed this, but for
13   purposes of the record, during the investigation you
14   collected volumes and volumes of volumes of records.  Is
15   there anything that would enhance -- either an enhanced
16   guidance or enhanced market agreement or the market
17   order or, if necessary, in regulation that would have
18   made the investigation run easier, smoother, and quicker
19   to identify sources if there were more requirements for
20   recordkeeping and providing those records from the
21   producer and processors?
22             MS. CASSENS:  From speaking with my staff and
0083
 1   those who had to work to pull these volumes of records
 2   together, we had extreme cooperation from the processor,
 3   the harvester, down to the individual ranches
 4   themselves.  I think we were fortunate this time because
 5   we were able to get a lot code that was identified in
 6   helping very, very quickly.  Otherwise, we would be
 7   looking at numerous other fields associated.  But any
 8   place where lot sizes can be relatively contained and
 9   any electronic means of keeping those records just to
10   help us sort through them.  They were available
11   partially electronically.  That did save us quite a bit
12   of time, but I think there's always room for
13   improvement.
14             MR. LANDA:  Thank you.
15             Dr. Farrar.
16             Dr. Buchanan.
17             DR. BUCHANAN:  Jeff, in your presentation you
18   put out a personal call for action.  And certainly FDA
19   and the country agrees with it.  But I'd like to follow
20   up a little bit on somewhat the unique nature of
21   California and whether or not the lessons learned in
22   California were extrapolatable to other regions of the
0084
 1   country -- very often with major differences in the
 2   scale of the produce operations or the way that they
 3   actually conduct their horticultural activities.  And,
 4   also, how extrapolatable are the lessons from California
 5   taken to the fact that we do a substantial amount of
 6   imported produce coming into the country?
 7             DR. FARRAR:  I was hoping for the easy
 8   question.
 9             I think the answer to this question, as to
10   most others is we are going to learn as we go.
11   Certainly, California has some unique practices within
12   the state.  Other states, such as Colorado and New
13   Jersey do grow leafy greens.  We are well aware of that.
14   I personally am not familiar with the growing practices
15   in Colorado and New Jersey.  I think we are
16   unfortunately a little more centered on looking at the
17   issue here in California, which has been the recipient
18   of twelve of the twenty-two tracebacks.  So we need to
19   fix the problem here.  As we do that, as the industry
20   puts forward the GAP metrics, we hope they're reviewed
21   with an eye towards how they can be utilized in other
22   states.  But we have an issue before us in California
0085
 1   here and now that needs to be resolved.  And I think we
 2   are moving in the right direction to deal with that.
 3             MR. LANDA:  Dr. Buchanan.
 4             DR. BUCHANAN:  To follow that up with an
 5   additional question, we hear a comment that this is a
 6   California problem, not a national problem.  How would
 7   you address that?
 8             DR. FARRAR:  Well, I disagree with that.  I
 9   think produce safety is a national issue.  Clearly, as
10   you've seen, not every produce-associated outbreak,
11   thank God, has come back to California.  And there are
12   certainly issues in other states and other countries
13   that need to be addressed.  And we understand FDA is
14   aware of that as well.
15             So I don't know how to answer your question
16   beyond that.
17             MR. LANDA:  I just have one question.
18             Assume for a minute -- just assume -- that you
19   favor requirements -- imposed regulations -- as opposed
20   to guidance.  If it's the case that there are different
21   growing conditions and practices in different parts of
22   the country, why wouldn't it make sense to have state,
0086
 1   as opposed to national, requirements so the state
 2   requirements could be closely tailored to local
 3   conditions and practices?
 4             DR. FARRAR:  It's a struggle not only with
 5   produce, as you know, but for a lot of other
 6   commodities.  There was some legislation that was
 7   recently offered to try and bring all the states under
 8   one umbrella in the National Uniformity Act.  We felt
 9   that it went a little too far and did not allow any
10   flexibility for specific urgent issues that may exist
11   within states.  But I think generally we agree that
12   there should be, where possible, a broad umbrella
13   nationally so a large chain does not have to deal with
14   ten to fifteen different regulations in ten to fifteen
15   different states.  So it's somewhat walking a tightrope,
16   but I think the states very much appreciate the
17   opportunity to provide some flexibility for those very
18   unique situations.
