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 know, in that regard we
 5   wanted to make a couple of recommendations.  First, you
 6   know, we appreciate the collaborative work and
 7   relationship that we've had with the regulatory
 8   community in the past and we believe that we need to
 9   sustain this, particularly in the prospect of trying to
10   analyze some of those more recent events and rank
11   suspected points of contamination for potential as a
12   source.  Attribution, you know, and source information
13   is going to be one of the things that we need to
14   continue to strive to define if we are going to be able
15   to, you know, enhance the best practices that are
16   engaged and employed by the industry.  We also believe
17   that resources need to be allocated to this -- resources
18   that can help underwrite research that can leverage
19   industry money to help fund research and training and
20   other things that need to go hand in hand with the
21   development and improvement of metrics.
22             There's been a lot of discussion about
0108
 1   traceback.  And industry is, you know, very interested
 2   in this.  We've heard a lot of discussions in the past
 3   about traceback systems not being adequate to facilitate
 4   quick response, but every time we've asked we have not
 5   been able, you know, to have any real feedback on here's
 6   what we would like to see the industry do better.
 7             Rapid traceback is in everybody's best
 8   interest.  It allows investigators and companies to
 9   pinpoint and put definitive limits on the amount of
10   product in question right away.  So, you know, we're
11   strongly in favor of trying to bring forward some
12   traceback standardization, if you will -- at a minimum
13   documentation that can be maintained that would allow
14   investigators to trace back from the retail outlet to
15   the suppliers, identify their location, the product and
16   number of cases ordered and delivered, to trace that
17   back to individual packages which contain information
18   that would indicate dates, shifts, lines within a
19   processing facility, and the date the product was
20   received at the processor.
21             I think I'm probably cutting into Dr. Harris's
22   time here, so maybe in kind of conclusion we're going to
0109
 1   submit written remarks or written comments on all of the
 2   Federal Register questions.  I would just say, you know,
 3   that we are operating on a common goal -- protecting
 4   public health -- doing all that we can to reduce the
 5   number of outbreaks of foodborne illness associated with
 6   fresh fruits and vegetables.  Western Growers and other
 7   industry partners are committed to that, you know.
 8             We caution that because this is not
 9   necessarily a sanitary environment that we will not be
10   in a position in the near-term future to guarantee that
11   these outbreaks will not occur but we are in a position
12   to commit to move the industry forward more rapidly than
13   any other proposed construct and to continue to serve as
14   a catalyst for enhancements to the fresh produce food-
15   safety systems.
16             MR. LANDA:  Thank you, Mr. Giclas.  If you
17   don't mind, if you would stay.  We'll ask questions and
18   then we'll hear from Dr. Harris.  That will help me
19   limit the questions to the panel.
20             Dr. Acheson.
21             DR. ACHESON:  Thank you.  Let me give my
22   question quickly.
0110
 1             You mentioned that the proposed market order
 2   that you are working on was going to come ninety percent
 3   by volume -- I think that's what you said -- of the
 4   industry.  What's your perspective on what's going on
 5   with the other ten percent?
 6             MR. GICLAS:  Well, our perspective is that
 7   we'll be able to shift that other ten percent in through
 8   the marketing order.  Our perspective is that we need to
 9   capture that other ten percent, but, you know, our
10   movement, again, is kind of a tiered approach based on
11   what we can do most rapidly.  But the ultimate, you
12   know, goal, if you will, is to try to move this to a
13   mandatory construct for all suppliers and for all
14   handlers.
15             MR. LANDA:  Mr. Roh.
16             MR. ROH:  Thank you, Hank, for presenting
17   today.  We really appreciate it.
18             Did I understand you correctly to assume that
19   Western Growers does support some sort of enhanced
20   recordkeeping requirement, be it through advanced
21   guidelines, market order, or, if necessary, state or
22   federal regulations?
0111
 1             MR. GICLAS:  Absolutely.  I mean we are in the
 2   process of developing, if you will, the details of our
 3   proposed vision for the verification system.  The
 4   verification system obviously will be ultimately
 5   implemented by CDFA and USDA inspectors in association
 6   with the marketing agreement, but throughout the
 7   metrics, throughout the new best practices and the
 8   production and harvest end of the supply chain there are
 9   numerous requirements for records and documents to be
10   maintained at either the handler or grower location. And
11   we are writing those in up-front as a means of trying to
12   facilitate, number one, the gathering of additional
13   information about some of the key inputs and things like
14   that; and, number two, to facilitate inquiries that may
15   come either from the inspectors charged with verifying
16   or tracebacks that may occur if there is, God forbid, an
17   event.
18             MR. LANDA:  Dr. Buchanan.
19             DR. BUCHANAN:  Hank, long experience with
20   working in other aspects of the food industry has
21   indicated that often problems are aggravated by poor
22   design of equipment and processors.
0112
 1             And has the industry taken any look at all at
 2   the equipment it currently uses at the farm level and at
 3   some of the practices that they have there to try to
 4   tease apart what are some of the areas that can be
 5   improved?  For example, I look at a spinach-harvesting
 6   machine and say that would be a great way of
 7   contaminating a product.  Is there any evaluation of
 8   that type of technology to find better ways of doing it?
 9             MR. GICLAS:  There is absolutely a constant
10   look at both -- I mean on the part of industry -- by
11   both companies who are individually manufacturing and
12   building some of these and trying to improve them.
13   There's also, as Dr. Farrar said earlier, there's a very
14   comprehensive research agenda that has been proposed.
15   And some of those items are being looked at.
16             And the focus of our best practices and
17   metrics so far have not been necessarily on replacing,
18   you know, existing equipment or existing schemes, if you
19   will, within the industry but rather, you know, how do
20   we work to prevent contamination in the systems that are
21   currently in the field.
22             The second part of this is a second-tiered
0113
 1   question; that is, I think it's a research question and
 2   baited question, et cetera.
 3             I would also say that we haven't had a lot of
 4   feedback, although we do continually look at these
 5   things, that these are necessarily the highest orders of
 6   risk and the highest orders of focus for us at the
 7   moment.
 8             MR. LANDA:  Ms. Bohm.
 9             MS. BOHM:  You mentioned and I wasn't -- I
10   wasn't quite clear on what -- where along the way this
11   will occur.  You mentioned that state and federal
12   inspectors would be able to enforce or verify adherence
13   with particular something.  And my question was I
14   understand that this is -- currently, anyway -- a
15   voluntary approach and how will an inspector at any
16   level be able to enforce something that's not a law?
17             MR. GICLAS:  You know, we don't like the use
18   of the term "voluntary."  It's not a voluntary
19   construct.  It is a mandatory construct for those
20   individuals who sign on to the marketing agreement.  So
21   anybody who signs into the marketing agreement today --
22   and we have fifty-three out of seventy-nine handlers
0114
 1   subscribing in California today, representing
 2   approximately ninety percent of the volume of commercial
 3   product.
 4             But for all of those people who sign in, they
 5   are bound by contract to only source product from
 6   growers who are implementing the best practices that
 7   have been accepted, if you will, by this marketing
 8   agreement board.  Those best practices are the next --
 9   they're almost the third generation, if you will, of
10   commodity-specific guidance put forward by the industry.
11   And they contain a lot more specifics, if you will, in
12   terms of the numerical values that can be measured
13   against, et cetera.  That whole system will then be, you
14   know, verified, if you will, by state and federal
15   inspectors who are employed by the marketing agreement
16   board under separate contract and go out and observe,
17   you know, what the handlers are doing, do their sourcing
18   (inaudible) of what's going in the fields, et cetera. So
19   that verification system right now, what they look at,
20   when, frequency -- those types of things is in the
21   developmental process.  But the marketing agreement
22   really officially kicks off April 1, 2007, so we're
0115
 1   pushing forward to have that done and ready.
 2             MR. LANDA:  Ms. McGarry.
 3             MS. MCGARRY:  You mentioned the verification
 4   component to the marketing agreement and in some of the
 5   outbreak investigations, there have been audits done of
 6   the growers and that have received high scores.  What in
 7   the marketing agreement is addressed to try to ensure
 8   the training and qualifications of those who are
 9   conducting audits?  And is it strictly a government
10   auditing or is it a private/government?  Can you talk a
11   little bit more about that.
12             MR. GICLAS:  Yeah, at this particular point in
13   time, the vision for this verification system and for
14   the inspectors that will be, you know, engaged under the
15   verification system is for it to be a government
16   construct.  In other words, it would be a USDA or a CDFA
17   employee operating under USDA authority that would go
18   out and do the verification.
19             You will have to talk with CDFA specifically
20   about the level of training that those particular
21   auditors are going through, but it is, you know, a
22   fairly significant series of, you know, training that
0116
 1   positions them to be able to pick this program up and
 2   run with it.  And they do these types of verifications
 3   and audits throughout the country in different areas so
 4   -- and in different commodities.  And at some point in
 5   time they may be able to certify third-party inspectors
 6   or others.  But, again, for the first year, for the
 7   foreseeable future, it's going to be a state or federal
 8   inspector.
 9             MR. LANDA:  Ms. Bohm.
10             MS. BOHM:  Can you explain what you foresee as
11   the driving factor or factors that will encourage those
12   producers who haven't signed on yet to sign on and
13   therefore protect all consumers, not just the ones of
14   the consumers who are purchasing product of the
15   producers who have signed up?
16             MR. GICLAS:  Well, in terms of trying to
17   provide incentives for individuals to sign on we have
18   had separate conversations with buyers and others to try
19   to encourage them to source their product from
20   individuals who are subscribed to the marketing
21   agreement.  But I don't think that ultimately we will be
22   able to incentivize, for lack of a better term,
0117
 1   everybody to get into the program, which is why we're
 2   moving to the marketing order, which upon a super-
 3   majority vote would make it a mandatory construct for
 4   everybody.
 5             MR. LANDA:  I just have one question.  What
 6   kind of micro testing are growers doing now and what
 7   should they be doing?
 8             MR. GICLAS:  Well, you know, I think growers
 9   now today, again, are looking at the integrity, the
10   safety, the quality of their inputs.  I think what we
11   are doing -- one of the -- I guess one of the challenges
12   of generic guidance is we don't tell people exactly what
13   to look for, exactly how often to look for it, exactly
14   where to take the samples -- you know, those types of
15   things.  So what we are trying to do is come forward
16   with a lot more solid and specific information to drive
17   and to sort of standardize -- here's the best practice,
18   if you will, in the industry.  So all of the things that
19   we are talking about today with currently sampled, you
20   know, by growers in the field at some level or another.
21             Are they all operating on the same level?  I
22   couldn't answer that.
0118
 1             MR. LANDA:  Ms. McGarry, last question.  And
 2   one question, no two-parters.
 3             MS. MCGARRY:  There has been a lot of talk
 4   about the testing component of the marketing agreement;
 5   and while testing (inaudible) can be a very useful tool
 6   and give you a snapshot, what's the balance in the
 7   program of the metrics between testing and preventive
 8   means and environmental -- kind of comprehensive
 9   assessment of what's going on (inaudible).
10             MR. GICLAS:  Everything that is employed in
11   terms of testing is really employed as part of a
12   surveillance or monitoring program more than anything
13   else.
14             If you just look at water, for example, one of
15   the things that we're asking everybody to do is go back
16   and do a risk assessment associated with their sources,
17   their distribution systems, the environment that's
18   surrounding those areas and look and identify the
19   potential points of risk that may be associated with
20   that system in that environment; to address those points
21   of risk; and then to use sampling data, et cetera, to
22   sort of monitor the integrity and performance of your
0119
 1   system over time.  We're carrying that same rationale
 2   forward with soil amendments and with adjacent land use
 3   and every else.  So it's not that we're trying to test
 4   our way to safety, if you will.  We're trying to put the
 5   entire package forward as this multiple-tier approach
 6   that will reduce risk when all of the factors are
 7   combined.
 8             MR. LANDA:  Thank you, Mr. Giclas.
 9             Our next speaker is Dr. Linda J. Harris, who's
10   associate director of research with Western Institute
11   for Safety and Security.  She's with the Department of
12   Food Science and Technology at U.C. Davis and provides
13   statewide expertise on food microbiology to producers,
14   processors, retailers, and consumers.
15             DR. HARRIS:  Well, thank you for inviting me
16   to give a presentation today.
17             Many people have already mentioned the need
18   for further research in this area; and the way I look at
19   my presentation is to couple both what is the state of
20   the science and what are some ideas for further
21   research.  It was pretty challenging.  There's been
22   research done in multiple disciplines in this area for
0120
 1   probably over sixty years.  Most of the research,
 2   however, has been within the last decade, as we
 3   increasingly recognize the association with foodborne
 4   illness and fresh produce.
 5             I want to say that in looking at the overall
 6   research that has been done, a lot of what you might
 7   consider the low-hanging fruit -- the easy stuff -- has
 8   been done.  There's some very targeted research that is
 9   left to do.  But I think that in moving forward some of
10   the questions that are still remaining are big
11   multidisciplinary types of questions that are going to
12   take teams of researchers to try and solve.  And I just
13   want to make that statement up front.
14             One of the challenges that I see to even
15   beginning to collect data when looking at food safety of
16   produce is just the diverse selection of produce that's
17   available in a typical U.S. grocery store -- anywhere
18   from three hundred to three hundred and fifty produce
19   items.  Almost all of it is highly perishable.  That
20   makes it a challenge to source product, to do laboratory
21   studies.  Even if we narrow it down to the three or the
22   five or the seven top contributors associated with
0121
 1   foodborne illness, we are still talking about multiple
 2   different items.  And each of these types of crops --
 3   melons or leafy greens, tomatoes -- the way in which
 4   they are produced, harvested, and their post-harvesting
 5   handling system differ.  And they differ not only among
 6   the produce types but within and among regions in the
 7   U.S. and within and among countries.  And so actually
 8   the risks that we need to look at may be different
 9   whether it's a tomato grown in California or a tomato
10   grown in Maryland.  And I think that those are some of
11   the challenges that have contributed to some of these
12   issues.
13             In addition, you see varying lists of multiple
14   pathogens.  We've heard that Salmonella and E. coli
15   O157:H7 are near the top of the list, but there are
16   others.  And each one of them has either different major
17   sources, different groups of contamination.
18             Another factor when looking at naturally
19   contaminated product, because you can learn a lot from a
20   naturally contaminated product, is the state of the
21   organism, the levels that are there compared to
22   organisms that you are inoculating in the laboratory.
0122
 1   But with produce -- and it's a very fortunate thing --
 2   in general, we accept the fact that overall there's a
 3   low level of contamination of these products. Otherwise,
 4   we would see significantly more illness.  So the percent
 5   of positive units are very low.  And that makes it a
 6   challenge to do surveys in a statistically valid manner.
 7    We don't have virtually any data on what the numbers of
 8   the pathogen might be on a naturally contaminated
 9   produce item, but we do believe that those numbers are
10   likely to be very low; and that also makes it
11   challenging.
12             We also don't have very good information on a
13   naturally contaminated field or lot.  How likely is that
14   contamination to be uniform?  And I think most
15   scientists would agree that it's unlikely, given the
16   variability of a field and the variability in the way we
17   believe that produce is contaminated.  So low-level
18   contamination, low numbers per positive unit, and uneven
19   distribution make statistically valid studies of
20   naturally contaminated products difficult.
21             Now, if we look at any of the pathogens that
22   have been listed and we ask the question how do they
0123
 1   survive in the environment, the data that has been
 2   generated by multiple researchers over the last couple
 3   of decades certainly indicate that these organisms are
 4   more robust in the environment than traditionally
 5   considered.  So instead of surviving for days they
 6   survive potentially under certain circumstances for
 7   weeks and perhaps months in the environment.  It's less
 8   clear if they are able to also exist in stable
 9   multiplying populations in the environment in the
10   absence of a host.  This idea was brought up maybe
11   thirty years ago.  There's been very little research
12   since then, but most people think that you get
13   contamination and then prolonged survival, but I think
14   that in certain circumstances the ability for these
15   organisms to multiply in the environment is possible;
16   and there's evidence of generic E. coli multiplying in
17   tropical environments and stable populations.
18             So when we look at them, one of the primary
19   reservoirs for these pathogens -- we talked about the
20   animal and the human factor.  We also have to look at
21   the environment.  If organisms are surviving for longer
22   periods of time in the environment then the movement
0124
 1   through the environment is important.  And depending on
 2   where the organism is coming from -- what is the primary
 3   route of contamination?  Is that direct contact?  Is it
 4   water?  Is it dust?  Is it aerosols?  And I would think
 5   that in different circumstances any one of those things
 6   could be a factor?
