00001
  1   
  2    DEPARTMENT OF HEALTH AND HUMAN SERVICES
          U.S. FOOD AND DRUG ADMINISTRATION
  3   CENTER FOR APPLIED FOOD SAFETY AND APPLIED
                  NUTRITION (CFSAN)
  4   
                        - - -
  5   
  6   
  7     SAFETY OF FRESH PRODUCE PUBLIC HEARING
  8                     - - -
  9   
 10   
 11             FRIDAY, APRIL 13, 2007
 12             9:00 A.M. to 4:30 P.M.
 13   
 14                     - - -
 15   Aside from minor spelling and style corrections, the wording 
 16   of this document is exactly as received from the commercial 
 17   transcribing service. Accordingly, FDA makes no representation 
 18   as to its accuracy.
 19   
 20                   FDA/CFSAN
 21           5100 PAINT BRANCH PARKWAY
 22             COLLEGE PARK, MARYLAND


00002
  1       A P P E A R A N C E S 
  2   
  3   PARTICIPANTS:
  4   
  5   ROBERT BRACKETT, PH.D.
  6   Director
  7   Center for Food Safety and Applied
  8     Nutrition (CFSAN)
  9   Food and Drug Administration
 10   ART LIANG, M.D.
 11   Acting Director
 12   Foodborne Disease 
 13   Centers for Disease Control and
 14     Prevention
 15   MICHELLE SMITH, PH.D.
 16   Office of Food Safety
 17   Center for Food Safety and Applied
 18     Nutrition (CFSAN)
 19   Food and Drug Administration
 20   MARION ALLER, PH.D.
 21   President
 22   Association of Food and Drug Officials


00003
  1   PARTICIPANTS:
  2   
  3   CPT. THOMAS HILL
  4   Office of Food Defense, Communications
  5     and Emergency Response
  6   Center for Food Safety and Applied
  7     Nutrition (CFSAN)
  8   Food and Drug Administration
  9   JIM RUSHING, PH.D.
 10   Director of the Coastal Research and
 11     Education Center
 12   Clemson University
 13   THOMAS E. STENZEL
 14   President
 15   United Fresh Produce Association
 16   BRYAN SILBERMANN
 17   President
 18   Produce Marketing Association
 19   CAROLINE SMITH DeWAAL
 20   Director of Food Safety
 21   Center for Science in the Public
 22     Interest


00004
  1   PARTICIPANTS:
  2   
  3   MARTHA ROBERTS, PH.D.
  4   Special Assistant to the Director
  5   Florida Agricultural
  6   Experiment Station
  7   University of Florida
  8   AMY GREEN
  9   Office of Food Safety
 10   Center for Food Safety and Applied
 11     Nutrition (CFSAN)
 12   Food and Drug Administration
 13   MICHAEL M. LANDA, ESQ.
 14   Deputy Director for Regulatory
 15     Affairs
 16   Center for Food Safety and Applied
 17     Nutrition (CFSAN)
 18   Food and Drug Administration
 19   
 20   
 21   
 22   


00005
  1   PUBLIC PARTICIPANTS:
  2   
  3   THOMAS NASSIF
  4   Western Growers Association
  5   RICHARD ROSS
  6   Path Tracer
  7   MICHELLE MARCOTTE
  8   International Irradiation
  9     Association
 10   REGINALD BROWN
 11   Florida Tomato Exchange
 12   ANTHONY CORBO
 13   Food and Water Watch
 14   RAYNE THOMPSON
 15   California Farm Bureau Federation
 16   JOE RAJKOVACZ
 17   Owner-Operator Independent Drivers
 18     Association
 19   ALFRED MURRAY
 20   New Jersey Department of Agriculture
 21   GREG DROUILLARD
 22   Sunkist Growers


00006
  1   PUBLIC PARTICIPANTS:
  2   
  3   CHARLES HALL
  4   Georgia Fruit and Vegetable Growers
  5     Association
  6   SALLY GREENBERG
  7   Consumers Union
  8   ROBERT GRAVANI
  9   Cornell University
 10   JENNY SCOTT
 11   Grocery Manufacturers/Food Products
 12     Association
 13   JILL HOLLINGSWORTH
 14   Food Marketing Institute
 15   
 16   
 17   
 18   
 19   
 20   
 21   
 22   


00007
  1   FDA PANEL:
  2   
  3   RAYNE THOMPSON
  4   California Farm Bureau Federation
  5   JOE BACA
  6   Director
  7   Office of Compliance
  8   Center for Food Safety and Applied
  9     Nutrition (CFSAN)
 10   Food and Drug Administration
 11   JACK GUZEWICH
 12   Acting Director
 13   Division of Public Health and 
 14     Biostatistics
 15   Office of Food Defense, Communication
 16    and Emergency Response
 17   Center for Food Safety and Applied
 18     Nutrition (CFSAN)
 19   Food and Drug Administration
 20   
 21   
 22   


00008
  1   FDA PANEL:
  2   
  3   STEVE SOLOMON, DVM, MPH
  4   Deputy Director
  5   Office of Regional Operations
  6   Office of Regulatory Affairs (ORA)
  7   Food and Drug Administration
  8   DON ZINK, PH.D.
  9   Senior Food Scientist
 10   Office of Food Safety
 11   Center for Food Safety and Applied
 12     Nutrition (CFSAN)
 13   Food and Drug Administration
 14   GLENDA LEWIS
 15   Supervisor
 16   Retail Food Protection Team
 17   Office of Food Safety
 18   Center for Food Safety and Applied
 19     Nutrition (CFSAN)
 20   Food and Drug Administration
 21   
 22   


00009
  1                   C O N T E N T S   
  2                                                 PAGE
  3   .   Welcome/Opening Remarks/Overview
  4            By Dr. Robert Brackett, Ph.D.           7
  5   .   Foodborne Illness Outbreaks Associated
  6        with Fresh Produce Consumption
  7            By Dr. Art Liang, M.D.                 11
  8   .   GAPs/GMPs, Produce Safety Action Plan
  9       Opportunities and Challenges
 10            By Michelle Smith, Ph.D.               24
 11   .   AFDO Perspective
 12            By Marion Aller, Ph.D.                 39
 13   .   Investigation Findings
 14            By CPT Thomas Hill                     50
 15   .   State Perspective
 16            By Jim Rushing, Ph.D.                  63
 17   .   Questions from the FDA Panel                76
 18   .   Industry Perspective
 19            By Thomas “Tom” E. Stenzel             90
 20            By Bryan Silbermann                   104
 21   .   Consumer Perspective
 22            By Caroline Smith DeWaal              115


00010
  1               C O N T E N T S   (Continued)
  2                                                 PAGE
  3   .  Science/Research
  4            By Martha Roberts, Ph.D.              128
  5   .  Questions from the FDA Panel                140
  6   .  Issues and Questions from the Federal
  7       Register Notice
  8            By Amy Green                          158
  9   .  Public Comments                             166
 10   .  Adjournment                                 281
 11   
 12   
 13   
 14   
 15   
 16   
 17   
 18   
 19   
 20   
 21   
 22   


00011
  1                   P-R-O-C-E-E-D-I-N-G-S
  2                                             (9:00 A.M.)
  3             WELCOME/OPENING REMARKS/OVERVIEW
  4             DR. BRACKETT:  Welcome to a public hearing
  5   with the Center for Food Safety and Applied Nutrition. 
  6   For those of you who don’t know me, I’m Bob Brackett. 
  7   I’m the director of the Center here.  
  8             Today, I am going to be the presiding
  9   officer of today’s hearing, which is called a Part 15
 10   hearing because the rules for it appear in Part 15 of
 11   Title 21 of the Code Federal Regulations.  
 12             A Part 15 hearing is informational.  There
 13   is no direct or cross-examination or no redirect or
 14   recross examination, and the rules of evidence do not
 15   apply as in other types of hearings.
 16             There is one hard-and-fast rule, which is
 17   that the only people may ask questions of the speakers
 18   are the members of the FDA Panel, sitting in front,
 19   and me.
 20             In addition, I will insist that speakers
 21   keep to their allotted time for two reasons.  First of
 22   all, because we have a lot of ground to cover today


00012
  1   and we want to make sure that everyone scheduled to
  2   speak gets his or her time to speak.  Second, because
  3   it would be unfair to the speakers who do keep to
  4   their allotted time for others to take up more than
  5   their fair share.  To help you with that, we have in
  6   the second row here a big, fluorescent, red stop.
  7             (General laughter.) 
  8             DR. BRACKETT:  I do have a book.  There is
  9   no food allowed in this room, so we appreciate it if
 10   you remember that.  
 11             We do know that there are people from the
 12   press here, so we want to make sure that we facilitate
 13   things for you as well.  For those of you who may have
 14   questions here today, we will provide some assistance
 15   for you in that we have some FDA CFSAN staff that will
 16   be wearing blue name tags.  If you have questions, ask
 17   them, and they should be able to help you with that. 
 18   We will keep to the schedule as I said.
 19             We do have a sign language interpreter on
 20   hand today for those individuals needing information
 21   regarding the recent outbreaks that we have seen in
 22   the last year.  


00013
  1             More importantly, we are here to solicit
  2   your comments, data that you might have, or any other
  3   information that will help today.  We will have a
  4   series of FDA speakers, some invited speakers, then
  5   questions from the FDA Panel, and towards the end of
  6   the day we will have public comments.  
  7             After the hearing, when we are finished, all
  8   of the presentations will be provided to Dockets.  We
  9   will accept public comments onto the Dockets as well. 
 10   Again, the date is June 15, 2007.  We will have
 11   transcripts of the hearing available within about two
 12   or three weeks of this hearing.
 13             Just to tell you who we have on our FDA
 14   Panel participants, as I mentioned, I am the presiding
 15   officer over this hearing.  We have Mr. Joe Baca, who
 16   is director of Office of Compliance.
 17             Joe, you can raise your hand.
 18             (Mr. Baca complies.)
 19             DR. BRACKETT:  Jack Guzewich, acting
 20   director of the Division of Public Health and
 21   Biostatistics, Office of Food Defense, Communication
 22   and Emergency Response.


00014
  1             Dr. Steve Solomon, deputy director of the
  2   Office of Regional Operations.  Dr. Don Zink, senior
  3   food scientist, Office of Food Safety.  Finally,
  4   Glenda Lewis, supervisor of the Retail Food Protection
  5   Team with the Office of Food Safety.
  6             Our first speaker this morning will be
  7   Dr. Art Liang, who is acting director of the Division
  8   of Public Health and Biostatistics and Zoonotic,
  9   Vectorborne and Enteric Diseases in Atlanta.  He is
 10   also the acting associate director for the Science
 11   Center’s Division of Foodborne Bacterial and Mycotic
 12   Diseases at the CDC.  
 13             From 1989 through 2006, he currently serves
 14   on a number of committees throughout the food safety
 15   area including the Executive Committee of the National
 16   Advisory Committee for Microbiological Criteria for
 17   Foods and the Preventative Residency Advisory
 18   Committee for the Walter Reed Army Institute of
 19   Research.
 20             Dr. Liang is the chief of the Communicable
 21   Disease Division with the Hawaii Department of Health. 
 22   Dr. Liang currently serves on a number of committees


00015
  1   throughout in the food safety area, including: the
  2   Executive Committee of the National Advisory Committee
  3   for Microbiological Criteria for Foods, and the
  4   Preventative Medicine Advisory Committee for the
  5   Walter Reed Army Institute of Research, as well as the
  6   Board of Directors of the American Association for
  7   Public Health Physicians.
  8             With that, Dr. Liang.
  9          FOODBORNE ILLNESS OUTBREAKS ASSOCIATED
 10                 WITH PRODUCT CONSUMPTION
 11             (PowerPoint™ slide presentation in
 12   progress.)
 13             DR. LIANG:  Thank you.  
 14             Good morning.  Hopefully, I only have ten
 15   minutes now.  I know this is a very sophisticated
 16   audience, and a lot of you will be aware of a number
 17   of slides, the information that I show.  To get
 18   started, we know that foodborne illnesses are common.  
 19             Luckily most of them are not serious, but
 20   unfortunately a share of them are.  About one in a
 21   thousand Americans may end up being hospitalized for a
 22   foodborne illness, then of course we know that from


00016
  1   the economic research from the FDA that there is a
  2   considerable loss, economic loss due to direct and
  3   indirect costs of foodborne illness.
  4             I think generally we, society, have agreed
  5   that foodborne diseases, the ecology of foodborne
  6   diseases, is complex and that efforts from farm to
  7   table need to be considered as we try to prevent
  8   foodborne illness.
  9             Of course, today’s talk is about produce. 
 10   From CDC’s perspective and from the public health
 11   departments’ perspective, fresh produce is
 12   increasingly recognized as a problem.
 13             Again, I know a lot of this is sort of
 14   foodborne disease 101, but of course foodborne
 15   illnesses are not one thing.  They are a number of
 16   different chemicals as well as microbiologic agents. 
 17   We are going to mainly talk about microbiology.  We
 18   seem to be adding to that list on a daily basis.
 19             Microorganisms all have different ecologies,
 20   some of them are what we would call in sort of a
 21   “human reservoir,” meaning where does this organism
 22   normally hang out so that there are human,


00017
  1   person-to-person type illnesses like Shigella
  2   hepatitis or Norovorirus are probably the more common
  3   ones that we deal with.  
  4             Some seem to make their home in animals of
  5   various sorts, again, Salmonella and Campylobacter.  I
  6   think many of you are familiar with the list, the cast
  7   of characters here.
  8             Then, the other issue to be made is that
  9   from CDC and the state and local health departments of
 10   tracking illnesses and outbreaks illnesses, many of
 11   these agents, though, can have multiple modes of
 12   transmission.  
 13             Even though some of them may commonly be
 14   transmitted by food, we know that they can find their
 15   way into people’s mouths via water; maybe from direct
 16   contact hand-to-mouth; contact from animals; or from
 17   other human beings.
 18             A little bit of background on the foodborne
 19   outbreak surveillance, which is the major way that we
 20   can make the association.  How do we know whether this
 21   agent was caused by food or water or aerosol.  
 22             Our major way of making that inference is


00018
  1   from the foodborne outbreaks that are conducted by the
  2   state and local health departments, sometimes with CDC
  3   assistance, most often without.
  4             When CDC does collect reports from the
  5   50 states -- but these reports I need to point out are
  6   done voluntarily, and even though we request certain
  7   kinds of data, and as many of you know, we like to
  8   collect more and more -- it’s really up to the states
  9   how much information they can or will provide. 
 10   Although, we think what has been provided is quite
 11   good.  
 12             For the purposes of analyzing this database
 13   from the 50 states, our definition for a “foodborne
 14   outbreak” is two more cases of illnesses resulting
 15   from the ingestion of a common food.
 16             Again, what we normally monitor are the
 17   illnesses through the investigation we conclude or
 18   don’t conclude what the vehicle is and whether it is
 19   food-related.
 20             What kind of data do we get from the states
 21   or do we request from states, clearly whether or not
 22   they think that an outbreak has happened and whether


00019
  1   it is foodborne in order to get into the database and
  2   how many cases.  We ask them what food was implicated
  3   and what was the causative agent or the ideology.
  4             For the period prior to 1998 and before, we
  5   received about a total of 500, plus or minus,
  6   outbreaks reported per year to CDC.  This is just
  7   showing you a chunk of that data, not going all the
  8   way back to the fifties and sixties and seventies, but
  9   you can see that from ‘90 up until ‘98 you can see
 10   what the level of reporting was.  That was fairly
 11   stable.  
 12             After ‘98, partly related to the Food Safety
 13   Initiative at that time, the CDC began stimulating
 14   more reporting, in the beginning it was paper,
 15   requesting states to report on a more regular basis
 16             We provided more guidance on what we wanted
 17   them to report, and indeed the states complied and we
 18   had increased reporting.  Later, after 2000, the
 19   system became automated, and now it’s no longer just a
 20   paper-based system.
 21             I show this to you now because you can take
 22   this into consideration when I show you some of the


00020
  1   data and when we try interpret some of the data.
  2             Because of this change, this is why I’m
  3   presenting the data actually in two chunks.  The
  4   chunks are related, but the analysis is not exactly
  5   the same.  You need to keep that in mind.  
  6             From the period from 1973 to 1997, using the
  7   definition of “fresh produce” as being uncooked
  8   produce items or salad which did not have another
  9   ingredient -- just mainly eggs, cheese, seafood, or
 10   meat included -- that is the case definition for what
 11   we are going to be showing you in terms of a
 12   produce-associated outbreak.
 13             During that period, there are a total of
 14   190 foodborne outbreaks linked to fresh produce.  You
 15   can see there are over 16,000 illnesses, almost
 16   600 hospitalizations, and 8 deaths.
 17             Again, for the entire reporting period, this
 18   represented about 3.2 percent of all outbreaks that
 19   were reported that had a determined source and agent
 20   identified.
 21             Then, when you count up the number of cases
 22   that occurred amongst that 3.2 percent, it was a total


00021
  1   of 6.2 percent outbreak-associated cases.  Okay, so
  2   that is how many outbreaks and how big they were, just
  3   how many people were involved as compared to all
  4   outbreaks that were reported -- oh, I’m sorry, all
  5   other outbreaks, not produce-associated.
  6             This gives you some a little different. 
  7   This gives you a comparison of in the seventies on the
  8   early end, there was 190 cases, and then what happened
  9   in the nineties up to and including 1997.
 10             You can see that during the seventies part
 11   of this period there was an average of 2 outbreaks,
 12   produce-associated outbreaks, per year and then by the
 13   time we get to the seventies there are 16, then the
 14   average number of cases per outbreak in the seventies
 15   was 21 as compared to the nineties where there are an
 16   average of 43 cases per outbreak.
 17             The percent of outbreaks of known vehicle,
 18   comparing produce-associated outbreaks with other
 19   outbreaks where we knew what the vehicle was, that
 20   turned out to be .7 percent.  Produce-associated
 21   outbreaks were .7 percent of all outbreaks of known
 22   vehicle, with a known vehicle.  In the seventies and


00022
  1   in the nineties, it’s 6 percent.  
  2             Then, the same comparison this time of the
  3   outbreak-associated cases and how many people got ill,
  4   in the seventies we have .6 percent and then compared
  5   to 12 percent in the nineties.
  6             Okay.  Then, with the same period, ‘73 to
  7   ‘97, there is a peak.  This is a summary of what were
  8   the vehicles, what types of vehicles were implicated. 
  9   “Generic” and “multiple” are things like not a single
 10   item.  
 11             Salad is probably the simplest example. 
 12   There may be a number of items in the salad but they
 13   are all produce, so that’s when we say “generic” and
 14   “multiple.”  We can’t say, we don’t know whether it is
 15   one component of that salad or the whole salad.  There
 16   are 105 of those outbreaks.
 17             Then, the rest are outbreaks where a single,
 18   specific food could be could be implicated.  There are
 19   85 of those outbreaks during this period.  You can
 20   see, you can read the slide, you can see that those
 21   seven items sort of represent 88 percent of all the
 22   outbreaks where one item was able to be implicated.


00023
  1             Okay.  Then, of course, this is how we see
  2   the world.  We see the world in terms of infections,
  3   diseases at CDC.  This gives you a breakdown of how
  4   many were bacterial, viral, parastic, and chemical.
  5             We do get chemical outbreaks, but they are
  6   usually very small.  Frankly, that’s not our area of
  7   expertise, so we don’t do a lot work in that area in
  8   the part of CDC where I work.
  9             Then, there is a breakdown here of also,
 10   roughly, which have animal reservoirs versus human
 11   reservoirs.  Don’t try to add up the columns because
 12   there are some there that are in that other column
 13   that are thrown into that categorization.  
 14             The point is that, again, sort of in keeping
 15   with this farm-to-table theme, these represent a
 16   variety of foods, of produce items, with basically a
 17   variety of ecologies.  You know better than I in terms
 18   of the farm-to-table continuum that that continuum can
 19   be quite different depending on the item and the
 20   animal, human, or otherwise.
 21             Now I’m going to talk about this period from
 22   ‘98 up through 2004.  A similar question looking at


00024
  1   produce-associated outbreaks, but because of the
  2   changes in the reporting it’s not precisely comparable
  3   to the other years, although it is relatable.  We can
  4   talk about that.
  5             Again, in this case produce was defined
  6   somewhat differently.  We tried to classify them as
  7   either they were fruit- or vegetable-associated
  8   outbreaks, okay.
  9             Then, from ‘98 to 2004, the total number of
 10   outbreaks was 384, nearly 16,000 cases, over
 11   700 hospitalizations, and 15 deaths.  Now, remember
 12   that this is a time where reporting, overall
 13   reporting, has increased.  
 14             Then, we see that overall 7 percent of all
 15   outbreaks that had a determined ideology were
 16   produce-associated.  Then, 14 percent of outbreaks
 17   associated with produce, 14 percent of the cases, were
 18   aa part of these outbreaks.  Again, these are compared
 19   to the denominator here.  The percentage is the
 20   percentage of all outbreaks where we identified an
 21   agent and a vehicle.
 22             Okay.  I realize this is a little bit hard


00025
  1   to see, but the main reason for showing this is the
  2   type of categorization that we use.  It is still
  3   produce focused, but it’s not the same as what we
  4   defined earlier, in the earlier period.  
  5             I think the take-home message here is you
  6   see it’s a polychrome slide, meaning, again that we
  7   are talking about a number of different types of food
  8   items throughout the years.
  9             Okay.  Then, the next slides are presented
 10   in a way similar to what you already have seen.  You
 11   see the number of generic or mixed produce outbreaks,
 12   and then you see the items that were implicated when
 13   there was a single, specific food that was able to be
 14   implicated.
 15             Okay.  Then, again, bacterial, viral, and
 16   parasitic -- I think that as the slide tries to point
 17   out, again, we are talking about pathogens that have
 18   animal as well as human reservoirs, this is a very
 19   diverse problem and involves a diverse farm-to-table
 20   continuum.  
 21             To point out the increase in norovirus
 22   outbreaks, we don’t think that means that there is


00026
  1   more norovirus-associated produce as much as we know
  2   during that period that there were now diagnostics
  3   available to the public health community where you
  4   could actually document and confirm that, yes, this
  5   was not just your suspicion that this was norovirus,
  6   but this in fact was norovirus.  
  7             We think that 70 percent, that apparent
  8   increase is not necessarily a real one.  It is more
  9   associated with our ability to diagnose norovirus in
 10   the public health community.
 11             Okay.  Bottom line, we think there has been
 12   an increase, a real increase, in produce-associated
 13   outbreaks from the seventies to the nineties, and that
 14   from the nineties to 2004, it hasn’t gone away.  
 15             I guess the current estimate, the current
 16   figure, is that 14 percent of all outbreak-associated
 17   cases, that’s the current figure of the percent of all
 18   outbreak-associated cases that were associated with
 19   produce outbreaks.  
 20             There have been more outbreaks through the
 21   nineties, and even through the two thousands there
 22   seem to be larger outbreaks.  As I said, there are a


00027
  1   variety of produce items implicated.  There are a
  2   variety of different pathogens.  
  3             In terms of looking at where to intervene in
  4   terms of contamination amplification, it’s
  5   complicated.  You probably know more than I it’s going
  6   to depend on the ecology of what is that
  7   farm-to-continuum pathway that we are looking or how
  8   are those items handled.
  9             Thank you.  I certainly welcome any
 10   questions.  If anything is not clear, please ask, feel
 11   free to ask any clarifying questions.
 12             (Applause.) 
 13             DR. BRACKETT:  Thank you, Dr. Liang.
 14             Next on the agenda is Dr. Michelle Smith. 
 15   Michelle is a interdisciplinary scientists with FDA’s
 16   Office of Food Safety, and she was the lead author on
 17   FDA’s “Guide to the Minimized Microbial Food Safety
 18   Hazards for Fresh Fruits and Vegetables,” or the
 19   so-called “GAPs and GMPs Guide.”  
 20             Dr. Smith also led the development of FDA’s
 21   2004 Produce Safety Action Plan.  She has played an
 22   active role in implementing the guidance, the


00028
  1   educational and the outreach as well as regulatory
  2   oversight and research components of the Produce
  3   Safety Action Plan.  Dr. Smith is currently leading a
  4   workgroup to identify options to enhance fresh produce
  5   safety.
  6           GAPs/GMPs, PRODUCE SAFETY ACTION PLAN
  7               OPPORTUNITIES AND CHALLENGES
  8             (PowerPoint presentation in progress.)
  9             DR. SMITH:  Thank you for that wonderful
 10   introduction that I had the opportunity to write
 11   myself.
 12             (General laughter.) 
 13             DR. SMITH:  It’s a pleasure to be here, and
 14   I’m really happy to see so many familiar faces in the
 15   audience including my past boss who is now retired,
 16   Terry Troxel.  
 17             With that, my objectives for this morning
 18   are to share a little bit of the background on the
 19   GAPs guidance; the 2004 Produce Safety Action Plan;
 20   some of the opportunities and challenges that we’ve
 21   encountered in implementing both the GAPs guidance and
 22   the action plan; a little bit about where we are now;


00029
  1   and some speculation, probably mostly questions, about
  2   where we may go from here towards ensuring food safety
  3   of fresh produce.
  4             Now, the first three points on this slide
  5   many of you have seen and heard quite a few times. 
  6   Fresh produce is grown in a nonsterile environment. 
  7   There are opportunities for contamination, and fresh
  8   produce by its very nature is likely to be consumed
  9   raw.  There is not a cook or kill step if pathogens
 10   are present.
 11             FDA does not expect fresh produce to be
 12   sterile.  However, the presence of pathogens is not
 13   the natural state of fresh produce.  There are
 14   practices that can and should be implemented to reduce
 15   or minimize the opportunities for contamination of
 16   fresh fruits and vegetables.
 17             As Art Liang mentioned, there was a
 18   significant increase in foodborne illness outbreaks
 19   associated with fresh produce between 1973 and 1997. 
 20   CDC brought this data to our attention in the late
 21   nineties, and that was the driving force behind
 22   development of the good agricultural practices.