19             MR. LANDA:  Thank you.
20             Any other questions?  Dr. Acheson.
21             DR. ACHESON:  Not a question, Dr. Farrar, more
22   of a comment.
0087
 1             Again, I just want to go publicly on the
 2   record to thank you and your team in California for what
 3   you have done with regard to spinach in the recent
 4   leafy-greens outbreaks.  Without you, this would have
 5   taken a lot longer and frankly I think your dedication
 6   and your effort save lives.  I think it's important that
 7   we document that.
 8             DR. FARRAR:  Thank you.
 9             MR. LANDA:  Ms. McGarry.
10             MS. MCGARRY:  There have been mention of the
11   GAP metrics quite a bit; and can you elaborate a little
12   more on the voluntary versus requirements on the GAP
13   metrics in the marketing order.
14             DR. FARRAR:  I think I will for the most part
15   defer to the industry to explain the specifics of the
16   marketing order and marketing agreement -- or my
17   colleagues at CDFA, since it falls under their statutory
18   authority.  My understanding of marketing agreement,
19   which relates to handlers, is that it's voluntary.
20   However, the marketing orders relates to growers and
21   would be mandatory if implemented.  But, beyond that,
22   I'll let either industry or CDFA explain the details.
0088
 1             MR. LANDA:  Ms. McGarry, last question.
 2             MS. MCGARRY:  Thank you for your patience.
 3             It's been mentioned by a few speakers that in
 4   many cases the investigation teams are unable to
 5   specifically, definitively identify the cause of
 6   contamination, because the contamination occurs before
 7   the outbreak event.  But it's also been mentioned in
 8   your presentation as well as Ms. Cassens' that there are
 9   recurrent themes that are observed.  What would you say
10   to the voluntary GAPs application in light of some of
11   these recurring themes?  What are your thoughts on that?
12             DR. FARRAR:  Well, clearly, those recurring
13   risk factors have to be addressed.  As others have said,
14   these outbreaks are rare opportunities to get detailed
15   glimpses into how this contamination may occur.  And our
16   state and federal investigations consistently come back
17   to those four areas -- waters, workers, manure, and
18   wildlife.  So it is absolutely imperative that, as much
19   as is practical and reasonable, that those four areas be
20   included on every farm every day.
21             MR. LANDA:  Mr. Roh.
22             MR. ROH:  I'm sorry, Jeff.  The same question
0089
 1   I presented to Barbara: Is it your belief and the
 2   State's belief that with the enhancement of guidelines
 3   or agreements or orders or, if it came to that,
 4   regulation that enhancements to the recordkeeping
 5   requirements would have shortened the investigation time
 6   and made your work even shorter and faster and quicker?
 7             DR. FARRAR:  These investigations unfolded at
 8   a pace that's slower than anyone would like, quite
 9   honestly.  We would all like to be on the farm within
10   the first couple of days.  That's just simply not
11   possible for a lot of reasons.
12             Recordkeeping can be improved.  In every
13   facility I've been in recordkeeping can be improved.  In
14   this particular outbreak, we were fortunate that the
15   processor, although not necessarily able to hit a button
16   and give us a report in thirty minutes, was able to work
17   through their records fairly quickly, linking this
18   incoming record -- incoming and receiving product to
19   bin-dump logs to processing to outgoing records and give
20   us a pretty quick list in a fairly short time period.
21   But I have yet to see the processor that couldn't
22   improve on recordkeeping.
0090
 1             MR. LANDA:  Thank you, Dr. Farrar.
 2             Dr. Aller.
 3             Dr. Acheson.
 4             DR. ACHESON:  Two things.  Let me just follow
 5   up on my previous question in terms of the
 6   exportability.
 7             For you, the question is importability of the
 8   CalFERT model.  I think taking your AFDO hat off maybe
 9   for a minute and put your Florida hat, if we're allowed
10   to do that at this forum --
11             DR. ALLER:  Absolutely.
12             DR. ACHESON:  -- what do you think?
13             DR. ALLER:  Yeah.  In fact, I made a note to
14   that effect, to go back and look at that.  I do think
15   that does offer a model that is certainly exportable.