 7             Obviously, we are working with human
 8   pathogens, so generating data on how these organisms
 9   survive in the field has been a challenge, to say the
10   least.  You can't as a researcher, no matter how much
11   you might want to, you can't go out in the field and
12   start spraying around Salmonella and E. coli to identify
13   exactly what happens to these organisms in a field.  But
14   I think we have generated some information on behavior
15   in greenhouse plants.  I think there's more information
16   we need to understand about the specific environmental
17   factors -- such as humidity and UV index, moisture --
18   that will influence pathogens; and I think we can do
19   more work in this area in the laboratory that is
20   targeted to factors that also occur in the field.
21             In addition, we've also heard about the
22   connection between Salmonella and tomatoes and E. coli
0125
 1   0157:H7 and lettuce and leafy greens; and I think that
 2   there are some evidence beginning to be published that
 3   there's generous species or even strains that may be
 4   adapted to unique environments presented by these
 5   various produce items.  I think that this is an area of
 6   further research.  If this proves out to be a case we
 7   need to understand better the molecular level why these
 8   abilities exist; and then that may ultimately lead to
 9   ways in which to control the proliferation.
10             Now, Hank already mentioned -- everybody
11   mentioned -- good agricultural practices as a means of
12   reducing risk contamination.  And I think that's where
13   our focus is.  And people have mentioned water; soil
14   amendments, or manure; workers; and wildlife.  I put
15   adjacent land use, because domestic animals could come
16   into play with that as well.
17             And even though we have metrics I think
18   everyone would agree that it's a place to start, but
19   there's certainly room for adding some more science to
20   some of those metrics.  And does an individual evaluate
21   the risk of a single animal in a field?  How do you
22   continually monitor?  Are we using the right monitoring
0126
 1   tools?  And how do you ultimately manage the risk or set
 2   up corrective actions where risk is identified?
 3             So even though we do have composting
 4   guidelines that have been developed, I think there is
 5   still work to be done in this area.  How to best
 6   validate a composting operation?  How to best monitor?
 7   How to best verify?  And answering questions on what
 8   happens when the contamination of composed materials
 9   occurs, how significant that is in leading to the
10   overall risk.
11             Now, I'm going to throw up this slide on
12   preharvest internalization of pathogens only because
13   everybody brings it up and I just want to deal with it.
14   The state of the science is that, yes, under laboratory
15   condition under certain circumstances with certain
16   organisms and certain plants it has been demonstrated
17   that pathogens can be taken up by either the root system
18   or, in the case of inoculated flowers, sometimes into
19   their mature fruit.  But I think that the missing link
20   has been how likely are the conditions that have been
21   used under laboratory studies to occur in the field and
22   so is that data transferrable into the field?
0127
 1             There's another several factors, including the
 2   microbe and the plant itself.  But I think, also, we all
 3   have to remember that, even if we say that this is
 4   possible to happen in the field, I think we have to look
 5   at the picture and ask the question what does it really
 6   contribute to the overall risk of foodborne illness. And
 7   I think that, still, external contamination -- roots of
 8   contamination -- are probably always going to be more
 9   significant than some type of internalization.
10             Now, washing produce does not eliminate the
11   problem; and if it did we probably wouldn't be here
12   today.  There's been a tremendous amount of data
13   generated on a tremendous number of antibiotic
14   microbials that can be used in wash water.  And
15   antimicrobials effectively used in wash water are
16   excellent means of reducing cross-contamination of
17   produce; and I would argue that's their number-one use
18   in packing houses and in processing facilities.  They
19   can reduce populations of microorganisms externally
20   applied.
21             And we know that the reduction is highly
22   variable.  It's easier to reduce microorganisms from
0128
 1   unblemished and undamaged and unwaxed skin, especially
 2   when you can apply some sort of physical force.  But as
 3   soon as you start looking at blemishes or damages or
 4   injuries or skin scars, the difficulty goes up; and when
 5   you have complex or delicate surfaces where physical
 6   force is difficult then again you have a reduced
 7   efficacy.
 8             Despite the fact that significant research has
 9   already gone on in this area, I think there is still
10   hope for additional -- perhaps better -- methods for
11   certain types of fruits and vegetables.  And it's
12   already been mentioned that ideally you would have a
13   kill step that was -- that could be validated and
14   monitored and reliably implemented.
15             Now, this is a slide talking about post-
16   harvest infiltration of pathogens.  And this is where I
17   would think this is one of the research areas that we
18   know that this can occur.  And it's been demonstrated
19   for a number of fruits and vegetables.  We know that
20   temperature and pressure differential are important --
21   water deficit, depth of water.  But this can absolutely
22   be controlled by maintaining water quality.  So this is
0129
 1   one of the areas that, you know, you don't need a lot of
 2   research to put something into action, which is already
 3   in action, I would argue.
 4             I think that are some questions still
 5   remaining in this area; and that is, in the absence of
 6   water, can you still have infiltration at cut surfaces
 7   or wounds or during vacuum cooling?  And what happens to
 8   the organism once it's internalized?  How does it
 9   behave?  Does it die?  Does it multiply in certain
10   circumstances?
11             And speaking of survival and multiplying, this
12   is an area, also, that is well studied, basically, on
13   intact fruits and vegetables with no wounding.  Survival
14   is variable depending on the type, depending on the
15   available of moisture so that a high-humidity
16   environment, where there's usually free moisture on the
17   fruit or vegetable and then permissible temperatures
18   also influence that.  And in some intact fruits and
19   vegetables, researchers have demonstrated multiplication
20   on some intact fruits given the right conditions of
21   moisture and temperature.
22             Once you cut or wound a fruit or vegetable,
0130
 1   pathogens have been shown to be attracted to the cut
 2   surfaces.  Survival and growth potential increases and
 3   even acidic products, such as chopped tomatoes have been
 4   demonstrated under certain circumstances to support the
 5   growth of pathogens.  Certainly, growth in nonacidic
 6   products like melons has been clearly demonstrated.
 7             I'm going to finish up with just a couple of
 8   comments on microbiological methods, because the data
 9   that you generate and the way you interpret your results
10   is highly influenced by the method that you choose and
11   the design of the study.  And I would say -- and I think
12   a lot of people in the room would agree with me -- that
13   there have been almost as many methods used in research
14   as there have been studies done and that microbiologists
15   unfortunately don't like to use other people's methods
16   very often; and I think that actually has been
17   detrimental in some ways to moving things forward.
18             I think we haven't taken enough consideration
19   of the state of pathogens at the time that we do
20   laboratory studies and inoculate.  We know that
21   environmental and naturally contaminated fruits and
22   vegetables are likely to be contaminated by stress
0131
 1   itself; and I think we need to look more closely at that
 2   to ensure that what our data is saying is relevant.
 3   Inoculation method has been studied extensively, but I
 4   think there's still not necessarily a consensus in this;
 5   and then recovery methods will influence whether or not
 6   you're able to identify all the viable microorganisms
 7   remaining.
 8             So I would strongly suggest that the microbial
 9   research community look at greater evaluation,
10   validation, and justification of the methods that they
11   are using; and I think more laboratory studies should
12   attempt to mimic approximate and realistic enviromental
13   conditions.  I also think that there might be a need for
14   better coordination and agreement or encouragement of
15   researchers to agree on standards methods and that
16   methods should be shared when somebody has a new method
17   that is working better that the old; and development of
18   approved methods in sampling strategies.  And I stress
19   the sampling strategies for interpretation of data and
20   for finding and recovery of pathogens from environmental
21   samples is also really critical.
22             With that, I'll --
0132
 1             MR. LANDA:  Thank you, Dr. Harris.
 2             The next speaker also has to leave fairly
 3   early this afternoon, so I think we're going to have her
 4   up here.  And then, time permitting, with your schedule
 5   and hers, we'll ask you back for questions.
 6             Our next speaker is Lisa Odabashian, who's the
 7   West Coast director of Consumers Union, which is a
 8   nonprofit publisher of Consumer Reports.  She's an
 9   expert on food-safety issues.
10             MS. ODABASHIAN:  Good morning.  My name is
11   Elisa Odabashian, as you've heard.  I am the West Coast
12   director of Consumers Union, the nonprofit publisher of
13   Consumer Reports magazine, with four million
14   subscribers, and Consumer Reports Online, with more than
15   2.5 million subscribers.
16             I appreciate today's opportunity to
17   participate in this public conversation with the FDA
18   about the safety of fresh produce.  You've heard today
19   from a number of scientific experts from government and
20   industry about all that has been done and is being done
21   and will be done, hopefully, about the safety -- to
22   ensure the safety of fresh fruits and vegetables, much
0133
 1   of which is grown in California.
 2             I've been asked here today to give the
 3   consumer perspective.  That perspective is currently
 4   worth a hundred million dollars.  It's a hundred million
 5   dollars in lost revenue to the California leafy-green
 6   industry in just about five months, because last
 7   September more than two hundred unlucky consumers across
 8   twenty-six states ate spinach contaminated by a
 9   particularly virulent form of E. coli that killed
10   between three to five, hospitalized more than a hundred,
11   and sickened another one hundred.
12             The spinach disaster was quickly followed by a
13   Salmonella outbreak from contaminated tomatoes served
14   from a restaurant which sickened one hundred eighty-
15   three people in twenty-one states.  On the heels of this
16   came another E. coli outbreak from shredded lettuce at
17   Taco Bell and Taco John restaurants that sickened one
18   hundred fifty-two people.
19             A national survey released by Rutgers
20   University's Food Policy Institute last month suggests
21   that last September spinach recall could have lasting
22   effects on consumers' consumption of spinach and other
0134
 1   vegetables.  The survey showed about one in five people
 2   who were aware of the recall also stopped eating other
 3   bagged produce.  More than seventy-five percent of the
 4   responders with spinach in their home threw it out
 5   during the recall; and seven percent threw out fresh
 6   produce other than spinach.  More than half of the
 7   people who typically ate spinach prior to the recall had
 8   not returned to eating it when the survey was taken
 9   months later.
10             At this moment, all across America, the
11   consumer perspective is one of deep disappointment in
12   government agencies, both at federal and state levels,
13   that have failed to safeguard the food supply -- deep
14   distrust in the leafy-green industry that is responsible
15   for nearly two dozen foodborne illness outbreaks in the
16   last ten years and confusion about whether fresh fruits
17   and vegetables are indeed the most healthful foods to
18   eat or whether they're potentially deadly.
19             In 1997, President Clinton, as part of the
20   Produce Safety Initiative, assured Americans that fresh
21   fruits and vegetables met the highest standards of
22   safety, directed FDA to issue voluntary industry
0135
 1   guidelines outlining good agricultural and management
 2   practices for growers, processors, and distributors.
 3   Ironically, from almost the minute those voluntary
 4   guidelines were issued in 1998, the public has endured
 5   recall after recall after recall of produce containing
 6   microbial contamination.  Clearly, the FDA's voluntary
 7   approach to regulation of fresh produce has utterly
 8   failed to make it safer.
 9             There's only one way to ensure that fresh
10   fruits and vegetables that reach the marketplace are
11   safe -- only one way to rebuild consumer trust.  FDA or
12   the California Department of Health Services, separately
13   or in conjunction, must assume the authority and be
14   given the staff to effectively mandate GAPs for every
15   farm and HACCP programs for every processor, including
16   thorough and regular inspection programs, effective
17   traceback programs, third-party audits, and rigorous
18   enforcement of standards.  The leafy-green industry in
19   particular has brought dangerous products to market too
20   many times for consumers to believe that it will
21   suddenly meet voluntary safety standards.  For many
22   consumers, it's simply safer to stop buying leafy-green
0136
 1   products altogether, healthy notwithstanding.
 2             In California, the California Department of
 3   Food and Agriculture -- CDFA -- in partnership with the
 4   leafy-green industry is furiously pushing forward a
 5   marketing agreement, of all things, to development
 6   voluntary best practices standards.  This is being done
 7   behind closed doors without any public input.
 8   Furthermore, the CDFA is allowing the oversight board to
 9   be made up almost exclusively of the leafy-green
10   industry, some of which have been accused of marketing
11   contaminated products.  CDFA has admitted that they will
12   accept whatever best practices the very industry that
13   brought us spinach contaminated by E. coli comes up
14   with.  This is a serious abdication of government's duty
15   to certify the food supply and protect the public.
16   Industry self-regulation seldom protects consumers and
17   often provides industry with cover when contamination
18   occurs.  Simply put, if the leafy-green industry ever
19   hopes to regain consumer trust, it must be regulated by
20   an authority other than itself.
21             Now, by its very nature, a voluntary program
22   of safety standards does not account for the bad actors
0137
 1   and does not ensure that all products that come to
 2   market are safe.  Nor do voluntary standards create an
 3   incentive for everyone to comply, particularly when
 4   meeting safety standards cost money.  If not all
 5   producers and processors are subject to the same
 6   standards the door remains open for contaminated produce
 7   to reach consumers, with all the attendant negative
 8   public health effects, publicity, and economic impact
 9   that that incurs.
10             Another bad idea that has come out of this
11   California industry-driven marketing agreement is the
12   use of a certification mark to convey to consumers that
13   leafy-green products from participating farms and
14   processors in California are subject to best practices.
15   This approach turns safety into value-added in the
16   marketplace.  The safety of the food we buy is a
17   fundamental expectation of consumers.  And government
18   must ensure it.  Safety should not something that is
19   used as a marketing tool when it comes to food.  It
20   should not be something that consumers must search out
21   and possibly pay extra for, leaving poor consumers at
22   risk.  All of our food should be safe.
0138
 1             Now is the time for FDA to do everything in
 2   its power, including seizing adulterated products, as
 3   authorized by Section 402 of the Federal Drug and
 4   Cosmetics Act and established HACCP programs on farms
 5   and as authorized by Section 361 of the Public Health
 6   Services Act to ensure the safety of produce.
 7             Further, FDA must expand its power by
 8   demanding that Congress give it more money and staff to
 9   effectively enforce mandatory authority over this
10   industry.  Again, the voluntary approach to regulating
11   this industry simply has not worked and will continue to
12   endanger consumers with contaminated products.
13             A recent Associated Press analysis of the
14   federal records found that in 2006 FDA conducted just
15   half the inspections of U.S. food manufacturing
16   facilities that it did three years earlier in 2003.  And
17   it conducted seventy-five percent fewer safety tests of
18   U.S. produced food in 2006 that it did in 2003.
19             Last May former FDA official William Hubbard
20   published an opinion piece in the Washington Post in
21   which he explained that for some years now the FDA's
22   budget has remained essentially flat while major new
0139
 1   responsibilities have been piled on, resulting in a
 2   serious weakening of the agency.  Mr. Hubbard wrote that
 3   FDA food inspections dropped from fifty thousand in 1972
 4   to about five thousand in 2006.  That is a ninety-
 5   percent reduction.  And that U.S. food processors are
 6   inspected on average about every ten years.  Every ten
 7   years.  And that the chance of a food product from
 8   overseas being inspected is in his words infinitesimal.
 9   Clearly, FDA must demand considerably more resources for
10   food-safety inspectors and Congress must appropriate the
11   necessary funds immediately to sure the safety of the
12   food supply.
13             The FDA's voluntary industry guidelines
14   published last week states that -- and I quote --
15   prevention of microbial contamination at all steps in
16   the farm to table continuum is preferable to treatment
17   to eliminate contamination after it has occurred, end
18   quote.
19             Now, consumers representing the table side of
20   that continuum could not agree more.  But prevention of
21   microbial contamination in fresh-cut fruits and
22   vegetables requires mandatory regulation that is
0140
 1   enforced by a government watchdog that does not have as
 2   parts of its charge the promotion of the industry it
 3   regulates.
 4             Some essential components of the regulations
 5   should be GAPs for all farms; HACCP programs for all
 6   processors; written good safety plans showing how
 7   producers will comply with GAPs; third-party audits;
 8   traceback systems that include package identifiers so
 9   that each item can be traced all the way back to the
10   field in which it originated; FDA inspections at least
11   yearly, made possible by substantially increased funding
12   by Congress; and, finally, FDA enforcement that has
13   teeth.