00030
  1             Since the time of the good agricultural
  2   practices, there have been approximately 72 reported
  3   outbreaks associated with about 20 fresh produce
  4   commodities.
  5             Now, FDA is concerned about fresh produce in
  6   general.  Twenty commodities, as I mentioned, have
  7   been identified as the vehicle in these outbreaks
  8   during this time frame.  
  9             On this slide, I’ve listed leafy greens,
 10   tomatoes, and melons because these commodities
 11   together accounted for more than half of those
 12   outbreaks.
 13             Now, I could have listed four commodities,
 14   five, or six instead of these three.  The point is
 15   that there are trends that we’re seeing, trends in
 16   burden associated with particular commodities.  Part
 17   of what we will need to address is how or should we do
 18   things for individual commodities as opposed to fresh
 19   produce across the board.
 20             The GAPs guidance document, very briefly,
 21   was broad-scope guidance.  We needed to cover
 22   practices common to the growing and packing of most


00031
  1   fresh produce consumed in the United States,
  2   regardless of what region of the United States the
  3   produce was grown in or which other country.  The
  4   objective of the guide is risk reduction, not
  5   elimination; and it’s guidance, not a regulation.
  6             A few comments about what we have seen in
  7   our experience over the last eight to ten years from
  8   foodborne illness investigations.  One of the phrases
  9   that’s showing up more and more often is that “There
 10   was no smoking gun,” or “Investigators were not able
 11   to determine the source of contamination.”
 12             An investigation by it’s very nature occurs
 13   after the contamination event has happened.  Sometimes
 14   it may take a significant amount of time to identify
 15   where the produce came from and get investigators back
 16   to that location to try to figure out what has
 17   happened, what went wrong.
 18             Even if the investigators find the outbreak
 19   strain of the pathogen at or near that location, they
 20   may not be able to say how it got from where it was
 21   found onto the produce.  This is what is kind of meant
 22   by “We couldn’t find the source of contamination.”  


00032
  1             We are a regulatory agency, and we need to
  2   state things very explicitly.  Thomas Hill in his
  3   presentation will present in a lot more detail some of
  4   his observations.  
  5             As we gain more experience, we are relying
  6   very heavily on continued information coming in from
  7   our investigators, also information from researchers
  8   and other experts in areas such as wildlife and water
  9   quality management that we had not engaged in this
 10   kind of search some time ago.
 11             Now, having said that there is a need for
 12   research and a need for more information, the other
 13   aspect of what we see in our investigations are
 14   instances where failure to implement appropriate good
 15   agricultural practices and good manufacturing
 16   practices in the field, packing facility very well
 17   could have led to contamination of fresh produce.
 18             Examples of things like insanitary
 19   conditions, failure to have adequate sanitary
 20   facilities or hand washing facilities for workers,
 21   failure to have appropriate training for workers,
 22   these are things that we have seen and these are


00033
  1   causes of contamination that are preventable.
  2             The 2004 Produce Safety Action Plan remains
  3   a priority for FDA and for the Center for Food Safety
  4   and Applied Nutrition.  This action plan builds upon
  5   existing programs and expertise and it covers fresh
  6   fruits and vegetables from the farm to the table.
  7             The overarching goal of the Produce Safety
  8   Action Plan is to minimize foodborne illness
  9   associated with the consumption of fresh produce. 
 10   There are four general objectives in the action plan.
 11             When we developed this action plan with
 12   input from stakeholders, we realized that the plan
 13   itself was just the first step, that implementation of
 14   the plan is critical, so we also built into the plan
 15   measurable outcomes, actions within the plans that
 16   could achieve these objectives and accomplishments
 17   that would count towards achieving the objectives.
 18             For example, under the first objective,
 19   preventing microbial contamination, measurable
 20   outcomes would include: the release of guidance,
 21   regulations, or other tools to assist the industry in
 22   implementing appropriate best practices.


00034
  1             Under objective two, “Minimizing public
  2   health impact when contamination occurs,” measurable
  3   outcomes would include things like guidance for
  4   investigators, farm investigation training, things
  5   like that that would help speed the traceback process
  6   and better ensure that the information that
  7   investigators are able to gather in the course of an
  8   investigation is the best possible information
  9   available.
 10             Just a few of the things that we have
 11   accomplished in implementing the Action Plan, in March
 12   we released a draft final guidance for fresh-cut
 13   produce.  This guidance complements existing GMP
 14   regulations in Part 110.
 15             In August of last year, FDA in cooperation
 16   with the California Department of Health Services and
 17   the California Food and Agriculture initiated a
 18   multiyear, risk-based, ongoing Leafy-Greens Safety
 19   Initiative.  
 20             This initiative gave the three agencies an
 21   opportunity to work together in collaboration,
 22   strengthened that collaboration, and goes out to


00035
  1   various fields, cooling facilities, and fresh-cut
  2   operations in California to observe operations in
  3   advance of an outbreak.
  4             This initiative also included an important
  5   communications component to build cooperation and to
  6   very rapidly initiate communication with consumers and
  7   others in the event of an outbreak, which in fact did
  8   occur shortly after the initiative started.
  9             One of the other things that we did in 2006
 10   was update materials for training for farm
 11   investigations and hold training in the state of
 12   California for FDA, state investigators, and foreign
 13   counterparts.
 14             We also finalized guidance for farm
 15   investigations to provide more detailed instructions
 16   to investigators on what to look for and how to do
 17   that.
 18             Now, the 1998 GAPs guidance has been both a
 19   challenge and an opportunity.  The opportunity
 20   includes a chance to raise awareness about potential
 21   sources of microbial contamination at the farm and
 22   packing facility and of the food supply chain.


00036
  1             This is an area that had not previously
  2   gotten much attention, so the guidance was very
  3   timely.  It has given us a basis to work with many of
  4   our food safety partners.  
  5             The challenge is that it is guidance.  It is
  6   voluntary, not a regulation.  In implementing the GAPs
  7   Guide, we have taken the approach of making
  8   recommendations for practices and encouraging
  9   adoption.  
 10             In a compliance situation, we are not able
 11   to specifically enforce the recommendations in the
 12   guidance; however, we can and do reach back to our
 13   statutory authority to ensure that fresh produce is
 14   not adulterated.
 15             In addition, the guidance was broad scope. 
 16   In the guidance itself, we recommended that operators
 17   take these recommendations and tailor them to their
 18   individual operations.  Doing this without more
 19   specific information can be a challenge.  
 20             We understand that one size does not fit
 21   all, that the risk of microbial contamination results
 22   from the interaction of several factors, including:


00037
  1   the characteristics of the commodity, the production
  2   environment where the commodity is grown, and the
  3   practices that are used by the individual operations.
  4             Some of the opportunities that we have
  5   experienced in implementing the action plan are
  6   communication with research, academia, federal, state,
  7   and industry partners.
  8             An example of this collaborative cooperation
  9   is the industry-led, commodity-specific supply chain
 10   guidance.  Public and private partners are also
 11   forming coalitions to get research identified and
 12   funded to address some of the specific issues that we
 13   have identified as needing more science.
 14             When we developed the 2004 Produce Safety
 15   Action Plan, that is an FDA guidance or that is an FDA
 16   action plan, we understood for it to be most effective
 17   it would require all food safety partners working
 18   independently and collaboratively to achieve the most
 19   effective results.  Many of the food safety partners
 20   that we are working with are here today.
 21             Just another few words about the
 22   commodity-specific guidance.  Today, guidance is


00038
  1   available for melons, lettuce and leafy greens, and
  2   tomatoes.  
  3             One of the advantages of guidance is that
  4   guidance is a living document.  As the science
  5   advances, the guidance can be reopened and updated. 
  6   In fact, this is the case with the lettuce and
  7   leafy-greens guidance.
  8             Additions to the production of this section
  9   have been drafted based on our experiences and things
 10   that have been learned since the outbreaks last fall.
 11   The tomato guidance is also being reopened and groups
 12   formed to see what they can take from those lessons
 13   and apply to tomatoes.  
 14             Some of the challenges that we face, clearly
 15   fresh produce outbreaks are continuing.  The
 16   challenges include things like globalization,
 17   complexity of distribution, and the variety of
 18   products available.  
 19             There is a growing high-risk population in
 20   the United States.  There are currently practical
 21   limitations to investigations and the information
 22   gained.  


00039
  1             Traceback is certainly an area where we can
  2   all do better.  This is also an area where there are
  3   significant opportunities for collaboration.
  4             Lastly, probably most importantly, there is
  5   the challenge of identifying and promoting risk-based,
  6   preventive controls.
  7             Our starting point, we believe that the
  8   measures outlined in the Produce Safety Action Plan
  9   and the GAPs Guide and other public and private
 10   guidelines have or can be effective when properly
 11   implemented.
 12             However, the continuing outbreaks cause us
 13   to ask a number of questions, including:  What is the
 14   extent of implementation of the current
 15   recommendations?  What is the effectiveness of these
 16   recommendations when they are implemented properly? 
 17   What additional or different interventions might be
 18   appropriate to reduce future outbreaks?
 19             The purpose of this meeting is to gather
 20   information along those lines and help determine which
 21   path we should take from here.  Should it be guidance,
 22   regulations or different or additional mechanisms?


00040
  1             In “The Federal Register Notice” for this
  2   public hearing, there is a section that talks about
  3   the regulatory approach that FDA has taken for a
  4   number of different food groups other than fresh
  5   produce.  For purposes of this presentation, I’ve
  6   pulled out juice HACCP, which is 21 C.F.R., Part 120,
  7   as an example.
  8             I want to say first and foremost that I
  9   recognize fresh produce is not juice.  In juice, we
 10   have the advantage of having multiple treatments
 11   available to juice processors to deliver a five-log
 12   pathogen reduction or greater to the product.  I don’t
 13   think we are there with fresh produce at this point in
 14   time.
 15             In addition, I don’t think that HAACP itself
 16   is appropriate for the farm level, but there are many
 17   things in HAACP that might be applied to farms,
 18   packing facilities, and other aspects of produce
 19   production.
 20             For example, the idea that you look at an
 21   operation and you identify potential risk factors, and
 22   based on this assessment you develop a safety plan


00041
  1   that may put in place appropriate preventive controls.
  2             Some of the other requirements in the juice
  3   HAACP rule that may have a place in consideration for
  4   fresh produce include training and other requirements
  5   for specific job functions to ensure that the person
  6   who is performing that function either has the
  7   training or the experience to do that function well.  
  8             There are options for importers to choose
  9   between to be able to verify that the product that
 10   they are importing into this country was produced in a
 11   manner consistent with the rule, and there are records
 12   that would allow producers and investigators to be
 13   able to verify that the appropriate practices are
 14   being followed over time.
 15             In addition, the juice HAACP rule is
 16   augmented by a number of other things including a
 17   hazards and controls guide to assist in implementation
 18   and a recognized training curriculum to ensure that
 19   the job functions that have training or experience
 20   requirements have guidelines to go by to make sure
 21   that the training or experience is adequate to do the
 22   job.


00042
  1             FDA’s mission is to ensure the safety of all
  2   domestic and imported fresh and fresh-cut fruits and
  3   vegetables consumed in the United States.  For as long
  4   as we have been pursuing this mission with fresh
  5   produce, our continuing themes have been increasing
  6   Americans’ consumption of fruits and vegetables to
  7   achieve a healthier diet and improving the safety of
  8   fresh fruits and vegetables to the greatest extent
  9   possible.  Common to both these themes is the need,
 10   the critical need, for consumer confidence in fresh
 11   produce.  
 12             Thank you.
 13             (Applause.) 
 14             DR. BRACKETT:  Thank you, Michelle.  
 15             Our next speaker is going to provide the
 16   AFDO’s -- that is, “Association of Food and Drug
 17   Officials,” for those of you who don’t know --
 18   perspective.  
 19             Since 1998, Dr. Marion Aller has served as
 20   the director of the Division of Food Safety with the
 21   Florida Department of Agriculture and Consumer
 22   Services and her current responsibilities include


00043
  1   oversight of a comprehensive inspection and compliance
  2   program along with laboratories which analyze food
  3   samples for microbiological and chemical
  4   contamination.
  5             She has held several offices and
  6   chairmanships in AFDO.  She received her bachelor of
  7   arts in English from Stetson University and her
  8   doctorate of veterinary medicine from the University
  9   of Georgia.
 10                     AFDO PERSPECTIVE
 11             (PowerPoint presentation in progress.)
 12             DR. ALLER:  Thank you.
 13             As he said, or as Dr. Brackett just
 14   indicated, I am Marian Aller.  I am with the
 15   Association of Food and Drug Officials, also called
 16   “AFDO.”
 17             I wanted to give you a little bit of
 18   background on AFDO, who we are and what brings us here
 19   and our perspective on this issue.  We were
 20   established in 1896, and the mission of our
 21   organization is to foster uniformity in the adoption
 22   of food safety laws, rules, and regulations.  


00044
  1             We are made up of predominantly regulatory
  2   officials from state, local, and federal authorities. 
  3   We also have memberships in academia and associate
  4   memberships with industry.
  5             The background in this issue comes
  6   specifically from a forum which was held in Florida in
  7   November of last year by the tomato industry, which is
  8   calling for regulations to address produce safety,
  9   particularly the safety of fresh tomatoes.
 10             During that forum, a number of concerns were
 11   expressed, and some of the other speakers will address
 12   those.  I want to focus on the regulatory aspect and
 13   the concerns spoken of there.
 14             As I said, there was a general call for
 15   regulations, and at the same time a very real concern
 16   expressed about the potential in the absence of a
 17   federal regulation for states to adopt a patchwork of
 18   different regulations based on potentially different
 19   factors or perhaps even an understanding of what those
 20   specific causative agents may or may not be and how
 21   best to mitigate those or address those.
 22             Also, as the background factor, there is a


00045
  1   general recognition I think by all of us here that the
  2   size and scope, as we heard from Dr. Liang, of
  3   foodborne illnesses associated with fresh produce are
  4   unacceptable and that we do need to move forward
  5   collaboratively to address this issue.
  6             I want to talk a little bit about the
  7   existing guidances which we believe are a very strong
  8   first step, but the challenges that Michelle addressed
  9   are that the existing guidances lack specific criteria
 10   and metrics.  
 11             It is difficult for a producer or a grower
 12   to know both what specific criteria they need to meet
 13   and then more importantly what to do in response if
 14   their operation is outside of those guidance or
 15   criteria.  It is identifying the criteria and
 16   identifying the appropriate response.
 17             Also, as previously alluded to, those
 18   factors and criteria may be very different, depending
 19   on various production practices and the
 20   commodity-specific practices as well.  We have
 21   regional, geographic, and commodity-specific issues to
 22   be addressing.


00046
  1             There is a very real need for research to
  2   address these causes.  That again I’m not going to go
  3   into, and we will let other speakers address that.  We
  4   do believe that FDA does have a very real role, and we
  5   turn to our federal partners to guide that.
  6             I do think, however, that we do need and it
  7   is our association’s belief that we do need to move
  8   forward, recognizing that science is not always there,
  9   and, that where science is lacking, we do need to move
 10   forward and exercise our best professional judgment.
 11             In light of all of that, our association,
 12   and to respond to the request that was made of us, has
 13   appointed an ad hoc committee.  They have asked me to
 14   chair this group.  
 15             The charge that we have been given in this
 16   group is to go beyond, however, just tomatoes,
 17   recognizing again that we are dealing with a very much
 18   broader concern about produce safety.  Our charge is
 19   specifically to develop a model code, and by “model
 20   code” I do mean regulation, to address produce safety
 21   at the farm and packing house.
 22             We have been asked to look, the group has


00047
  1   been asked to look at those specific areas in general
  2   because we believe FDA has and there are other
  3   mechanisms to address the contamination issues further
  4   along that supply chain, and that this is where the
  5   greatest lack has been.
  6             Why AFDO and some of why we may have been
  7   approached with this?  Well, I think, first of all,
  8   we’ve had a very long history of a strong partnership
  9   with FDA and USDA.  We also have some experience in
 10   development of model codes going back more than
 11   20 years ago with a model food safety law.  
 12             I’ve listed a couple of more recent codes
 13   that have been developed.  These codes are developed
 14   in partnership with academia; federal, state, and
 15   local regulatory officials; industry; and consumer
 16   input. 
 17             Why a model code as opposed to federal
 18   regulation?  I don’t want to suggest here that federal
 19   regulation should not be considered.  However, we
 20   think that just given the encumbrances of federal
 21   rulemaking processes, that the development of a model
 22   code by our organization might be a little bit more


00048
  1   quick in bringing it about.  It is also more readily
  2   modified going through a process of this nature.
  3             It is a more open process.  By that, I don’t
  4   want to suggest that FDA does not seek input from all
  5   of the stakeholders.  However, there is a point in the
  6   federal rulemaking process when the public comment
  7   period closes at which FDA or the federal agencies can
  8   no longer discuss where they are going with that.  
  9             The time of closure of public comment to
 10   publication of a rule can, as we all know, be somewhat
 11   lengthy.  Again, this is just part of the process. 
 12   With the process that we are envisioning through an
 13   AFDO Working Group, it is a more iterative and open
 14   process throughout.  
 15             I think, again, one of the advantages to a
 16   process of this nature in developing a model code like
 17   this is that it does provide for what I consider to be
 18   ground truthing, again, through the participation of a
 19   broad spectrum of people providing input into it and
 20   can undergo continual modification as necessary.
 21             Also, as a model code, and I think to
 22   address industry concerns, the model code through the


00049
  1   addition of annexes or appendices provides for state
  2   and local authorities, regulatory authorities to
  3   tailor equivalences in production practices over
  4   geographic concerns may be not applicable across the
  5   board through the national regulations.  
  6             If I’m not being very clear, ask me
  7   questions what I mean about that.  But I think that
  8   this is a process that provides for that, to address
  9   those concerns as well.  Again, I want to stress
 10   equivalency there in levels of protection.
 11             Again, to carry that theme, we believe that
 12   because of the process potentially involved here that
 13   it is a more collaborative work product and therefore
 14   can enjoy wider success and, most importantly, broader
 15   implementation.
 16             Because states and locals have ongoing
 17   partnerships and certainly a perception, I won’t say
 18   it’s always the reality, but as we know what
 19   perception and reality are, we can work much more
 20   closely with the smaller- and medium-sized farms and
 21   businesses. 
 22             It is often those where our regulatory


00050
  1   options and regulatory compliance tends to break down. 
  2   Again, we need for regulation to ensure that all
  3   producers are participating.
  4             I mentioned a moment ago that we have, AFDO
  5   has, set up a committee.  At this point in time the
  6   Committee has had one meeting, that’s by conference
  7   call, at the moment.  
  8             At the moment members include state
  9   regulators from Florida, California, Virginia, Ohio,
 10   North Carolina, and members from FDA and USDA.  It
 11   also includes a representative from the Association of
 12   Fruit and Vegetable Inspection Standardization
 13   Agencies, a bigger mouthful than AFDO, “AFVISA.”  
 14             We have industry representation.  We have
 15   several growers -- or at least, excuse me, one grower. 
 16   We will probably be adding a couple of other growers
 17   to come and go as we are addressing specific
 18   commodities, again, for that ground truthing.
 19             Academia is on this committee, and I say
 20   others.  When I was first approached to put this
 21   together, I had a wonderful idea that this would be a
 22   small, very nimble group and quickly found out that


00051
  1   no, small doesn’t quite cut it.  You really need to
  2   have very broad membership.  We hope we will keep that
  3   agility and ensure that we cover all of our bases in
  4   terms of membership.  
  5             Specifically, what are the next steps.  Our
  6   goal is to pick up where existing guidance documents
  7   have left off.  We want to incorporate the, I think,
  8   very good and excellent work, recent work, by both
  9   leafy greens efforts out in California and through the
 10   tomato industry out on the East Coast.  
 11             We want to extract from those documents
 12   those overarching principles and then, as I mentioned
 13   before, tailor to specific commodities and perhaps
 14   geographic-specific concerns as well or specific
 15   production practices.
 16             I would love to think that AFDO had all the
 17   money in the world, and that we could do this through
 18   great meetings and have public input.  We are a very
 19   small organization.  We are made up of regulators.  We
 20   don’t have a lot of dollars, so we will be working
 21   predominantly through emails and conference calls.  We
 22   do plan to meet at our annual educational conference


00052
  1   this June in San Antonio.
  2             In summary, I want to stress our support for
  3   FDA’s leadership and desire to move forward on this
  4   issue.  We applaud those efforts.  We do not believe
  5   we are trying to go divergently but collaboratively,
  6   maybe along parallel tracks.  
  7             Those tracks may merge at some point in
  8   time, if regulation is the path chosen; if not, we
  9   want to have something in place for states to have and
 10   for industry.
 11             We also urge our federal partners to
 12   “leverage.”  I use that word.  You hear it a lot more
 13   when money is tight.  Money is certainly tight.  We’ve
 14   all heard of the budgetary woes to leverage the very
 15   limited research dollars and ensure that we do get the
 16   biggest bang for our buck researchwise.  
 17             There are many, many, many questions that
 18   one can ask.  We want to ensure that the funding is
 19   directed to those that have the greatest application
 20   for risk mitigation.
 21             We think that we offer a slightly different
 22   approach than a federal regulatory approach, as I’ve


00053
  1   said, not necessarily in lieu of, but at least as a
  2   step forward in that process as FDA determines where
  3   it’s going to go.
  4             We welcome both FDA’s comments and
  5   suggestion as well as any of you here.  We will
  6   continue to work together.  I also just want to
  7   mention we will be providing more specific comments on
  8   the issues raised in “The Federal Register Notice.”  I
  9   have listed my contact information here at the bottom. 
 10   Denise Rooney is AFDO’s executive director.  That’s
 11   her phone number.  
 12             Oh, my, my, there we go.  I didn’t know that
 13   was in there, my apologies, as it fades into
 14   existence, fades away, comes into existence.  
 15             Those are our contact information there. 
 16   Thank you very much, and I’ll be available obviously
 17   for questions.
 18             (Applause.) 
 19             DR. BRACKETT:  Thank you Dr. Aller.
 20             The final speaker before our scheduled break
 21   is Thomas Hill.  Thomas is an environmental health
 22   officer here at CFSAN with the U.S. Public Health


00054
  1   Service, and he is assigned to the Emergency
  2   Coordination Response Team here within the Center for
  3   Food Safety and Applied Nutrition.
  4             Captain Hill has been involved in numerous
  5   farm and packing houses’ investigations that are
  6   related to produce outbreaks, so he comes with some
  7   experience.
  8                  INVESTIGATION FINDINGS
  9             CPT. HILL:  Thank you.  Can somebody help me
 10   find my slides?  
 11             (General laughter.)
 12             (PowerPoint presentation in progress.)
 13             CPT. HILL:  Here is the question for today. 
 14   Does anyone know the answer?
 15             (No verbal response.)
 16             CPT. HILL:  No?  There are only two things
 17   in life money can’t buy.  That is true love and
 18   homegrown tomatoes.
 19             (General laughter.) 
 20             CPT. HILL:  All right.  Okay.  You can start
 21   the clock now.  All right, I’m Thomas Hill, and I’m
 22   going to talk a little bit today about some of the


00055
  1   environmental findings that we have seen at tomato
  2   farms and packing houses.  
  3             I have a lot of slides to get through, all
  4   right.  In the next 15 minutes I’m going to try to
  5   cover all of this material, so bear with me.  I’m
  6   going to talk really fast.
  7             Okay.  I need to give you a little
  8   background, the references that we use for farm
  9   investigations, and four sources of particular
 10   concern.  
 11             I’m going to focus really on two, and then
 12   I’m going to show you some of our farm and packing
 13   house findings and give you a summary.  You have often
 14   heard it said, “Tell them what you’re going to tell
 15   them, tell them, and then tell them what you told
 16   them.”
 17             (General laughter.) 
 18             CPT. HILL:  Four points.  After I finish
 19   this slide, I’m done.  “We don’t know exactly how the
 20   contamination occurs.”  You’ve heard that before this
 21   morning, but we have found salmonella species in the
 22   environment on the farm.  