16   Whether it's exportable to all states, I certainly
17   couldn't speak.  But I think very definitely in Florida.
18             And I think back to -- we have a lot of
19   experiences, I think you're quite well aware, in
20   emergency responses in natural disasters there in
21   Florida -- some famous hurricanes from several years
22   back.  And that I think would be a very complementary
0091
 1   and a very good next step to build on, taking from what
 2   we have internally and working this model to build and
 3   expand.  Absolutely.
 4             MR. LANDA:  Dr. Acheson.
 5             DR. ACHESON:  Change of topic:  To get back to
 6   the -- to what Arthur was doing -- what is your sense of
 7   a timeline on this?  And when do you think your first
 8   deliverable will be?
 9             DR. ALLER:  Oh, boy.  I wish I had a crystal
10   ball that was that clear.
11             We have held a first conference call; and the
12   substance of that call was basically to begin to ask
13   questions.  Do we have the right people involved?  The
14   answer was no.  And to start working on pulling out --
15   identify -- and I think Dr. Farrar identified those sort
16   of common things.  And from there, yeah, to start to
17   extract.  The sooner the better.
18             I hate to try to guess at a time frame, only
19   because I think we have got to iron out some issues like
20   process -- how did we -- where there are disagreements
21   how are we doing to work through that?  Are we going to
22   do general consensus?  Are we going to do some sort of
0092
 1   voting?
 2             I also think that there is potential that this
 3   committee could grow into something much -- I think the
 4   potential is there -- much bigger than an AFDO
 5   committee.
 6             DR. ACHESON:  Thank you.
 7             MR. LANDA:  Dr. Buchanan.
 8             DR. BUCHANAN:  I have two connected questions
 9   that I'll give all at once.
10             When I think of a model code, I think of a
11   document that is ultimately adopted into law by
12   individual states.  And I want to make sure that we are
13   working on the same definition of a model code.
14             And then, two, model codes are usually
15   associated with activities that take place relatively
16   locally.  How would a model code be used in helping FDA
17   deal with imported products, an increasingly important
18   component of the fresh-produce market?
19             DR. ALLER:  Okay.  Let me try to answer the
20   first question and that's part of the answer to the
21   second question.
22             Yes.  And I used the term "model code," and I
0093
 1   was a little bit loose in my discussions and that was
 2   somewhat intentional.  I think the desire is to develop
 3   a model code something that can be adopted by regulation
 4   within states.  Model codes, as AFDO looks at them, both
 5   exist in terms of model laws as well as model
 6   regulations.  I think regulatory adoptions are more
 7   malleable, more changeable and easier to maintain
 8   currency with compliance and practices.
 9             I didn't -- we also, though, did not want to
10   rule out the option of a guidance document if in the
11   discussion we find that there is not enough meat to put
12   into a model code, if you will; that is, if there is --
13   if the -- if we should discover, for instance, that
14   there aren't enough specifics to extract across
15   commodities.  I'm just not -- so we didn't want to rule
16   anything out at this stage of the game.  It's so early.
17   But the idea and hope is to develop a model code.
18             Having said that, what do we do with imports?
19   That's where, you know, we kind of look to our federal
20   partners, and we say, Guys, help us out here, because we
21   want a level playing field.  I think we all do.  I think
22   that having FDA on the AFDO committee will help to
0094
 1   assure that what we -- whatever direction we take we do
 2   keep in mind the work and awareness that is being done
 3   internationally.  I do think that the United States does
 4   lead the charge in many, many instances.  We would hope
 5   that we would continue to do that and apply or leverage
 6   -- if I can use that word -- for FDA to leverage that to
 7   assure that product coming in meets the same standards.
 8             MR. LANDA:  Ms. Bohm.
 9             MS. BOHM:  Mary, I don't know if you've gotten
10   far enough down the road of developing or starting work
11   on your model, but have you decided yet whether this
12   document will have -- take a tiered approach?  Tiered in
13   the sense of risk or tiered in the sense of size of
14   producer or tiered in the sense of type of commodities
15   that will be addressed in different categories?