14             The FDA's guidelines fall well short of
15   industry oversight.  They state, and I quote, FDA
16   guidance documents do not establish legally enforceable
17   responsibilities.  Instead, they describe the agency's
18   current thinking on a topic and should be viewed only as
19   recommendations.  The use of the word "should" in agency
20   guidance means that something is suggested or
21   recommended but not required.
22             I leave you today with a couple of one-
0141
 1   hundred-million-dollar questions from the consumer
 2   perspective.  First, why is the FDA only suggesting and
 3   recommending safe practices for the fresh-produce
 4   industry and not requiring them despite numerous
 5   incidents of contaminated fresh-cut produce reaching the
 6   marketplace and harming, even killing, consumers?  And,
 7   finally, how many more deadly outbreaks must there be
 8   before FDA's "should" becomes a must.  And their
 9   suggestions recommendations and current thinking become
10   rigorous mandatory oversight by a credible government
11   watchdog that is well-funded and adamant about
12   protecting the food supply and public health?  Consumers
13   are sitting on their pocketbooks waiting for the
14   answers.
15             Thank you.
16             MR. LANDA:  Questions?  Dr. Acheson.
17             DR. ACHESON:  Thank you for your comments.  We
18   appreciate it.
19             One of the points that you bring out is the
20   dilemma that consumers are facing in terms of the health
21   benefits of fresh produce versus the potential risks.
22   And essentially what that comes down to in my mind --
0142
 1   and I'm interested in your opinion -- is a relevant-risk
 2   argument.  Given as we have heard that reducing the risk
 3   of fresh produce to zero is essentially not going to
 4   happen in our lifetime, we will always be faced with a
 5   relative-risk message.  How, from your perspective, do
 6   you see that best communicated to the consumers?
 7             MS. ODABASHIAN:  Well, I think consumers
 8   understand that these products are grown in the outside
 9   external environment; and things happen in the external
10   environment.  But I think that we can expect that
11   contamination will be caught before it gets to the
12   marketplace.  We understand that contamination will
13   occur, but consumers have right to expect that it will
14   be caught before it gets to the marketplace.  And to do
15   that you need to put in a lot of steps, a lot of
16   tracebacks, a lot of inspections, a lot of rigorous
17   safety testing.
18             With regard to the message given to the
19   consumers, this has been one of the most difficult
20   messages to convey to consumers, because on one side
21   we're telling them that you can't stop eating vegetables
22   and fruits.  It's the most important thing that you eat
0143
 1   for a healthy life.  On the other side we have outbreak
 2   after outbreak and people are calling us hand over foot,
 3   writing our Web site, contacting us over and over
 4   saying, Well, what do we do here?
 5             And, you know, if it were -- with a lot of
 6   other food issues like, for instance, bovine growth
 7   hormone in milk, if consumers don't want that, we say,
 8   Well, you can go and buy a product that says "not
 9   produced with bovine growth hormone."  You can buy
10   organic.  If people want to avoid mad cow disease, if
11   they really are, you know, aimed -- you know, if they
12   really don't want mad cow disease, they can buy grass-
13   fed beef, they can -- not buy beef that has nervous-
14   system tissue in it.  There are things that they can do
15   to safeguard themselves from such horrors.  But with
16   this one we are left not being able to tell them
17   anything.  Because in essence it's a bit of a crap shoot
18   when you go to the grocery store and you buy a head of
19   lettuce; and you just can't know.  You can't know where
20   it came from, because it's not, you know, it doesn't
21   have a label on it.  So consumers are really sitting
22   ducks around this one.  And they really need
0144
 1   governmental intervention.  They need it rigorous and
 2   they need it mandatory.
 3             MR. LANDA:  Ms. Bohm.
 4             MS. BOHM:  You mentioned -- and you said other
 5   speakers have as well -- you've mentioned the need for
 6   increased oversight and increased number of inspectors
 7   and all kinds of things that mean an increased budget
 8   for that particular program.  Do you believe consumers
 9   are willing to pay the increased costs that this will be
10   generated not only by the government oversight but by
11   the required changes that would occur at the industry
12   level as they increase their testing and increase their
13   whatever?
14             MS. ODABASHIAN:  Absolutely, I believe it.  I
15   believe that consumers are willing to pay more if they
16   are guaranteed a safe product.  But what we don't like
17   is when some products in the marketplace are considered
18   safe because they have a certification mark and they're
19   probably more expensive, possibly; and others are not
20   safe because they don't have the certification mark.  We
21   want to make sure that there's a standard of safety for
22   everything in the marketplace.  But I do believe that
0145
 1   they would be willing to pay for that, yes.  And I
 2   believe Congress should give you more.
 3             MR. LANDA:  Dr. Buchanan.
 4             DR. BUCHANAN:  I'll going to ask a question
 5   that is in some way rhetorical, but I would appreciate
 6   your insight into this.  One of the things that FDA is
 7   faced with on a continuing basis is -- we will call them
 8   opposing activity.  We have the need to establish
 9   rigorous safety programs.  We also then must deal with
10   issues like the organic rule that comes out in
11   pertaining in terms of certain technologies, at least in
12   the view of consumers.
13             We have the need to be able in many ways
14   isolate food production area, but we have consumers
15   moving their suburbs into the rural areas so that we
16   interface two environments that should not likely be put
17   together.
18             We have concerns about the environment and
19   fostering wildlife habitat.  At the same time we know
20   that food -- production areas -- there's a potential
21   area of contamination.
22             Do you have any insight on how we bring these
0146
 1   issues before the consumer and articulate the trade-off
 2   that take place when you deal with these opposing risks
 3   that we're facing.
 4             MS. ODABASHIAN:  I would say that,
 5   unfortunately, the only way consumers learn about FDA is
 6   when they get sick from food or they read in the
 7   newspaper that a product has been recalled and one
 8   hundred fifty-eight people have been sicken across
 9   twenty-six states.
10             That's the only time most people even think
11   about the FDA.  And I realize you have lots to do, but
12   protecting the food supply should be goal number-one;
13   and consumers believe that strongly.  And most of them
14   don't realize that the safety standards for industry
15   producing food are not mandatory.  Most of them believe
16   that there is a government body who is rigorously
17   overseeing the safety of the food that gets to market;
18   and when they learn that that's not the case there's a
19   lot of anger.  We've experienced an enormous amount of
20   anger over the last six months from consumers whose
21   faith has been shattered by outbreak after outbreak
22   after outbreak on a product that they want to eat, they
0147
 1   should be eating.  And we don't know want to tell them,
 2   frankly.
 3             MR. LANDA:  Thank you very much.
 4             Dr. Harris, if you can come back, please.
 5             Questions for Dr. Harris?  Ms. McGarry.
 6             MS. MCGARRY:  Dr. Harris, you mentioned water
 7   quality and the effects of post-harvest cooling.  Can
 8   you talk a little bit -- or if you know -- a little of
 9   the science on the role of turbidity on the water
10   quality in this connection?
11             DR. HARRIS:  I think that that depends on the
12   microbial that's within the water and the turbidity.  I
13   think it's your monitoring system to ensure that the
14   level of a microbial is there in this function.  And I
15   can't say particularly.  I'm sure that turbidity has
16   some impact on water quality.
17             MR. LANDA:  Dr. Buchanan.
18             DR. BUCHANAN:  Linda, you graciously agreed to
19   participate in a research priority-setting activity a
20   few weeks ago to get a consensus on what are the
21   priority areas that need to be dealt with.  And I wonder
22   if you would reflect on that process and whether that
0148
 1   process should be used for a variety of other
 2   commodities.
 3             For the audience, I'm referring to an NHS
 4   activity that took place with tomatoes; and there seems
 5   to have been a very different approach to setting the
 6   research agenda for tomatoes, which was done on much
 7   more of a national level than there has been for leafy
 8   greens, which has been primarily set based on
 9   consideration of one region of the country.
10             Would you reflect on -- you've been involved
11   in both processes.  Could you reflect on that?
12             DR. HARRIS:  In fact, I was involved yesterday
13   in a process for strawberries, so I've had multiple
14   experiences.
15             I think that one of the reasons that the
16   research priorities were dealt with in California for
17   lettuce and leafy greens was because, as you've already
18   previously pointed out, this is where the problem was.
19   This is where it is.  And, quite frankly, the majority
20   of the industry is here.  And so by understanding how
21   the industry works here and what the issues are, what
22   the production practices are, I think we did have
0149
 1   national participation in that committee, including
 2   yourself.  As far as the tomato, you know primarily
 3   tomatoes and Salmonella have been an East Coast issue --
 4   Virginia, Maryland, and Florida.  And, primarily, the
 5   committee that met together was really focused on
 6   experts from those regions.  And I think with good
 7   reason.  I think it's good to get a broader perspective,
 8   but I think the process is actually easier in setting
 9   research priorities when you have a target to go after.
10             Yesterday we struggled a bit.  Strawberries
11   have not been associated -- fresh strawberries have not
12   been associated with outbreaks, so setting a research
13   agenda there was a little bit more of a struggle on what
14   you put first and second and third.  So with tomatoes
15   having Salmonella and leafy greens having E. coli, it's
16   been in some ways a little bit easier to identify what
17   you need to know to move toward.
18             I don't know if I answered your question.
19             MR. LANDA:  Additional questions?
20             Dr. Buchanan.
21             DR. BUCHANAN:  Totally separate one:  The
22   produce industry is enamored with water with washing
0150
 1   things.  It floats things.  It moves things around in
 2   streams of water, whereas, much of the rest of the food-
 3   processing industry has learned that in terms of safety
 4   you need to minimize water.  Is there much in the way of
 5   a research agenda finding alternate technologies that
 6   start to reduce the produce industry's reliance on
 7   water?
 8             DR. HARRIS:  Well, I think that was one of the
 9   things that was brought up with tomatoes.  One of the
10   reasons that water is used is because most fruits and
11   vegetables are exceptionally sensitive to bruising, so
12   water is used as a cushion and a way to gently move
13   product through a system.  I think another example comes
14   where you look at melons that are harvested directly
15   into a box or heads of lettuce that are harvested.  A
16   lot of products are harvested in compete absence of
17   water.  Melons could be harvested either into a packing
18   house where water is added or in a field.  I would agree
19   with you that although conceptually a wash step might
20   seem like a good idea, it also opens up opportunities
21   for contamination.  So in the melon case if your melons
22   are not in need of a wash step that might be a better
0151
 1   approach.  But, yes, I believe that people will be
 2   looking at reduced water use.
 3             MR. LANDA:  Any other questions?
 4             Thank you very much.
 5             We'll break for lunch.  Let's reconvene at
 6   2:15.
 7         (Lunch recess from 12:41 p.m. to 2:15 p.m.)
 8             MR. LANDA:  Our first speaker this afternoon
 9   is Amy Green, who is a consumer safety officer in the
10   office of Food Safety in CFSAN.  She is lead author of
11   the recently issued fresh-cut guidance that was
12   mentioned several times this morning.  She is going to
13   briefly summarize for us issues and questions posed in
14   the notice of hearing.  That will set the stage for the
15   public comment this afternoon.
16             MS. GREEN:  Welcome to the second part of our
17   program.  As Mike said, I'm going to talk to you about
18   issues and questions in the Federal Register notice.  I
19   just want to -- after that, we'll have a comment from
20   the public commenters.  If you remember, this second
21   half of the purpose of this meeting was to solicit
22   comments from the public.  So let me start with -- I'm
0152
 1   going to start with the issues.
 2             There are five issues in the Federal Register
 3   notice.  The first issue has a lot to do with risk
 4   factors.  There are four questions, so that one has more
 5   questions than any of the other issues.  The second
 6   issue has to do with FDA measures -- the measures that
 7   FDA has already taken and the measures that they may
 8   take in the future.  The third has to do with traceback
 9   and the challenges to tracking a product through the
10   supply chain.  The fourth issue has to do with records,
11   not the traceback records but the written food-safety
12   program SSOPs, monitoring records -- those types of
13   records.  Then the last issue has to do with
14   verification.  And it's verification that the good
15   agricultural practices have actually been following.
16             Issue 1 deals with risk factors throughout the
17   entire supply chain for each industry sector.  So this
18   is quite a mouthful.
19             Here's a very simple supply chain.  So the
20   risk factors we're talking about would be those that are
21   involved in production; and there are many steps through
22   production that you have to look at:  Harvesting; post-
0153
 1   harvest processes like cooling and packing; then
 2   processing, if it's a fresh-cut product; and all of the
 3   steps in processing from receipt to distribution.  Then,
 4   also, it includes the consumer -- going to the consumer
 5   and what kind of practices should the consumer use to
 6   prevent contamination from occurring.
 7             There are some risk factors that apply to
 8   multiple stages in the supply chain; and I've just
 9   picked three that we think are extremely important.
10   You've heard a lot about water today -- agricultural
11   water in production; processing water, processing fresh-
12   cut produce; or cooling water and cooling the produce in
13   a post-harvest practice.
14             The second risk factor is worker health and
15   hygiene; and I just want to add to that it's not just
16   worker health and hygiene; actually, it's food handler
17   health and hygiene and also food-safety practices that a
18   particular food handler uses.  That, you can see, would
19   apply to almost every step in the supply chain.
20             And then the last risk factor that I have up
21   here is the environmental sources of contamination,
22   which you know often are thought to be in the production
0154
 1   environment, but it can also mean the processing
 2   environment, the adequacy of sanitation programs to
 3   clean the facility.
 4             This is the first question in the four.  First
 5   issue:  What are the practices that contribute to risk?
 6   What are the risky practices at each stage of the
 7   produce supply chain?  So this question is basically
 8   identifying what the risk factors are throughout the
 9   entire supply chain.
10             And the second question is, How can we change
11   those practices to reduce risk?  What can we do?
12             And the third question:  What current
13   practices reduce risk?  And is there data to support
14   that, like data saying that GAPs guidance is being
15   followed?
16             Question 4 is -- and I think we heard Hank
17   talk about this a lot today -- is fresh produce or input
18   such as agricultural water sampled and tested for
19   pathogens or indicator organisms at any stage of the
20   supply chain?  If yes, then please describe the sampling
21   and testing done.  And we heard a lot about sampling and
22   testing that's being done with -- I guess -- in regards
0155
 1   to best practices that at least Western Growers are
 2   promoting.
 3             So sampling can be done at any point in the
 4   supply chain.  It can be done with -- actually, we just
 5   finished an environmental study on the Eastern Shore in
 6   pond water -- pond water that was used for irrigation.
 7   It can be done in the processing facility, on food
 8   contact surfaces, water.
 9             The second issue has to do with the FDA
10   measures.  And FDA has implemented a lot of different
11   measures and we heard about them from Michelle this
12   morning.  Some of the measures -- I'll just repeat what
13   some of the measures are:  The 1998 Good Agricultural
14   Practices Guide, the fresh-cut produce guide.  We've
15   issued quite a bit of guidance.  We've issued letters to
16   industry.  We also call that guidance to both the tomato
17   and lettuce industries and we developed the 2004
18   produce-safety action plan.  Last year we started the
19   lettuce and leafy-green initiative.  And, actually, the
20   public hearings were also some measures that were taken
21   to ensure the safety of fresh produce.
22             So what should we do next?  What new federal
0156
 1   actions are needed to enhance the safety of fresh
 2   produce?  Are there federal actions that are needed and
 3   where should they focus in the supply chain?
 4             There's wide variation in the industry.  How
 5   flexible should we be?  These are the types of
 6   variations.  I think we've heard about these too.  The
 7   size and type of establishments is really highly
 8   variable.  The nature of the commodities:  Is it grown
 9   on the ground?  Is it grown on a bush?  The practices
10   used in production change from commodity to commodity
11   and, as we heard today, from region to region.  And the
12   vulnerability of a particular commodity to
13   contamination.
14             One challenge faced by public health officials
15   during an outbreak is to quickly identify through
16   tracebacks the source of contamination.  When an
17   unpackaged or raw agricultural commodity is involved in
18   an outbreak, there may be several packing and repacking
19   establishments and multiple opportunities for mingling.
20   So traceback with produce is very difficult.  Produce is
21   perishable.  Some produce is not packaged or labeled.
22   Even with packaged and labeled produce, traceback can be
0157
 1   difficult because there may be insufficient records to
 2   identify the farm or field; and there may be
 3   discrepancies between the records of incoming and
 4   outgoing product.
 5             Question 7:  What types of records and other
 6   information from what types of facilities would be most
 7   useful in facilitating traceback efforts?  These are
 8   traceback records.