00056
  1             Growers and packers, unfortunately, don’t
  2   always follow good agricultural practices or good
  3   manufacturing practices and research is needed. 
  4   You’ve heard that before.  
  5             I’m basically done, but I’ll go forward as
  6   quickly as I can.  If Dr. Brackett doesn’t bring out
  7   the hook, I’ll go as quickly as I can.
  8             Okay.  Some background, these are just
  9   general characteristics and of course include
 10   tomatoes.  These outbreaks are widely dispersed.  We
 11   have individual patient cases in many states, low
 12   attach rates, the epidemiology is tedious.  You know,
 13   what goes on a sandwich?  Lettuce, tomatoes, and
 14   cheese.  Often, it takes a long time to tease out
 15   exactly what is contaminated.
 16             Tracebacks are extremely difficult because
 17   of the nature of the supply chain.  You have the farm,
 18   you have the packer, you have wholesalers, and
 19   repackers.  It’s a very arduous task to do a
 20   traceback.
 21             The contamination is intermittent; it is
 22   very low level; and the implicated produce is rarely


00057
  1   still available.  We go to the farm, and it has
  2   planted in another crop.
  3             The one very important characteristic, there
  4   seems to be some geography here.  When we look at
  5   leafy greens, it’s California.  When we look at
  6   tomatoes, it’s the East Coast.  We have seen repeated
  7   outbreaks in two areas, in Florida and in Virginia. 
  8   Keep that in mind.
  9             These are stake tomatoes -- mature, green
 10   tomatoes.  East Coast style, the plants are on
 11   plastic, a very, very neat, tidy operation as opposed
 12   to in California they have bush tomatoes that are just
 13   picked once.  The stake tomatoes are picked one, two,
 14   three, or more times.
 15             Shifting gears, we do have guidance that we
 16   use when we do a farm and packing house investigation. 
 17   Here it is, and it’s available on the Web.  You can
 18   take a look at that.
 19             Again, four areas of particular concern:
 20   soil, water, animals, and workers.  I’m really going
 21   to talk and focus, I’ll mention all of the them, but
 22   I’m really going to focus on water and domestic and


00058
  1   wild animals.
  2             Okay.  When you’re talking about soil, you
  3   want to know what it’s the soil, how does it drain,
  4   and what is its contact with the plant or the fruit. 
  5   These are just some photos that show you some
  6   well-drained soils and sandy soils, just to give you a
  7   little flavor of what we see out there.
  8             Weather, weather is not soil but weather has
  9   an impact on the soil and these other variables that
 10   we are going to talk about.  Outbreaks are often
 11   chased away by hurricanes like Hurricane Charley.
 12             You can see evidence of weather, flooding or
 13   drought.  In this case, in this slide, you can see
 14   where the plants, their roots have been saturated and
 15   the plants are dwarfed by excessive rain or flooding.
 16             Places like Florida in particular where
 17   drainage is poor there are large ditches and
 18   dewatering operations.  These ditches are very great
 19   environments for animals and plants and habitat, if
 20   you will.  These are some pictures of dewatering
 21   equipment.
 22             Also, on the other extreme is drought.  When


00059
  1   there is a drought, animals are drawn to the areas of
  2   moisture and many times you will see animals or animal
  3   activity in these ditches around the field.
  4             Here are some FDA investigators.  Normally,
  5   the water would be up to their waist here, and they
  6   are taking samples.  This particular sample did test
  7   positive for salmonella.  You know, when there is a
  8   drought, you have the plant which has lots of moisture
  9   and can serve as an attractant to animals to the
 10   field.
 11             Okay.  Let’s get into water.  This is where
 12   I will spend most of my time.  The microbial quality
 13   of water is very important here, and the water that’s
 14   used must be suitable for the intended purpose.  
 15             Here you see pictures of wells; ponds;
 16   sprayers; and the actual dump tank, the washing of
 17   produce.  Water is also used in irrigation, just to
 18   give you an idea of what’s going on.
 19             Wells, we go from deep agricultural wells to
 20   shallow wells, wells that are used that go directly to
 21   the field, and wells that recharge ponds.
 22             This is a busy picture, but just to give you


00060
  1   an idea.  A well, this well is very close to a pond. 
  2   It’s used to keep a pond filled.  There may be several
  3   of these wells around the pond.  Well water in this
  4   case is being used to also mix chemicals.  
  5             There are some current concerns and research
  6   needs to be done on what’s happening between this well
  7   and the pond and what may be happening between the
  8   sprayer and the well.  Cross connections are something
  9   that we are very concerned about in
 10   cross-contamination. 
 11             Here, you see a picture.  The pipe on the
 12   right is coming from the well, and the overflow pipe
 13   or drain is above.  That is a potential cross
 14   connection if you were to lose power.  Or, if the
 15   ponds got high enough, you could see water go back and
 16   contaminate the well.
 17             This is another example.  This well is very
 18   close to the pond, and you can actually see the rust
 19   stain on the fill pipe from where the pond has gotten
 20   so high, and then again you have another connection to
 21   a sprayer and a potential cross connection.  We see
 22   lots of this while we are out in the field.


00061
  1             All kinds of ponds are used, natural ponds
  2   and manmade ponds.  We will talk about that.  Now,
  3   this is a pond, source water to irrigate a field. 
  4   Here are some investigators.  Dr. Mark Walderhaug
  5   taking a sample.  
  6             That sample did test positive for
  7   salmonella, but they cleaned this water up.  It’s
  8   filtered, drip-tape cleanser is added; and fertilizer,
  9   the plant is fed under the plastic as you saw earlier. 
 10   Here we have an FDA laboratory person collecting
 11   samples from sand filters, and we found salmonella
 12   there.  
 13             Moving on into other uses of water, crop
 14   sprays are very important.  They are always using a
 15   spray on tomatoes after a rain event and at least
 16   weekly herbicides, pesticides, and fungicides.  The
 17   stake tomatoes aren’t just picked one time, so they
 18   may be spraying the day before picking.  Some of these
 19   crop sprays can be applied the day before picking.
 20             Where does this water come from?  Again,
 21   ponds, wells, and something that is particularly
 22   concerning is using portable pumps to draw raw pond


00062
  1   water and mix that with chemicals.  Some people seem
  2   to think those chemicals will kill bacteria that may
  3   be in the pond, but that isn’t so.
  4             Here is another connection here to a pipe
  5   that’s going to irrigate a field.  In this case,
  6   filtered pond water would be used to mix sprays.  Here
  7   is the portable pump that we see sometimes that really
  8   shouldn’t be used.
  9             When you look up close at a tomato, in this
 10   case you can see the residue on the tomato either from
 11   splash or from spray, so these tomatoes are constantly
 12   wetted and dried and wetted and dried from all kinds
 13   of sources of water.
 14             Let’s talk a little bit about different
 15   potential sources of contamination.  These are animals
 16   that we see in and around ponds: turtles, frogs,
 17   ducks, geese, waterfowl and their evidence, feathers
 18   and droppings.
 19             Now, this is a drainage ditch teeming with
 20   fish and frogs and alligators and you name it.  I
 21   mean, this is just the perfect environment.  Here
 22   actually we have gators in the pond.  We can swab


00063
  1   turtles, but we’re not too good at gators yet.
  2             (General laughter.) 
  3             CPT. HILL:  Here is a investigator swabbing
  4   the rear end of a turtle.  Again, the proximity of
  5   these nice environments to the tomatoes, we need to
  6   look at that and see what’s going on.  This is another
  7   ditch in close proximity to a field of tomatoes.
  8             Also, bordering some of these farms are
  9   cattle operations.  You can see here the potential for
 10   movement of cattle waste into a ditch in close
 11   proximity to a tomato field.
 12             Drainage, again, here this picture is kind
 13   of busy but in the background you can see a ditch, and
 14   there is a swell there.  In times of heavy rain or
 15   flooding, that swell is going to carry water away from
 16   the field or from the ditch towards the field. 
 17   Equipment is crossing here.  You have cattle on the
 18   other side.  You have these situations that are
 19   something we need to look at.
 20             Also, here we have a swell, a drainage ditch
 21   where wild pigs have broken the fence and are going
 22   between the cattle ranch and the tomato farm in this


00064
  1   ditch that is dry right now, which would be filled
  2   during heavy rain.
  3             You can see the tomato field in the
  4   background and places where wild hogs have been
  5   looking for moisture, rooting in these ditches that
  6   may be dry.
  7             This is just to illustrate some of the
  8   salmonella’s that we are finding in the environment on
  9   animals, lizards, and turtles in animal droppings that
 10   we collect; ditch water media, sand media from
 11   filters.
 12             I will just mention a little bit about
 13   harvesting.  We really haven’t seen evidence of
 14   problems with harvesting in the investigations that
 15   I’ve been on.  Port-o-Potties are there.  Workers are
 16   trained, and they are doing a good job.  But it is an
 17   area that we need to look at closer.
 18             Here we have some workers about to pick a
 19   field of tomatoes.  Here FDA is collecting tomato
 20   samples and flowers in one of our investigations.
 21             I will mention just briefly the packing
 22   house.  This is a dump tank.  Take note of the organic


00065
  1   debris in the tank.  They use chlorine and hot water
  2   here, but it’s something we need to look at closer. 
  3   You can see the quantities of organic material that is
  4   being removed from the dump tank on the right there. 
  5             We found little critters like this in the
  6   dump tank.  Birds are a concern.  In one packing
  7   house, they had evidence of birds, and they quickly
  8   resolved that.
  9             When you look a little further down the
 10   line, fresh-cut operations, they may take nice, ripe
 11   toamotes right out of the ripening room and put those
 12   in ice-cold water.  We know that tomatoes will suck
 13   water in, in those situations, so that’s something we
 14   need to look at as well.
 15             Again, here is our summary.  Just two more
 16   bullets, the last two bullets.  The FDA is committed
 17   to improving produce safety, and it’s going to take
 18   collaboration between federal, state, local, academia,
 19   industry, trade associations, and consumers.
 20             Thank you.
 21             (Applause.)
 22             DR. BRACKETT:  Thank you, Thoms.


00066
  1             Well, we do have a scheduled break now.  We
  2   are just a few minutes behind here.  It is now 10:25. 
  3   We will reassemble back here at 10:40.  Again, the
  4   restrooms, if you need them, if go out the door, back
  5   down to your left, they are on your right side.
  6             Thank you.
  7             (Recess is taken.)
  8             DR. BRACKETT:  Well, we do want to get
  9   started so we can keep on time, but I do have one
 10   reminder for all of you and those in the hallway who
 11   can’t hear me, which is, we would like to ask you to
 12   make sure that you actually sit in the chairs in here.
 13             There are plenty of chairs for the people
 14   that we have here, although you may have to shift
 15   around a bit, but what we cannot have are people
 16   sitting on the stairs.  That is a violation of the
 17   fire code.  Also, it makes it dangerous that are
 18   coming in after you.  So if you would, please take
 19   your seats.
 20             The final speaker of the first panel that we
 21   are having is Dr. Jim Rushing.  Dr. Rushing is a
 22   professor of horticulture with Clemson University.  He


00067
  1   is also the director of the Coastal Research and
  2   Education Center in Charleston, South Carolina.
  3             He first began to work in fresh produce
  4   safety in 1990 when South Carolina tomatoes were
  5   implicated in outbreaks of illness.  Since that time,
  6   he has collaborated both with national and regional
  7   programs in food safety and is an instructor for an
  8   internationally led course by JIFSN, the “Joint
  9   Institute for Food Safety Nutrition.”  He spent one
 10   year here at FDA CFSAN as a visiting scientist on
 11   sabbatical, so we are glad to have him back, too.
 12             Jim.
 13                     STATE PERSPECTIVE
 14             DR. RUSHING:  Thank you.  Good morning
 15   everyone.
 16             I’m just going to talk for a few minutes
 17   with you.  I’m not going to use photographs and things
 18   like that.  I should be able to give a couple of
 19   minutes back to the organization here this morning.
 20             It certainly is a pleasure to be here and
 21   see a few old friends.  I’ve never seen Jack so
 22   well-dressed.  He looks more like an attorney.  I wore


00068
  1   my tweedy professor clothes so I couldn’t be confused
  2   with the attorney-looking folks here.  
  3             My name is Jim Rushing, and I have worked
  4   with Clemson University for over 20 years.  We have
  5   had our share of problems very early on with food
  6   safety, with outbreaks of illness associated with our
  7   fresh produce.  Because of that, I got involved in
  8   1990 and have continued to try to stay with the things
  9   that are going on.  
 10             My purpose here this morning was to give a
 11   perspective of the states or from the states on the
 12   current status of fresh-produce food safety.  First of
 13   all, there is no one person who can speak for all the
 14   states.  I’m not sure even one person could speak for
 15   their own state because of the disagreement within.
 16             That’s going to be tough, but I see that
 17   there’s a number of others on the program after me who
 18   will clarify any confusion that I create in the few
 19   minutes that I’m here.  
 20             I have had an opportunity to have a lot of
 21   collaboration with other states with the national GAPs
 22   program.  Dr. Gravani from Cornell is here.  It’s been


00069
  1   a pleasure to work with him and 25 states or so.  
  2             We had a fourteen-state southern regent
  3   teaching program that I was involved in for seven or
  4   eight years that also gave me some opportunity to get
  5   a little insight and then I’ve been blessed with the
  6   opportunity to work in over 30 countries and always
  7   arrived home safely.  Hopefully, some of that
  8   experience would be useful for this short discussion.
  9             I also in that collaboration am not only
 10   with land-grant universities, there are state
 11   departments of agriculture and state health
 12   authorities who participate in those and provide some
 13   insight as well.
 14             I studied the issues and the questions in
 15   “The Federal Register Notice.”  I’ve tried to limit my
 16   comments to those issues and questions, although I’m
 17   not going to go in exactly the order that they are
 18   stated in the “Notice.”  I believe the issues
 19   surrounding fresh-produce food safety are much broader
 20   than the points as they are described in that Notice,
 21   and so it will be necessary to stray just a little bit
 22   out of the box at times but not too much.


00070
  1             The first two issues there deal almost
  2   entirely with the guide that Michelle mentioned that
  3   was first published in 1998.  I’m just going to refer
  4   to that as “the guide.”
  5             For those of us who teach, for those of us
  6   in the university system and who have collaborative
  7   programs, the guide has been an invaluable tool.  It
  8   has provided the template for us to expand upon and
  9   develop the training programs.
 10             But since the guide was released nine years
 11   ago, there has been a tremendous amount of research, a
 12   lot of industry experience, and I think we need to
 13   update that document with some really specific things.
 14             I believe one of the highest priorities of
 15   FDA and other FDA authorities, USDA and perhaps
 16   others, would be update that with more specific
 17   information.  There must be uniformity across state
 18   boundaries in the implementation of safe practices. 
 19   There has to be uniformity.  
 20             The states are looking to the FDA and the
 21   USDA for leadership in establishing that uniformity. 
 22   Only the federal folks really have the capacity to do


00071
  1   that in a way that can be broadly implemented.  
  2             I will give some examples about the things
  3   I’m talking about, but this would give all of us at
  4   the state level a uniform basis upon which to build
  5   our own programs.
  6             While there are commodity-specific needs and
  7   commodity groups have developed their own documents,
  8   all of those commodity-specific documents need to go
  9   back to, in my opinion, one template -- one, uniform
 10   document that is well grounded in science that we can
 11   all refer to.
 12             If I could give just a couple of the
 13   specific examples about that.  In recent meeting with
 14   Dr. Gravani’s group and those twenty or so states that
 15   were represented, this topic of agricultural water was
 16   one thing that we discussed in great detail.
 17             While common sense tells us that we should
 18   test, I don’t think anyone argues that it’s wrong to
 19   test.  Producers will counter that recommendation with
 20   a whole series of questions.  
 21             What do we test for?  How often do we test? 
 22   What’s the critical level at which we should not use


00072
  1   water?  And, the inevitable question, if it’s dirty,
  2   how do we clean it up?
  3             If we as public servants of the state or the
  4   Federal Government are unable to answer those
  5   questions, then I believe we cannot reasonably expect
  6   industry to make broad implementation of
  7   recommendations that are really quite vague and
  8   incomplete.  
  9             We have a responsibility in public service
 10   to do a better job with that.  We need specific
 11   answers to those questions based upon science.  The
 12   same questions that we ask about water could be asked
 13   about soil and organic fertilizers, exactly the same
 14   questions.
 15             In the Eastern U.S., I believe that in terms
 16   of numbers not many numbers of fruit and vegetable
 17   growers have a formal testing program for irrigation
 18   water, not many I know, not many of our South Carolina
 19   folks do and many of the smaller operations do not.
 20             If there is no regulation that requires
 21   testing and there are no specific guidelines that we
 22   can pass to a grower, then I would not anticipate that


00073
  1   many growers would begin to test water in the near
  2   future, unless they get in trouble of some kind.
  3             Another critical issue that has been at the
  4   forefront is the proximity of animals to production
  5   areas.  Again, common sense tells us that two types of
  6   farming, plants and animals, present risks to
  7   consumers of fresh produce, but once again those of us
  8   in public service are unable to answer the specific
  9   questions from producers.  
 10             How far away should animals be?  How serious
 11   is the risk of airborne contamination?  What is the
 12   proper way to design a buffer zone?  What about
 13   waterborne contamination?  The only thing I believe we
 14   are really certain of is that water runs down hill,
 15   and that can bring contamination with it.
 16             There is not enough information there to
 17   convince producers to bring about change because they
 18   have not.  We still have those kinds of practices
 19   going on.  We cannot simply say, “There is an animal. 
 20   You can’t grow here.”  We have to do better than that
 21   to bring about change in the industry.  
 22             It is not my intent to criticize the FDA or


00074
  1   the USDA or anyone in state service.  My only intent
  2   is to try to point out some of the areas where, in my
  3   opinion, we should dedicate resources for scientific
  4   study.
  5             In addition to that research effort, we
  6   should continue to strive to improve our communication
  7   between researchers and those of us who need that
  8   information to develop guidelines and to extend that
  9   to the industries we serve.
 10             This leads logically to the topic of
 11   regulation.  I believe that most state agencies do not
 12   seek or desire more regulation.  Certainly, I believe
 13   the industry in general would prefer not to be
 14   burdened with more regulation, but regulation seems to
 15   be the only recourse, unless there is some voluntary
 16   compliance with the things that we now believe to be
 17   true, safe, practices based upon common sense and some
 18   science.
 19             Do we use that threat of regulation when we
 20   are training?  When we are doing educational programs,
 21   do we use that threat of regulation to try to bring
 22   about change?  I don’t believe that is really going to


00075
  1   be a very effective way to get folks to change the way
  2   they do their business.
  3             As an educator, education is critical to our
  4   effort.  Food safety programs have been developed and
  5   taught, and they have been largely grounded in the
  6   land-grant university system.  They have been
  7   delivered to broad audiences.  
  8             We have trained practically every extension
  9   county agent, I know we have in 14 Southern states, to
 10   go out and train others in safe-handling practices. 
 11   Federal funding has generally been adequate for those
 12   programs.  Anyone working in any discipline would like
 13   to have money, but we have had enough money to develop
 14   materials and travel and train those people.
 15             What is the next step for educators like
 16   myself?  Do we simply do more of the same?  I believe
 17   in order for us to do our job better, we must have
 18   that more specific guidance with more specific
 19   science-based information that we can use in our
 20   teaching program.
 21             If we go back just a minute to the topic of
 22   regulation, there is some human behavior involved here


00076
  1   in bringing about change, certainly some sociological
  2   aspects as well.
  3             We know that many companies have implemented
  4   GAP and GMP.  We also know that some have not.  It
  5   might useful just to think for a moment about the
  6   challenges or the obstacles in getting people to bring
  7   about that change.
  8             Many people in the fresh-produce industry
  9   still do not believe there is a problem.  They don’t
 10   perceive any problem.  They say, “We’ve been doing
 11   this for decades, and no one has ever gotten sick from
 12   our produce.”  
 13             Secondly, the cost of implementing a food
 14   safety program is large, and much of that cost is due
 15   to requirements or third-party audits, which I will
 16   mention briefly in a moment.
 17             Then, third, we don’t give those specific
 18   recommendations that we need to give.  When we go in
 19   and talk about the management of processing water or
 20   irrigation water, we need to really know what we’re
 21   talking about.
 22             Then, companies that have never been


00077
  1   impacted by an outbreak of course say, “Well, we don’t
  2   have a problem, so we don’t worry.”  Money is a big
  3   motivator.  When people lose money, they are more
  4   likely to do something.  We have seen this in specific
  5   industries like melons and tomatoes and the leafy
  6   greens and so on.
  7             But let’s assume for a moment that all of
  8   our educational effort, all of the monetary
  9   considerations do not bring about industrywide
 10   compliance.  Regulation becomes a necessity.  
 11             How will those regulations be developed? 
 12   Who will develop them?  How will you take the guide
 13   now, which is a very general document, and create
 14   regulations which must by definition be very specific? 
 15   Once they are developed, how will they be enforced? 
 16   At which level will enforcement reside?  Do we do that
 17   as states, or will the federal folks do that?
 18             I believe many states are in the same
 19   situation as we are in South Carolina.  Our state
 20   Department of Ag, our Department of Health and
 21   Environmental Control, and Clemson University are the
 22   three agencies who would do that.  


00078
  1             None of us really have the people or the
  2   funding or the training really across the board to go
  3   out and do inspections and enforce regulations. 
  4   Development of fair and reasonable regulations
  5   followed by fair and reasonable inspection and
  6   enforcement are only two steps.  
  7             What will be the fair and reasonable
  8   punishment for people who do not comply?  There are a
  9   lot of questions there with really no answers, and I
 10   think all of us together have to strive to fill in the
 11   blanks there.
 12             I need to talk just a minute about auditors. 
 13   I realize that auditing is not a responsibility of the
 14   FDA.  But if we are going to move into the area of
 15   regulation, we need to consider that industry which
 16   has grown dramatically.  
 17             There may be auditors in the audience. 
 18   Certainly, it is not my intention to criticize your
 19   work, but there is very little uniformity in the
 20   auditing process.  Growers and handlers often are
 21   asked to have multiple audits, and different auditors
 22   have different expectations.


00079
  1             There is not an official, uniform auditing
  2   instrument.  We need some consistency in that
  3   industry.  Perhaps, USDA can handle this best, since
  4   they have developed an auditing tool.  Qualifications
  5   of the auditors themselves are not understood, and, to
  6   my knowledge, they are not standardized.
  7             If regulation is developed for this
  8   industry, I believe that regulation somehow has to
  9   consider the auditing industry as well.  The audit, we
 10   all recognize, is merely a snapshot.  It’s just a
 11   picture of a moment that the company is doing
 12   business, and food safety has to be a lifestyle and
 13   not just passing an audit.
 14             The last thing I would mention is the
 15   subject of risk.  In my opinion, we could never
 16   eliminate all risk of consuming fresh produce or any
 17   other food.  
 18             We do not yet have compelling evidence that
 19   I know of that GAP has reduced our risk.  I don’t know
 20   of any study comparing GAP and non-GAP companies, and
 21   such a study would not be easy to conduct and perhaps
 22   would be impossible.  


00080
  1             I think that we have not come to grips with
  2   the idea that small risk will always be present in
  3   almost anything we do.  In closing, I believe at the
  4   state level we have reached a point where we need
  5   guidance about how to proceed.  
  6             I think, again, we in the states are looking
  7   to federal authorities to help us find that direction. 
  8   I believe that in most states most of us are eager to
  9   collaborate and make a contribution where we can.  My
 10   hope is that meetings like this will point us in the
 11   right direction.  Thank you for your attention.
 12             (Applause.) 
 13             DR. BRACKETT:  Thank you, Dr. Rushing.
 14             At this time we have provided time for the
 15   FDA panel to ask our speakers panel some questions,
 16   and I will go through starting from Dr. Solomon and
 17   then move down the line and provide each of them a
 18   question and then go back again, so we need to get
 19   microphones down to them.
 20             Our first questioner is Dr. Steve Solomon.
 21               QUESTIONS FROM THE FDA PANEL
 22             DR. SOLOMON:  Thank you.  I guess my


00081
  1   question is, Dr. Smith, we heard that the GAPs/GMPs
  2   document was created in 1998, and that has not been
  3   updated.  Yet, we have a lot of the specific guidances
  4   and we are looking to update those guidances.  Do you
  5   feel there is a need to update the original 1998
  6   guidance?
  7             DR. SMITH:  That’s a good question.  We
  8   asked the same question in 2004 when we were working
  9   on the Produce Safety Action Plan, should we update
 10   the ‘98 GAPs guidance.  Comments at that time were all
 11   over the board.  
 12             There was some leaning in the direction of
 13   keeping the 1998 GAPs guidance as it was based on the
 14   value of the principles set out in that guidance and
 15   putting resources towards supplementary, more specific
 16   guidance.  
 17             In fact, the industry-led, commodity-
 18   specific guidance fills part of that need, but it’s
 19   not just commodity-specific guidance that we need.  We
 20   also need practice-specific guidance, issue-area
 21   specific guidance such as Jim Rushing mentioned, more
 22   details on water quality management, water quality. 


00082
  1   We need the standards before we can develop that
  2   guidance.
  3             That doesn’t mean that we are not going to
  4   revise the GAPs guidance.  It’s just a matter of
  5   deciding where is the best place to put our resources
  6   at this point and time.  Some of our decision making
  7   for what to do next may ask that question again.
  8             DR. BARRETT:  Okay.  Next, Dr. Zink.
  9             DR. ZINK:  (No microphone.)  I have a
 10   question for Dr. Rushing.  I appreciated your comments
 11   about the lack of specificity really with how close
 12   should animals be and about water contamination.  
 13             I’m wondering if you could elaborate on it a
 14   little bit more.  I am intrigued by the recent
 15   publication of some new tests for fecal contamination
 16   of water based on mitochondrial DNA, looking at
 17   specific animal species, which I think that might be
 18   interesting, since I think our problem is fecal
 19   contamination of water.  
 20             You didn’t mention feral animals.  Do you
 21   have any thoughts about feral animals?  Can you
 22   elaborate just a little bit more, maybe give us some


00083
  1   more specific direction?
  2             DR. RUSHING:  Well, probably I can’t because
  3   I’m not a microbiologist or a genetic molecular
  4   biologist either, but I have been present in a number
  5   of discussions about testing for water.  
  6             It’s so an incredibly complex.  I’ll stick
  7   my neck out a little bit.  In the last discussion that
  8   I had, if I were a farmer in that room, I probably
  9   would as a farmer have chosen not to test.  
 10             Because, as the discussions went on, we just
 11   found more and more weaknesses in almost any plan we
 12   could come up with.  We’re dealing with bacteria, with
 13   waterborne parasites, with virus.  
 14             I don’t know of tests -- well, perhaps this
 15   test that you mentioned is one that would allow us to
 16   do a broad test for all of those different forms of
 17   contamination.  
 18             I don’t know that, but I see that as a real
 19   limitation in water testing is how to do a broad,
 20   comprehensive test that actually has utility that can
 21   be done fairly quickly and that can really tell us
 22   something about what is in the water.