16             DR. ALLER:  A, no, we have not gotten that far
17   along.  As I said, we've only had one conference call.
18             I have to stress that in my own thinking --
19   and while I don't think any one of us have all the
20   answers, but I do see that as a very real and likely
21   direction -- that it will be tiered certainly by
22   commodity but very definitely to risk, to the extent
0095
 1   practicable.
 2             The other thing I should mention is that, just
 3   like everyone else in the room, we are faced with --
 4   this committee is faced with issues like funding.  So
 5   this is all voluntary.  The work that we do is going to
 6   be done by e-mail, conference call.  We do hope to get
 7   together at the AFDO conference in June in San Antonio.
 8   But there are some constraints under which we're working
 9   as well.
10             MR. LANDA:  One more.
11             Ms. McGarry.
12             MS. MCGARRY:  You said one.  I had two.  Two
13   parts to this one question.
14             One is (inaudible) guidelines or model code,
15   where you think they're moving (inaudible).  And then
16   Part B of the one question is since the GAPs guidance is
17   from 1988 -- it's been mentioned here -- is broad, what
18   would be the additional benefit if there were additional
19   guidelines, given the recurring themes that we've seen
20   in the outbreak investigations?
21             DR. ALLER:  Okay.  The answer to the first
22   question is, no, we are not envisioning farm to fork. We
0096
 1   are looking at the farm and packing-house documents, to
 2   look at those areas.
 3             And what was the second question?  I'm sorry.
 4             MS. MCGARRY:  In looking at whether it's code
 5   or a guideline, what would be the benefit that you see,
 6   given the 1998 guidelines?
 7             DR. ALLER:  Well, I think that others have
 8   addressed that issue; and I'll just reiterate that those
 9   are very, very broad and lack specificity and -- in my
10   mind, as a regulator -- are not enforceable.  If we're
11   looking at model codes, we're looking at an enforcement
12   component.  And I think that was one of the very clear
13   messages that our tomato industry brought forward in the
14   forum in November; and that was it's one thing for an
15   industry to adopt self-regulation but self-regulation in
16   those situations -- and I hope I don't get shot for
17   saying things like this -- means it's those that buy in
18   that adopt the practices.  They are another population
19   that don't necessarily agree to buy in; and that's the
20   advantage of the regulatory approach.
21             Having said that, I think that we must proceed
22   judiciously and that the codes, or regulatory approach,
0097
 1   that is taken has to be taken in a measured approach
 2   with appropriate outreach and education to assure
 3   compliance and consistency.
 4             MR. LANDA:  Thank you, Dr. Aller.
 5             Next we're going to hear from Hank Giclas,
 6   who's with Western Growers.
 7             MR. GICLAS:  Thank you for the opportunity to
 8   provide some remarks and some perspective from the
 9   industry this morning; and I apologize for hesitating. I
10   thought that there was going to be some kind of
11   executive order discussion there.
12             So my name is Hank Giclas.  I'm vice-president
13   of strategic planning science and technology for Western
14   Growers.  We are a trade association that represents
15   growers, processors, and shippers of fresh fruits, nuts,
16   and vegetables from both California and Arizona.  Our
17   members collectively grow more than half of the U.S.
18   output of these key commodities; and as such we are
19   acutely focused on the activities of USFDA and
20   California Department of Health Service and others to
21   address the safety of fresh produce.
22             In early discussions with organizers of
0098
 1   today's public hearing, I was encouraged to focus my
 2   presentation on questions itemized in the Federal
 3   Register.  But before I do that -- and I will try to
 4   attend to as many of those as I can -- I would like to
 5   provide a little bit of overarching discussion of the
 6   industry's historical and current efforts to enhance
 7   food safety in produce.
 8             First of all, we have heard a lot of remarks
 9   this morning about the 1998 guidance; but I think it's
10   important to recognize that it was the industry who upon
11   recognizing the lack of uniform food-safety standards
12   worked to develop the first-ever good agriculture
13   practices document in 1997.  The following year this was
14   adopted by U.S. FDA in the guide to minimize microbial
15   food-safety hazards for fresh fruits and vegetables.