 9             Issue 4:  It's about records other than
10   traceback records, such as written food-safety plans,
11   SSOPs, monitoring records, training records, records
12   than can be used as tools for both industry and
13   regulators -- for industry, to conduct operations that
14   will enhance the safety of fresh produce and for
15   regulators to verify that certain practices are being
16   followed.
17             For growers, an assessment of field
18   environment and agricultural inputs is also important
19   because it could contribute to the development of
20   records, written food-safety plans, and SSOPs that it's
21   sort of like a hazard analysis in a hazard plan where
22   the grower will look at the process -- at the production
0158
 1   process -- and actually identify areas where controls
 2   are needed.  It could also help to determine what
 3   factors should be monitored and the frequency of
 4   monitoring.
 5             Question 8:  Are written food-safety plans,
 6   written SSOPs, periodic assessments, training and/or the
 7   establishment and maintenance of records useful for risk
 8   identification and risk mitigation or management
 9   purposes?  And to what extent are these practices in
10   place?  And in what sectors of the industry?
11             The fifth issue and the last issue has to do
12   with verification; and it's verification -- we have
13   heard today, too, that some buyers are now requiring
14   that producers and other suppliers provide self and/or
15   third-party audit verification that showed that they're
16   following the GAPs guide.  But we don't know how the
17   extent to which these verifications actually reflect
18   adherence to the guidance.
19             Question 9:  How should adherence to the GAPs
20   guide or new produce safety guidance be measured and
21   verified by the grower or operator, government
22   regulators, or third-party auditors in the event of any
0159
 1   new recommended federal action or in the event you are
 2   not recommending any new federal action?
 3             And the last question is, if you're
 4   recommending any new measures, describe how they may
 5   affect small businesses such as roadside stands, farm-
 6   gate operations, farmers markets, or other small
 7   businesses involved in direct sales.
 8             So that is all of the questions and issues.
 9   I'll just talk a little bit about the public comments.
10             Speakers will be limited to approximately five
11   minutes.  We have a little bit more time, but we are
12   going to try to keep you within five to ten minutes.
13   Speakers will be heard in the order in which they
14   registered, so as the speaker before you is ending his
15   or her comments then start making your way to the front
16   of the auditorium so you just speed up the process.
17             Now, these are oral presentations at a public
18   meeting, but we also are interested in getting whatever
19   data and information or comments that you have; and you
20   can submit electronic comments until June 13th to this
21   Web address.  This address is in the Federal Register
22   notice.  You can submit written opponents to this
0160
 1   address.  This is also in the Federal Register notice. I
 2   think everybody should have one if they have a packet.
 3   Make sure you include the agency name and docket number
 4   -- the docket number, again, is 2007N-0051 -- on your
 5   comment submission.
 6             MR. LANDA:  Thank you.
 7             First speaker this afternoon is Senator
 8   Florez, California State Senate.
 9             SENATOR FLOREZ:  Thank you very much.  I do
10   appreciate the opportunity to say a few words to our
11   FDA.  And I want to thank you for holding this public
12   hearing and creating a forum where all those that are
13   interested can come to speak on this very important
14   topic.
15             First and foremost, I should say that,
16   obviously, in California this is of great interest,
17   given the amount of spinach that we grow for the nation.
18   I should tell you that a very quick review of the
19   current history of this epidemic of E. coli shows that
20   government action, and government action alone, has been
21   the sole impetus for change in this industry.
22             And I'd like to tell you why.  I think it's a
0161
 1   question of what type of government action.  Obviously,
 2   we are in favor of the government action that is more on
 3   the demanding side rather than, if you will, on the
 4   asking side.  So let me go through and tell you why I
 5   believe that should be the case as we move forward.
 6             First and foremost, I want to say that the FDA
 7   issued voluntary good agricultural and manufacturing
 8   practices as far back as 1998.  In fact, in 2004 the FDA
 9   issued a product safety action plan, yet nothing
10   changed.  The FDA even sent two open letters to
11   California, one in February of 2004 and one in November
12   of 2005, raising concerns about continuing outbreaks,
13   yet nothing happened.  It wasn't until the FDA finally
14   put its foot down and issued a nationwide advisory
15   against eating bagged spinach did we see any significant
16   action by the industry.  And, in fact, in this case it
17   wasn't the marketplace that grabbed the industry's
18   attention.  Obviously, it was government action taking,
19   if you will, action on behalf of the health and safety
20   of consumers throughout the nation that made this
21   happen.
22             The only question I believe that should be
0162
 1   before you today is how long we have to wait until
 2   government steps up to the plate and takes serious
 3   action on this issue.  For consumers, this translates
 4   into the question of how many more people have to get
 5   sick; how many people will die; and, ultimately, what we
 6   need to do in government to best to protect them.
 7             I can tell you that the industry, which you
 8   probably heard today, has repeatedly made the argument
 9   that market forces are sufficient to cause change in the
10   industry and that we should rely somehow wholeheartedly
11   on the industry, in essence, to fix this epidemic
12   themselves.
13             I can tell you that the most obvious rebuttal
14   to this argument is the fact that we have had twenty-two
15   outbreaks of E. coli in leafy greens since 1995.  We
16   have had three outbreaks in the last six months alone.
17   And if market forces are going to work, they should have
18   worked by now; and they would have worked, but that has
19   not happened.
20             Maybe, hopefully, the industry will argue that
21   they have finally lost enough money to do something
22   about this this time.  But the question for many of us,
0163
 1   particularly in government, is how many more consumer
 2   deaths are acceptable?  Consumers, our citizens, deserve
 3   the best food safety system, not food safety determined
 4   by whether they are inside or outside of the acceptable-
 5   loss category.  Food safety by collateral damage, in our
 6   view, is not what people elected their government
 7   officials to protect them and provide for.
 8             However, the real fallacy of the industry's
 9   argument, in my view, is revealed when you look behind
10   the market forces that are actually behind the leafy-
11   green industry.  There are many market factors that
12   people don't talk about.  However, I think the most
13   important are actions such as was taken just today in
14   Los Angeles, where one large shipper said they would not
15   take product anymore, if you will, if it was grown with
16   recycled water or compost of a nature that would not
17   necessarily lend itself to health standards.  That is a
18   marketing force in itself.  They should change because
19   of that.  And, yet, when not everyone signs up for that
20   program, it leaves the window open for those to say that
21   this doesn't in any way a level playing field on which
22   to have, if you will, a standard that makes people feel
0164
 1   better about what is in their spinach.
 2             I can tell you that in our thought process, we
 3   are very culpable in government in terms of this
 4   particular issue.  I think the FDA needs to step to the
 5   plate.  I believe it's not enough to issue good
 6   agricultural and manufacturing processes to growers and
 7   processors, yet fail to mandate these practices and
 8   demand that they be implemented.  It's very good and
 9   fine that after seven years of issuing good agricultural
10   practices yet again.  But I think here is at this point
11   in time from our vantage point we have to say that we
12   have to make these mandatory.  And letters urging
13   California to do anything at this point, at least in
14   terms compliance, from my point of view in terms of this
15   are simply insufficient.
16             I can also tell you that California's
17   government is equally to blame.  The California
18   Department of Health Services and the Department of Food
19   & Ag repeatedly received warning letters from you folks,
20   the FDA, yet failed to take any necessary steps to
21   mandate compliance.  I learned in testimony before a
22   select committee on foodborne illness that the
0165
 1   Department of Health Services didn't even know whether
 2   it had followed up on investigations had been conducted
 3   on farms implicated in past E. coli outbreaks.  And, in
 4   fact in their testimony, they didn't know whether they
 5   had followed up; and after question after question, it
 6   started to concern us that when they issued reports on
 7   E. coli, when there are specific recommendations, and
 8   our own department of health services hasn't followed up
 9   to see if those changes have taken place that we have a
10   problem in the State House as well.  I can tell you that
11   what is even more concerting (sic) when corrective
12   actions were talked about at this hearing.  In fact, the
13   Department of Health Services detailed in their own
14   investigative reports that had been implemented in the
15   fields that these actions had not yet taken place and,
16   in fact, we believe that issuing broad recommendations
17   have no weight and, in fact, no enforcement value when
18   it come to our own investigations in the state.
19             As you probably know, we are waiting for the
20   latest report.  Apparently, there is a joint effort by
21   the FDA and the State of California.  We are still
22   waiting for those edits.  We are still awaiting the
0166
 1   report.  We are very anxious at the state level to have
 2   a hearing on that report, so I would urge you as quickly
 3   as possible to release that report so we can get on our
 4   business at the state to take this issue apart and put
 5   it back together and find out ultimately what is the
 6   best way to mandate, if you will, these practices that
 7   will give consumers the best possible produce.
 8             Let me also say that despite all of these
 9   outbreaks and these hearings, the California Department
10   of Health Services, the California Department of Food &
11   Ag, along with the Governor, continue to support
12   industry self-regulation in some sort of marketing
13   agreement.
14             Over the past few months I have heard a lot of
15   support for self-regulation based upon the speed of that
16   implementation; self-regulation is somehow the fastest
17   way to change the market.  And I can tell you at least
18   from my vantage point fast does not mean safe.  I think
19   at the end of the day, we are very interested in
20   anything that has a higher benchmark than speed.  And so
21   we should instead be asking ourselves, quite frankly,
22   what is the best plan?  What is the safest plan?  What
0167
 1   is the long-term plan in terms of making leafy greens a
 2   much better product in terms of California produce?
 3             I can't tell you that the current marketing
 4   agreement is good.  It covers about ninety percent at
 5   best.  And because it only covers ninety percent of the
 6   produce that comes out of California, I believe it gives
 7   us a ninety-percent plan.  And I believe that a ninety-
 8   percent plan is unacceptable.  I think what consumers
 9   absolutely want is a plan that covers industry one
10   hundred percent of the time.  That means, if you will,
11   that best plans guarantee that every farm every day have
12   these practices being implemented on a consistent basis.
13    I'm not sure we can say that under the current self-
14   regulatory marketing agreement -- the marketing-order
15   approach.
16             I believe that the only way to guarantee this
17   is thorough a government-mandated approach, obviously,
18   to make sure the State of California takes action.  And
19   in that regard we've introduced three bills.  I'm sure
20   you're all aware of them.  The bills, in essence, deal
21   with pre-outbreak authority to inspect growers; to test
22   water and soil and produce; as well as the power to
0168
 1   quarantine, destroy, and recall produce determined to be
 2   infected.  These are all powers the agency -- the
 3   Department of Health Services -- currently doesn't have.
 4   Our state veterinarian has those powers, but somehow our
 5   State Department of Health Services, when it comes to
 6   leafy greens and other types of produce, doesn't have
 7   that power.  We'd very much like them to have that
 8   power.
 9             I believe that just as milk is a product that
10   everyone counts on, no less so for produce, particularly
11   spinach.  We should have the same types of authorities
12   when it comes to produce in California.
13             Let me also say that the bills authorize, if
14   you will, and push forward good agricultural practices
15   in the form of regulation.  We want to make sure that
16   any good agricultural practices is put in statute, that
17   flexible regulations are put forth from that statute;
18   and those regulations allows, if you will, the science
19   to prevail on an ongoing basis.  So things are very
20   flexible but at the end of the day we need something to,
21   in essence, enforce.  And the only way to do that is to
22   make sure that there is something in law to enforce.  So
0169
 1   this bill would, in essence, allow those opportunities.
 2             I should also say that, obviously, good
 3   agricultural practices are very important to the state
 4   of California, to the industry, and to everyone in the
 5   State House.  However, they need to be in statute and
 6   they need to be put forth in terms of regulation and
 7   need to be enforced by health officials.
 8             The last bill of ours is something that I
 9   mentioned earlier and it has to deal with traceback. And
10   there's no doubt that as we wait for the upcoming report
11   on FDA/California, we need a better traceback system
12   that will allow us to, in essence, get to the processor,
13   the grower, the distributor, the retailer quickly; that
14   won't push us -- or you -- to actions that somehow
15   blanket the entire industry.  As has been mentioned, we
16   lost about a hundred million dollars in economic value
17   due to spinach earlier this year.  We think a traceback
18   system that is much more specific and modeled maybe
19   after the strawberry commission's traceback system would
20   work very well with leafy greens.
21             I've said enough, but let me simply say, if I
22   could, as I stated that the highest public official in
0170
 1   the State of California -- and that would be the
 2   governor -- and many of our federal representatives that
 3   the message on the wall is very clear.  We do not
 4   believe time is a luxury; and we do not believe that we
 5   can afford, if you will, a voluntary action that, if you
 6   will, a regulatory action is absolutely required in this
 7   case.  The next outbreaks really should not be on all of
 8   us who are, in essence, pushing a voluntary approach.  I
 9   think that the next outbreak will be on those who don't
10   mandate a better approach.  And I think that's all of us
11   here sitting here in government, particularly those who
12   are elected to protect the health and welfare of their
13   citizens.
14             Lastly, let me say that when we think about
15   those losses, we always turn back on our committee to
16   those who lose real children, real grandmothers, real
17   aunts and uncles and parents -- those who, in essence,
18   will look us in the eye and ask the question, Did you do
19   everything you could?  Have you done everything you
20   could have to make this product safe?
21             I think at this point in time, I don't believe
22   consumers have confidence because they're skeptical. And
0171
 1   they should be skeptical, because any plan that's less
 2   than a hundred percent is not going to bring back
 3   consumer confidence.  And I think at the end of the day,
 4   really beyond making a safe product that's what's going
 5   to make all of this process work much better.
 6             I can tell you that at least we're moving our
 7   bills through, that we're going to try our best.  We're
 8   going to push as hard as we can on the edges to have the
 9   highest standards.  We do appreciate all of the
10   statements by the FDA today that we'd better take this
11   seriously, we'd better have high standards, and we'd
12   better make sure that we enforce those.  And I can tell
13   you our bills attempt to do that.  Hopefully, we've
14   offered our best in that regard.
15             And I do want to thank you for having us; and
16   I appreciate the opportunity today.  Thank you.
17             MR. LANDA:  Thank you.
18             Is Mark McAfee here?
19             Edward Beckman from California Fresh Tomato
20   Growers.
21             MR. BECKMAN:  Thank you for this opportunity
22   to address the FDA as well as those who are in the
0172
 1   audience today.
 2             My name is Ed Beckman.  In my current
 3   position, I serve as President of California Tomato
 4   Farmers.  We are a cooperative that represents really
 5   about nine out of ten fresh tomatoes that are produced
 6   in California.  Previously I served as CEO of the
 7   California Tomato Commission, a mandated state program
 8   that developed the first commodity-specific GAP document
 9   back in 1999.  And in 2006 we were able to amend
10   California's agricultural code to strengthen the
11   traceback provisions as they applied to fresh tomatoes.
12   I am also cofounder of the North American Tomato Trade
13   Work Group, which goes by the acronym NATTWG.  It is an
14   association of producers from throughout North America
15   in response to the 2004 directive of the FDA to the
16   lettuce and tomato industries to develop commodity-
17   specific guidance documents.  We took charge of that
18   task, and I was the project leader.
19             I thought it would be appropriate to share
20   with you some of the lessons that we learned from the
21   development of this GAP document.
22             First off, we found out that adherence to GAP
0173
 1   is at the highest in California and also in Florida, the
 2   largest producer for fresh tomatoes.  The vast majority
 3   of producers at the time that we began the development
 4   of this document were already employing third-party
 5   verification of their GAP practices.  However, we found
 6   significant evidence to conclude that those who were
 7   smaller and more seasonal producers were not following
 8   GAP protocol in their production.  This, in part, was
 9   due to the fact that (a) the economy of scale of farming
10   were prohibiting that, at least in the growers' mind;
11   and, number two, that the sales to other than major
12   food-service and supermarkets did not require third-
13   party verification of their agricultural practices.
14             Another key issue that we learned in the
15   development of this GAP document was the fact that the
16   standards employed by the grower were not always
17   maintained in the distribution channel, meaning that
18   those actually who purchased and then resold the product
19   were often ultimately responsibility for quality.  We
20   found that traceback, or the lack thereof, was a concern
21   as well as certain practices related to fresh-cut
22   tomatoes, where ice baths were used to firm tomatoes for
0174
 1   slicing, which may increase risks.  Again, we found that
 2   standards employed by the grower were not always
 3   continued all the way through the distribution chain.