00084
  1             DR. BARRETT:  Jack Guzewich.
  2             MR. GUZEWICH:  I have a question for
  3   Dr. Aller, kind of a two-part question for her.  She
  4   was talking about this concept of AFDO developing this
  5   model regulation or code.  I want to see what you
  6   think the relationship is between that kind of a
  7   document and the commodity-specific documents that
  8   have been put together industry in recent times,
  9   that’s Part A.  The “B” part is what is your timeline
 10   for developing your guidance?
 11             DR. ALLER:  I knew you were going to ask
 12   that second part.  The relationship between the
 13   commodity-specific guidances and where we are with
 14   what we are thinking of doing with AFDO, I think that
 15   we definitely need to draw from those.  They are not
 16   out there in isolation.  
 17             We see those as a major contribution to
 18   this.  We also see that that is guidance versus a
 19   code, which is regulatory and which will provide for
 20   those.  
 21             There is a very real call for regulation and
 22   that’s our interest is to have something that states


00085
  1   can adopt for regulatory input.  I understand there is
  2   a lot of complexity to that and what not, but those
  3   guidance documents would be drawn upon to develop,
  4   rate that code.
  5             Timeline?  Boy, if I had a crystal ball, if
  6   I could devote all of my time to this, and if all of
  7   the people on the Committee could devote all of their
  8   time to this, to the rest of you who are on the
  9   Committee that are sitting in the audience, I would
 10   love to try to put something out there.  
 11             It is very difficult because it is a fairly
 12   broad charge.  To be quite honest, I’m not sure if the
 13   charge which is to cover all produce is in fact
 14   doable.  I can’t give you a timeline.
 15             I would hope that it will be more rapid than
 16   it might take to do this through a federal rulemaking
 17   process, but I would like to say within a year or so.
 18             DR. BARRETT:  Mr. Baca.
 19             MR. BACA:  I have a question for Dr. Liang. 
 20   I guess my question is we appear to be having an
 21   increase in the incidence in illnesses and operations
 22   associated with produce.  My question is, is there a


00086
  1   correlation?  Have you superimposed the increased
  2   consumption of fresh produce on the apparent increased
  3   illnesses?
  4             DR. LIANG:  The quick answer is no, only in
  5   the broadest sense of the way epidemiologist think,
  6   these medical epidemiologists see an increase in
  7   illness and then they start running though their
  8   minds, “What are the hypotheses?  Well, you know, what
  9   could it be?”  That’s one of the hypotheses that we
 10   have run through our minds.  Have we done a study to
 11   actually try to get more precisional?  The answer
 12   would be no.
 13             DR. BARRETT:  Ms. Lewis.
 14             MS. LEWIS:  My question is for Dr. Aller. 
 15   You mentioned that in your workgroup you would explore
 16   the options of states tailoring their equivalency
 17   levels in protection, and I’m wondering how much
 18   leeway would be involved in that?  How would they
 19   determine equivalencies?  How would maintain
 20   uniformity across a broad spectrum in doing that?
 21             DR. ALLER:  Yes.  I probably need to clarify
 22   what I meant by that statement was that a model code


00087
  1   would provide for those practices, would actually set
  2   those that a state would choose to adopt those
  3   portions of a model code applicable to the commodities
  4   and/or geographical production practices.  That is
  5   what I meant by that, that the model code would
  6   address that.
  7             DR. BARRETT:  Okay.  We have time for
  8   another round.
  9             Dr. Solmon.
 10             DR. SOLOMON:  (No microphone.)  Thank you.
 11   I’ll just open it up to anyone.  I think theoretically
 12   when you look at the GAPs/GMPs document, I mean, you
 13   heard from Dr. Rushing that there is no editing right
 14   now to demonstrate how they work.  How would you
 15   approach demonstrating that GAPs and GMPs works?
 16             DR. SMITH:  Okay.  I’m going to defend the
 17   GAPs/GMPs Guide.
 18             (General laughter.) 
 19             DR. SMITH:  I’ve got to admit that I’m
 20   somewhat prejudice.  CDC is the keeper of the data and
 21   so I’m not the final word, but I do know that there
 22   was this significant increase going on when we got


00088
  1   involved in the development of the guide.  Things
  2   appear to have been leveling off since then.  
  3             I have a lot of anecdotal experience, things
  4   that I’ve seen where in foreign training efforts even
  5   where packing facilities have instituted hand washing
  6   and sanitary facilities.  They have instituted worker
  7   training.  
  8             They have improved not just probably, in my
  9   opinion, the safety of their product and the health of
 10   their workers, but even the health and literacy of the
 11   community that the workers are coming from.
 12             I think there are many substantive benefits
 13   from the GAPs/GMPs Guide.  I have a friend who is in
 14   charge of the Integrated Pest Management Program in
 15   the state of Maryland.  At a picnic a number of years
 16   ago he came up and he said, “There is something that
 17   I’ve noticed that I really don’t understand.  All of a
 18   sudden the farms I go to have these contraptions,
 19   Port-o-Potties connected with a hand-washing device in
 20   between.”  It’s something that he was seeing with such
 21   an increased frequency that it was worth mentioning at 
 22   a picnic.  


00089
  1             I think that is not scientific data, but I
  2   think that it does point to positive changes and
  3   positive impact, as Jim mentioned, a study to actually
  4   gather data on the effect of good agricultural
  5   practices we’ve missed ground zero.  We could just
  6   study what things are like now.  
  7             Also, Investigator Thomas’ comment, the
  8   picture of the birds in the packing house, the
  9   investigators had cause to go to that packing house. 
 10   They saw the bird problem.  He also mentioned that
 11   they quickly remedied it.  Those are anecdotal
 12   evidence of improvement resulting from the GAPs.
 13             DR. BARRETT:  Mr. Guzewich.
 14             MR. GUZEWICH:  This is Jack Guzewich for the
 15   recorder.  
 16             I want to follow up on Dr. Solomon’s
 17   question with Dr. Rushing.  I want this done before
 18   Dr. Solomon asks his question, by the way.  I want to
 19   see from your perspective as a teacher and as an
 20   instructor, do the farmers, the growers, understand
 21   the GAPs?  In your opinion, are they implementing the
 22   GAPs or trying to implement the GAPs?


00090
  1             DR. RUSHING:  I think that GAPs are working,
  2   and I agree with Michelle’s comment.  I believe there
  3   is no study to show they are, but I believe they are. 
  4   As an educator, I believe it is extremely important
  5   that we continue on the track that we are on.  
  6             To answer your question, some industries
  7   have done an excellent job.  I had a talk with the
  8   peach industry in our state about eight or nine years
  9   ago, and I thought it was the least interested
 10   audience I had ever spoken with.  
 11             Since that time, every one of our growers
 12   and packers to the very last one have largely
 13   implemented GAP as they were taught to do so.  We have
 14   actually had one significant grower, who because he
 15   farmed cattle and he was reaching retirement age, he
 16   felt like the best thing for him to do was just stop
 17   farming and so he did.  We see industries like that
 18   where we have broad implementation.  
 19             I believe the tomato industry is another
 20   good example of broad implementation.  But because of
 21   the environmental issues, I’ve heard Thomas,
 22   Captain Hill, say that salmonella can be found in


00091
  1   almost any stream or pond anywhere around the tomato.  
  2             With that kind of challenge, it doesn’t mean
  3   we should not implement GAP at all.  I’m just not
  4   sure, I’m at a complete loss for an idea about how to
  5   overcome that kind of environmental challenge.  That
  6   was part of the basis for the concluding remark about
  7   risk.  Every time we take a shower, drive our car, or
  8   ride our bicycle we are taking a risk.  
  9             In the balance I believe the produce
 10   industry has done an outstanding job.  I think if you
 11   look at the thousand and thousands of tons of produce
 12   that we eat and the relatively small numbers of people
 13   who become ill, I think we are doing a good job, but
 14   we have to continue doing better.  There are a lot of
 15   patient who have not implemented as they should.
 16             DR. BARRETT:  Mr. Baca.
 17             MR. BACA:  Joe Baca.  A quick question for
 18   Captain Hill, and that is, would you comment on
 19   agricultural wells?  I know there is a lot of concern
 20   about water and we talked about the ponds and the
 21   ditches.  What have you seen buy way of wells?
 22             CPT. HILL:  Well, no pun intended there.


00092
  1             (General laughter.) 
  2             CPT. HILL:  There are all kinds of wells out
  3   there.  Agricultural wells are very different from
  4   residential or private wells.  If we take the state of
  5   Virginia, for example, the requirements for
  6   agricultural wells are much less than the residential
  7   wells.  
  8             The issues with the use of ponds for
  9   irrigation water on the Eastern Shore, many wells are
 10   very close to those ponds.  With Virginia’s current
 11   regulations, they don’t consider ponds sources of
 12   pollution.  
 13             But at least in those two counties on the
 14   Eastern Shore as an interim precaution, any new wells
 15   that are put in, any new agricultural wells, are going
 16   to be required to stand off 200 feet from any pond.
 17             That is something that we need more research
 18   on, but good common sense.  They are going to try and
 19   stand off from those wells for any new wells that are
 20   put in.
 21             DR. BARRETT:  Okay.  Well, that is the end
 22   of time for the questioning period.  What we’re going


00093
  1   to do is take a minute here and switch out the panels. 
  2   Next, we will have both private-industry perspectives,
  3   consumer perspectives, and research.
  4             (Pause in the proceedings.)
  5                   INDUSTRY PERSPECTIVE
  6             DR. BARRETT:  Okay.  Our first two speakers
  7   for this panel will represent the industry position. 
  8   The first of them is Mr. Tom Stenzel, who is the
  9   president and CEO of United Fresh Produce Association.
 10             He served as CEO for the United Fruit and
 11   Vegetable Association, its prior iteration, and
 12   continued this position after United Fresh had its
 13   merger with the International Fresh-Cut Association in
 14   2006.
 15             Mr. Stenzel was a founding president of the
 16   International Food Information Council or “IFIC” in
 17   1986 where he built a very credible and sound
 18   scientific program in food safety, risk
 19   communications, and crisis management.  He is a 1977
 20   magna cum laude graduate of the University of Richmond
 21   and achieved a certified association executive, a
 22   “CAE,” designation in 1990.


00094
  1             I will introduce his partner in this today,
  2   which is Mr. Brian Silbermann.  Brian Silbermann is
  3   the president of the Produce Marketing Association. 
  4   It is the largest worldwide, not-for-profit trade
  5   association, representing companies that market fresh
  6   fruits, vegetables, and related products.  
  7             PMA’s membership of 2,100 companies and
  8   nearly 50 countries ranges from supermarket retailers,
  9   farmers, foreign exporters, to restaurant chains.  
 10             The association’s programs promote the
 11   efficient distribution and increased consumption of
 12   its members’ products worldwide: through industry
 13   events, consumer research, training, standardized
 14   coding, information technology, global outreach,
 15   government relations, public affairs, and food safety
 16   efforts.
 17             First, Mr. Stenzel.
 18             MR. STENZEL:  Thank you very much,
 19   Dr. Brackett.
 20             Let me begin by thanking FDA and you
 21   personally for holding this hearing and your ongoing
 22   commitment to enhancing the safety of fresh produce. 


00095
  1   Let me also thank two members of our staff for their
  2   support, Dr. David Gombas, who is here today, and also
  3   Dr. Jim Gorny, who lead our food safety efforts.
  4             We in the industry look to FDA as our most
  5   important and credible partner in assuring the
  6   American public that the produce industry and
  7   government alike are taking all needed measures to
  8   assure a safe supply of fresh fruits and vegetables.
  9             After all FDA’s mandate to protect public
 10   health requires an equal commitment to promote public
 11   health through increase consumption of fresh fruits
 12   and vegetables to meet the U.S. dietary guidelines.
 13             Public fear of consuming fresh, healthy, and
 14   safe produce, even with the inevitability of a small
 15   level of risk, cannot be an acceptable outcome to the
 16   public health mandate of the Department of Health and
 17   Human Services.
 18             Let me quote from “The Federal Register
 19   Notice” announcing today’s hearing:
 20             FDA is responsible for ensuring the safety
 21   of all domestic and imported fresh and fresh-cut
 22   fruits and vegetables consumed in the United States. 


00096
  1   We believe that responsibility is at the very core of
  2   our discussion today.  
  3             Our industry must and will do all that we
  4   can to grow, pack, and process the safest possible
  5   products.  But no matter what steps we take as an
  6   industry, the law requires and the public expects that
  7   FDA as an independent public health agency be the
  8   final arbiter of what is safe enough.
  9             The spinach outbreak last fall was a tragic
 10   occurrence, and we can never forget the real human
 11   impact when something goes wrong in our food safety
 12   systems.  
 13             That is what drives food safety to be a
 14   process of continuous improvement, not a static
 15   achievement.  We are on a continuum constantly
 16   striving toward perfection while understanding that
 17   scientifically there is no such thing as zero risk.
 18             When the spinach outbreak occurred, our
 19   entire industry immediately pulled all spinach from
 20   shelves nationwide and cooperated fully with FDA in
 21   tracking this problem back to its source. 
 22             That total industrywide shutdown was an


00097
  1   unprecedented action and one from which I hope we have
  2   all learned many lessons.  In fact, we now know that
  3   the only contaminated product in the marketplace came
  4   from one 50-acre farm packaged in one processing plant
  5   and only on one production shift one day.
  6             That’s out of more than 300,000 acres of
  7   lettuce, spinach, and leafy greens grown in the
  8   nation’s most productive growing region that was
  9   unnecessarily impugned last fall.  
 10             But, when faced with an immediate public
 11   health question, we readily accepted FDA’s advice to
 12   err on the side of caution and literally destroyed
 13   truckloads of healthy foods and plowed under acres of
 14   safe production.
 15             Our commitment to public confidence in all
 16   of our foods demanded nothing less, but it is also
 17   clear that neither government nor consumers are well
 18   served by generating such broad fear about wide swaths
 19   of a safe food supply.
 20             Consumers know that when there is a peanut
 21   butter outbreak associated with one brand they have
 22   confidence in choosing another brand to feed their


00098
  1   children.
  2             FDA must be committed to the same standard
  3   for fresh produce, aggressively addressing specific
  4   threats if they occur without implicating other
  5   sources of safe product.
  6             But, while the source of this outbreak
  7   proved to be very narrow, our entire industry
  8   immediately began a comprehensive evaluation of all
  9   spinach production, handling and process to make sure
 10   that we were doing everything on an industrywide basis
 11   to assure safety.
 12             This effort has led to an important
 13   initiative spearheaded by the leafy greens industry in
 14   California to adopt stringent food safety measurement
 15   criteria which can be implemented and verified.
 16             The California Department of Food and
 17   Agriculture has recently certified a leafy greens
 18   marketing agreements which will serve as a means of
 19   setting rigorous measurements of safe production of
 20   leafy greens.  These science-based standards include
 21   careful attention to all of the risk factors that we
 22   have talked about already today.  


00099
  1             Taking a step like this towards
  2   self-regulation in a private-industry sector is not an
  3   easy task, but we believe it is a critical step in
  4   continuing to assure the public that our industry is
  5   doing everything we can to make our product safe.
  6             It is within the context of these industry
  7   efforts that I now want to turn my attention to the
  8   appropriate regulatory framework that we believe is
  9   best suited for the fresh-produce industry.
 10             While there is much our industry can and
 11   must do, we also recognize the important role of the
 12   Federal Government in setting the overall regulatory
 13   framework.  
 14             Our industry has but one goal when it comes
 15   to food safety, and it starts with the consumer.  We
 16   believe consumers must be able to shop in any grocery
 17   store or order fresh produce in any restaurant with
 18   complete confidence that their produce selection is a
 19   safe and healthy choice.
 20             Whatever low risk that might be present must
 21   be viewed as an acceptable risk based on strong
 22   government assurance that proper food safety systems


00100
  1   are in place and the benefits of consumption far
  2   outweigh the low risk.
  3             Let me review, briefly, three key principles
  4   we believe are important in the food-safety regulatory
  5   framework.  First, we believe produce-safety standards
  6   must be consistent for an individual produce commodity
  7   grown or packaged anywhere in the United States or
  8   imported into this country.  Consumers must have
  9   confidence that safety standards are met no matter
 10   where the commodity is produced.
 11             Second, we believe achieving those
 12   consistent produce safety standards across our entire
 13   industry requires strong Federal Government oversight
 14   and responsibility in order to be most credible to
 15   consumers and equitable to producers.
 16             FDA has the legal mandate to determine
 17   appropriate nationwide safety standards in an open and
 18   transparent process with full input from the states,
 19   industry, academia, consumers, and all stakeholders.
 20             We are strong advocates for food safety
 21   standards based on sound science and a clear consensus
 22   of expert stakeholders.  In a situation where science


00101
  1   tell us there can be no such thing as zero risk and we
  2   have no cooking step for our product, the public must
  3   be able to trust in a independent, objective
  4   government body as the ultimate arbiter of what is
  5   safe enough.  It is also FDA’s responsibility to
  6   ensure that industry is complying with these
  7   standards.  
  8             Now, that doesn’t mean that FDA needs to
  9   hire 5,000 inspectors to travel to every farm in the
 10   country or around the world, but it does mean that FDA
 11   must have relationships with other country
 12   governments, USDA, state agriculture and regulatory
 13   officials to ensure that compliance is taking place.
 14   Cooperative agreements between FDA and the states have
 15   been extremely effective in providing oversight of
 16   food safety standards.
 17             Third, we believe produce safety standards
 18   must allow for commodity-specific food safety
 19   practices, best of the best available science.  In a
 20   highly diverse industry that is more aptly described
 21   as hundreds of different commodity industries, one
 22   size clearly does not fit all.


00102
  1             In “The Federal Register Notice” announcing
  2   this hearing, FDA confirms that five produce
  3   commodities, only five, have been associated with
  4   80 percent of all foodborne disease outbreaks
  5   associated with produce in the past 10 years.  That is
  6   where we must direct our resources.
  7             Let me now talk specifically about several
  8   regulatory options for FDA.  First, we support the
  9   approach taken by FDA to establish the broad GAPs and
 10   GMPs applicable to all producers at farm level.
 11             The 1999 guidance document continues to
 12   provide an effective roadmap for producers and
 13   cooperative agreements with USDA and the states could
 14   assure greater compliance with these guidelines based
 15   on today’s science and as they are modified by FDA in
 16   the future to reflect increasing knowledge.
 17             These guidelines can truly minimize risk
 18   when well understood and implemented by growers and
 19   packers.  The need for greater implementation of GAPs
 20   calls for a well-funded, intergovernmental effort
 21   between FDA, USDA, the states, and industry to educate
 22   producers across the country and internationally.


00103
  1             Second, we support FDA’s approach to develop
  2   commodity-specific GAPs where there is a demonstrated
  3   need.  This must be a scientific process looking at
  4   outbreak history and potential risk factors to ensure
  5   that resources are not diluted, trying to address
  6   hundreds of commodities that have never been linked to
  7   illness.   
  8             Today, FDA has published commodity-specific
  9   GAPs only for fresh sprouts.  Alternatively, the
 10   Agency has asked the industry to develop
 11   commodity-specific GAPs for leafy greens, tomatoes,
 12   melons, green onions, and herbs.
 13             We have taken this challenge seriously and
 14   worked diligently to bring scientists from academia,
 15   government, and industry together in formulating these
 16   best practice documents.  
 17             But we believe it is important that the FDA
 18   now pursue this regulatory model used with fresh
 19   sprouts and publish its own commodity-specific GAPs
 20   where warranted rather than simply provide technical
 21   input to industry-prepared documents.
 22             FDA must endorse, embrace, and defend these


00104
  1   standards as sufficient to allow public confidence in
  2   the safety of the food supply based on the best
  3   science available.  Now, don’t underestimate the power
  4   of FDA-published, commodity-specific guidance.  Let me
  5   quote from the sprout guidance document:  
  6             “The following recommendations identify the
  7   preventive controls that the FDA believes should be
  8   taken immediately to reduce the risk of raw sprouts
  9   serving as a vehicle for foodborne illness and ensure
 10   sprouts are not adulterated under the food safety
 11   provisions of the Food, Drug & Cosmetic Act.  Failure
 12   to adopt effective preventive controls can be
 13   considered insanitary, conditions which may render
 14   food injurious to health.”  
 15             Producers of fresh sprouts do not consider
 16   this voluntary guidance or an option that they may
 17   choose or not choose to follow.  We believe the same
 18   approach should be taken with specific commodity
 19   groups in which FDA determines there is a specific
 20   preventive control necessary for food safety.
 21             I would also add that FDA’s administrative
 22   process of public notice and comment on draft and


00105
  1   final guidance offers the most equitable way to
  2   receive broad input on such standards from industry as
  3   well as all other stakeholders.
  4             Finally, we strongly support FDA’s approach
  5   to address specific standards for fresh-cut processing
  6   as contained in the Agency’s “Guide to Minimize
  7   Microbial Food Safety Hazards of Fresh-Cut Fruits and
  8   Vegetables published just last month in its final
  9   version.
 10             We strongly support HAACP food safety
 11   programs in all fresh-cut processing plants.  Although
 12   research has not yet identified a kill step such as
 13   pasteurization for fresh-cut, ready-to-eat produce, we
 14   must apply strict processing controls to minimize any
 15   risk that might be introduced from incoming raw
 16   agricultural product or a the processing level.
 17             Again, consider the legal power of this as a
 18   guidance document.  FDA has provided its
 19   interpretation of what is required to comply with
 20   mandatory GMPs to which all fresh-cut processors must
 21   adhere.  This carries seriously liability both in
 22   terms of government inspection of fresh-cut processing


00106
  1   plants and product liability.
  2             Let me conclude with a few comments about
  3   funding and spending priorities.  We believe one of
  4   the most critical issues at this hearing is whether
  5   FDA is adequately funded, has sufficient staff with
  6   scientific training and experience in our sector of
  7   the food industry, has research dollars available to
  8   address key questions, has strong working agreements
  9   with the states to provide support in the field, and
 10   has the commitment of the administration and the
 11   Congress.
 12             We believe those criteria are essential to
 13   have a strong, effective federal regulatory framework
 14   for the produce industry.  In the past several months,
 15   I have testified at both House and Senate
 16   appropriations’ hearings in support of increased
 17   funding for FDA for both senior scientific staff and
 18   research in the area of produce safety.
 19             Our industry is doing everything today we
 20   know to reduce the risk of foodborne disease, but
 21   there are many scientific questions literally begging
 22   for research.


00107
  1             We need better understanding of ways to
  2   reduce E. coli in cattle.  We need better ways to
  3   prevent potential contamination from pathogens that
  4   might be present in the natural environment.  We need
  5   to develop more effective microbial reduction and
  6   elimination techniques after harvest and in
  7   processing.
  8             While there is no obvious kill step around
  9   the corner, developing such a step as pasteurization
 10   while still protecting the natural texture and flavor
 11   of our product would be a critical advancement in
 12   preventing even rare foodborne illness.  
 13             In conclusion let me return to the important
 14   role fresh fruits and vegetables play in public
 15   health.  With the public health imperative to increase
 16   our consumption of fruits and vegetables, we simply
 17   cannot allow fear of food safety to become linked with
 18   these healthy foods.
 19             We as an industry must do all we can to
 20   prevent illness from ever occurring, and we will.  At
 21   the same time we pledge to support a strong federal
 22   food safety regulatory framework that assures the


00108
  1   public that appropriate safety standards are in place
  2   and are being met by the industry.
  3             Thank you.
  4             (Applause.)
  5             MR. BARRETT:  Thank you, Mr. Stenzel.  
  6             Next, Mr. Bryan Silbermann from PMA.
  7             MR. SILBERMANN:  Thank you very much, Bob. 
  8   Thank you for this opportunity.  
  9             Good morning everybody.  Let me tell you
 10   that it is not just the members of the Produce
 11   Marketing Association and the United Fresh Produce
 12   Association who benefit from us working together and
 13   avoiding duplication.  
 14             Tom and I have worked closely to make sure 
 15   that what I say is not going to duplicate necessarily
 16   everything that he says.  Let me start off by saying
 17   that a lot of what he says I agree with 110 percent. 
 18   Thank you, Tom, for that.  I also want to acknowledge
 19   my colleague Kathy Means, who is known to many of you
 20   here at FDA.
 21             PMA is the largest association representing
 22   the fresh produce marketers worldwide across the


00109
  1   entire supply chain.  As Dr. Brackett said, that is
  2   everybody from growers and shippers through the retail
  3   chain, some of whom are represented here, as well as
  4   other associations, restaurant chains and the like.
  5             This unique supply chain orientation gives
  6   us the benefit of what we like to call a 360-degree
  7   view of the world of produce.  Also, let me tell you
  8   my personal belief.  As chairman of the Partnership of
  9   Food Safety Education, which involves federal agencies
 10   including FDA and CDC as well as food industry and
 11   consumer groups, some of whom are here today.
 12             I am personally committed to ensuring that
 13   we always view produce safety as a continuum that
 14   stretches from the farm to the dining table.  I thank
 15   FDA and specifically CFSAN for convening these
 16   hearings to address produce safety.  
 17             We applaud the Agency for its commitment to
 18   food safety for the new fresh-cut produce guidance and
 19   all the other efforts, both well known as well as not
 20   so well known.  These all contribute to fresh-produce
 21   safety.  Later, I will comment on specific steps where
 22   we should consider doing even more together.