16   These GAPs included baseline food-safety provisions on
17   the farm as well as in processing and shipping
18   facilities to reduce the risk of pathogens and were
19   generic in their approach.  But in addition to these
20   generic guidance, major produce buyers began to impose
21   increasingly demanding food-safety requirements enforced
22   by their own as well as independent third-party auditors
0099
 1   throughout the produce industry.  This system over time
 2   has enabled California's growers and shippers to provide
 3   billions of servings of fresh and healthy produce, but
 4   it has not been sufficient to resolve ongoing concerns
 5   about continuing contamination.  So industry has stepped
 6   up to develop second generation food-safety guidance.
 7             And, as was remarked earlier, Western Growers
 8   and other collaborators in the industry worked together
 9   to develop commodity-specific guidelines for select
10   commodities, the most recent of which is the lettuce and
11   leafy-greens guidelines that were published in April of
12   2006.  This forty-page document identified potential
13   risk factors associated with microbial contamination and
14   suggested prevention and mitigation strategies to
15   enhance the safety of leafy greens from farm to fork.
16   Again, not enough.  So to further these commodity-
17   specific guidelines the industry has been working to
18   develop even more specific best practices and
19   measurable, verifiable metrics and values that can be
20   implemented in conjunction with these good agricultural
21   practices to demonstrate compliance throughout -- at
22   least at this point -- the production and harvest-unit
0100
 1   operations within the supply chain.  This is part of a
 2   three-step approach that we are moving forward to assure
 3   that not only do we have new specific best practices
 4   that are measurable but they are uniformly and
 5   universally applied throughout the industry.
 6             It begins with the binding contract between
 7   handlers, the marketing agreement construct, to only
 8   source product from supplies who adhere to these new
 9   best practices.  Adherence to the terms of the contract
10   would be verified by state and federal inspectors.  This
11   is the first step in a progression to a state marketing
12   order which would bring all producers and handlers into
13   a mandatory construct, the first of which only binds
14   those who voluntarily sign up.  But today we have almost
15   ninety percent of the California volume subscribed
16   voluntarily to the lettuce and leafy-greens marketing
17   agreement.
18             Again, this is a California approach at this
19   point -- a California marketing agreement and a
20   California marketing order -- but our intention and our
21   directive from industry leadership is to take this to a
22   national construct as well.  And at that point we are
0101
 1   exploring the options for a national marketing order
 2   that would include handlers and growers in this country
 3   and beyond.
 4             All of these are designed to provide for
 5   mandatory adherence to the best practices that have been
 6   developed by industry in close collaboration and concert
 7   with academia and the regulatory community.  And this
 8   adherence would be overseen by state and federal
 9   government authorities.
10             Just talking briefly about some of the new
11   specific GAP metrics, again, you know, the risk areas
12   have been known for sometime -- water, wildlife, soil
13   amendments, workers, et cetera.  You've heard them
14   itemized several times today.
15             In the area of water, we are developing
16   specific best practices for the testing, the analysis,
17   the measurement, the evaluation of water sources and
18   distribution systems prior to and during production to
19   assure the safety of this critical input.  We have put
20   forward specific numerical values for microbial
21   indicators that can be used to evaluate system
22   performance and input safety and protocols to further
0102
 1   evaluate and take action when those values are exceeded.
 2             In the area of soil amendments we are doing
 3   the same thing:  Requirements for evaluating the safety
 4   of soil amendments that contain composted or heat-
 5   treated animal products have been established.  The
 6   requirements include a validation of the treatment
 7   process that's in conjunction with soil amendments as
 8   well as additional testing for pathogens and a time
 9   interval prior to their application and the harvest of
10   the crop.  These metrics are based on state standards
11   for composted material.
12             In the areas of animal intrusion and adjacent
13   land use we have also significantly stepped up what we
14   are asking the industry to do.  And, basically, it's
15   performed preproduction, preharvest, and at-harvest
16   assessments of the risk associated from these potential
17   points of contamination to look for signs of intrusion,
18   to document everything, and make it available in a form
19   that can be accessible to investigators and inspectors
20   should an outbreak occur or should the inspectors and
21   verification system access those when they need to
22   access those for compliance purposes within the
0103
 1   marketing agreement.  So the produce industry, you know,
 2   continues to kind of lead in this area; and we continue
 3   to serve as a catalyst for change and for improvement of
 4   the current systems that we have in place.