 4             I would say, since we began the development of
 5   that document back in 2004, there has been a significant
 6   advancement by the practices of industry.  We've also
 7   paid very close attention to what science exists; and
 8   now today we recognize the first GAP document that was
 9   produced just last year is now outdated.  And,
10   therefore, our members are now working with FDA and the
11   California Department of Health Services and our
12   counterparts in Florida as well as those from Mexico and
13   Canada as we form a team that will begin the development
14   of new guidance in a very transparent environment.
15             That said, there are farmers who want more --
16   farmers who want a national standard.  And because of
17   that fact the members of California Tomato Farmers this
18   year are moving to mandatory GAP, starting in June.  We
19   are doing so because there is no mandatory GAP standard
20   and it is unlikely that we will see a standard in the
21   near term.  Our members believe that it is time to
22   become more proactive on the establishing and
0175
 1   endorsement of such standards.  And this is a supply
 2   effort that is taking place today on the other side of
 3   the country in Florida, where there is now pending
 4   legislation that will require production under verified
 5   good agricultural practices that would become effective
 6   this fall.
 7             So, again, the California Tomato Farmers begin
 8   this summer employer mandatory GAP in the production of
 9   our tomatoes.  To ensure compliance, we'll include
10   verification by government authorities.  And the metrics
11   we will be using will be based very much upon a national
12   standard that is under consideration by both California
13   and Florida, with the understanding there must be
14   consideration given to the production practices in each
15   state.  However, the problem we have now is with
16   California and, also, with Florida moving to mandatory
17   GAP, we have roughly seventy percent of the tomatoes in
18   the United States produced under mandatory GAP
19   standards.  It does represent an impressive start.
20   However, we were very much in agreement that when we
21   decided to go down the path towards mandatory GAP, there
22   was much more to be done; and, therefore, we do
0176
 1   represent, again, nine out of ten tomato growers in the
 2   state saying that we believe there needs to be a move to
 3   a mandatory standard that is based upon sound science,
 4   one would that require production under GAP by all
 5   tomato producers in all states, and, further, that
 6   imports that supply upwards of thirty percent of the
 7   nation's supply of fresh tomatoes be subject to the same
 8   standards.
 9             We're committed to finding a short- and a
10   long-term solution to the problem.  We recognize that
11   there are environmental factors in the East, which you
12   heard about this morning, where most of the outbreaks
13   involving fresh tomatoes have originated, are the
14   primary cause of Salmonella.  However, we also believe
15   that all growers, no matter where you produce, must
16   learn from these unfortunate events and understand the
17   risks that can exist in production.
18             As you also heard this morning, in response to
19   the concerns of the tomato industry, in the last month,
20   the Maryland Joint Institute for Food Safety and
21   Nutrition, the University of Florida, and FDA held a
22   workshop to prioritize the research needs of the
0177
 1   industry related to reducing if not eliminating the
 2   food-safety contamination at any point in the production
 3   and distribution chain of fresh tomatoes.  There are a
 4   number of questions today that we don't have answers
 5   for.  And that, we believe, should be just as much of a
 6   priority as seeking regulation of tomato production
 7   based upon a mandated GAP program.
 8             Briefly, several issues that I think warrant
 9   further investigation:
10             Are there specific seasons, microclimates, or
11   weather events associated with the contamination of
12   tomatoes?  Previously, the identification of such risk
13   factors could lead to practical guidance.  Such guidance
14   would be an important determination in the development
15   of different implementation and intervention strategies
16   for the various production regions.
17             Number two, what vectors and vehicles are
18   important in transmitting pathogens to tomato plants and
19   fruits?  A number of scenarios have been presented;
20   however, we don't fully understand the importance of
21   those vectors and vehicles; and without such knowledge
22   the science-based selection of risk-mitigation
0178
 1   strategies is not possible and we're using a much less
 2   focused approach than we would like.
 3             And, number three, what are the cooling and
 4   cold-chain requirements that are needed to prevent
 5   growth of pathogens on tomatoes?  As I've indicated,
 6   what we learned from the development of the first GAP
 7   document is that there were not consistent practices all
 8   the way through from farm to fork.  And that is a
 9   concern.  There's very little information available to
10   assess what portion of the microbiological food-safety
11   risks associated with tomatoes are due to inappropriate
12   temperature being both too warm or too cold.  And that
13   is a question that needs to be answered.
14             I will also say that these three issues only
15   represent the beginnings of the research.  The question
16   is, of course, where are all the funds going to come
17   from to be able to go out and find the research as well
18   as the researchers and the funding mechanism to complete
19   this task.
20             So, in summary, while the fresh tomato
21   industry, I believe, has responded to the conditions
22   that FDA represented in their 2004 letter to the
0179
 1   industry that we develop commodity-specific guidance
 2   guidelines, I believe that we are going past that.  We
 3   are joining with our counterparts in Florida to enact
 4   mandated GAP.  We recognize still only that's only one
 5   step toward finding a final solution.  That final
 6   solution, we believe, requires a national action plan.
 7             A second guidance document is under
 8   development.  We hope to have that published by the end
 9   of this year.
10             And then, again, one major task that I would
11   ask you to take into consideration -- and that is the
12   need to better understand the problem at hand and how we
13   can craft a long-term solution.  We believe that
14   research represents a major task that will provide a
15   true long-term solution to the issue of food safety in
16   the United States.
17             Thank you.
18             MR. LANDA:  Thank you.  Can you stay for some
19   questions?
20             MR. BECKMAN:  Yes, I can.
21             MR. LANDA:  Any questions?
22             Ms. McGarry?
0180
 1             MS. MCGARRY:  Traceback of tomatoes and other
 2   produce classes as well has been challenging.  What are
 3   some of the efforts being put forth in your industry to
 4   improve the traceability of tomatoes?
 5             MR. BECKMAN:  Well, there are several issues.
 6   One in California we went to actually -- carton labeling
 7   provides grower and lot identification.  The biggest
 8   challenge that we have has been in the commingling of
 9   product at the repack level; and that remains a concern.
10             The basis for our discussions has been with
11   the trade -- those who are involved in handling our
12   product -- to understand that any commingling of product
13   -- for example, the commingling of product that was
14   washed versus unwashed -- poses an unreasonable risk. 
15   We also addressed with USDA as well as PACA the whole
16   issue of the problem of product commingling. Again, I
17   don't think there's a final solution yet on that issue.
18             MR. LANDA:  Mark Roh.
19             MR. ROH:  Thank you.  You mentioned that with
20   your partners in Florida you were developing mandatory
21   GAPs.  Is that through some sort of state legislation or
22   some other mechanism?
0181
 1             MR. BECKMAN:  Mandatory GAP in Florida is
 2   being developed through state legislation.  In
 3   California, we have formed an agricultural cooperative
 4   that makes GAP, as well as verification by USDA in
 5   addition to other third-party auditors, a requirement
 6   for membership in the cooperative.
 7             MR. LANDA:  Dr. Buchanan.
 8             DR. BUCHANAN:  Earlier in your comments you
 9   indicated that you had done some work examining what
10   percentage of people in the tomato industry were
11   following GAPs in California.  Do you have any -- is any
12   of that data available?  And can you share that with us?
13             MR. BECKMAN:  There was research that was done
14   two years ago at the time the letter came out from FDA
15   in 2004 to determine what the compliance rate was.  At
16   that time the compliance rate was estimated at eighty
17   percent.  We estimate that has now increased.
18             MR. LANDA:  I think you mentioned in Florida
19   as well in terms of evaluating adherence.  Was that also
20   eighty percent?
21             MR. BECKMAN:   I can't speak to what the level
22   of GAP implementation adoption was in Florida at the
0182
 1   time of the survey.
 2             MR. LANDA:  Ms. Bohm.
 3             MS. BOHM:  You mentioned that tracebacks, or
 4   the lack of tracebacks, was a concern.  Would you be
 5   able to specifically comment on what could improve that
 6   situation in fairly specific terms?
 7             MR. BECKMAN:  Well, I think the specific issue
 8   we must look at is what is done at the repack levels to
 9   provide positive lot identification and simply to
10   prohibit the commingling of product.  That is a common
11   trade practice that needs to be concluded.
12             MR. LANDA:  Any other questions?
13             Thank you, Mr. Beckman.
14             The next speaker is James Gorny, with the
15   United Fresh Produce Association.
16             DR. GORNY:  Good afternoon.  My name is Dr.
17   Jim Gorny. I am the senior vice-president of good safety
18   and technology for United Fresh Produce Association.
19             Our trade organization represents more than
20   twelve hundred growers, packers, and shippers of fresh-
21   cut fruits and vegetables as well as raw agricultural
22   commodities.  This accounts for the vast majority of
0183
 1   produce grown and shipped in the United States.  We
 2   bring together companies across the produce supply chain
 3   from farm to retail including all produce commodities,
 4   both raw agricultural products and fresh-cut ready-to-
 5   eat fruits and vegetables from all regions of
 6   production.
 7             I mention these characteristics today because
 8   our organization's views on food safety are shaped by
 9   this broad, diverse membership across the entire produce
10   industry, not by one sector or one region of the
11   industry.  Within our industry there is always diverse,
12   robust, and strongly held views on every issue,
13   including food safety.  Our association attempts to
14   develope the best overall industry policies and
15   practices to best serve the American consumer.
16             Let me begin by repeating something that's
17   been said many times and will be said many times again
18   and again.  Food safety is our industry's top priority.
19   I personally know many of the men and women who grow,
20   pack, prepare, and ship product; and they are committed
21   to providing consumers with safe and wholesome products.
22             I would also like to say that the spinach
0184
 1   outbreak last fall was a tragic occurrence.  And on
 2   behalf of the entire industry, let me say that our
 3   hearts go out to all those who became seriously ill or
 4   died.
 5             We can never forget the real human impact when
 6   something goes wrong in our food system.  That's what
 7   drives food safety to be a process of continuous
 8   improvement and not a static achievement.  We are on a
 9   continuum, constantly striving towards perfection; but
10   we heard earlier today that, scientifically, perfection
11   and zero risk is simply not possible.  American
12   consumers safely consume over a billion servings of
13   fresh fruits and vegetables every day.  But our industry
14   cannot rest when even a rare outbreak in the food-safety
15   system can cause such an impact on human health and
16   well-being, such as was felt last fall.
17             Let me allay any concerns that our industry
18   has just now begun to address the food-safety issue. Our
19   association first published food-safety guidelines for
20   the fresh-cut produce industry over fifteen years ago,
21   in 1992.  We are now on our fourth edition.  We also
22   work with Western Growers and others to provide good
0185
 1   agricultural practices in the mid '90s.  And our mission
 2   has been to serve the American public for many years. 
 3   When a tragedy such as the E. coli O157:H7 outbreak
 4   occurs, we're committed; and that's why we're here
 5   today, to learn all the lessons possible and incorporate
 6   what knowledge we can learn into the continuing process
 7   of improvement.
 8             I want to address two main points today.
 9   First, I want to talk specifically about what our
10   industry has done since the outbreak and what we are
11   doing to improve food safety.
12             And, second, I want to share what our
13   association's views are on the most appropriate produce-
14   safe regulatory framework to protect public health. 
15   When the spinach outbreak occurred, our entire industry
16   immediately pulled all spinach from the shelves
17   nationwide and cooperated fully with FDA in tracking
18   this problem back to its source.  That total industry-
19   wide shutdown was, quite frankly, unprecedented in
20   response.  But FDA felt it was necessary until they were
21   certain that any and all contaminated product was
22   removed from the marketplace.
0186
 1             In fact, we now know that the only
 2   contaminated product came from one fifty-acre farm,
 3   packaged in one processing plant, and only on one
 4   production shift.  That's out of more than 300,000 acres
 5   of lettuce, spinach, and leafy greens grown in the
 6   region, where this product was grown in dozens of
 7   processing plants around the country.  But when faced
 8   with an immediate public health question, we agreed with
 9   the FDA to err on the side of caution.
10             Once we averted the outbreak, our industry
11   also immediately began a comprehensive reevaluation of
12   spinach production, handling, and processing to make
13   sure that we are taking all the appropriate steps to
14   assure the safety of these products.  This included not
15   only the company directly involved in the outbreak but
16   companies throughout the spinach supply chain that were
17   growing and processing in this sector.  While the source
18   of the outbreak itself proved to be narrow, the entire
19   industry joined together to make sure we collectively
20   addressed all the common risk factors that can be
21   associated with fresh leafy greens which are grown
22   outside in nature and consumed without cooking.
0187
 1             This effort has led to important initiatives
 2   spearheaded by the lettuce and leafy-greens industry to
 3   adopt stringent food-safety measurement criteria which
 4   can be implemented and verified across this sector of
 5   the industry.  The California Department of Food and
 6   Agriculture has recently adopted a lettuce and leafy-
 7   greens marketing agreement which will serve as a means
 8   of verifying rigorous compliance of safety for lettuce
 9   and leafy greens from this major production region.
10             We also believe similar standards must apply
11   nationally and internationally; and I'll address those
12   issues specifically in a moment.  What we have developed
13   are scienced-based standards, including careful
14   attention to site selection for growing fields based on
15   farm history, proximity to animal operations,
16   appropriate standards for irrigation water and other
17   water that can come in contact with crops; prohibition
18   of raw manure with use of only certified safe
19   fertilizers; good employee hygiene in the field
20   handling; and, of course, strong food-safety controls in
21   all food-processing plants.
22             Under the leafy-greens agreement, handlers
0188
 1   will be audited by the CDFA to ensure that they are
 2   complying with these standards; and they will face
 3   penalties if they are found not to be in compliance --
 4   and the ultimate consequence of not being allowed to
 5   sell their product if they don't comply.  Taking this
 6   step toward self-regulation for the private industry
 7   sector has been not been an easy task.  But we believe
 8   this is a critical step in continuing to assure the
 9   public that our industry is doing everything possible to
10   make our product safe.
11             I want to publicly recognize those brother
12   shippers and processors of leafy greens who have made
13   this commitment.
14             Stepping out now to a national and multi-
15   commodity perspective, I can tell you that many other
16   sectors of our industry are pursuing similar efforts to
17   define and implement and verifying best practices from
18   field to table.  We've heard about a number of those
19   today from the tomato industry, both in Florida and here
20   in California.
21             Also, I had the opportunity to meet with
22   growers in New Jersey a few weeks ago, where a new food-
0189
 1   safety task force has been put together by their
 2   department of agriculture and is looking at specific
 3   GAPs and training programs for growers.  Another good
 4   example is the Georgia Fruit and Vegetable Growers
 5   Association, which has its own GAPs training program to
 6   help small growers in the state to better understand and
 7   apply best practices.  All these efforts represent
 8   industry-led initiatives to further reduce risk and
 9   ensure the safest possible produce for the public.
10             It's within this context of all these
11   industry-driven numbers that I turn now to discuss what
12   we believe to be the most appropriate regulatory
13   framework for fresh-produce safety.  While there's much
14   our industry can and must do, we also have to recognize
15   the important role of the federal government.  Today our
16   country faces a critical public health challenge to
17   increase our consumption of fresh produce.  The 2005
18   U.S. dietary guidelines calls on all Americans to
19   literally double their consumption of fresh fruits and
20   vegetables.  And now our nation is faced with an obesity
21   crisis that threatens the long-term health of our
22   children unless we radically change our eating habits
0190
 1   and help them make good lifetime choices.
 2             I'm here today because I fear that if we not
 3   ensure public confidence in the strong, credible, and
 4   comprehensive food-safety regulatory framework, we are
 5   putting that goal at risk.  It is simply unacceptable
 6   for Americans to fear consuming the very fruits and
 7   vegetables that are essential to their good health.  Our
 8   industry can have but one goal in food safety; and it
 9   starts with the consumer.  We believe consumers must be
10   able to shop at any grocery store, order produce at any
11   restaurant with complete confidence in the produce
12   selection, that it is safe and wholesome for them to eat
13   and a healthy choice.  Put simply, fear has no place in
14   the produce department.  Whatever the risk that might be
15   present must be viewed as an acceptable risk, based on
16   strong government assurance that proper food-safety
17   systems are in place and that the benefits of
18   consumption far outweigh the low risk.
19             I'm personally confident about the choices
20   that I make today because I know many of the people who
21   grow, ship, and process produce items.  I know a lot
22   about the industry.  I know about the practices that
0191
 1   have been implemented, all the measures that they're
 2   taking to assure produce and food safety.  I also know
 3   how our team at United Fresh is working to make sure
 4   every corner in our industry is focused on food safety.