00110
  1             Michelle Smith, thank you very much for also
  2   drawing attention to the fact that it is both the
  3   focus on increasing consumption as well as on produce
  4   safety that is important to CFSAN.  Let us never
  5   forget that.
  6             September 14, last year, was not the
  7   beginning of the produce industry’s commitment to food
  8   safety.  That commitment started generations ago with
  9   American farmers whose tradition of excellence forms
 10   the very foundation of today’s highly sophisticated
 11   produce industry.
 12             We also recognize that the growth and
 13   complex nature of the produce supply chain in recent
 14   decades demands that we approach food safety as a
 15   collective responsibility.  
 16             Industry has spent tens of millions of
 17   dollars to employ the best and most recent scientific
 18   knowledge to protect our products and to protect our
 19   customers.  Protecting our customers is paramount.
 20             We have demonstrated commitment to good
 21   agricultural practices on farms, good manufacturing
 22   practices in processing plants, and ongoing education


00111
  1   for food handlers as well as the public.
  2             PMA’s latest member survey just conducted
  3   last month makes it abundantly clear once again
  4   consumer confidence in our products remains as fragile
  5   as the tender leaves of the freshest salads.
  6             We never, never take nor have we taken that
  7   confidence for granted because doing so would be
  8   irresponsible to the public and harmful to our own
  9   livelihoods.  We have a vested interest in doing what
 10   is right every bite and every time.
 11             PMA has helped other associations and FDA
 12   develop the industry precursor to the good
 13   agricultural practices that, as you heard, have been
 14   in place since 1998.
 15             We have prepared our members through
 16   training and education so that they would have robust
 17   food-safety programs.  We have collaborated with the
 18   folks right here at CFSAN for a long time.  I’m
 19   delighted to see my good friend, I won’t say “old
 20   friend,” Fred Shank a little while ago.
 21             We have participated in industry coalitions
 22   including the one formed with UFPA in the summer of


00112
  1   2004 to address the development of commodity-specific
  2   produce guidance together with FDA.  
  3             Working with the Canadian Produce Marketing
  4   Association, PMA has been at the forefront of adopting
  5   information technology that facilitates rapid
  6   tracebacks including a pilot program and a
  7   best-practices document.
  8             Our efforts have not been limited just to
  9   industry.  Through the partnership of food safety
 10   education that I mentioned earlier, two years ago we
 11   funded guidelines to help consumers handle fresh
 12   produce safety.
 13             FDA is an important collaborator in the
 14   partnership and we welcome and encourage your support
 15   for its ongoing education efforts.  Industry and
 16   government must do their part to deliver safe,
 17   nutritious fruits and vegetables, and consumers have a
 18   role to play in this, too.
 19             We also regularly track consumer confidence
 20   in fresh produce nationwide through ongoing research. 
 21   We take our role as an industry leader seriously.  We
 22   are committed to doing whatever it takes to protect


00113
  1   public health and rebuild consumer confidence in the
  2   delicious healthful products our members grow and
  3   market.  I know this is a goal FDA shares.  
  4             Let me now turn to what we have done in
  5   recent months and what is being planned, particularly
  6   in the areas of research and training.  We have just
  7   committed two and three-quarter million dollars in
  8   additional resources to food safety.  
  9             Two days ago, at the University of
 10   California at Davis, I joined California Secretary of
 11   Agriculture A.G. Kawamura as we launched the new
 12   Center for Produce Safety at Davis under the umbrella
 13   of the Western Institute for Food Safety and Security
 14   aimed at coordinating, funding, and disseminating
 15   research to enhance the safety of fresh produce
 16   worldwide.  
 17             The center will bring together experts from
 18   industry, government, and academia to find answers to
 19   how it is that our products get contaminated, and,
 20   even more importantly, what we can do to stop that.
 21             I am delighted that we were joined by
 22   officials from federal and state government at this


00114
  1   launch including FDA and the California Department of
  2   Health Services.
  3             PMA has committed $2 million specifically to
  4   help launch the Center for Produce Safety, and I fully
  5   expect that PMA will provide more as we see results. 
  6   Those funds have already been matched with another
  7   $2 million from one industry company, and we expect
  8   more to follow.
  9             The State of California committed another
 10   half million dollars.  I know that FDA is working to
 11   strengthen its ties with the Western Institute at U.C.
 12   Davis.  
 13             I urge the Agency to look very closely at
 14   these commitments from industry, from the State of
 15   California, and the university and to do everything
 16   FDA can to support this critical effort to improve the
 17   understanding of produce safety and to supply answers
 18   to critical questions, some of which have already been
 19   raised here this morning.
 20             This deserves your active involvement and
 21   your strongest support.  Let me be very clear about
 22   the goal of the Center for Produce Safety.  We intend


00115
  1   to create nothing less than a world-class center of
  2   excellence for produce safety research and training
  3   outreach applicable far beyond the borders of
  4   California.  
  5             I know I also speak for the leadership of
  6   the University of California and our membership in
  7   committing to that goal.  We are also committing funds
  8   for enhanced education and training for all parts of
  9   the supply chain in conjunction with other
 10   organizations including Western Growers Association
 11   and the California Farm Bureau Federation.
 12             We will be spending at least $200,000 in
 13   this effort, and these will be coordinated through the
 14   new center.  We applaud the work of other
 15   organizations including the successful effort to
 16   establish a California Lettuce and Leafy Greens
 17   Marketing Agreement, founded on strong science-based
 18   food safety protocols and state verification.
 19             In addition to these efforts I have just
 20   outlined, let me offer the following recommendations
 21   to CFSAN.  No one can be everywhere at all times. 
 22   Food safety efforts have to be prioritized based on


00116
  1   risk.  You’ve heard this several times.  FDA has
  2   identified those commodities most likely to be
  3   associated with outbreaks, and efforts should be
  4   focused there.  
  5             As I said, we applaud California’s efforts
  6   to create a marketing agreement for lettuce and leafy
  7   greens, and we believe that those efforts as well as a
  8   host of others are all-important components to
  9   enhanced produce safety.
 10             We believe that the initiative in California
 11   needs to be followed by a robust federal effort that
 12   is verifiable and applies to any products grown in the
 13   United States or abroad.  
 14             We need to promote public confidence and
 15   avoid a “patchwork” approach to an issue that is
 16   crying out for an umbrella solution, and yet under
 17   that umbrella we should have commodity-specific
 18   protocols based on sound science and prioritized by
 19   risk.
 20             I mentioned traceability earlier.  At a
 21   session I moderated at PMA’s annual meeting last
 22   October, Dr. Brackett noted that traceability is the


00117
  1   one biggest improvement he would like to see from our
  2   industry.
  3             We suggest that FDA joins with the experts
  4   from association staff and membership to better define
  5   the very specific needs for traceability that are not
  6   currently being met by industry practices.
  7             We have a strong foundation in the work
  8   already done in the United States and Canada to define
  9   best practices.  We want to work hand in hand with FDA
 10   to target what it is that industry can do better the
 11   meet the Agency’s needs and expectations moving
 12   forward.
 13             We share the same goal with FDA, creating
 14   the tool so industry can quickly help narrow the scope
 15   of any future outbreak.  Another shared goal we have
 16   is public health.  We welcome the opportunity to work
 17   with FDA to improve communications.  
 18             We must assure that the public has all the
 19   information required to take appropriate action by
 20   being as specific as possible as early as possible in
 21   the event a public health risk is identified.  
 22             Rapidly narrowing the focus of an


00118
  1   investigation is responsible to public health and
  2   mitigates damage to those in the affected industry
  3   that are not implicated and should not be implicated
  4   in an outbreak.
  5             Again, thank you very much for this
  6   opportunity to speak here today.  I’m happy to answer
  7   any questions you may have.
  8             (Applause.)
  9             DR. BRACKETT:  Thank you, Mr. Silbermann.
 10             We will next hear from a representative of
 11   consumer interests, and this will be by Ms. Caroline
 12   Smith-DeWall, and she is the director of the Food
 13   Safety Program at the Center for Science in the Public
 14   Interest and also the coauthor of “Is Our Food Safe: 
 15   A Consumer’s Guide to Protecting Your Health and the
 16   Environment.”
 17             Ms. DeWaal is the leading consumer analyst
 18   on reform of laws and regulations governing food
 19   safety.  Ever since 1999, she has maintained an
 20   annually published listing of foodborne illness
 21   outbreaks organized by Food Source that now contains
 22   15 years of worth of outbreak data.


00119
  1                   CONSUMER PERSPECTIVE
  2             (PowerPoint presentation in progress.)
  3             MS. SMITH-DEWAAL:  Good morning.  I
  4   represent the Center for Science in the Public
  5   Interest.  We have over 900,000 consumer members.  We
  6   publish a newsletter called Nutrition Action Health
  7   Letter to communicate with our members.  
  8             We are one of the big promoters of eating
  9   your fruits and vegetables.  Despite my talk today and
 10   what I’m about to tell you, I want you to know that
 11   CSPI wants you to eat your fruits and vegetables.
 12             I’m going to cover a number of issues here. 
 13   The key issue is declining consumer confidence.  I’ve
 14   never been to a hearing like this where there is
 15   literally so much agreement between the industry and
 16   the consumer panels right off the bat, because the
 17   problem impacts us all.  We don’t want consumers to
 18   fear their lettuce.  We want them to be eating their
 19   lettuce, so this is a critical issue.  
 20             We are going to talk about the produce
 21   outbreak trends.  Art Liang covered a lot of it, but
 22   I’m going to show you very visually what this means


00120
  1   and how it is impacting, what the real trends look
  2   like, the failure of the voluntary guidelines and then
  3   the roadmap to the future.
  4             These outbreaks were very, very clear but
  5   consumers didn’t know that the hazards in their
  6   produce could be as serious as the hazards in their
  7   meet.
  8             This was a Rutgers University telephone
  9   survey that basically documented the impact for months
 10   afterwards of the outbreak and the public messages
 11   around it.  
 12             It is critical, though, that FDA get out the
 13   information it knows in an outbreak situation in order
 14   to prevent people from continuing to eat the products,
 15   get sick, and potentially face life-threatening
 16   illnesses.  Communication is critical and early
 17   communication, which happened in this case, was very
 18   important.
 19             Here are the trends we’ve been watching. 
 20   Our outbreak data covers 15 years and is largely
 21   composed of outbreaks collected by the Centers for
 22   Disease Control and Prevention; although, some of the


00121
  1   earlier outbreaks we also got from articles.
  2             Art talked about the change in the outbreak
  3   data in 1998, which is reflected in our slides.  This
  4   shows you the same slide on produce, but it also shows
  5   you what we are looking at -- because we track all
  6   food products, all major food categories, not just
  7   produce -- what it looks like with respect to seafood,
  8   beef, and poultry.
  9             The big news, and we were getting this out
 10   as CDC was as well, was that produce is becoming
 11   probably the major contributor to outbreaks and
 12   illnesses in the U.S.  
 13             The blue line that is above the produce
 14   outbreaks indicates how many people are getting sick
 15   from outbreaks per year.  You can see that while
 16   seafood also has a lot of reported outbreaks, the
 17   cases are much lower, the number of cases, and beef
 18   and poultry we monitor as well.  
 19             The trends there are also worth watching,
 20   but produce is clearly making a lot of people sick,
 21   and this is why.  The size of each outbreak is in fact
 22   significantly larger when it comes to produce than


00122
  1   other commodities.  Here are the pathogens.
  2             Farida Bhuiya is my epidemiologist trained
  3   at Emory.  Thank you, Farida, for putting this
  4   together.
  5             This shows the pathogens.  We divided it out
  6   by vegetables, fruits, and produce dishes.  Norovirus
  7   constitutes about 40 percent of the produce outbreaks. 
  8   Art really described the importance of having the
  9   human pathogens controlled as well as the animal
 10   pathogens.  
 11             Salmonella is second, and E. coli comes in
 12   at different points on the different lists.  But the
 13   bottom line is when we have analyzed the data,
 14   human-transferred pathogens constitute about
 15   40 percent of the outbreaks.  Salmonella and E. coli
 16   together constitute about 25 percent of the outbreaks. 
 17   These are both significant things that need to be
 18   controlled.
 19             Here are major product outbreaks linked to
 20   imports.  Back in 1996-97, we really became aware of
 21   this with both the cyclospora in raspberry outbreaks,
 22   those coming from Guatemala, and then also an outbreak


00123
  1   of Hepatitis A in a school system which caused some
  2   pretty severe illnesses.  
  3             These have continued, though.  The outbreaks
  4   from cantaloupe from Mexico has resulted in at least
  5   one death, and then in 2003 we had the major outbreak
  6   linked to Chi-Chi’s.  That one outbreak from a single
  7   restaurant, over 500 people became ill.  I think the
  8   numbers were really topping 600, and three people
  9   died.
 10             What is really significant to me in that
 11   outbreak is that the same scallions had also caused
 12   three other outbreaks I think in three other states,
 13   but they weren’t caught; they weren’t tracked.  No
 14   public notice was made in that case.  Chi-Chi’s
 15   unknowingly went forward and purchased the green
 16   onions that caused that outbreak.  
 17             I was very critical of the Agency at that
 18   point, which I wasn’t with respect to their
 19   announcement on spinach.  The spinach outbreak was not
 20   our first produce outbreak in ‘06.  In fact, I’m
 21   probably missing a few here, but the slide was too
 22   small.


00124
  1             In June, we had a lettuce outbreak from
  2   another strain, hazardous strain, of E. coli, then in
  3   September, we had both the spinach outbreak and an
  4   outbreak of tomatoes with salmonella.  Unfortunately,
  5   CDC didn’t even notice the tomato outbreak until it
  6   was all over.  In November and December, we had the
  7   Taco John’s and Taco Bell outbreaks, one in the
  8   Midwest and the other in the Northeast.
  9             We have been very concerned the FDA’s
 10   guidelines are not mandatory.  We think if there are
 11   food safety steps the industry needs to take they need
 12   to take them.  This isn’t rocket science.  The growers
 13   know this probably better than we do.  But if there
 14   are steps that can protect your customers, you need to
 15   do them.
 16             The guidelines, the GAPs, were published in
 17   1998.  In 2004, FDA noticed, or I’m sure they did in
 18   advance, but they sent a letter to lettuce and tomato
 19   growers saying, “Guys, listen up, you’re not following
 20   the rules or the guides,” and asked people to review
 21   their guidelines.  FDA has made a lot of noise to the
 22   industry and a lot of requests.


00125
  1             Very significantly, a Cornell study I
  2   believe in 2004, and Robert Gravani can correct me
  3   when he gets up here, found that one-third of the
  4   New York State producers were unaware of the GAPs for
  5   their crops in that year.  Really, the message, I know
  6   you guys are trying to do education but the messages
  7   aren’t sinking in.  
  8             CSPI had petitioned both the State of
  9   California in October and FDA in November following
 10   the spinach outbreak.  As I said, we had been aware of
 11   these trends.  We were waiting for this event.  Once
 12   it happened, I felt we had to move very quickly.  
 13             I think the key here and I think what we are
 14   hearing from industry, too, is ensuring that consumer
 15   confidence is not further eroded is critically
 16   important right now.  Moving quickly is very
 17   important.
 18             What I am proposing to FDA is that they
 19   follow a model they have followed before with a
 20   similarly situated industry.  In the early 1990s,
 21   there was a lot of news and information and
 22   congressional interest in seafood safety.


00126
  1             Now, the seafood industry is made up of a
  2   lot of small players, a lot of small business people
  3   maybe with a boat and some also very large ones, but
  4   FDA at that point implemented the first HAACP
  5   regulation for use in the industry.  There had been a
  6   much more prescriptive approach used for low-acid can
  7   food, but this was the first of the modern HAACP
  8   rules.
  9             For the produce industry, we think this is a
 10   great model.  It requires that the growers or
 11   processors develop a food safety plan that you write
 12   down what you already know and what you are doing to
 13   protect the safety of the products; that FDA should
 14   set requirements for what should be in the plan based
 15   on he evidence from the outbreak data; and that in
 16   order to establish the metrics and the science, to
 17   bring the science in, that they use another tool that
 18   they used with the seafood industry.  
 19             Now, remember seafood is a very diverse
 20   products:  It’s oysters, it’s salmons, it’s octopus,
 21   and calamari.  Each of these has unique hazards.  In
 22   fact, there are about 300 different species of seafood


00127
  1   and the hazards range -- I love seafood, sorry -- it’s
  2   ciguatera, we have ciguatera, which is a chemical
  3   toxin; scombroid poisoining; vibrios.  There are some
  4   very cool hazards that arise in seafood.
  5             (General laughter.)
  6             MS. SMITH-DeWAAL:  They are all different. 
  7   Sorry, no one invites me to dinner because I like this
  8   stuff.  They are all different; they are all unique. 
  9   This is also true for the produce industry.  What they
 10   did in that case is they published a hazards and
 11   controls guide, “If you are fishing for tuna, here are
 12   the hazards you need to be concerned about,” which
 13   happens to be in part scombroid.  “These are the
 14   controls you need to use, which are temperature abuse
 15   or controls from temperature abuse.”  These are pretty
 16   straightforward, and it is a really good model to use
 17   in this case.
 18             CSPI has petitioned the Food and Drug
 19   Administration already, and we are considering
 20   petitioning them again.  We would like your support
 21   for moving forward with a petition.
 22             FDA should require all growers to have a


00128
  1   written food safety plan that is specific to the
  2   environmental conditions on the farm.  This is
  3   designed by the grower, the farmer, themselves.
  4             They should develop uniform standards for
  5   evaluating the plans for thinks like water quality,
  6   manure use and management, and worker sanitation, and
  7   that the written plan should be audited once per
  8   growing season either by FDA or FDA should review
  9   state or third-party audits of written plans.  
 10             Now, this is a radical suggestion.  The
 11   audits, we understand the FDA cannot hire an army of
 12   on-farm inspectors.  It wouldn’t be a great use of
 13   federal resource, frankly, when there are other people
 14   who can probably do this job.
 15             The audits, FDA should utilize state
 16   programs, if the states can do it, but the second
 17   place is produce buyers.  We rely on the Safeways and
 18   the Giants and the Wal-Marts and the Costcos to
 19   actually send auditors out to check the quality of the
 20   products.  We think that army of people can be
 21   utilized to help implement this program.  
 22             What everyone is crying for is consistent,


00129
  1   uniformed standards.  The standards should cover the
  2   application of manure and animal waste.  These
  3   standards are already utilized in the organic
  4   industry.  If you are a certified-organic grower, you
  5   already must comply with standards for the use of
  6   manure.
  7             Water for assessing both the microbial and
  8   chemical quality water.  Hygiene, as I mentioned,
  9   40 percent of the outbreaks are traced to human
 10   pathogens.  
 11             While those can enter at any point, they
 12   could enter on the farm.  They could enter in the
 13   kitchen.  Yeah, we want to make sure farm workers are
 14   using good hand washing and sanitation facilities.
 15             Also, the processing plants are clearly not
 16   going to be forgotten in this process.  We should have
 17   standards, sanitation standards, and good
 18   manufacturing practices for the processors.
 19             Finally, the issue of traceback is
 20   critically important.  When mistakes occur, it does
 21   help the industry if people can identify the product
 22   quickly and narrow the scope of the recall.  That


00130
  1   helps everyone involved.  It doesn’t mean FDA should
  2   wait to make an announcement.  If the products are
  3   marked adequately, then the announcement will be more
  4   narrow.
  5             My final point is that none of this can be
  6   done without resources.  FDA lacks the staff and
  7   resources to function effectively.  The food program
  8   and the inspection program has been declining.  
  9             Really, when you look at it, the Food and
 10   Drug Administration regulates about 80 percent of the
 11   food supply, but they do it on a shoestring budget. 
 12   With the recent 2008 budget, FDA was only given
 13   $10 million in additional funding, and it hasn’t been
 14   approved by Congress yet, to deal with these issues. 
 15   That’s no where near enough.
 16             USDA in contrast was given about 10 times
 17   that amount, $104 million for meat and poultry
 18   inspection, which is also needed in that area because
 19   they have been facing significant vacancies, but FDA
 20   needs to be more on par with that agency.  We need to
 21   be looking at hundreds of millions of dollars in this
 22   program rather than $10 million.


00131
  1             Just one final note on the budget because
  2   I’ve watched these things in Washington.  The U.S.
  3   Department of Agriculture was also given $164 million
  4   in new money for the Food and Agriculture Defense
  5   Initiative.  Well, gosh, we want our food safe and we
  6   want it protected, but FDA has a huge responsibility
  7   here, and it wasn’t given any of that money.
  8             Thank you.  Here is the information.  You
  9   are welcome to contact us to get more from our
 10   outbreak database.  We respond to email requests all
 11   the time.
 12             Thank you.
 13             (Applause.)
 14             DR. BRACKETT:  Thank you, Ms. DeWaal.
 15             Our final panel member this morning speaking
 16   is going to talk on behalf of the research needs, and
 17   this is Dr. Martha Roberts, who is now with the
 18   Institute of Food and Agricultural Science, or “IFAS,”
 19   at the University of Florida.  
 20             She is the former deputy commissioner of
 21   agriculture for the State of Florida from 1991 to 2003
 22   in the Florida Department of Agriculture and Consumer


00132
  1   Services and assistant commissioner of agriculture,
  2   which she happened to be the first woman in the U.S.
  3   to do that.
  4             From 1984 to 1991, she has served on
  5   numerous food safety committees and is known quite
  6   well to the food safety community, and so we are
  7   pleased to have her here as well.
  8                     SCIENCE/RESEARCH
  9             (PowerPoint presentation in progress.)
 10             DR. ROBERTS:  Hello.  I’m very glad to be
 11   speaking with you today and to be a part of this
 12   wonderful public meeting and public hearing, and I
 13   commend FDA for this.
 14             I’m going to be speaking to you today and
 15   covering the subject of the state of science.  Now,
 16   quite frankly, I can sum it very easily in that there
 17   is a huge body of scientific information out there,
 18   but the current science is inadequate to address all
 19   of the questions on media, production, processing, and
 20   handling.
 21             I think you have already arrived at this
 22   conclusion yourself from some of the comments of the


00133
  1   earlier speakers.  However, I think you would be
  2   surprised to see the vast amount of applicable science
  3   that has been published that we don’t as yet have
  4   transferred into everyday practices.  
  5             You cannot talk about present science
  6   without talking about future science, and so some of
  7   these comments relative to future needs will be
  8   blended into the presentation.
  9             But we certainly have a critical need for
 10   integrated, concentrated, and a multidisciplinary
 11   approach to ferret out the best practices that are not
 12   currently incorporated by the industry and not
 13   currently founded on sound scientific studies.
 14             We need to strengthen this coordination
 15   among our researchers nationwide, worldwide and the
 16   communication that we have between all of our
 17   regulators, researchers, and industry on what
 18   available science is out there.
 19             There is a tremendous amount of industry
 20   science that is not available generally to the
 21   regulators and to the general public that is working
 22   with individual companies.  To have more than industry


00134
  1   data available, would be excellent.
  2             Now, we have multiple difficulties with
  3   current science.  Quite frankly, none of the
  4   researchers want to publish any negative data.  They
  5   accumulate negative data, and they put it aside and
  6   never mention it, but it is extremely valuable if you
  7   are out there in the regulated community.
  8             Survey work is sometimes look down your
  9   nose, if you’re involved in a survey, but it is very,
 10   very valuable to have this information available to
 11   you and we must find some way of publicizing this.  We
 12   currently have great difficulty in funding applied
 13   research or any of this survey work.  Regrettably,
 14   many scientists love science and do not love writing.
 15             (General laughter.) 
 16             DR. ROBERTS:  We know of multiple
 17   scientists, right now I know of one scientist who has
 18   enough data for 10 publications on the food safety of
 19   tomatoes.  It’s extremely needed information.  They
 20   won’t release it in detail, of course, until it’s
 21   published in a peer reviewed journal, but we have to
 22   have some way to speed up the availability of this


00135
  1   science to us.
  2             Duplication, I hate to mention this, but we
  3   don’t have enough money to fund the science that’s
  4   needed now and we certainly don’t need people in
  5   multiple universities conducting the same study.  It’s
  6   sort of wasted time and effort.  
  7             We need sufficient science to confirm the
  8   validity of the science, but we do not need, as
  9   Dr. Buchanan said at one of our last meetings, 20 more
 10   papers on the effects of chlorine.  Any efforts that
 11   we can have to have more coordination and
 12   communication back and forth between our scientific
 13   communities is well put.
 14             Regrettably, I hate to tell you that the
 15   metrics we are developing, and I think everyone will
 16   recognize it here, are not based on sound science
 17   related to produce.
 18             They may be based on sound science related
 19   to water standards, but we don’t have the studies to
 20   document that these are the metrics that we need for
 21   produce.  There is a really critical need there.
 22             These are just some of the dilemmas.  I


00136
  1   don’t have the solutions, but there needs to be a lot
  2   of close examination to see if some of the scientific
  3   studies that have been done on lettuce, for instance,
  4   have particular applicability to tomatoes or to
  5   melons.  We have not had that critical review.
  6             There is a huge body of science out there,
  7   over 60 years.  But just as we were talking about
  8   FDA’s budget compared to USDA’s, there has been a
  9   minuscule amount of money devoted to produce safety
 10   research compared to animal research.  There has been
 11   very limited research on the farms and the actual
 12   production areas.  I think we all agree that this is
 13   needed.  
 14             The interpretive reviews of science status
 15   is desperately needed.  As to whether FDA can play
 16   that role, we need someone to gather together an
 17   august body of scientists to critically review the
 18   science that’s out there.  The goal of everyone is the
 19   prevention of the illness and contamination.  As yet,
 20   we don’t have a complete science to support that.
 21             There are many produce safety areas that are
 22   being discussed and studies being done now, but we