 5             I would say, I guess -- just going back for a
 6   second about the marketing agreement -- the current best
 7   practices that we have developed have been proposed and
 8   a motion to accept them was made at the last leafy-
 9   greens marketing agreement board meeting.  The motion's
10   been tabled for a week while we work to finalize
11   proposals for full-fledged inspection and verification
12   programs; and we also bring forward proposals for
13   training programs that can be implemented within the
14   industry to ramp up the knowledge base, if you will, on
15   the new metrics and best practices that's being
16   proposed.
17             So now on to, you know, some of the specific
18   questions in the Federal Register notice.  FDA's first
19   issue asked about unit operations or stages in the
20   supply chain and the corresponding risk.  That's been
21   talked a lot about today, but it's important to note
22   that unit operations or stages include production,
0104
 1   harvesting, and transportation from the field,
 2   receiving, cooling, processing, transportation and
 3   shipment, receiving and storage at other levels, food
 4   service, preparation, retail display, and end-use.  And
 5   it does not take into account at that point, you know,
 6   that list what happens prior to production or post
 7   sales.  So contamination can be introduced in any one of
 8   these stages.  The industry has attempted to focus on
 9   those areas of the supply chain with the most risk to
10   the greatest amount of product and by extension the
11   greatest number of people may occur will be affected
12   [sic], so that continues to drive us to areas of
13   production, harvest, cooling, and processing.  But we
14   can't overlook handling in both retail and food-service
15   operations because they can present significant
16   potential for risk as well.
17             How should current practices be changed to
18   reduce the risk of contamination?  I think, absent the
19   proverbial silver bullet that ensures the safety of all
20   finished products for consumers, the industry will
21   strive to continue to develop standard operating
22   procedures and best practices that can minimize the
0105
 1   potential for contamination.  We are focused on
 2   prevention.  We focus on steps that can be taken to
 3   prevent the introduction, as opposed to trying to deal
 4   with pathogens once they are in the system.
 5             To do this, we are working on a multiple-
 6   hurdle approach, some of which we have itemized in the
 7   metrics there.  And that's a similar approach to some
 8   that are being used in other industries, such as the
 9   beef industry, where there's been a successful reduction
10   in the incidence of foodborne illnesses associated with
11   those commodities.  But every unit operation in the
12   supply chain does implement steps to prevent
13   introduction of contamination.  In the production and
14   harvest environment those practices are developed from
15   guidance that's been formulated through industry,
16   academia, and government collaboration.  But programs
17   are also in place in processing facilities up and down
18   the supply chain.
19             I think, you know, that we need to continue to
20   refine; we need to continue to review; we need to
21   continue to inform these programs based on research,
22   which is another thing that has been highlighted here
0106
 1   this morning and I'll talk about here in a second.
 2             But our attention, again -- you know -- and I
 3   guess the question -- the question in the Federal
 4   Register notice about inputs, our focus has been on
 5   inputs, including irrigation water, soil amendments,
 6   wash water, sanitizers, et cetera, and the need to
 7   sample these routinely in agricultural production
 8   systems and beyond.
 9             And in addition to this sampling, you know,
10   we're recommending, you know, that it be implemented
11   more frequently and, you know, consistently within the
12   entire supply chain looking for indicator organisms such
13   as generic E. coli and in some instances looking for
14   specific pathogens.
15             It's important to note that the federal
16   actions that are highlighted in Sections 1 B through 1-
17   E, you know, have placed a lot of emphasis and a lot of
18   responsibility on the industry for the development and
19   implementation of practices and procedures to reduce
20   risk.  And we have responded, you know, with the good
21   agriculture practices, the commodity-specific
22   guidelines, et cetera.  But the reliance on industry,
0107
 1   while appropriate and well placed, still, I guess,
 2   brings the question, you know, of what else can FDA do
 3   or others do.
 4             And I think, you k