 5   But no matter how hard our industry works, public
 6   confidence ultimately depends on government as the final
 7   health and regulatory authority.  They must determine
 8   that proper food-safety standards are in place and that
 9   they ensure they are being met.
10             Let me review three key principals we believe
11   at United Fresh to be critical for our nation's food
12   supply regulatory framework.
13             Number one, we need consistent produce food-
14   safety standards.  We believe produce food-safety
15   standards must be consistent for individual produce
16   commodities grown anywhere in the United States or
17   imported into this country.  Consumers simply must have
18   confidence that the safety standards are met, no matter
19   where the commodity is grown or processed.  Because of
20   the variation in our industry's growing and harvesting
21   practices in different climates and regions, flexibility
22   is very appropriate and necessary.  For example, some
0192
 1   production areas use deep wells for irrigation while
 2   others use river water supplied by dams.  Some farmers
 3   use overhead-sprinkler irrigation.  Others use drip
 4   systems laid on the ground.  Other use furrow
 5   irrigation.  But the common factor must be that all uses
 6   of water for irrigation must meet safety standards that
 7   protect the product.  That must be true whether the
 8   product is grown in California, Florida, New York, or
 9   Mexico.  We strongly applaud the industry groups in
10   different states and regions that are working to enhance
11   local practices.  Their work demonstrates the industry's
12   commitment to do all that we can to enhance safety in
13   growing and handling.  But to build consumer trust,
14   strong scientific standards that were developed for one
15   region can only be successful if applied consistently
16   across the industry.
17             Our second major point:  Federal oversight and
18   responsibility.  We believe achieving consistent produce
19   safety standards across the industry requires federal
20   government oversight and responsibility in order to be
21   most credible to consumers and equitable to producers.
22   We believe that the USFDA, which is the public health
0193
 1   agency charged by law with ensuring the safety of the
 2   nation's produce supply, must determine appropriate
 3   nationwide safe standards in an open and transparent
 4   process with full input from states, industry, academia,
 5   consumers, and all affected stakeholders.  We are strong
 6   advocates for food-safety standards based on sound
 7   science and clear consensus of expert stakeholders; but
 8   in a situation where science tells us that there can be
 9   no such thing as zero risk and there is no cooking step
10   for our products, the public must be able to trust an
11   independent, objective government body as ultimate
12   arbiter of what is safe enough.  In the future we must
13   be able to stand side by side with government to
14   reassure the public that together we have done
15   everything necessary to implement and comply with strong
16   mandatory government standards that protect public
17   health.
18             Let me say here a word specifically about the
19   role of USDA in helping the industry enhance safety.
20   USDA is a strong ally and offers a number of means to
21   assist the produce industry in safely growing handling
22   and processing fresh produce.  First, as a diverse
0194
 1   agricultural industry, marketing orders have been an
 2   extremely useful means of setting quality standards,
 3   conducting research, and promoting specific commodity
 4   groups.  These orders fall under the agricultural
 5   marketing services of USDA and are increasingly being
 6   looked at as a potential means to stimulate good food-
 7   safety practices as well.  Growers of the commodity can
 8   come together and vote to require specific practices
 9   that then become mandatory for all growers of that
10   commodity.
11             In addition, USDA through AMS offers auditing
12   programs that assist the industry in measuring GAPs,
13   good handling practices, and HACCP programs in
14   processing plants.  These are good educational training
15   programs as well as a means to measure individual
16   operators' understanding of implementation of food-
17   safety practices.  We believe these programs can be
18   helpful.  They are an important element in enhancing
19   good food safety.  Yet these programs are an important
20   means for specific sectors of the industry to enhance
21   performance; and long-term public trust requires that
22   FDA set the most appropriate regulatory safety
0195
 1   standards.  That is simply a call the industry cannot
 2   make alone.  FDA must have the ultimate responsibility
 3   to ensure that the industry is complying with these
 4   standards.  That does not mean that FDA has to hire five
 5   thousand new inspectors to visit every farm in America
 6   or travel around the world.  But it does mean that FDA
 7   must have relationships with other governments, the
 8   USDA, state agriculture, and regulatory officials to
 9   ensure that compliance is taking place.
10             Cooperative agreements that were discussed
11   earlier today between FDA and the states have been in
12   the past extremely effective in providing oversight of
13   food-safety standards.  Our analysis -- our legal
14   analysis -- is that FDA does have the regulatory
15   authority today to promulgate any needed rules and
16   regulations; issue guidance that compels industry to
17   action; enter into agreements with states to provide
18   field investigations; and generally set all necessary
19   standards to protect public health.
20             Thirdly, the third important aspect of our
21   vision is commodity-specific scientific approach.  We
22   believe food-safety standards must allow for commodity-
0196
 1   specific food-safety practices based on the best
 2   available science in a highly diverse industry that's
 3   more aptly two or three hundred industries, not just
 4   one.  For example, food-safety requirements for products
 5   grown close to the ground versus tree crops need to be
 6   significantly different because the risk factors are
 7   different.  This will be an extremely important point in
 8   looking at the produce and looking at produce food
 9   safety in the future.  Government and industry alike
10   must be careful that broad strokes do not result in
11   requirements that should not apply to specific
12   commodities and do nothing to enhance food safety.
13             We support the FDA's scientific approach --
14   and, finally, a few short words about the fresh-cut
15   guidance document.  We support FDA's approach to address
16   specific standards for fresh-cut processing as contained
17   in the agency's fresh-cut guidance document.  We
18   strongly support HACCP and processing plants.  Though
19   there's been criticism of this document, that it is not
20   mandatory, we believe that it essentially provides an
21   interpretation as to what processors must do to comply
22   with 110 CFR -- or 21 CFR 110.
0197
 1             In conclusion, let me return to the important
 2   role of fresh fruits and vegetables in public health --
 3   and we've got to assure public health.  Of course any
 4   reasonable person in the food industry would want
 5   produce not only -- would want to produce only the
 6   safest possible product.  But for us somehow it seems
 7   even more important because of the healthfulness of the
 8   products we introduce.  With that public health
 9   imperative, we simply cannot allow fears of food safety
10   to keep people away from fresh produce.  We as an
11   industry must do all we can to prevent these illnesses
12   and working hand in hand with government.  We pledge to
13   support government efforts to provide a long-term
14   regulatory framework that assures the public that
15   appropriate safety standards are in place and are being
16   met by the industry.  But together we can help consumers
17   enjoy an ever increasing array of safe, healthy, and
18   nutritious fruits and vegetables.
19             And I thank you for your time.
20             MR. LANDA:  Thank you.
21             Any questions?  Dr. Acheson.
22             DR. ACHESON:  Dr. Gorny, thank you for that.
0198
 1             What's your opinion of a mandatory HACCP or
 2   HACCP-like program on the farm?
 3             DR. GORNY:  It's a very good question.
 4             I think we need potentially -- we need to not
 5   confuse the difference between a HACCP-based approach
 6   and a true HACCP program.  I find it very difficult to
 7   understand how we could have a HACCP program on the farm
 8   based on the seven items outlined by NACNIF.  I think we
 9   can have a HACCP risk-based approach but I truly doubt
10   we can ever have HACCP on the farm.  It's certainly
11   applicable to food-processing plants.
12             DR. ACHESON:  As a follow-up to that, then
13   would you advocate that?  A mandatory HACCP-like
14   approach?  I think that's what you just said -- on the
15   farm?
16             DR. GORNY:  A HACCP-based approach definitely.
17   I don't know another way to approach it.
18             MR. LANDA:  Mandatory?
19             DR. GORNY:  Mandatory HACCP-based approach?  I
20   think it's the only way to do it.  You've got to look at
21   all the risk factors.
22             MR. LANDA:  Thank you.
0199
 1             Dr. Buchanan.
 2             DR. BUCHANAN:  Doctor, I'm a little puzzled by
 3   one of your comments, where you desire to have an
 4   oversight involvement by FDA in ensuring the safety of
 5   products.  A lot of this will be at some point feet on
 6   the ground.  That in no way indicated that we ought to
 7   have more inspectors.  You sort of implied that that was
 8   not a necessary component.  And I'm just tying to figure
 9   out how the numbers add up.  We --
10             DR. GORNY:  Understood.  I had to skip through
11   that part.
12             Certainly I believe that FDA needs more
13   resources.  We need commitment from the Congress to
14   provide more resources to FDA.  The President needs to
15   make that commitment.  But we don't understand how it
16   would be possible to have FDA solely involved in produce
17   food safety.  We believe that state cooperative approach
18   is probably the most appropriate, involving state
19   government, involving local government, because it is --
20   agriculture is just so diverse.  So if you'd like to
21   have five thousand inspectors, I guess that's a
22   possibility, but I don't understand how that would work
0200
 1   potentially.
 2             DR. BUCHANAN:  I think the concern is we don't
 3   need another unfunded mandate.
 4             DR. GORNY:  You have every right not to want
 5   an unfunded mandate and I absolutely believe that more
 6   appropriations are needed by FDA for research and/or
 7   compliance.
 8             MR. LANDA:  In your model, then, would FDA
 9   perhaps serve an auditing function for whoever did the
10   inspections?
11             DR. GORNY:  I really couldn't say what the
12   model would look like at this point, but it certainly
13   probably needs cooperation from state government as
14   well.
15             MR. LANDA:  Ms. McGarry.
16             MS. MCGARRY:  One of your comments you
17   mentioned that there's in the spinach outbreak, one
18   ranch with basically the outbreak strain.  What are your
19   thoughts about the fact that there are other ranches
20   that had the 0157 but not the outbreak strain and what
21   that means for (inaudible)
22             DR. GORNY:  It's my understanding that there
0201
 1   were four ranches that were implicated -- that 0157:H7
 2   was found on adjacent land.  It was not found on the
 3   ranch itself, but until we see the final report, I'd
 4   hate to speculate.  Obviously, it's disconcerting; and I
 5   think that it points out some of the issues that Dr.
 6   Harris brought out is when do these pathogens stop
 7   becoming fecal pathogens and when do they start becoming
 8   environmental pathogens?  So I guess we have to wait
 9   until we see the final report.
10             MR. LANDA:  Ms. Bohm.
11             MS. BOHM:  You mentioned some programs that
12   were going on in New Jersey and Georgia as examples of
13   some of the good things that were being done.  Were
14   there specific programs or whatever that they're doing
15   that you think should be and could be applied on a
16   national basis?
17             DR. GORNY:  I think what's important is that
18   we have to look at the diversity of agriculture in these
19   various states.  I think it's very important that it is
20   being done on a regional basis, like in Georgia. They're
21   dealing with environmental conditions that are specific
22   to Georgia.  They're dealing with small growers. 
0202
 1   Basically what they are doing is educational outreach at
 2   a grassroots level, but we applaud them.  I don't know
 3   if we really need to blow that up to a national level,
 4   but I think we need to encourage a lot of grassroots
 5   outreach at the regional levels to deal with that
 6   diversity in the industry.
 7             MR. LANDA:  Thank you, Dr. Gorny.
 8             Our next speaker is Richard Ross of Path
 9   Tracer.
10             MR. ROSS:  I'll try to keep this as succinct
11   as possible.  My name is Richard Ross.  My company is
12   called Path Tracer.  I come from Dallas, Texas.  And I
13   spent over thirty years in the food-manufacturing
14   business.  I'm also a landowner and grow wheat and
15   soybeans.  And I'd like to spend a little time with you
16   today about traceback -- the third element of the
17   certification process.
18             The verification process, as everyone is
19   trying to do -- you've got third-party audits associated
20   with it.  You've got the best practices.  And the
21   tracebacks and that's what I want to visit with you
22   today about, where you can certify the hard work and
0203
 1   reap the benefits.
 2             In my opinion, six months of investigation and
 3   six weeks of lost sales is just not appropriate.  What
 4   that tells me is that the reactive ability of traceback
 5   is not the way to go.  I call that the "shoebox method,"
 6   where you go and you say, I need to find about so-and-
 7   so.  And you look and you go, There's my shoebox. I'll
 8   bring that down and let's see if we can find things.
 9             That's substantially inappropriate.  With
10   today's modern technology and the way things are today,
11   we should be able to do a proactive approach to
12   traceability.  The proactive approach lets you control
13   what you do, show exactly what you do, why you do it,
14   and be able to prove that in the way of a certification
15   process to your customers and for them to be able to
16   show their customers.  I believe it's the only way
17   really we should look at traceback.
18             The advantages are that buyers and sellers
19   have a transparent relationship.  If you deliver
20   something to a customer and you got a code date, they
21   can go into your Web site, drill right on down, and see
22   exactly what you did with that particular crop and what
0204
 1   you did with the people that you had.  Look at all the
 2   best practices.  Look at all the tests associated with
 3   it, because the program also has a limb system
 4   associated with it; all the things that are necessary
 5   for you to know about that particular product that was
 6   delivered to you yesterday or today is every bit of
 7   information you need for traceback and all.  And it is
 8   computerized.  The tracebacks can take minutes.
 9   Basically it's -- as the gentleman already said, it's
10   not a punch of the button -- yeah, it really is.  It's
11   the punch of a button.  You can go all the way back.
12                   (cellphone interruption)
13             My wife.
14             So let's talk about the ability to look at it.
15   The traceback and adding to food safety.  This
16   particular graph came from the California Davis folks.
17   And you can see what it does is, as the degree of
18   traceability of the farms increase, the safety of the
19   products increase.  This is what the designer of this
20   graph -- I asked him specifically, you know, traceback
21   adds to food safety.  What kind of traceback?  And he
22   said, Oh, just traceback.
0205
 1             Well, it's my opinion that if you do a
 2   proactive traceback system, you're going to be able to
 3   increase the safety of your products by at least another
 4   half percent or so.
 5             Let me explain why that is.  If you're
 6   certified and your products are certified and your
 7   competitor is not, you have market advantage over the
 8   other guy.
 9             What I have to tell you is that in my thirty
10   years in the business, I was investigated by the FDA one
11   time; and if I say something bad I apologize -- and it
12   was not a pleasant experience.  I was down for three
13   days.  I had customers that were screaming, yelling.  It
14   was terrible; and after all that was over, I'm never
15   going to have that happen again.  So we started document
16   -- this is back in the '80s -- we started documenting
17   all of our activities.  We started watching to see what
18   we were doing, why we were doing it, and what tests were
19   being done to make sure that what we were doing was
20   appropriate.
21             Well, it took about three months, but it was
22   just amazing what we found throughout this time.  We had
0206
 1   people taking short cuts we didn't know about.  We had
 2   people that were doing all sorts of strange things that
 3   just -- there's just no particular reason.  And what we
 4   were able to do was to turn that around and make more
 5   money than the other guy.  This business we had in
 6   Lincoln, Nebraska, had no business being there.  But we
 7   were able to, using these methods, sell to companies
 8   that we shouldn't be selling to.  We were selling to
 9   companies in Asia.  We were selling in Europe, selling
10   all over the United States -- the General Mills, the
11   Pillsburys of the world.  And probably the one I like to
12   brag about the most is the fact that we had the folks
13   from Campbell Soup say that we were the only supplier
14   they would use for their products for six months,
15   because we were the only ones that had product that fit
16   their specification.
17             Now, I think that speaks volumes for the
18   profitability that you can have if you try to certify
19   yourself or if you have everybody along the process to
20   certify themselves all the way through the end-user.
21             Now, if you're certified -- and even more than
22   certified -- you can sell to anyone.  Your products can
0207
 1   be taken care of by almost anyone in the United States
 2   and potentially, if you export, you can take care of
 3   anywhere else you'd like to go.  So when you verify
 4   yourself and you have traceback associated with it,
 5   that's your first number-one option; and that gets you
 6   more money than the other guy.  You can sell when others
 7   can't.  If you have another incident like you did in
 8   October -- like we had in October -- if you can prove
 9   what you've been doing is accurate and in the best
10   practices and maybe even a little above the best
11   practices, they're going to have a hard time saying you
12   can't sell.  It may be something that somebody else did
13   if you've done everything you can do, they're going to
14   stay away from you because they've got other fish to
15   fry.  And that's been my experience, too, with the FDA
16   when they come back again just to inspect you and you
17   show them all the documents; and they go, Oh, it looks
18   like you're in control.  And they're going to march out.
19             And if you do the traceback system and you can
20   verify what you've done through the third-party audits,
21   through the tests that you've done and through the
22   traceback process, you're going to be able to reduce
0208
 1   your personal and company risk.  And, to me, you do that
 2   because you like to have an insurance policy; and you
 3   have an insurance policy on your car and you say, Gee, I
 4   hope I don't have to use this.  But in case you do it's
 5   always good to have.  So that's what's in it for you.