00137
  1   don’t have all of the disciplines integrated together. 
  2   As you all know, the whole produce safety area
  3   involves very complex questions with diverse crops,
  4   widespread geographical areas, extreme low levels, and
  5   environmental contamination.  
  6             As yet, I have not been able to find very
  7   many people in this country who are extremely versed
  8   in certain disciplines that we need involved such as
  9   microbial ecology of salmonella and some of the other
 10   pathogens we’re dealing with, and the geneticists need
 11   to be involved.
 12             We have multiple pathogens.  As you know,
 13   there is something that is causing there to be very
 14   geographical distinctions between these, and we don’t
 15   know scientifically and there are no studies out there
 16   to show this.
 17             Most of the research conducted in the past
 18   and being conducted at the moment is concentrating on
 19   the contamination focus.  Everything from the farms to
 20   the farms, packing houses.  We have a lot of research
 21   that has been devoted to good agricultural practices,
 22   trying to show what practices can be effective to


00138
  1   prevent contamination from feces, irrigation waters,
  2   soil amendments, et cetera.
  3             We have a whole host of research papers on
  4   internalization of pathogens, and none of it is
  5   conclusive.  Quite frankly, some of the research areas
  6   that are most critical to produce safety are not
  7   involved in produce safety at all, and that is the
  8   real need for continued research and more definitive
  9   review of what is out there on microbial methods of
 10   analysis.
 11             If you are trying to investigate a foodborne
 12   outbreak, or if you are trying to confirm whether or
 13   not a foodborne outbreak is there, you cannot be using
 14   an analytical method that’s going to take you three to
 15   ten days for confirmation.
 16             The whole collaborative process with
 17   acceptance of methods by the Food and Drug
 18   Administration through the AOAC collaborative process
 19   or through some other collaborative process, we have
 20   to have a great deal more rapid methods which are
 21   accepted by the regulatory community.
 22             Again, we have found a great deal of science


00139
  1   out there on kill steps, but basically there is no
  2   magic bullet.  The difficulty most prominently, as
  3   shown in the last two lines, is that we have a huge
  4   body of research that is being done on various
  5   antimicrobial compounds, none of which are registered
  6   for use on produce.  We have to have the cooperation
  7   of EPA and with rapid approval with what science is
  8   showing could be very effective agents.
  9             I want to go over a little bit about what
 10   we’ve done on science in the area of tomatoes on the
 11   East Coast with just a brief mention of two meetings,
 12   because it brings up some excellent work that
 13   Dr. Buchanan and Gendall have done.
 14             Back on November 30th, down in Orlando, we
 15   worked cooperatively with FDA to pull together all of
 16   the researchers, industry, and regulators in the seven
 17   East Coast states that were involved in the growing of
 18   fresh tomatoes and tried to invite them to at least
 19   start and increase the coordination and cooperative
 20   effort between all of these scientists.
 21             All of these documents are availability on
 22   the website shown there, which is a research website


00140
  1   for the University of Florida.  
  2             As a part of this, you have already had a
  3   presentation by Dr. Marion Aller, the three things
  4   that came out of this meeting were the researchers and
  5   the industry said that there was a real critical need
  6   to continue to review science but to establish
  7   priorities for the research that was needed to fill
  8   these data gaps; we requested of AFDO assistance in
  9   development of the model; and promised more rapid
 10   communications.
 11             Well, out of this Dr. Buchanan and Gendall
 12   presented an excellent bibliography of all of the
 13   scientific papers that had applicability to the whole
 14   problem of tomato food safety.  
 15             Dr. Buchanan, I’ll call your attention to
 16   one of the presentations on that website where he
 17   actually went through all of the individual papers and
 18   picked out the nugget of most applicability to the
 19   problem and did an excellent review.  
 20             Some of the papers went back into the
 21   seventies and eighties, as you will see here, just
 22   challenging some of the common beliefs, for instance,


00141
  1   that tomatoes are an acidic food and don’t support the
  2   growth of foodborne pathogens.
  3             Well, here are a whole host of papers that
  4   show the opposite -- some of which, as you will see,
  5   even authored by our illustrious chairman of this
  6   hearing today.
  7             Even going into some of the papers in 2003
  8   by Beuchat and 2006.  There was an excellent review of
  9   this scientific information, again, looking at the
 10   antimicrobial treatments in this specific instance for
 11   tomatoes, but going through some of the published
 12   scientific information available for those individual
 13   treatments, and showing very definitely how they could
 14   be utilized.  I call your attention to that
 15   bibliography.
 16             Some of the evidence and some of the
 17   scientific studies, though limited, was on production
 18   but the body of science here is very limited.  As a
 19   followup to that, one of the requirements that
 20   everyone challenges us with was to try to bring all
 21   the researchers together to establish a priority of
 22   the data gaps.  


00142
  1             We were very pleased at the university to
  2   cosponsor this with the Joint Institute of Food Safety
  3   and Applied Nutrition, just in late February, where
  4   40 different scientists from around the country from
  5   coast to coast were invited to come in to look at all
  6   the data gaps that had been identified by FDA and CDC
  7   and try to prioritize those as to what was needed and
  8   to begin the process of an ongoing platform of
  9   communication with these scientists.
 10             Again, if you want to look at all these
 11   papers and the comments there, go the JIFSAN website
 12   or either go to the University of Florida research
 13   website, and it will have a link to that.
 14             These were the priorities as far as the food
 15   science needs for tomatoes.  The difficulty is there
 16   are 12 or 15 categories here -- no money, no funding. 
 17   The requirement is, as you well know, to get a
 18   congressional appropriation, a minimum of a year or
 19   two or to go through a competitive grant process.  We
 20   are in desperately desperate need of funding, but this
 21   is what the scientists told us were the real needs.
 22             Are there alternative processing


00143
  1   technologies, particularly dry processing systems that
  2   can be used to either reduce the presence or spread of
  3   microbial contamination?  Are there specific seasons
  4   or microclimates or weather events associated with
  5   contamination of tomatoes in the field?
  6             You could likewise expand that to lettuce or
  7   any other produce.  What vectors and vehicles are
  8   important in transmitting pathogens?  What is the
  9   relative importance of this internalization question
 10   versus surface contamination? 
 11             Are there specific microbial serotypes or
 12   genotypes associated with tomatoes or associated with
 13   onions or associated with lettuce?  Are there specific
 14   varieties of a particular produce that more likely to
 15   carry the pathogens?  Then, are there effective
 16   approaches that can be used to activate internalized
 17   pathogens?  This goes on.  
 18             Basically, we found that there is a
 19   tremendous amount of work ongoing in many of the
 20   universities involving multiple departments.  I’m
 21   delighted that I’ve even found a microbial geneticist
 22   who is doing a whole genetic microarray of the genes


00144
  1   in every salmonella that may have some effect or tie
  2   with salmonella in tomatoes.  It’s an unbelievable,
  3   exciting field, but the summary is the current science
  4   is expanding, but it’s inadequate.
  5             We call for a critical review and for some
  6   long-term thinking, and we would hope that FDA can
  7   have this leadership to provide an overview and an
  8   in-depth review of the science that is there.
  9             Thank you very much.
 10             (Applause.)
 11             DR. BARRETT:  Thank you, Dr. Roberts.
 12             Again, we will have our FDA Panel questions
 13   with the same rules as before.  I will start off with
 14   Dr. Steve Solomon.
 15                 QUESTIONS FROM FDA PANEL
 16             DR. SOLOMON:  Mr. Stenzel, I will address
 17   this to you.  You talked about the need for oversight
 18   over the industry and you talk about the mechanisms
 19   doing that domestically.  You talked about cooperative
 20   agreements with USDA, and you talked about agreements
 21   with the states.  I would like your thoughts more on
 22   how that could be done on product grown overseas and


00145
  1   imported.
  2             MR. STENZEL:  Dr. Solomon, I think on the
  3   international front probably the best model we can
  4   look at is what you’ve done with cantaloupes from
  5   Mexico.  
  6             You basically have to move into a
  7   cooperative relationship with the foreign government
  8   in order to make sure that the production from that
  9   particular country is meeting a similar set of
 10   criteria.
 11             In some sense, there is a very tough
 12   restriction on imports of melons because of that. 
 13   Again, it is a cooperative type relationship that I
 14   think FDA has to adopt with those governments.
 15             As far as actual verification and
 16   compliance, some of the same mechanisms that we have
 17   talked about in the U.S., government doing audits or
 18   perhaps even third-party, independent auditors, but
 19   auditing to a standard that FDA sets in conjunction
 20   with that foreign government.
 21             DR. BARRETT:  Dr. Zink.
 22             DR. ZINK:  Mr. Silbermann, you mentioned


00146
  1   that you track consumer confidence in produce, produce
  2   safety.  Can you comment a little bit about how that’s
  3   holding up and maybe even forecast what sort of time
  4   frame we’ve got to work in here to maintain consumer
  5   confidence?  I think that’s probably what I’m most
  6   interested in.
  7             MR. SILBERMANN:  Well, certainly since
  8   September 14 we have been tracking consumer confidence
  9   much more closely than we ever have before.  Let me
 10   say that it is directly impacted by outbreaks.  
 11             When we had the outbreaks, for example, with
 12   Taco Bell and Taco John’s you saw an immediate dip. 
 13   It has slightly risen since the middle of September. 
 14   It is not nearly as high as I would personally like to
 15   see it.  I will share the very latest research with
 16   you later on.  It is a couple of weeks’ old I think.
 17             As to forecasting, I think the best thing we
 18   can do as an industry is obviously to adopt the kind
 19   of practices that have been urged on our industry by
 20   commodity-specific guidance.  The best impact in the
 21   marketplace is prevention.  
 22             As to how long consumers are going to give


00147
  1   us, I think they are already judging some of the
  2   things that have happened and are responding favorably
  3   to those.  The steps in California, for example, on
  4   the marketing agreement I think have had a very
  5   positive impact on the way consumers view us.  
  6             We have had some evidence of cooperative
  7   work like the Center for Produce Safety, who impacts
  8   on consumers’ perception of how government and
  9   industry are working together.  I think that is
 10   absolutely critical.
 11              I will tell you that probably the single
 12   biggest thing that stands out from our research in my
 13   mind is the credibility that consumers place on
 14   various different spokespeople.  The number one most
 15   credible source of information on the safety of fresh
 16   produce comes from farmers.  
 17             Eighty-six percent of the public put the
 18   farmer at the top of the list in terms of speaking to
 19   the steps that are taken to ensure that the produce
 20   that they grow and harvest and feed to their own
 21   families and put into the marketplace is safe to eat,
 22   significantly higher than if FDA says it, if USDA says


00148
  1   it, even higher than their family physician.  An
  2   interesting fact.
  3             DR. BARRETT:  Mr. Guzewich.
  4             MR. GUZEWICH:  Yes.  I have a question for
  5   Caroline Smith-DeWaal.  She made an observation about
  6   the fact that produce needs to be labeled to
  7   facilitate traceback.  There are some practical
  8   limitations to that.  
  9             In the outbreak like we had in the fall with
 10   the spinach, that came in a package, and that makes
 11   traceback a whole lot easier.  But if I go to the
 12   tomatoes that we’ve had here on the East Coast, by and
 13   large, those move through the marketplace unlabeled
 14   and to the point of use unlabeled.  In fact, they are
 15   in boxes only, in large quantities in boxes, and
 16   sometimes they are resorted during the distribution
 17   system and put in other boxes.  
 18             I just want know if you have any ideas, how
 19   do we work on that?  Packaging and labeling alone
 20   isn’t going to get us there I guess is what I wanted
 21   to comment on.
 22             MS. SMITH-DeWAAL:  Yes, Jack, it’s a really


00149
  1   good question because these commodities do often move
  2   in very different ways, but I have been really
  3   interested to see the extent to which labeling has
  4   been applied when the industry felt like there was
  5   some benefit.
  6             For example, if I’m purchasing apples today,
  7   I will get an individual sticker saying it’s a gala
  8   apple from New Zealand, which clearly has been applied
  9   much earlier in the chain and has followed, stayed on
 10   the apple, all the way through.
 11             I think that the traceability issues are
 12   protective not only of consumers in an outbreak
 13   situation, but also of the industry.  We have had
 14   similar questions about how to trace back ground beef
 15   and other commodities, which similarly are mixed.  I
 16   think it is a challenging problem, but it’s also one
 17   that is critical that we address in order to ensure
 18   that we don’t have another September outbreak.
 19             DR. BARRETT:  Mr. Silbermann, you had a
 20   comment?
 21             MR. SILBERMANN:  Yes.  Jack, I think we have
 22   to differentiate between on-product labeling, which is


00150
  1   what you asked about, such as stickers on an apple,
  2   and case labeling, which is really the critical
  3   component that I think sometimes we all miss.
  4             The best practices guidelines in the pilot
  5   study that we did with CPMA up in Canada clearly shows
  6   that there is a way to really narrow down the focus,
  7   if we use the technology and the standards that GS1
  8   International has put in place, that’s the old Uniform
  9   Code Council.  Those are spelled out in the white
 10   paper that we have available.  
 11             That’s what we really need to sit down and
 12   take a look at, because there is definitely a way. 
 13   Even in comingling product from different producers,
 14   there is a way to narrow that more effectively, if we
 15   use these standards in the existing technology.
 16             MS. SMITH-DeWAAL:  One other point on that. 
 17   If my recollection is correct, the Bioterrorism Act
 18   does require traceability, so this is already built
 19   into the law.  It’s a matter of how to implement it
 20   effectively.
 21             DR. BARRETT:  Mr. Baca.
 22             MR. BACA:  This is for Mr. Stenzel or


00151
  1   Mr. Silbermann.  You expreessed concern about the
  2   broad, very sweeping warning that FDA provided last
  3   September on the spinach outbreak.  I was wondering if
  4   you had some ideas about how that could have been
  5   handled differently.
  6             MR. STENZEL:  Well, I’ll start, Mr. Baca.  I
  7   think at the very initial stage no one questioned
  8   FDA’s leadership from a public health standpoint.  The
  9   ultimate number one priority has to be protection of
 10   public health, but very, very quickly thereafter I
 11   there is better data and better ability to narrow this
 12   down to specifically where the source of dangerous
 13   food was in the marketplace.
 14             My colleague, Mr. Silbermann, mentioned the
 15   way we communicate with the public.  The science of
 16   risk communication is something that all of us need to
 17   spend a lot more time on.  I hope that is one of the
 18   lessons learned from that outbreak.
 19             Simply as case reports were accumulating
 20   through late September and October, we had nightly
 21   media reports of increasing illnesses.  The public
 22   across America thought people were still getting sick,


00152
  1   but those were simply statistical accumulation of
  2   illnesses that occurred prior to September 16.
  3             The way were communicating with the public
  4   throughout that period, not necessarily the initial
  5   statement, that is a decision that FDA will always
  6   have to make with public health as the first priority. 
  7   After that point, how could we more quickly narrow it
  8   down to what’s the real threat to the consumer in the
  9   marketplace today?
 10             DR. SILBERMANN:  I really can’t add much to
 11   that.  I think that Tom did a great job in answering
 12   it.
 13             DR. BARRETT:  Ms. Lewis.
 14             MS. LEWIS:  My question is directed to
 15   Mr. Silbermann and Mr. Stenzel as well.  We have heard
 16   a lot today about a request for regulation from the
 17   Federal Government.  In the absence of that, we are
 18   not there, what measures or mechanisms, how have you
 19   changed practices to implement the GAPs and the GMPs? 
 20   Are there any differences that you’re dealing with?
 21             MR. STENZEL:  Well, let me try to respond to
 22   that.  Clearly, what you’ve seen with the leafy greens


00153
  1   agreement in California is a massive move forward in
  2   terms of quantifiable, verifiable specific practices
  3   to illustrate that commodity-specific guidance.
  4             That practice is going to take place not
  5   only in California but across the country.  I think
  6   the real issue for us as an industry, we are going to
  7   take those steps.  We are going to do everything we
  8   possibly can to make sure that all of our growers and
  9   packers and processors are complying with the best
 10   practices.
 11             What we are crying out for is some
 12   endorsement of that from the FDA.  As opposed to
 13   asking the industry to write our own standards, write
 14   our commodity-specific guidance and then have it sit
 15   on the website, we really need to have the FDA advise
 16   us and advise the public that we are taking the steps
 17   that you believe are necessary.
 18             MR. SILBERMANN:  I would add to that,
 19   relative to my comment about the creation of the
 20   Center for Produce Safety at U.C. Davis, we have
 21   already had discussions with FDA, with DHS, other
 22   states folks, and Dr. Roberts mentioned this, too, the


00154
  1   need to have the regulatory agencies help us to define
  2   the research priorities I think is absolutely
  3   critical.  
  4             Dr. Buchanan certainly has committed to be
  5   involved in that.  I would love to have Dr. Roberts
  6   involved in that and some of her colleagues at other
  7   places around the country, because we really have to
  8   make the most of the resources we have.  I think FDA
  9   can play a major role in that area, too.
 10             DR. BARRETT:  Okay, another round. 
 11   Dr. Solomon.
 12             DR. SOLOMON:  Dr. Roberts, thank you for
 13   your presentation.  During the discussions of the
 14   various forums you have been part of, you talk about
 15   the science and the ecology and the genetics.  How
 16   about on the analytical methodology issues, the need
 17   for more refined methodologies, validation of
 18   different matrices, is that also on the scope of
 19   priorities?
 20             DR. ROBERTS:  Absolutely.  I’m sorry I was
 21   rushing so on that.  That was one of the key needs of
 22   science.  We have a tremendous body of science out


00155
  1   there on new, rapid methods.  We don’t have as much of
  2   a rapid address on collaborative studies so they can
  3   be accepted in a regulatory framework.  
  4             There is just a real critical need from some
  5   Agency, hopefully, review of the methods that are
  6   there, and, hopefully, trying to garner in more of an
  7   active role by AOAC or whatever other organization
  8   might be out there that could provide some rapid,
  9   collaborative confirmation that these are accepted,
 10   that we could use them.  
 11             Because as I said, if you’re in the middle
 12   of an investigation -- I think the FDA experts here,
 13   they need a rapid response.  They need the rapid
 14   answer.  If you can’t confirm for six to ten days,
 15   that’s just inadequate.
 16             DR. BARRETT:  Okay.  Mr. Guzewich.
 17             MR. GUZEWICH:  Mr. Silbermann, a question. 
 18   I’m going to ask you to be precise about your precise
 19   comment (chuckling).
 20             (General laughter.) 
 21             MR. GUZEWICH:  You in your presentation
 22   earlier referred to the need for the FDA to use more


00156
  1   precise language when talking about outbreaks of
  2   foodborne disease associated with produce.  Could you
  3   be more precise in what you have in mind there?
  4             (General laughter.) 
  5             MR. SILBERMANN:  I’ll be as precise as I can
  6   be in public, Jack.  I think certainly at the time of
  7   an outbreak, and Tom alluded to this earlier, it is
  8   critical to define, if you’re looking at a single
  9   commodity, exactly what that commodity is to the
 10   extent you can.  
 11             If it’s a bagged product, say that it’s a
 12   “bagged product.”  If it’s not just a bagged product,
 13   and it’s the overall product, bagged or bulk, say
 14   that.  Try and be as specific as possible.  Be as
 15   specific as possible, as he mentioned, about what
 16   additional cases mean when you’re reporting that.  I
 17   understand that is not necessarily FDA, sometimes it’s
 18   CDC.
 19             That kind of risk communication component is
 20   absolutely critical because my family doesn’t
 21   understand it when they hear that on the news.  Trust
 22   me.  That’s another piece of it.


00157
  1             I think the other thing that I would ask you
  2   to do is, to the extent that you can either prior to
  3   making public announcements on situations such as we
  4   faced last September, involve the industry
  5   associations as much as you can to give you the
  6   maximum understanding of the distribution
  7   characteristics of some of these products.  
  8             You folks aren’t necessarily produce
  9   distribution experts.  You have become much more
 10   expert over the last 10 years.  I’ll grant you that. 
 11   To the extent you can, work with us.
 12             Let me give you an example.  I know this
 13   wasn’t FDA, but it was another agency.  In the
 14   Taco Bell situation, there was a lot of confusion
 15   about what color onion was actually involved.  The
 16   particular regional authority in that case, I can’t
 17   remember if they said it was white onions or yellow,
 18   but actually it was the opposite.  
 19             That was the kind of lack of specificity
 20   because an inspector went in and didn’t realize that
 21   the inside of a yellow onion is actually white once
 22   you peel it all the way down to the center, so he had


00158
  1   the wrong color in the report.  
  2             That caused all kinds of confusion in the
  3   industry as to what color of onion was this actually
  4   that was being implicated.  Those are the kinds of
  5   things I think talking to the industry at the time
  6   that agencies all working in a situation like this
  7   would help tremendously.
  8             DR. BARRETT:  Mr. Baca, one quick question.
  9             MR. BACA:  This is for Ms. DeWaal.  When you
 10   mentioned applying HAACP to produce and you mentioned
 11   having written plans, did you imply also then that we
 12   would require significant or adequate recordkeeping in
 13   terms of, for example, if they test the water
 14   periodically that they would be able to demonstrate
 15   through the investigator that yes, the water had been
 16   tested?
 17             MS. DeWAAL:  Yes.  The very important
 18   element of HAACP is both planning, putting your food
 19   safety plan in place and then also keeping records
 20   about what you’re doing.  
 21             The difference here, and I don’t really call
 22   what we are asking for here HACCP, because I don’t see


00159
  1   that there are critical control points, per se.  I
  2   think there are a lot of control points along the
  3   chain, but there aren’t critical control points.  
  4             I’m comparing it to seafood HAACP, but I
  5   don’t think you need a HAACP for fresh produce
  6   necessarily, but I think you need to follow the model.
  7   Recordkeeping, especially when they are doing testing
  8   or ensuring that the water is working, the kinds of
  9   records have to be maintained just every day on the
 10   farm, those should also be part of the food safety
 11   plan.  
 12             Then, in the audit they are not only looking
 13   at the plan itself to see if it’s adequate, given the
 14   environmental conditions, but they are also checking
 15   the records to see that they are maintained and that
 16   they say the things to ensure the safety.
 17             DR. BARRETT:  Okay.  The last question. 
 18   Ms. Lewis.
 19             MS. LEWIS:  My question is also for
 20   Ms. DeWaal.  You mentioned about the auditing, and
 21   having perhaps state regulators do an audit or produce
 22   buyers do an audit.  


00160
  1             I would like to know your feelings. 
  2   Sometimes there is a case where a farmer may have
  3   audits by several different companies based on what
  4   the buyer chooses to have.  How do you feel about
  5   farmer audits versus those that you mentioned?
  6             MS. DeWAAL:  The key for keeping the audits
  7   trustworthy is that the farmers are not themselves are
  8   paying for the audit, but it’s being either done by a
  9   state or a federal agency or it is being done by
 10   somebody who is actually going to purchase the
 11   product.
 12             I think actually we are stepping out a
 13   little on this.  This is not a position we have taken
 14   with respect to any other food commodity, but I feel
 15   in this instance that the buyers have the same
 16   interests.  
 17             The key to the audits that are done by
 18   third-party buyers is the fact that they should be
 19   done according to these kind of uniform standards that
 20   FDA would set.  
 21             Now, the buyer may in fact have a whole
 22   bunch of other quality criteria and other things that


00161
  1   they want to audit for as well, but those should be
  2   kept separate from this audit that would then be used
  3   by the states and the Federal Government in their
  4   review.
  5             DR. BARRETT:  Okay.  Well, I would like to
  6   thank both of our panels for the presentations they
  7   have made.  We will adjourn for lunch now and be back
  8   here at 1:45.  
  9             Again, if you look for individuals with blue
 10   tags, they can direct to where you want.  There is one
 11   place to eat right here in the Wiley building.  If you
 12   choose to go elsewhere, there are places nearby in
 13   College Park.
 14             Thank you.
 15             (At the hour of 12:30 p.m. the luncheon
 16   recess was taken, the proceedings to be resumed at
 17   1:45 p.m.)
 18   
 19   
 20   
 21   
 22   


00162
  1              A-F-T-E-R-N-O-O-N  S-E-S-S-I-O-N
  2                                              (1:45 P.M.)
  3             MR. LANDA:  Why don’t we get started on this
  4   afternoon’s session.  Does anyone need signing
  5   services?  If you could, raise your hand.
  6             Thank you.
  7             My name is Michael Landa.  I’m deputy
  8   director for regulatory affairs in CFSAN. 
  9   Dr. Brackett was called away this afternoon, so I will
 10   be continuing for the balance of the day on his
 11   behalf.  With that said, Amy Green.
 12                ISSUES AND QUESTIONS FROM 
 13                THE FEDERAL REGISTER NOTICE
 14             (PowerPoint presentation in progress.)
 15             MS. GREEN:  Can you hear me?  Okay.  I’m
 16   kind of short.  I never make it up to the microphone.
 17             In the second half of the hearing, I’m going
 18   to go over the issues and questions in “The Federal
 19   Register Notice,” and everybody should have a copy of
 20   it in the folder that you were given when you
 21   registered.
 22             The major purpose of the hearing is to


00163
  1   solicit comments from stakeholders, and so after I get
  2   done reviewing the questions and issues, then we will
  3   hear from the public commenters.
  4             For the most part, the invited speakers
  5   focused their remarks on issues addressed in “The
  6   Federal Register Notice.”  The remainder of the
  7   program, as I said, will be devoted to the people who
  8   signed up to give public comments, and we are hoping
  9   that they also focus on the issues and questions that
 10   are in “The Federal Register Notice.”  We have a lot
 11   of commenters this afternoon, so I’m going to do this
 12   as fast as possible.
 13             There are three major issues that were
 14   identified in the Notice.  The first issue was talking
 15   about risk factors or factors that contribute to the
 16   microbiological contamination of fresh produce.
 17             The second issue had to do with FDA
 18   measures.  You heard about some of them this morning. 
 19   An example is the 1998 “Good Agricultural Practices
 20   Guide,” the 2004 “Produce Safety Action Plan,” and the
 21   sprout guidances in the new “Fresh-Cut Guide.”
 22             Also, you heard this morning that FDA


00164
  1   provided technical assistance to the industry in
  2   developing the commodity-specific guidances.
  3             Okay.  The third issue is traceback, and
  4   that is the process of tracking foods back to their
  5   source.
  6             The fourth issue has to do with records. 
  7   This is written food safety records or SSOPs/SOPs. 
  8   It’s not the records that have to do with traceback,
  9   because the questions about those are under traceback
 10   issue.
 11             The last issue is that of verification.  It
 12   is the verification that the “Good Agricultural
 13   Practices” have been implemented successfully.
 14             As I mentioned before, “risk factors” are
 15   factors that contribute to the risk of microbial
 16   contamination of fresh produce.  We have asked
 17   stakeholders to share any information, actually you’re
 18   the stakeholders, that you have to enable us to
 19   identify and understand factors that contribute to the
 20   microbial contamination of fresh produce.
 21             We are talking about risk factors in the
 22   entire supply chain.  This morning most of the risk


00165
  1   factors that were discussed were those that we see on
  2   the farm, but this particular issue we really want to
  3   look at the entire supply chain.  We want information
  4   on risk factors in post-harvest processes, in
  5   processing of fresh-cut produce, and the transport and
  6   distribution and retail.
  7             There are three areas, and they were
  8   discussed quite a bit this morning, that appear in
  9   multiple steps in the supply chain.  Water is a
 10   carrier of human pathogens.  It is used for irrigation
 11   with chemicals and topical sprays.  It is also used in
 12   other steps in the supply chain to cool or transport,
 13   to wash, and in processing of fresh-cut fruits and
 14   vegetables.  
 15             Worker health and hygiene is another area
 16   that may cause problems.  Workers can transmit
 17   disease, foodborne illness.  Food handlers often need
 18   training.  I think Michelle mentioned that this
 19   morning.  They often need training in food safety
 20   practices.
 21             Then, the third is environmental sources of
 22   contamination.  That is a really big area.  I think


00166
  1   Thomas talked a lot about that this morning: animals,
  2   manure, flooding, those kinds of things in the field. 
  3   Also, the environment might be the environment in a
  4   processing facility and how good the sanitation
  5   practices are.
  6             There are four questions under the first
  7   issue, “risk factor.”  The first one basically is,
  8   what are today’s risks or practices that could lead to
  9   microbial contamination?  I’ll go through these
 10   quickly.
 11             The second question has to do with, to
 12   paraphrase, what can we do about these risky
 13   practices?  The third question is, what current
 14   practices reduce risk?
 15             These are all in your “Federal Register
 16   Notice.”  If you can’t read them fast enough, you can
 17   read them in there.
 18             The fourth question is, what kind of testing
 19   of pathogens or indicator organisms is done throughout
 20   the supply chain?  
 21             Okay.  The second issue has to do with FDA
 22   measures.  As I mentioned earlier, FDA has


00167
  1   implemented, already implemented certain measures to
  2   ensure the safety of fresh produce.  The first
  3   question under “FDA measures” is, what else does FDA
  4   need to do, or do they need to do anything else?  I
  5   think we heard this morning that they probably need to
  6   do a lot.  Where in the supply chain should they
  7   focus?
  8             The next question, how should we consider
  9   the wide variation in the produce industry?  There’s
 10   all kinds of variation: variation in size, nature of
 11   commodity, practices used, vulnerability to
 12   contamination of a particular commodity.
 13             Okay.  We are at the third.  The third issue
 14   is traceback.  Traceback can be difficult.  I’m sure
 15   Jack Guzewich and everybody in here would say the same
 16   thing.  
 17             It is particularly difficult with unpackaged
 18   produce because of all the packing and repacking that
 19   may be done with the produce.  There are lots of
 20   chances for comingling.  
 21             It is also difficult with packaged produced,
 22   packaged and labeled product, because often the


00168
  1   information is insufficient or incorrect.  What
  2   records do we need to assist in a traceback?  
  3             Okay.  The fourth issue, this refers to
  4   records, as I said, other than those used for
  5   traceback and includes written food safety plans,
  6   SSOPs, HAACP monitoring records, for example.  Those
  7   are examples.
  8             They can be tools for both the industry and
  9   the regulators to enhance food safety.  They can be
 10   used by the growers as well.  A grower can do an
 11   assessment of the field environment and agricultural
 12   inputs which will help contribute to the development
 13   of a written food safety plan and SSOPs.
 14             The first question for records is, are
 15   records useful for risk identification, risk
 16   mitigation, or risk management?  Does industry use
 17   them for that?
 18             The last issue is verification.  You heard
 19   this morning that there is increasing pressure on
 20   industry from buyers for industry to provide
 21   assurances that their product is safe.  They ask for
 22   verification from the suppliers themselves or from


00169
  1   third party auditors.  
  2             The question is, how well do these types of
  3   verification reflect that suppliers are successfully
  4   following the good agricultural practices?
  5             How do growers, regulators, and third-party
  6   auditors measure and verify that good agricultural
  7   practices or other produce safety guidance is being
  8   followed?  What standards do they use?  What effect
  9   would any new federal measures concerning verification
 10   have on small businesses?
 11             Okay.  That’s it.  Now we are ready for
 12   public commenters.  Here are the ground rules. 
 13   Speakers are limited to -- well, it’s not really
 14   approximate.  
 15             We have so many speakers they will be
 16   limited to five minutes each.  They will be heard in
 17   the order that they appear on the agenda.  As the
 18   speaker before you is ending his or her comments,
 19   please begin to come down to the front of the
 20   auditorium so we can move this process along.
 21             What we did at the previous public hearing
 22   in California is we had the FDA Panel ask questions of


00170
  1   the speaker right after they have given their
  2   presentation, and I believe we are going to follow
  3   that process here.  Okay, that seemed to work the
  4   best.
  5             Oh, okay, just a couple of other things.  We
  6   are also asking for written comments.  This is where
  7   you can send your electronic comments.  These are all
  8   in “The Federal Register Notice.”  This is where you
  9   can send written comments.  This is the address.  Make
 10   sure you include agency name and docket number on the
 11   comment submission, and the deadline is June 13.
 12             Thanks.
 13             (Applause.) 
 14                      PUBLIC COMMENTS
 15             MR. LANDA:  Our first speaker this afternoon
 16   is Perry Bowen from King George, Virginia.
 17             (No verbal response.)
 18             MR. LANDA:  There is some question about
 19   whether he made it this afternoon, apparently not. 
 20   Our first speaker is Thomas Nassif from Western
 21   Growers Association.
 22             MR. NASSIF:  Thank you very much.  


00171
  1             I am the president and CEO of Western
  2   Growers.  We represent the fresh produce industry in
  3   California and Arizona.  We represent about 95 percent
  4   of the vegetables and 75 percent of the fruits and
  5   nuts that are produced, which is about 50 percent of
  6   everything produced in the country.
  7             We drafted the California Leafy Green
  8   Marketing Agreement, and we are the proponents of the
  9   metrics that were used with the “Good Agricultural
 10   Practices” which have been accepted by the Marketing
 11   Board.
 12             As all of you know, the dual mission of FDA
 13   is to protect and promote the public health.  FDA
 14   must, however, place equal emphasis on both aspects of
 15   its mission.  FDA has a strong record in protecting
 16   the public health.
 17             While FDA is focused on this component of
 18   this mission, more could be done to promote public
 19   health.  Part of promoting public health is increasing
 20   the consumption of fresh produce which FDA has always
 21   supported.
 22             In March 2004, FDA proposed an action plan


00172
  1   to confront the nation’s obesity problem and said that
  2   increasing the consumption of fresh fruits and
  3   vegetables was a critical element of any plan to
  4   reduce obesity, the obesity epidemic.
  5             In the May/June 2005 publication of “FDA’s
  6   Consumer Magazine,” the article “Healthier Eating”
  7   notes the following:
  8             “Currently, the typical American diet is low
  9   in fruits, vegetables, and whole grains and high in
 10   saturated fats, salt, and sugar.  As a result, more
 11   Americans than ever are overweight, obese and at
 12   increased risk for chronic diseases such as heart
 13   disease, high blood pressure, diabetes, and certain
 14   cancers.”
 15             As part of the recommendation, the article
 16   suggests eating a variety of fruits and vegetables. 
 17   Specifically, the article urges consumers to get a
 18   variety of dark-green vegetables such as broccoli,
 19   spinach, and greens.
 20             The article even points out that you can buy
 21   salad in a bag to make eating vegetables more
 22   convenient.  However, the net effect of the FDA


00173
  1   consumer alert in the spinach alert together with the
  2   press releases thereafter has been more to promote the
  3   nonconsumption of fresh produce.
  4             In addition to spinach, many related
  5   commodity groups were also affected by the FDA
  6   warning.  A loss of confidence in these products works
  7   against public health by discouraging consumers from
  8   increasing their consumption of lettuce and leafy
  9   greens, which public health advocates for urged for
 10   years as a means of reducing key diet-related
 11   illnesses such as heart disease and diabetes.
 12             In this initial alert to the public on
 13   September 14, 2006, FDA implicated bagged, fresh
 14   spinach as a possible cause of the E. coli outbreak
 15   associated with the consumption of produce.
 16             Twenty-four hours later, the implicated
 17   processor recalled all of the bagged spinach salads. 
 18   After six months of investigation, it was determined
 19   that it was bagged spinach, as they had said on
 20   September 14, and that the implicated processor that
 21   was identified and recalled their product on the 15th
 22   was the same at the end of the end of the six-month


00174
  1   investigation.
  2             In the meantime, however, the entire spinach
  3   industry suffered the consequences.  By September 22,
  4   FDA had narrowed the scope of the outbreak to three
  5   counties in California and advised the public that
  6   spinach grown in non-implicated areas could be
  7   consumed.
  8             To the consumer, they made no distinction
  9   because they didn’t know where the spinach that they
 10   were eating in these bagged salads came from.  The net
 11   result of the FDA advisory was to damage consumer
 12   confidence in all forms of spinach -- fresh, frozen,
 13   canned -- grown in all regions of the country.
 14             Today, many restaurants around the country
 15   still refuse to put fresh spinach on their menus. 
 16   Believe me, I ask every time I dine out.  Even today I
 17   noticed in “USA Today” headlines saying, “CDC Reports
 18   E. Coli Cases Are on the Rise In the Leafy Greens.”
 19             Now, there is almost nothing in the article
 20   that talks about the leafy greens.  It talks about
 21   mostly other commodities.  And the picture?  The
 22   picture is a picture of a market saying, “Quarantine


00175
  1   all spinach.”  It’s dated 9/15/06.  This is today, the
  2   April 13 headline in “USA Today.”
  3             It is FDA, in my opinion, that need to
  4   reassure the public that spinach is safe to eat. 
  5   Recent consumer surveys indicate that the high degree
  6   of influence that FDA has and other government
  7   agencies have on public behavior, consumers look to
  8   FDA as the leading authority on safety of the food
  9   supply.
 10             Complicating matters was the fact that all
 11   the media attention had created an overarching fear
 12   that there was a fundamental breakdown in the safe
 13   production and handling of leafy greens.
 14             A recent report by the Perishables Group
 15   reviewed the impact of the spinach recall at the
 16   retail level.  Packaged spinach saw their sales
 17   decrease over 27 percent in the period following the
 18   outbreak and over 43 percent lower than the same
 19   period the previous year.
 20             Packaged salads with spinach were down
 21   nearly 38 percent from the prior year and down
 22   42 percent from the previous year.  The E. coli


00176
  1   outbreak also had a devastating impact on the
  2   international sales of spinach.  
  3             Within days of the outbreak, Mexico
  4   responded by placing an embargo on all spinach that
  5   was exported from the United States.  In fact,
  6   Mexico’s Food and Drug Administration still has an
  7   advisory on U.S. spinach.
  8             For a number of weeks following the
  9   outbreak, Canada also prohibited all spinach imports
 10   from the United States.  Given the widespread and
 11   continuing impact of the outbreak, FDA must
 12   acknowledge it has a role in restoring consumer
 13   confidence in the safety of spinach and leafy greens,
 14   thereby aiding in the revitalization of the industry.
 15             Beginning on September 29, 2006, FDA began
 16   directing the leafy greens industry to:  “Develop a
 17   comprehensive plan which is designed to minimize the
 18   risk of another outbreak due to E. coli 0157:H7 in
 19   spinach grown in Central California.”
 20             Less than one month later, on October 26,
 21   2006, Western Growers’ Board of Directors unanimously
 22   voted to pursue a three-part approach to creating


00177
  1   mandatory food safety guidelines at the state and the
  2   federal level.  
  3             Western Growers along with its industry
  4   partners took the first step with the enactment of the
  5   California Leafy-Green Handlers Marketing Agreement on
  6   April 1, 2007.
  7             As part of the marketing agreement,
  8   virtually the entire leafy-greens industry has
  9   accepted the good agricultural practices that reflect
 10   the latest in science and technology.  As a matter of
 11   fact, 98 percent of the entire industry is a signatory
 12   to that.  Once they sign, it is mandatory that they
 13   comply for the term of the contract.
 14             Western Growers is now in the process of
 15   developing the next two steps, which include a
 16   California marketing order, which would be mandatory,
 17   and a federal approach to fresh produce safety
 18   regulations that would be mandatory.
 19             Clearly, the industry has responded to the
 20   call for enhanced food safety measures.  Spinach and
 21   leafy greens are now safer than they ever have been. 
 22   Undermining this effort, however, of the leafy green


00178
  1   industry, FDA personnel have gone on record recently
  2   saying that they do not believe that the food supply
  3   is any safer today than it was in September. 
  4   Furthermore, they have said we are looking “at a
  5   distinct probability of an outbreak linked to leafy
  6   greens in 2007.”
  7             While we agree that there is no guarantee
  8   against another outbreak, even if the California
  9   metrics are adhered to by the entire industry
 10   throughout the country, our actions have significantly
 11   reduced that possibility.
 12             FDA must extend the honest effort to reduce
 13   the risk of the production and harvest operations by
 14   calling on other parts of the supply chain, including
 15   transportation companies, food service companies, and
 16   retailers to develop their own robust best practices
 17   to ensure the safety and integrity of the product they
 18   receive, handle, and sell.
 19             Also, FDA should strongly discourage buyers
 20   from going around producers who are employing these
 21   good agricultural practices in favor of a lower-cost
 22   product.


00179
  1             Western Growers will be opening an office in
  2   Washington, D.C., at the end of this month in order to
  3   work further with FDA and other agencies on food
  4   safety, immigration, the farm bill, and other areas.
  5             Thank you very much for allowing me to speak
  6   to this group this morning (sic).
  7             (Applause.)
  8             MR. LANDA:  Questions?
  9             DR. SOLOMON:  Thank you for that
 10   presentation.  Help me understand.  With the outbreak
 11   my understanding is that there were many different
 12   bags of product that were out there produced at the
 13   same facility, and there were also larger bags that
 14   potentially could have been put onto grocery shelves
 15   and other places and products that was repacked.  How
 16   could the consumer be able to identify the product
 17   from the specific facility?
 18             MR. NASSIF:  Well, frankly, I don’t think
 19   there were any bagged salads that were still out there
 20   that were contaminated.  As you know, the illnesses
 21   occurred in August, and by that time most everything
 22   had been purchased.


00180
  1             The fact is that the processor who processed
  2   that bagged salad and all of the people who use their
  3   own brands that were processed by them, all of them
  4   recalled their spinach.
  5             MR. GUZEWICH:  One question.  Thank you,
  6   Mr. Nassif, for your presentation.  You made several
  7   times the comment that the FDA should promote the
  8   safety of spinach.  What do you have in mind when you
  9   say that?
 10             MR. NASSIF:  Well, for example, instead of
 11   saying that spinach is no safer today than it was in
 12   September, what I would like to have heard from FDA is
 13   that what the industry has done is to provide metrics
 14   which are far in excess of anything we have seen
 15   before from this industry, even the metrics we had
 16   suggested when we dealt with them earlier.  That has
 17   gone a long way toward improving the safety of the
 18   food supply so far as fresh spinach is concerned.
 19             While these metrics have gone a long way in
 20   limiting the contamination possibilities, it is a
 21   first step in a number of steps that yet need to be
 22   done in cooperation with FDA and with scientists. 


00181
  1   That would have been a truthful and a very
  2   straightforward statement that could have benefitted
  3   both the industry and FDA’s goal.
  4             MR. GUZEWICH:  Thank you.
  5             MR. BACA:  I mean, I agree the steps you’re
  6   taking are absolutely in the right direction and are
  7   very proactive, but I’m concerned with the uniformity
  8   of compliance.  
  9             How can a consumer be sure that every grower
 10   in this area is going to get on board with this and
 11   whatever they produce and that goes into the market is
 12   going to be produced under current state-of-the-art,
 13   good agricultural practices?
 14             MR. NASSIF:  Well, the marketing agreement
 15   that the handlers signed, as I said we have 90 percent
 16   of the entire industry, and they are bound.
 17             MR. BACA:  It’s that other 10 percent.
 18             MR. NASSIF:  We know that there is still
 19   part of our industry that is not bound.  We want
 20   everyone to be bound, so our next step is the
 21   marketing order, which is going to make it mandatory
 22   on everybody.  


00182
  1             We will probably do a mandatory order for
  2   the handlers, because we know the handlers are on
  3   board.  That means that everybody who grows and
  4   anybody who handles in the state of California will
  5   have to comply.  It will be verified by the state of
  6   California and the United States Department of
  7   Agriculture, AMS Division.
  8             The third step is mandatory federal
  9   regulation.  The reason we did it in this order was we
 10   did those things, we took those steps which would be
 11   the quickest in responding to what FDA had asked of
 12   us.
 13             Thank you.
 14             MR. LANDA:  Our next speaker is Richard Ross
 15   of Path Tracer.
 16             (PowerPoint presentation in progress.)
 17             MR. ROSS:  My name is Richard Ross.  It’s
 18   nice to be with you this afternoon.  I’m a 30-year
 19   food manufacturer.  I’ve been in charge of
 20   19 different food manufacturing facilities.  What I
 21   would like to talk to you today about is what the
 22   growers can do for themselves by doing tracebacks.


00183
  1             They are talking about the certification
  2   process for fruits and vegetables, particularly with
  3   the marketing order, tracebacks are a key. 
  4   Third-party audits are outstanding, best practices
  5   that are adopted are great, but tracebacks are the
  6   best thing that you can possibly do to enhance the
  7   best practices and the third-party audits.
  8             The thing about tracebacks that I don’t hear
  9   from anybody is the fact that there are two different
 10   types.  One is the reactive type, and the other is the
 11   proactive type.
 12             Now, the reactive type is the one that I was
 13   always associated with when the FDA would come in and
 14   they would say, “We need to see your records.”  We
 15   would open the door and there would be boxes upon
 16   boxes of records.
 17             When I gave this same speech a couple of
 18   weeks ago and I was looking at all the inspectors and
 19   all the inspectors were going, “Yes, that’s indeed the
 20   case.”
 21             They go for this shoe box and they would
 22   look and they say, “Oh, this isn’t so good,” and then


00184
  1   they would go for another shoe box.  By the time they
  2   were done, they had taken so much time and they were
  3   so confused in what they were trying to accomplish
  4   that it really lost all effectiveness.
  5             Let’s talk about proactive tracing. 
  6   Proactive tracing is where you do an activity log of
  7   everything that happens at your facility.  If you’re
  8   talking about a grower specifically, the grower is
  9   going to be able to say that “Yes, I planted this
 10   seed.  I applied this different fertilizer.  I did
 11   this soil amendment.  I had Crew A doing the
 12   harvesting.  They did indeed have stainless steel
 13   knives and dips.”  
 14             In order for them to take care or everything
 15   that they need to do, they will be able to demonstrate
 16   that then with a proactive system.  I think that that
 17   is the real key for today for what we are talking
 18   about with the leafy green vegetables.
 19             Why traceback at all?  The fact is, as you
 20   can see from this University of California at Davis
 21   slide, is that as you increase traceability, you will
 22   be able to increase food safety.


00185
  1             Now, if you will notice, it is a 1 percent
  2   increase associated with where we are today versus
  3   where food safety might take you.  The reality of it
  4   is that is one-third reduction in the differences of
  5   the outbreaks.  You are going to be able to reduce all
  6   of your outbreaks by a third.  Traceability is the
  7   key, as far as I’m concerned, with food safety in
  8   general.
  9             You talk about proactive tracing and
 10   reacting tracing and how tracing does help.  Here is
 11   the impact that it had upon the industry over the past
 12   six months.
 13             One that I like to bring up, besides looking
 14   at all the other red numbers that are up there, is the
 15   one in the lower, right-hand corner, which is the
 16   packaged salad non-spinach group.  They lost 8 percent
 17   of their sales, and they had nothing to do with the
 18   spinach outbreak at all.  That’s a $70 million hit. 
 19   That is just not acceptable in the year 2007.
 20             The grower has an advantage by doing this
 21   properly.  The grower has an advantage because he can
 22   say, “Yes, I’m certified.  Yes, I’m easy to audit.  I


00186
  1   can prove that I didn’t do it,” because of all the
  2   things that they have done in advance.
  3             The benefit then also goes to the
  4   packer/shipper because the packer/shipper is able to
  5   say that “Yes, I know that this guy did this, and so
  6   my products are going to be safer also.”  That will be
  7   driven all the way up to the consumer.  It’s just
  8   imperative that we talk about something like this.
  9             Now, you look at the advantages to everybody
 10   along the line.  What I would have to tell you is
 11   associated with this spinach outbreak, six months for
 12   an investigation is just too long.  Six weeks without
 13   spinach, that’s just not tenable in this day and age.
 14             If you ever put into effect the Bioterrorism
 15   Act, that would give people approximately six days. 
 16   At six days you would be able to do your analysis and
 17   such.  
 18             Is that really going to get you where you
 19   need to go when in 2007 you can actually do a
 20   traceback all the way from the fork all the way to the
 21   field in less than six minutes?  
 22             Our product does that.  A proactive tracing


00187
  1   system will allow you to accomplish that because as
  2   everybody keeps track of what they are doing you’re
  3   going to be able to go all the way back through the
  4   system in order to be able to get that traceability
  5   and get that kind of effect.
  6             It helps everybody including the FDA.  If
  7   you’ve got something that is on a Web base, you’re
  8   going to be able to have information available without
  9   having to travel, so the FDA is going to be able to
 10   have a more efficient use of their manpower.  
 11             You are going to have more accurate and
 12   complete information because this is kept in advance
 13   rather than going to the shoe-box method of trying to
 14   find out what you’ve done and when you did it.
 15             The proactive response is also proactive for
 16   the FDA and for all the consumers and for everyone
 17   else.  This is a step forward in accomplishing
 18   something that is only necessary for the protection of
 19   really the entire food supply.
 20             You’ve got immediate answers.  As I said two
 21   weeks ago with Dr. Buchanan, I said it is just a
 22   matter of just pushing a button.  Dr. Buchanan noticed


00188
  1   when I was making this speech last time that basically
  2   by doing an activity program, you were able to align
  3   that with ISO 9000.  It is not some guess.  It is
  4   something I have a lot of particular experience with.
  5             She just told me to stop.  With that thought
  6   in mind, I’ll answer any questions.
  7             MR. LANDA:  Thank you.
  8             (Applause.)
  9             MR. LANDA:  Our next speaker is
 10   Michelle Marcotte with the International Irradiation
 11   Association.
 12             (PowerPoint presentation is in progress.)
 13             MS. MARCOTTE:  Hello.  Thank you for
 14   inviting me and thank you for putting up with the
 15   technology problems.  I am Michelle Marcotte,
 16   presenting today on behalf of the International
 17   Irradiation Association and it’s affiliate, the Food
 18   Irradiators Processors Alliance.  
 19             We are called the “IIA” and we are an
 20   association of suppliers of irradiation equipment at
 21   over 90 percent of irradiation contract services
 22   worldwide.