 6             But that what's in it also for the growers and
 7   the users.  What's in it for the FDA?  What I tell you
 8   is that if it's on the Web and I've got everyone linked
 9   all the way through the grower and the supplier to the
10   grower all the way through to the end-user, in a minute
11   or two you can have a complete traceback of every
12   product that is associated with that product that's in
13   question.  So if everybody certifies themselves all the
14   way up the line, then you can do a traceback all the way
15   down in minutes.  However fast your printer goes, that's
16   how fast you get a report.
17             If you wanted to do things from the office
18   instead of going and inspecting fields, if you say, say,
19   I'd like to go to -- I'd like to check on Joe over here.
20   Well, you can call up Joe and say, Joe, give me one of
21   your numbers you had over the last couple of days -- one
22   of your lot numbers.  And, sure enough, you can go back
0209
 1   and get on his Web site -- with his permission, of
 2   course -- get onto his Web site, do a back-trace and you
 3   can see exactly what happened to that.  You can see the
 4   last third-party audit.  You can see all the tests that
 5   were run -- everything that's involved with it.  That is
 6   efficient use of government personnel.  You see
 7   something that's got an issue.  That's when you go out,
 8   rather than going out just as a matter of happenstance.
 9             So I've done all this before.  I know it
10   works.  I know it saves money.  I know it saves money
11   for the FDA.
12             I leave you with one other thing that I think
13   is real critical.  I have this installed in some dairies
14   and some grain industries.  The dairy that I bring up
15   right now is a group that, as they were trying to go
16   through their entire process, they found that they were
17   commingling just everything that they had.  And by the
18   time we were done installing, making sure that they
19   could use everything, that they could use a Path Tracer
20   we were able to reduce their lot size by half.  That's a
21   risk that they don't have to play with now; and I think
22   that's a real distinct advantage for the company itself.
0210
 1             So with that if you have any questions.
 2             MR. LANDA:  Any questions?  Dr. Buchanan?
 3             DR. BUCHANAN:  I'd like to clarify what your
 4   definition of certification is.  Are you using it in a
 5   framework sort of like they use for ISO?
 6             MR. ROSS:  No, the fact is this is an ISO
 7   program.  This is a traceable activity program.  It's
 8   ISO 9000 related.  So by taking care of all the
 9   activities you're saying that I did this and this and
10   this.  It's meaningful to you and it may be meaningful
11   to your customers, but normally it wouldn't be anything
12   other than what's meaningful.  You wouldn't want to, you
13   know, put in things that are extraneous.
14             DR. BUCHANAN:  So your recommendation is that
15   we encourage the produce industry to adopt the ISO 9000
16   type of approach to certification.
17             MR. ROSS:  I think that it will do the most to
18   increase the safety of the food product itself is my
19   personal contention.  I think it will.  You can avoid a
20   lot of issues that happen otherwise.
21             DR. BUCHANAN:  Okay.  I just wanted to get
22   that clarification.
0211
 1             MR. ROSS:  I'm tickled that I was succinct
 2   enough to have you pick up the ISO 9000.  That's neat.
 3             MR. LANDA:  Ms. McGarry.
 4             MS. MCGARRY:  Have you used the system on an
 5   actual emergency of sorts?
 6             MR. ROSS:  No, but I deal with it now because
 7   everybody's kept track really well.  We go back and I do
 8   audits of all the facilities.  And I say, You pick
 9   something you want to trace back; you give me a number
10   and I'll trace it back.  So far everybody that's
11   installed this product hasn't had an issue.
12             MS. MCGARRY:  And can you give us some
13   indication as to the cost up front -- not specifics,
14   just in general terms -- numbers as to what might be
15   saved and understanding your operations, because it
16   sounds like this facilitates that.
17             MR. ROSS:  The idea of facility --
18   understanding the facility is key to all this.  I charge
19   six hundred dollars per grower per year.  I look at the
20   industries that do the packing and shipping; and I look
21   at them at three hundred dollars a month; and then
22   anybody that does actual processing of the products is
0212
 1   also three hundred dollars a month.  So that's the way I
 2   tend to approach it.
 3             And the reason is the difference between the
 4   grower and the others is that the grower really doesn't
 5   have any instances for commingling.  And I have a
 6   patent-pending associated with the commingling of
 7   processes; and I figure it should cost them a little
 8   more to deal with my patent pending.
 9             MR. LANDA:  Any other questions?
10             Thank you very much.
11             Our next speaker is Sik-Lam Wong from L-3
12   Pulse Sciences.
13             DR. WONG:  Thank you.
14             We have heard a lot -- from various speakers
15   today that there's no way to have zero -- say, hundred-
16   percent food safety in the produce industry. But what I
17   would like to do is suggest that there a technology
18   available right now that can improve the facility by
19   thousand times.
20             Let me introduce myself.  My name is Sik-Lam
21   Wong.  I'm the director of accelerator applications with
22   L-3 Communications in the pulse sciences division in San
0213
 1   Leandro, California.  I'm a businessman by training.  I
 2   don't work in this community, frankly.  But on the other
 3   hand, though, I am a consumer.  I like salads.  I like
 4   fresh vegetables.  I grow my own in my backyard; and I
 5   travel a lot; and I eat in restaurants a lot; and I
 6   travel overseas a lot as well.  So one of the things I
 7   would like to do is to say that the U.S. produce country
 8   -- the FDA, the USDA -- and in general we have a much
 9   better food supply than most countries in the world.  So
10   I'm here not -- in other words, I don't want to ignore
11   the fact that we do have a better system that most other
12   countries.
13             This morning I heard about the CDC something
14   like seventy-six million cases of foodborne illness a
15   year -- that kind of thing.  That I think is a big
16   problem.
17             What we see as the E. coli problem may well be
18   tip of the iceberg.  That's still something that we need
19   to address.  Is a big problem.  And I can understand
20   that given the complexity of the supply chain that there
21   are many points of possible contamination that we're
22   dealing with.
0214
 1             And I have a very simplistic diagram here.
 2   Basically, from the farm somehow you end up with the
 3   packers and then you add the consumers.  And along the
 4   way I know they are doing their best with the best
 5   practice available in the farm and the best good
 6   manufacturing practices in the factories.  But yet still
 7   along the way there are many points of contamination,
 8   whether it is from wildlife or whether it is from the
 9   water, whether from workers -- whatever -- is a very
10   complex chain.  Is very difficult to control.  And the
11   contamination, as we know, can be deadly, as evidenced
12   by recent events.
13             And if we take a step back, I'm not part of
14   this community.  I have the luxury of being a bystander
15   and look at it.  Are we approaching a point of
16   diminishing returns approach?  Are we treating the
17   system, doing a lot of checks and so on?  And it's
18   great.  We know that we're doing a lot better than other
19   countries.  But are we coming to point of diminishing
20   returns now?  There's a question I would like to ask.
21   And is it time to bring in new tools to this community?
22             One thing is, like, this cold pasteurization,
0215
 1   or irradiation.  It has been proven method for
 2   controlling pathogens.  FDA actually has a number of
 3   publications on that and with guidelines and so on.  Has
 4   been proved by the FDA, the USDA, for control of
 5   pathogens such a E. coli, Salmonella in meats and other
 6   food products.  And it's used routinely for this
 7   infection of herbs, spices, seasonings and has been
 8   approved by FDA for the deinfestation of insects in
 9   green-leaf vegetables already.  So it's not something
10   new that I'm talking about.
11             But here if you look at it is that this
12   morning people talk about kill step; and I heard it from
13   a number of speakers here at the podium.  And that the
14   kill step is not available right now.  It may be true at
15   this point, but I would like to say that the technology
16   for such a kill step is already available.  It is at our
17   finger tips.
18             And cold pasteurization can be the final kill
19   step that can reduce the E. coli count by a thousand
20   eggs using existing one kGy that has been approved by
21   the FDA.  And not only is there many points of
22   contamination, the best way, of course, is to make the
0216
 1   last step after you pack it, you radiate it or you use
 2   the pasteurization -- the final step with the spinach or
 3   the green-leaf vegetable in a bag before you shoot it
 4   out to the consumer, knowing at that point in time
 5   whatever you start out with, it has reduced bacteria
 6   count by thousand times.  All right.
 7             And it is -- we're not saying we're going to
 8   relax the good manufacturing practice or the best farm
 9   practice and so on.  Nobody is suggesting that; and I'm
10   sure the produce industry is not suggesting that at all.
11   But if you add one more step to the supply chain, you
12   are going to make our food a thousand times safer.
13             So the FDA has already done a lot of work
14   along this line.  The FDA has already approved cold
15   pasteurization of green leaf vegetables such as spinach
16   up to one kGy for disinfestation of insects.  But at the
17   same time the same dose -- this kGy are available right
18   now -- it will reduce the E. coli contaminant a thousand
19   times.  The same dose has been approved already. Another
20   thing is that FDA has recently approved the irradiation
21   of various packaging materials -- up to three kGy.
22             So you guys have done the work already.  The
0217
 1   next step is to have the FDA approve the regulations to
 2   allow producers to put the spinach inside the bag, seal
 3   it, and then irradiate it to reduce the bacteria count.
 4             So right now -- what we have right now is that
 5   the FDA has approved cold pasteurization for control of
 6   insects.  What we need to do now is to have the FDA
 7   approve cold pasteurization for control of bacteria.
 8   Electrons would not care whether it is bacteria or
 9   insects.  That's the way it is, right?
10             And, also, two years, as I just mentioned
11   earlier, is to allow -- to approve cold pasteurization
12   for bagged vegetables for pathogen control, allow the
13   produce industry to put the spinach in a bag, seal it
14   up, and then cold-pasteurize it.
15             And the question I have is like -- as I said,
16   I'm not here to (inaudible).  I can see this is a
17   collaboration between the commercial sector and the
18   government sector.  So the question really is like this:
19   One, what needs to be done by the commercial sector to
20   get approval of cold pasteurization of bagged green leaf
21   vegetables by the FDA?  This is a question that I would
22   like to pose; and it is something that the commercial
0218
 1   sector need to do.
 2             The other is what needs to be done by the FDA
 3   to approve cold pasteurization of bagged green-leaf
 4   vegetables and when?  You folks have been moving along
 5   that road already.  And how can we go to the last step?
 6             So I guess to summarize is that we have data
 7   -- the FDA data to show that -- that with a kGy we can
 8   reduce the E. coli count by thousand times.  The data is
 9   here and by having this technology available to the
10   produce industry, we can have a quantum jump in food
11   safety.
12             And that's my message today.  Thank you.
13             MR. LANDA:  Questions?  David Acheson.
14             DR. ACHESON:  First two questions, if I'm
15   allowed two more questions.
16             To what degree do you think a three-log is
17   going to render it safe, is my first question.
18             And the second question is more general in
19   terms of, what about the industry and consumer
20   acceptance of this technology?
21             DR. WONG:  Okay.  First of all, again, I have
22   to repeat some of the other speakers.  There's nothing
0219
 1   called one-hundred percent safe unless you cook it,
 2   right?  On the other hand, three-log kill is going to
 3   improve the safety by a thousand times.  And depending
 4   on the approval -- I'm just standing on one kGy because
 5   it has been approved already.  If you go to, say, 1.25
 6   kGy, is about four-log kill.  For that kGy, you get
 7   four-log kill.  So it really depends on how -- what is
 8   the approval level.  If you can give me six-log kill
 9   it's a million times.  And typically for medical
10   products for medical community, six-log is about
11   sterile.  Okay.  So that's question one.
12             And I'm going back to your question.  Sorry
13   about that.  Other one in terms of, like, consumer
14   acceptance.  I think that at this point in time there's
15   a lot of work done by groups like UC Davis on that.  And
16   also two years there is a matter of chicken-and-egg
17   issue.  And in terms of, like, this product is not
18   available right now.  It's going to be held up and you
19   ask consumers about.  That is one.
20             But the other thing is if you look back at
21   the, say, what happened in 1993 with the E. coli problem
22   with hamburgers.  At that point in time the companies
0220
 1   that actually irradiated the products that had been
 2   selling it for a while.  And basically has been accepted
 3   by the customer as well.  So the issue in a way also is
 4   a choice to, just as was said earlier today with the
 5   person from the Consumers Union talking about there's no
 6   choice.  She is right.  There is no choice.  If this is
 7   available and if I'm a customer I would like to have
 8   that choice.
 9             MR. LANDA:  Dr. Buchanan.
10             DR. BUCHANAN:  Thank you.
11             I have a bit of a technical question here I'd
12   like to ask so I can get a better understanding of what
13   your anticipation is.  And since the sensitivity of E.
14   coli 0157 to irradiation is dependent on a number of
15   factors, including what it was exposed to before, the
16   values you get are consistent with the literature and
17   that it's -- under ideal conditions you get somewhere
18   between a two- and three-log kill.  However, these are
19   all based on small-scale irradiation sources.  When you
20   move up to a commercial scale electron beam facility,
21   such as I think you're anticipating here, you're dealing
22   with the issues of dosimetry mapping within your
0221
 1   affected field.  And in order for you to make sure that
 2   you don't exceed the maximum kGy -- limit the maximum
 3   setting is usually fairly wide, so your mean dose if
 4   you're not going to exceed a kGy is actually
 5   substantially lower in certain points that the affected
 6   field.
 7             How do you deal with this, because based on my
 8   understanding now with the current dosimetry map
 9   available with electron beam sources, you could be
10   delivering what you think is one kGy and some of the
11   bacteria may receive only a fraction of that as they go
12   through the commercial scale unit.
13             Would you care to comment on that?
14             DR. WONG:  Yes.  There are two parts to that.
15   Part one in terms of, like, the dose -- the mean/max
16   ratio and things like that, I think this part is
17   something that we need to work with the FDA.  If you
18   limit it to one kGy and depending on the thickness of
19   the product -- and, fortunately, green-leaf vegetables,
20   they're not packed together and so on, so penetration is
21   really good.  So the uniformity inside a bag of packed,
22   say, spinach, would be very good.  But, still, I would
0222
 1   like to see that one kGy level move up to give more room
 2   for the industry to work so that we can give the
 3   producer, say, a high-log kill.
 4             DR. BUCHANAN:  That wasn't the question I
 5   asked.  The question I asked specifically was, if your
 6   maximum dose permitted one kGy, what would be the
 7   effective dose you're actually delivering to make sure
 8   that you don't know exceed one kGy at any point within
 9   the dosimetry range?
10             DR. WONG:  Okay.  I would -- the other thing I
11   want to bring up is the packaging issue.  Let's say, for
12   example, if one box of spinach -- say, would be a couple
13   bags and so on.  Because density is low, the uniformity
14   is going to be very good.  So we start out with, say,
15   nine hundred gray -- kGy -- and inside the chances are
16   -- would be fairly close -- within ten percent,
17   depending on the thickness and density you're dealing
18   with.  If you compress all of them together they get
19   very thick, you know, like a piece of lead and so on, of
20   course, the inside would not work.  But, fortunately,
21   we're dealing with, you know, bagged vegetables.
22             MR. LANDA:  Ms. Bohm.
0223
 1             MS. BOHM:  You mentioned the irradiation of
 2   ground beef as one possibility that's been explored; and
 3   I know that for irradiated ground beef, it had to be --
 4   it was frozen and transported quite a distance to the
 5   irradiator and then brought back to the warehouse.  How
 6   would you envision with a huge volume of fresh produce
 7   that we are talking about -- how would you envision the
 8   treatment?  And where would it occur to -- how would you
 9   handle that large a volume of fresh introduce being
10   irradiated?
11             DR. WONG:   I can see a couple of -- one --
12   given the high volume of produce in California I imagine
13   -- I would suggest that a facility be built here to take
14   care of the high volume of produce producing in the
15   state.  Whether it is in the Northern California or the
16   Imperial Valley, it's really up to the investors working
17   with the produce industry to decide on that.  That's one
18   way.  That concept is something like a service, where
19   they would work with, say, people package it, send it
20   over, like was suggested earlier.
21             The other way is that depending on the volume
22   of the producer, if the volume is big enough, it may
0224
 1   make sense to have their own radiation facility right in
 2   the facility or right next door to it.  So it now
 3   becomes an economic model.  If this technology is
 4   approved for -- if the regulations are in place from the
 5   FDA, I'm sure there will be investors willing to put a
 6   facility here in California.
 7             MR. LANDA:  Ms. Bohm.
 8             MS. BOHM:  Have there been any estimates of
 9   what the cost of one of these facilities would -- to
10   construct and getting everything up to speed, what would
11   be the percent increase on the bag of spinach or per
12   unit in the estimates that -- have they been made yet?
13             DR. WONG:  Okay.  In terms of the cost of the
14   building and equipment, so you're talking about few
15   million dollars.  It is a fairly expensive item.  On the
16   other hand, though, if a situation of having a service
17   where people can take their produce over to have it
18   irradiated.  My estimation would be pennies, because
19   irradiation, if you're dealing with a kGy or two, you
20   will be very low.  But I don't have ability to set the
21   price, so I can only estimate in terms of what it would
22   cost.
0225
 1             MR. LANDA:  Ms. McGarry.
 2             MS. MCGARRY:  Can you comment on the effect of
 3   irradiation on the quality of the product and whether
 4   it's still appealing to the customer?
 5             DR. WONG:  Okay.  The FDA has actually done
 6   some work and published it in the last few years in
 7   terms of taste test and so on.  We -- one of our
 8   customers, the Sadex Corporation over in Sioux City,
 9   Iowa, has been doing a lot of work themselves.  They
10   actually radiated some spinach and ate it in front of
11   local TV; and they haven't seen any change in taste or
12   texture.  So I think there's some data available already
13   from the USDA on that as far as lettuce and spinach is
14   concerned.  So that doesn't seem to be an issue.
15             MR. LANDA:  Any questions?
16             Thank you, Dr. Wong.
17            (Break from 3:55 p.m. to 4:11 p.m.)
18             MR. LANDA:  Our next speaker is Ron Strochlic
19   from the California Institute for Rural Studies.
20             MR. STROCHLIC:  Good afternoon.  Thanks so
21   much for having me here today.  I'm Ron Strochlic from
22   the California Institute for Rural Studies.
0226
 1             And I want to touch on several issues that
 2   have not been touched on this afternoon.  As I'm sure we
 3   all agree, food safety is clearly a very important issue
 4   and it's essential that we keep our food safe.  However,
 5   it's also important that we balance the importance of
 6   food safety with other important issues, such as
 7   conserving our natural resources and maintaining the
 8   economic viability of California farms, especially small
 9   and medium family farms that contribute to the economic
10   health of our rural areas.
11             Some of the proposals for reducing the risk of
12   E. coli contamination have included efforts that result
13   in the elimination of systems that affect wildlife to
14   California farms.  These include things like hedgerows
15   and vegetative buffer strips.  From our perspective this
16   is a step backwards in many ways.  It will have negative
17   impacts on water quality and wildlife and it will also
18   impact the viability of the growing organic and
19   sustainable farming sector which depend on beneficial
20   insects and other natural predators for pest control.
21   The elimination of systems that would affect biology
22   would ultimately negate many, many years of effort on
0227
 1   the part of public and private agencies to conserve
 2   natural resources and promote a more sustainable food
 3   system in California.
 4             I think it's also really important that we
 5   address the fact that scientific research is still not
 6   conclusive about where the source of E. coli
 7   contamination is coming from.  We don't really know
 8   whether it's wild animals or is it in confined animals'
 9   feeding operations or some combination of the two.  The
10   likelihood would dictate that we need to understand the
11   source of the problem before developing solutions for
12   addressing it.  We heard a lot of recommendations for
13   addressing E. coli, but I haven't heard a lot about
14   going to the source and trying to find out where it's
15   coming from and addressing the issue at its source.  I
16   think that might be more of a rational approach.
17             Another issue I would like to touch on is that
18   there's been discussion on some of the on-farm systems
19   for testing and monitoring soil and water for E. coli.
20   As you know, the implementation of these systems can be
21   very expensive and is not at all scale-neutral.  So
22   these costs will disproportionately affect small- and
0228
 1   medium-sized farmers and has the potential to put these
 2   farms out of business.  I think that's something that we
 3   really need to be thinking about as we're moving forward
 4   in developing ways to address this issue.
 5             One big issue that I think is becoming
 6   increasingly apparent is that it seems like bagged leafy
 7   greens have some of the highest potential for spreading
 8   E. coli contamination, in addition to being affected by
 9   the E. coli washing thousands of pounds of greens
10   together is a very efficient way of spreading the
11   pathogen.  Studies have also shown that E. coli in bags
12   has a very high potential to multiply with very small
13   increases in temperature; and that's something that
14   could easily happen when someone goes shopping and they
15   have a bag of spinach sitting in their car in rush-hour
16   traffic or in summer for a couple of hours.  It's
17   something we really need to be thinking about.
18             And from our perspective this also points to
19   the need to focus our efforts on where the risk is
20   greatest, in this case, the most recent.  That would be
21   bagged leafy greens which come from large suppliers.
22             So I guess what I'm really getting to is to
0229
 1   make a call for approaching this issue level-headedly.
 2   The removal of systems that harbor wildlife and the
 3   implementation of expensive monitoring systems may solve
 4   one problem, which is that of E. coli contamination, but
 5   it has the potential to create a host of other problems
 6   that include raising the cost of food, forcing many
 7   small and medium farms all around the country out of
 8   business, and increasing environmental degradation.
 9             So as a professional and as a consumer I'd
10   like to call on us to take a big-picture approach to
11   this issue and consider all of the environmental,
12   social, and economic factors when we are seeking
13   solutions to promote a safer food system.
14             Thank you very much.
15             MR. LANDA:  Thank you.
16             Any questions?
17             Dr. Acheson.
18             DR. ACHESON:  Thank you for the comments.  You
19   said that you advocate addressing E. coli at the source.
20   Can you be more specific?
21             MR. STROCHLIC:  Yeah.  Again, the science is
22   not conclusive on the issue, but a lot of figures point
0230
 1   to cattle -- corn-fed cattle, specifically -- as a
 2   source of this 0157 contamination.  My understanding is
 3   that this strain of E. coli really is pretty recent on
 4   the scene.  It's only been on the scene since the 1980s,
 5   if I'm not mistaken.  And so this tells us something.
 6   This tells us that this is something that is a recent
 7   development.  We really need to understand what's going
 8   on.
 9             Again, my understanding is that the rumen of
10   cattle that are corn-fed is a very receptive environment
11   to E. coli 0157 and that it is found in very, very small
12   doses in wild animals and grass-fed cattle.
13             So in that sense we need to be looking at how
14   we can either isolate these confined-animal feeding
15   operations that would suggest -- I'm not saying that
16   it's conclusive -- but it would suggest that these are
17   one potential source of contamination and think about
18   ways of keeping this pathogen from spreading from these
19   operations, if that is indeed the case.
20             MR. LANDA:  Ms. McGarry.
21             MS. MCGARRY:  In the recent spinach outbreak
22   in the press we mentioned that feral swine (inaudible).
0231
 1   So can you comment on the balance that you would suggest
 2   in striking between the wildlife habitat and food safety
 3   and the interplay that occurs in the balance (inaudible)
 4             MR. STROCHLIC:  Well, I guess the initial
 5   question is, where is this really coming from.  If it is
 6   really coming from wildlife, we do need to think about
 7   other ways of approaching the issue.
 8             And, again, I think the issue is to take a
 9   more targeted approach.  Right now my understanding is
10   that a number buyers in the Salinas Valley, for example,
11   have been advocating basically bulldozing hedgerows and
12   vegetative buffer strips and are advocating I think it's
13   five hundred yards of bare ground surrounding any fields
14   of leafy greens.  That, to me, is a very draconian
15   approach.
16             There's got to be other ways that we can
17   address this if it is really coming from feral swine,
18   for example.  We can think of ways of getting them out
19   of the system by not just bulldozing all of these
20   systems that have taken years and years and years of
21   efforts to put into place and are very beneficial for
22   the environment.
0232
 1             MR. LANDA:  Any other questions?
 2             Thank you.
 3             Our next speaker is Dan Cohen with the
 4   Maccabee Seed Company.
 5             MR. COHEN:  I'm going to cover two topics that
 6   are under potentially FDA control or influence but not
 7   under the control of growers or handlers of leafy greens
 8   or salad vegetables.
 9             These are the therapeutic treatment of HUS,
10   hemolytic uremia syndrome; and the presence of O157 and
11   other shiga toxin E. coli in cattle and dairy as primary
12   contamination sources.
13             Let's begin by discussing some informal
14   interviews I did with law firm principals who have, in
15   total, won over $300 million in O157 lawsuits.  I'm
16   using them as surrogates.  I asked them about the
17   percent of settlements and the perceived damage to
18   clients due to HUS.
19             As an example, one firm, with fourteen years'
20   experience with O157, represented about two hundred HUS
21   cases out of over a thousand settled or litigated cases.
22   The non-HUS cases minimally included an ER visit and an
0233
 1   illness over one to two weeks, so we're leaving out many
 2   other people who were ill.
 3             Looking at both jury trials and settlements
 4   without trial, when HUS is present, collected damages
 5   range from a minimum of $500,000 to a maximum of over
 6   $15 million per patient.  The amount depends on the
 7   severity of damage and the long-term diagnosis of care
 8   that will be required.  Monetarily, HUS dwarfs other
 9   settlements.  HUS represents eighty-five to ninety
10   percent of total compensation, despite being less than
11   twenty percent of total litigated cases.
12             In their view, this is because the devastation
13   of patients over their compromised lifetimes or their
14   death due to hemolytic uremia syndrome dwarfs all other
15   medical harms due to O157.  And the observation that
16   improvement in medical care over the last fourteen years
17   has led to increased survival rates but no improvement
18   in prevention of damage due to HUS.
19             And their experience mirrors and quantifies
20   the concerns that I first heard expressed in
21   conversations with case investigators from the CDC,
22   following the apple cider and Odwalla cases.  It really
0234
 1   surprised me that thinking of an E. coli case, when O157
 2   cases elaborate into HUS, the symptoms can be horrible
 3   and the results can be devastating.
 4             It's been one hundred and ten years since
 5   Kiyoshi Shiga discovered the causal organism of
 6   bacterial dysentery, which also can elaborate into HUS.
 7   About thirty years ago, the genes associated with shiga
 8   toxin laterally transferred to E. coli strains.  Unlike
 9   dysentery, coliform bacteria were generally perceived as
10   indicator species for fecal contamination and as early-
11   warning signals for far more serious diseases.
12             With hindsight, the appearance of shiga toxin
13   E. coli should have been treated from the beginning as a
14   new disease entity, perhaps as a model case for
15   appearance of a toxin-associated, highly pathogenic
16   disease, with many of the same characteristics public
17   health officials would have to deal with in an
18   intentional contamination.
19             In my view, the FDA should lead an interagency
20   working group covering all aspects of O157 contamination
21   and outbreaks, including therapeutics.  This should
22   include special funding and research on HUS therapies.
0235
 1             For the leafy-green and salad industries,
 2   obviously, better therapeutics for HUS would mean that
 3   growers, handlers, and consumers would be exposed to the
 4   risk of a greatly reduced harm.  The working group
 5   should also conduct a complete review of off-site health
 6   dangers possibly posed by practices in the production of
 7   meat and milk and cattle and dairy.  Cattle and dairy
 8   have been repeatedly identified as the principal
 9   reservoirs of O157 and other shiga toxin E. coli strains
10   of concern.  They also have been reported to be
11   important origins and reservoirs of multiple antibiotic
12   resistances of concern to human health.  Both reservoirs
13   should be identified and reduced.  Many people in the
14   cattle industry are happy to work on that.
15             For the leafy-green and salad industries, of
16   course, a reduction in the sources and reservoirs of
17   contamination would mean a much smaller risk of causing
18   a harm.  They would have a safer environment in which to
19   operate, an environment, perhaps, with uncontaminated
20   irrigation water.  So if you combine the better
21   therapeutics for HUS and combine the reduction in the
22   reservoirs and sources of contamination, it would result
0236
 1   in a reduced risk of a greatly reduced harm.  I think
 2   improvements in growing and handling practices would be
 3   more effective in a general lower-risk environment.
 4             That ends my oral testimony.  I have written
 5   testimony about off-site issues to deal with regulations
 6   that I will leave for you.  The only comment that I
 7   would make right now is that I used the word
 8   "processing" in a very minimal sense.  You can use it in
 9   the same sense as the others used it this morning --
10   anything that cuts, shreds, or creates a wound that
11   provides an entry point for bacteria which would
12   normally not happen.
13             Thank you very much.
14             MR. LANDA:  Thank you.
15             Question for Mr. Cohen?
16             Ms. Bohm.
17             MS. BOHM:  You mentioned practices in the
18   production of milk and meat that pose risks of
19   contamination in produce and ultimately of consumers. Do
20   you have any particular practices in mind or any
21   particular interventions in mind that you were referring
22   to?
0237
 1             MR. COHEN:  Oh, there's some old ones that
 2   people know quite well in terms of how manure is handled
 3   in a dairy, where there is any litter associated with it
 4   -- deep litter on the dairy floor that actually
 5   decreases the risk of contamination.  And that has been
 6   studied in Canada for a long time.
 7             The previous speaker gave you another example
 8   of issues about diet.
 9             You also have the concern of the concentrate
10   in feedlots and the possibility of what McDonald's
11   doesn't like to call subtherapeutic use -- they have a
12   different term for it.  McDonald's contracts call for a
13   no -- what I used to call subtherapeutic use of
14   antibiotics in every contract for all their suppliers.
15   So that kind of issue is of concern to them as well. And
16   I believe the Virginia extension service has some data
17   on the relative cleanliness, I guess, of their grass-
18   fed industry in cattle.
19             There is some data out there, but this is the
20   kind of thing where you go in and work with the industry
21   and identify the points; and you may have to look at
22   changes.
0238
 1             MR. LANDA:  Any other questions?
 2             Thank you.
 3             Is there anyone here who did not sign up to
 4   speak before today but would like to speak?  Or have we
 5   worn you all out?
 6             Well, it turns that Mr. Cohen is our last
 7   speaker.
 8             Thank you.
 9             Let me just make few points before we finish
10   for the day.  The first is yet another reminder that the
11   docket remains open till June 13th and that we hope to
12   have the transcript available and up on the Web site
13   within four weeks or so.
14             Let me thank the speakers who came and
15   presented today and my fellow panelists.  Then let me
16   say my thanks to the people who really make this kind of
17   hearing possible.  I'm trained as a lawyer and practiced
18   law for most of my working life.  And I know if you look
19   at an administrative trial or a trial in a courtroom you
20   really do see the tip of the iceberg; and the lawyer is
21   the performer.  And that's true for this kind of hearing
22   as well.
0239
 1             So I want to thank the CFSAN staff who worked
 2   so hard on this.  Amy Green, you've already heard from;
 3   Juanita Yates; Shirley Turpin; Mike Herndon; and
 4   Sebastian Cianci, who is handling the media.  From the
 5   San Francisco district office, Janet McDonald and Mary
 6   Ellen Taylor.  A special thanks to Mark Roh and the
 7   regional staff -- James Wyman, Crystal Wong; and
 8   especially Jane Price, who is the regional training
 9   officer and has been in daily contact with the CFSAN
10   staff handling the logistics for setting up today.
11             I just want to close by saying something Dr.
12   Acheson said.  It's in the nature of a thank you to the
13   CDHS staff and the FDA staff in California for what I
14   think was truly exceptional work in the fall in the
15   outbreak related to spinach.  I think it may be true
16   that reasonable people can disagree on whether the
17   government has done enough or what the government's next
18   step should be, whether guidance is adequate, whether
19   regs are required.  But I don't think anyone could
20   disagree that the people in CalFERT really went well
21   above and beyond the call of duty.  And, actually, in
22   the case of the work they did, one can with total
0240
 1   accuracy say that their work was a lifesaver.
 2             Thank you for attending today.  And we hope to
 3   see some of you in Maryland.
 4               (Meeting concluded at 4:27 p.m.)
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 1   STATE OF CALIFORNIA                         )
 2   COUNTY OF SAN FRANCISCO                     )
 3   
 4                   CERTIFICATE OF REPORTER I, the
 5                   undersigned, a duly authorized
 6   Shorthand Reporter, do hereby certify that on the date
 7   indicated herein that the above proceedings were taken
 8   down by me in stenotype and thereafter transcribed into
 9   typewriting by me or under my direction and that this
10   transcript is a true record of the said proceedings.
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15      FREDDIE REPPOND
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