00189
  1             Our membership includes six American
  2   companies providing irradiation services in 39
  3   irradiation facilities in the U.S.  IIA/FIPA and its
  4   members have played the leading role in the
  5   development of radiation processing for the
  6   sterilization of medical and personal care goods as
  7   well as for food irradiation for several decades.
  8             Irradiation is a physical process that
  9   depending on how it is used can kill or control
 10   harmful or food spoilage microorganisms on and in
 11   foods.  
 12             It does not involve heat.  It is not a
 13   chemical treatment.  It leaves no residue in the food,
 14   and it will not affect the nutrient content of fresh
 15   produce.
 16             Irradiation should be viewed as part of an
 17   integrated food safety system that starts on the farm
 18   and carries through to the consumer or food service
 19   kitchen.  The difference is irradiated produce will
 20   land on the kitchen countertop much cleaner, and I
 21   mean that in a microbiological sense.
 22             Irradiation will kill harmful bacteria such


00190
  1   as E. coli and salmonella in and on the cells of
  2   fruits and vegetables.  Irradiated fruits and
  3   vegetables can be eaten raw safely.
  4             Research at USDA’s Agricultural Research
  5   Service in Wyndmoor, Pennsylvania, shows that
  6   irradiation could have prevented or significantly
  7   reduced the impact of recent infections of E. coli
  8   bacteria linked to contaminated spinach and other
  9   produce.
 10             Dr. Brendan Niemira of USDA ARS wrote: 
 11   “Irradiation is very effective at killing bacterial
 12   pathogens including human pathogens like E. coli
 13   0157:H7, salmonella, and listeria monocytogenes on
 14   fruits and vegetables including leafy salad products
 15   like lettuce, spinach, endive, and other leafy
 16   vegetables.  Different types of produce have different
 17   responses to irradiation, and some are more tolerant
 18   of the process than others.”  
 19             Dr. Xuetong Fan also at USDA ARS adds:
 20             “Studies conducated at the ARS Eastern
 21   Regional Research Center of USDA and other
 22   institutions have demonstrated that irradiation


00191
  1   decreases or eliminates human pathogens on fresh and
  2   minimally processed fruits and vegetables without
  3   significant detrimental effects on nutritional and
  4   sensory quality.  
  5             “Our studies on quality of irradiated
  6   produce indicate that most of the fresh-cut or
  7   minimally processed fruits and vegetables can tolerate
  8   a radiation dose of 1 kilogray, a dose that
  9   potentially inactivates 99.999 percent of E. coli
 10   0157:H7.”
 11             Dr. Fan asserts: “If human pathogens such as
 12   E. coli 0157:H7 get inside of produce, they will
 13   unlikely be killed or removed by any chemical
 14   sanitizer or wash without damaging the product. 
 15   However, internalized pathogens can probably be
 16   inactivated by irradiation because of its penetrating
 17   ability.”
 18             Dr. Anuradha Prakash at Chapman University
 19   wrote:  “Irridation is one lethal treatment that fresh
 20   produce can tolerate without affecting quality.  It’s
 21   particularly important for fresh-cut products that
 22   will not receive further lethal treatment prior to


00192
  1   consumption.
  2             “Irradiation does not replace good
  3   agricultural practices.  Given the fact that most
  4   fresh produce is processed in large, centralized
  5   facilities, irradiation provides additional insurance
  6   against foodborne pathogens.”
  7             Here is the problem.  Although FDA has
  8   approved the use of irradiation to killed insects and
  9   to extend the shelf life of fresh fruits and
 10   vegetables, the regulatory approval does not extend to
 11   killing harmful microorganisms and does not extend to
 12   minimally processed fruits and vegetables.
 13             FDA has dragged its “regulatory feet” for
 14   several years on several petitions that would have
 15   expanded the use of irradiation and improved public
 16   health.  FDA needs to immediately rectify this lack of
 17   regulatory action.
 18             Irradiation is already used and accepted in
 19   the U.S.  Current estimates are that approximately
 20   18 million pounds of irradiated ground beef and
 21   poultry are marketed in the U.S. annually.  It is also
 22   estimated that some 8 million pounds of irradiated


00193
  1   fruits and vegetables -- mainly mango, papaya, and
  2   guava -- are sold annually by U.S. retailers.  
  3             Spices have been commercially irradiated
  4   since 1986, and approximately one-third of commercial
  5   spices consumed in the U.S., or about 175 million
  6   pounds, are irradiated annually.
  7             Here are some companies you may be
  8   interested in contacting for further information. 
  9   Facilities presently irradiating food for human
 10   consumption in the U.S., include: Food Technology
 11   Services, Inc., located in Mulberry, Florida; Texas
 12   A&M University at College Station, Texas; Sadex, Inc.
 13   at Sioux City, Iowa; and Hawaii Pride on Hawaii’s
 14   Big Island.  
 15             New Jersey-based Gray Star is in the process
 16   of finalizing plans to build another gamma irradiation
 17   facility near Honolulu, Hawaii, and that facility
 18   wills serve Hawaiian growers as well as Asian
 19   customers and be operational in mid- to late 2007.
 20             Several additional facilities including
 21   those operated by SteriGenics, Steris Isomedics, and
 22   Food Technology Services irradiates spices,


00194
  1   dry ingredients, and garlic.  Food Technology Services
  2   irradiates fruit for interstate quarantine within the
  3   United States.  Sadex has an increasing meat and
  4   animal feed and supplement business.  Hawaii Pride
  5   began marketing irradiated produce in the mainland in
  6   2001.  
  7             MDS Nordion, I’m just running through the
  8   names of some of these companies here, is the largest
  9   irradiation equipment supplier of the food technology
 10   services.
 11             [Technical difficulties, loss of sound.]
 12             MR. ZINK:  [In progress.]  Virtually, every
 13   cell in a leafy vegetable would receive a lethal dose
 14   of irradiation.  I mean, you made the statement that
 15   some tolerate it well and some don’t.  Well, that’s a
 16   kind of a vague statement.  
 17             These products on the market now can have a
 18   40- to 45-day shelf life.  I wonder, has anyone really
 19   done any studies to show that products now in the
 20   marketplace could tolerate this kind of dose?
 21             Then, second is really a philosophical
 22   question, should we be using irradiation to clean up


00195
  1   what is essentially an adulterated product if we
  2   believe it’s possible through good agricultural
  3   practices to prevent adulteration?
  4             MS. MARCOTTE:  Those are good questions,
  5   Dr. Zink.  In fact, I’d asked them myself.  The reason
  6   that I just quoted the comments from those three
  7   research scientists is that they have done a lot of
  8   research, and I didn’t have time in five minutes to
  9   review it.  
 10             In fact, the Agricultural Research Service
 11   at Pennsylvania, the researchers there, have answered
 12   a lot of those questions with very specific and
 13   detailed research.  
 14             You can kill E. coli.  It has a low D10 in
 15   fruits and vegetables.  You can achieve more than a 2
 16   log reduction even between the minimum and maximum
 17   dose requirements, if we stay with the FDA current
 18   maximum of 1 kilogray.  It definitely can be done.
 19             There are some products that are damaged by
 20   this process, but the ones that seem to have, with the
 21   exception of tomatoes, caused a lot of the problems,
 22   they have done work both on the fresh product and on


00196
  1   minimally processed to say that yes, those outbreaks
  2   could have prevented.  
  3             Having a statement of a comment summarizing
  4   the research is one thing, reading the research is a
  5   different thing, and that’s what I encourage you to
  6   do.
  7             For your next question of whether you should
  8   be using irradiation, I mean, do you ask that same
  9   kind of question saying, do we really need to be
 10   telling people to cook poultry because they should
 11   have cleaned up the salmonella before the poultry got
 12   to the kitchen?
 13             Well, yes, there are some things where a
 14   terminal kill step is needed and would prevent the
 15   problem.  I don’t know whether if you’ve got -- you’ve
 16   had the GAPs/GMP document out.  There has been some
 17   compliance up till now.  
 18             Granted, there is probably a lot more
 19   compliance now, but you are still not going to
 20   terminally prevent, definitely prevent the occurrence
 21   of any microorganism in a very complex system like
 22   farming.  Having a terminal step, the point is that


00197
  1   some processors and packers are going to want to use
  2   it.  
  3             We have to get the regulation in place so
  4   that people who want to use it can do that.  Standing
  5   back and sort of saying, “Well, should people really
  6   use it or not, that’s not the issue?”  You know that
  7   it is a safe process.  
  8             Give the regulatory approval, and let people
  9   see where it fits and how to use it best.  There are
 10   some large companies that maybe would like to have the
 11   lack of liability of saying, “Hey, when that produce
 12   left our facility, we know it was clean inside and
 13   out.”
 14             MR. LANDA:  You had a question?
 15             MR. BACA:  I have one.  This is Joe Baca,
 16   FDA.  Has there been any change in the public’s
 17   acceptance of irradiated foods in the last few years?
 18             MS. MARCOTTE:  Yes, I really think that
 19   there has been.  We see continued marketings of meat
 20   and poultry.  The Hawaii Pride has been sending
 21   irradiated produce from Hawaii into the produce
 22   terminal in Chicago in increasing volume since 2001.


00198
  1             There have been more and more studies that
  2   say that people understand it, and they are interested
  3   in it.  They see the need for it, particularly in
  4   consumers of higher socioeconomic brackets.  
  5             I think that those are maybe the consumers
  6   that are both of the key target markets for bagged
  7   salad products and also maybe are the ones that are
  8   really aware of the food safety issues.
  9             MR. LANDA:  Any other questions?
 10             (No verbal response.)
 11             MR. LANDA:  Thank you.
 12             (Applause.) 
 13             MR. LANDA:  Our next speaker is
 14   Reginald Brown with the Florida Tomato Exchange.
 15             MR. BROWN:  Thank you.  I appreciate the
 16   opportunity to be here this afternoon.  My name is
 17   Reggie Brown.  I serve as the executive director of
 18   the Florida Tomato Exchange and also the manager of
 19   the Florida Tomato Committee, which is the exchange
 20   being a growership organization and the committee
 21   being a federal marketing order for tomatoes in
 22   Florida.


00199
  1             The fresh tomato industry in Florida is the
  2   largest in the United States and supplies somewhere
  3   around 40 to 50 percent of all domestically grown
  4   tomatoes to the American consumer.
  5             We have actively responded on several fronts
  6   upon receiving the CFSAN 2004 letter to growers,
  7   packers, and shippers expressing FDA’s concerns about
  8   fresh lettuce and fresh tomatoes.  
  9             The Florida Tomato Exchange has worked with
 10   other tomato groups throughout North America as a
 11   member of the North American Tomato Trade Working
 12   Group, or “NATTWG,” to address these concerns.
 13             Currently, we are working with the Food
 14   Safety Division of the Florida Department of
 15   Agriculture and consumer services to establish a
 16   mandatory state regulation for food safety for
 17   tomatoes in Florida.  
 18             These regulations are being drawn from a
 19   number of guidelines including the 1998 FDA “Guide to
 20   Minimizing Microbial Food Safety Hazards for Fruits
 21   and Vegetables”, the 2006 NATTWG document, the
 22   commodity-specific food safety guidelines for the


00200
  1   fresh tomato supply chain, and others.
  2             We have actively engaged with FDA, USDA, and
  3   the Florida Department of Agriculture and Consumer
  4   Service to explore dialogues and communications in an
  5   effort to establish the most effective, science-based
  6   regulations to address the risk factors for fresh
  7   tomatoes.
  8             Addressing this issue in such a manner
  9   allows for collaborative efforts to maintain public
 10   confidence in the purchase and consumption of fresh
 11   tomatoes.  
 12             The impact of the loss of public confidence
 13   is extremely high and will result in injury to all
 14   segments of the tomato industry.  The main goal must
 15   be to prevent foodborne illnesses.
 16             In addressing the questions you ask in your
 17   “Notice,” issue one, every segment of the supply chain
 18   must evaluate their specific risk factors and the
 19   necessary policies and procedures to manage them.
 20             While risks are universal, the mitigating
 21   processes and procedures must be established with
 22   consideration for specific production, packing, and


00201
  1   distribution systems and geographical areas as they
  2   exist throughout the supply chain.
  3             Practices that pose significant risk of
  4   microbial contamination should be evaluated and
  5   mitigation practices established to reduce them. 
  6   Responsible production, packing and handling
  7   procedures based on guidance documents available to
  8   the industry result in the vast majority or virtually
  9   all tomatoes posing no risk to public health.
 10             The focus needs to be on the relatively rare
 11   occasions when microbial contamination occurs. 
 12   Currently, there are no mandatory programs for
 13   microbial testing in place throughout the industry. 
 14   It is anticipated that the Florida program will be
 15   risk-based and will include those that are
 16   appropriately based on realistic risk assessments.
 17             Issue number two, the establishment of
 18   uniform science-based risk evaluations and mitigation
 19   procedures and procedures throughout the entire supply
 20   chain is essential to providing the safest food supply
 21   system possible.
 22             Nationally mandated and monitored regulation


00202
  1   presents the best opportunity for accomplishing the
  2   goal of overall risk reduction.  Such a program must
  3   be developed best on the commodity specific systems
  4   that implements risk-reducing procedures and
  5   procedures that address legitimate food safety
  6   concerns.  The industry in both Florida and California
  7   has begun this effort to develop functional GAPs and
  8   BMPs for tomatoes. 
  9             Issue number three, tomatoes due to the
 10   unique market structure of repacking and distribution
 11   presents real challenges to the traceback process.  I
 12   think Jack will attest to that.
 13             Rapid, accurate traceback is essential to
 14   all interests and should be pursued aggressively. 
 15   Mandatory traceback capability is the only acceptable
 16   solution to this issue.  
 17             Positive lot identification, “PLI,”
 18   throughout the system that minimizes comingling must
 19   become the requirement if traceback is to be used to
 20   limit injury to the public and the industry.  Rapid
 21   use of this tool can begin to provide valuable
 22   information on the specific route through which


00203
  1   microbial contamination occurs.
  2             Issue number four, mandatory compliance to
  3   GAPs and BMPs through a national program of regulation
  4   and regulatory oversight can significantly enhance the
  5   risk reduction provided by these practices.  
  6             The risk for fresh tomatoes will never go to
  7   zero with current technology, but significant
  8   reductions can achieved with such an effort.  Direct
  9   marketing of small quantities of tomatoes poses a very
 10   limited risk to public health.  
 11             Such activities could be carefully exempted
 12   from portions of such regulations to avoid
 13   unreasonable impacts provided significant
 14   circumvention would not be encouraged.  After all it
 15   is fundamentally in the interest of all participants
 16   in the industry to produce the safest tomatoes
 17   possible.
 18             In summary, the Florida tomato industry
 19   along with other groups such as the California tomato
 20   farmers are proceeding on a path to improve the
 21   overall food safety environment for tomatoes and, for
 22   the record, I would like to add the 10 high-priority


00204
  1   research needs from the Tomato Food Safety Research
  2   Needs Workshop held here in College Park on February
  3   21 and 22.  I appreciate the cooperation and ongoing
  4   discussions on tomato food safety with FDA and the
  5   opportunity to express our thoughts on these issues.
  6             Thank you.
  7             (Applause.) 
  8             MR. GUZEWICH:  Mr. Brown, thank you.  This
  9   is Jack Guzewich with FDA.  I have one question, and
 10   you will get tired of hearing it before the day is out
 11   from me.  In your estimation, are Florida tomato
 12   growers understanding and implementing GAPs?
 13             MR. BROWN:  A very significant portion of
 14   our Florida tomato production system, probably upward
 15   to 80 percent or better, are currently and have been
 16   for a number of years under third party audits for the
 17   GAP process and procedure and are practicing those on
 18   a routine daily basis.  
 19             Food safety and GAP regulation or GAP
 20   compliance is something that just shouldn’t take place
 21   and, hopefully, doesn’t ever take place in a situation
 22   of a single audit.  It’s something that’s got to be


00205
  1   fundamentally ingrained in the corporate psychic of
  2   these companies.  We are well on that way, and that’s
  3   why this industry is willing to step forward to a
  4   mandatory program.
  5             MS. LEWIS:  This is Glenda Lewis with FDA. 
  6   Actually, I have two questions.  You mentioned about
  7   the mandatory program.  What impact do you see for a
  8   mandatory testing and sampling program in the
  9   industry?  Is the industry willing to accept that?
 10             MR. BROWN:  A mandatory testing and sampling
 11   program?  We’re looking at a mandatory BMP/GMP program
 12   with an audit process that would ensure that those
 13   items are complied with.  
 14             We have not gotten down to the final
 15   rendition of the program to the point to be able to
 16   give matrices to specifically talk about this test of
 17   water and that test of water.  
 18             While those are significant parts of that
 19   process, the industry has committed to continuing
 20   their forward progress in dealing with food safety
 21   issue for tomatoes based on science and real risk.
 22             MS. LEWIS:  My second question, would you


00206
  1   expand a little on specific activities that you may
  2   recommend for exemption if there is any national
  3   program of regulation?
  4             MR. BROWN:  I believe in the regulation that
  5   we are proposing in Florida, and again it’s a proposal
  6   to go forward ultimately to be, hopefully, enacted
  7   into regulation by state government, we are exempting
  8   direct sales from the grower to the consumer in
  9   quantities of less than 50 pounds per individual sale.
 10             That allows for roadside stands that are
 11   growing and selling a limited number of tomatoes to a
 12   roadside operation.  It allows for a certain amount of
 13   you-pick business that may exist around the country or
 14   around in our state in some cases.
 15             It also doesn’t allow for significant
 16   circumvention of the requirements that may be upon the
 17   remaining portion of the industry to ensure that we
 18   are doing absolutely all we know how to do to make the
 19   tomato products that we are selling the safest
 20   possible products.
 21             MR. LANDA:  This is Mike Landa.  Just one
 22   question, is there some process for certifying or in


00207
  1   effect certifying auditors?
  2             MR. BROWN:  We have in the proposed
  3   regulation.  Initially the proposal for the regulation
  4   going forward will have the state government or state
  5   agency doing the auditing.  
  6             There is a provision within our documents
  7   to, after the creation of the audit, the creation of
  8   the audit procedure through governmental enforcement,
  9   a provision for third-party certification to the
 10   standard audit, to the standard procedure that has
 11   been established by a government regulatory audit.
 12             MR. LANDA:  Thank you.
 13             Anyone else?
 14             (No verbal response.)
 15             MR. LANDA:  Our next speaker is
 16   Anthony Corbo from Food and Water Watch.
 17             MR. CORBO:  Thank you very much.  My name is
 18   Tony Corbo, and I’m a legislative representative for
 19   Food and Water Watch, a nonprofit consumer
 20   organization that was founded in November 2005 and is
 21   based in Washington, D.C.  I welcome this opportunity
 22   to offer our comments on improving produce safety in


00208
  1   light of the recent national recalls. 
  2             At the outset, I want to reiterate the
  3   points that Caroline Smith-DeWaal made earlier today,
  4   that the Food and Drug Administration is an agency in
  5   crisis.  
  6             There have been too many recalls involving
  7   products under the Agency’s jurisdiction in recent
  8   years, and it’s becoming clear that the Agency may 
  9   not have the authority and the necessary financial
 10   resources to do its job to protect American consumers.
 11             These recalls are undermining consumer
 12   confidence in the Agency.  The situation is becoming
 13   especially critical on the food side of FDA.  The word
 14   “food” is the first noun in the Agency’s name, yet it
 15   seems that food safety has become the stepchild within
 16   the Agency and within the overall food safety net in
 17   the Federal Government.
 18             Just consider some of these facts.  FDA’s
 19   Center for Food Safety and Applied and Nutrition along
 20   with FDA’s Office of Regulatory Affairs are
 21   responsible for regulating $417 billion in domestic
 22   food and $49 billion in imported food that is produced


00209
  1   in some 126,400 domestic food establishments and
  2   172,000 foreign establishments.
  3             In the current fiscal year, CFSAN has been
  4   given the meager staff of some 2,700 full-time
  5   equivalent positions to police 80 percent of the
  6   nation’s food supply.
  7             An FDA inspector is lucky to have visited a
  8   plant on his or her beat once every five years.  FDA
  9   port inspectors are hard pressed to inspect even
 10   1 percent of imported food.  This situation is
 11   reprehensible and requires immediate action to
 12   correct.
 13             Food and Water Watch believes that there is
 14   need for national enforceable standards to regulate
 15   fresh produce food safety.  Simply issuing guidances
 16   to industry is not going to instill confidence in
 17   consumers that FDA is protecting the food safety.  
 18             FDA inspection personnel need to be able to
 19   act when they find the food safety system failures
 20   before the food enters into commerce.  There are some
 21   in the produce industry who are calling on FDA to
 22   develop enforceable standards.  


00210
  1             There are legislative initiatives in some
  2   states -- for example, we have already heard in
  3   California and in Florida -- to set up a regulatory
  4   framework to govern food safety in the fresh produce
  5   industry.
  6             FDA needs to heed these calls for
  7   regulation, begin the process to develop food safety
  8   standards that can be enforced by the Agency
  9   nationally.
 10             Furthermore, if the Agency does not believe
 11   that it has the authority to set up a regulatory
 12   framework for produce, then it should seek legislative
 13   authority to do so from the U.S. Congress.
 14             Food and Water Watch is also concerned with
 15   the public health consequences of concentrated animal
 16   feeding operations, or “CAFOs.”  There has been a
 17   growing trend in the nation to raise large numbers of
 18   livestock in confined quarters.  
 19             The manure that is produced by the animals
 20   in CAFOs can lead to polluted runoff, carrying
 21   pathogens from these facilities that can impact nearby
 22   produce fields.


00211
  1             I was surprised that there was so much
  2   discussion about water and animal reservoirs of
  3   pathogens and that EPA, the regulatory agency that
  4   regulates some of these operations, was not invited to
  5   participate in this conference.
  6             We are especially concerned with the
  7   ever-growing dairy cow population in the San Joaquin
  8   Valley of California.  There have been reports that an
  9   additional 300,000 heads of cattle will be moving into
 10   that area of California over the next few years.
 11             Over 75 percent of the state’s 1.7 million
 12   head of dairy cows already are raised there.  The
 13   San Joaquin Valley is also a major center of fresh
 14   fruit and produce production in the state whose
 15   products are shipped around the world.  
 16             The EPA regulates CAFOs as part of its
 17   responsibilities under the Clean Water Act.  Just last
 18   year, when it was forced to rewrite those regulations
 19   due to a federal court decision, the EPA had the
 20   opportunity to compel the operators of CAFOs to
 21   install more stringent pollution controls to reduce
 22   the levels of pathogens and discharges from these


00212
  1   farms, but it chose not to do so.
  2             We strongly urge FDA, EPA, state and local
  3   authorities to collaborate to develop reasonable
  4   buffers between livestock farming operations and
  5   produce fields to reduce the possibility of produce
  6   contamination from CAFO pollution, and for strict
  7   enforcement of the Clean Water Act as it applies to
  8   CAFOs.  With that action, there is recipe for major
  9   ecological and food safety disasters in a state that
 10   produces so much of our fresh produce. 
 11             Lastly, we would like to address the calls
 12   by some in industry for the increased use of
 13   irradiation to deal with foodborne pathogens.  Food
 14   and Water Watch opposes the use of food irradiation
 15   because we believe that FDA still has not done enough
 16   of its own research to determine whether the
 17   technology is safe.
 18             In the case of fresh produce, we believe
 19   that the use of irradiation could cause degradation of
 20   the product and raise palatability issues.  We also
 21   view irradiation as a potential “crutch” or “silver
 22   bullet” that could be used by some in industry as a


00213
  1   substitute for good manufacturing and agricultural
  2   practices.
  3             Consumers don’t want to eat poop whether it
  4   is treated or untreated.  We should encourage produce
  5   farmers and processing houses to maintain sanitary
  6   practices without the need for invasive technologies.
  7             Thank you very much.
  8             (Applause.) 
  9             MR. LANDA:  Any questions?
 10             Linda?
 11             (No verbal response.)
 12             MR. LANDA:  Thank you.
 13             We’re going to go a little out of order here
 14   due to some travel schedules, so our next speaker will
 15   be Rayne Thompson from the California Farm Bureau
 16   Federation.
 17             MS. THOMPSON:  Thank you very much.  I would
 18   like to get back to California tonight, so Charles has
 19   given me a pass.
 20             My name is Rayne Thompson with the
 21   California Farm Bureau Federation.  I am the director
 22   of international trade and plant health of the


00214
  1   California Farm Bureau Federation.  We represent
  2   91,500 farmers and ranchers in California that grow
  3   350 different commodities.  Consumers, growers,
  4   retailers, regulators and others are demanding change
  5   in food safety.  
  6             Our main goal is providing consumers with
  7   healthy, California-grown products.  The spinach
  8   incident underscored the importance of handlers and
  9   farmers creating a program that will establish best
 10   management practices and that can be uniformly applied
 11   and verified.  
 12             Through the recently accepted California
 13   Marketing Agreement, we have created this program. 
 14   This program allows USDA or its designee to verify
 15   good agricultural practices.  We believe USDA or its
 16   designee is the best venue because it has both the
 17   experience, oversight, and resources to implement an
 18   effective verification program.  
 19             As Mr. Nassif pointed out before, we have
 20   shown great success in our marketing agreement in
 21   terms of we have 98 percent of the volume of leafy
 22   greens that goes out of the state of California


00215
  1   covered underneath that program.  
  2             These GAPs focus on main areas on the farm:
  3   water, wildlife, soil amendments, and adjacent land
  4   use.  We have based our good agricultural practice
  5   metrics based on current science that leads us to
  6   believe implementing these programs will reduce food
  7   safety risks.
  8             These GAPs give growers indicators on
  9   potential risk areas and they give them mitigation
 10   action that they have to do.  If you want me to go
 11   further on that, I’m willing to with further
 12   questions.  
 13             Basically, they have to document all of
 14   these activities that they have done through water
 15   testing, adjacent land uses and then they are audited
 16   by USDA, which I currently think that they have
 17   designated CDFA to be the auditor in that program.
 18             We are looking at, the California Farm
 19   Bureau itself is looking at developing training
 20   programs that can be applied in the farm for primarily
 21   the farm worker to understand what this means to them
 22   and what practices they have to implement themselves.


00216
  1             One thing that we do have to consider is the
  2   impact this has on small to medium growers around the
  3   country as well as California.  We have to look at
  4   programs that offset the costs for complying with
  5   these food safety programs.  
  6             One of the major benefits with this program
  7   is that we will have more on-farm data available to
  8   us, so we can better define practices down the road. 
  9   One of the main components that was brought up this
 10   morning and that we have found with the spinach
 11   outbreak is that there are so many questions with so
 12   little information.  
 13             Research is obviously a main component.  We
 14   ask both the public, consumers, FDA, and the industry
 15   to invest their funds in further research.  PMA has
 16   done a great job of stepping forward with $2 million.
 17             We see the whole entire continuum.  Farmers
 18   have focused on on-the-farm practices, but we also
 19   realize that we need to be looking at transportation,
 20   processing, and once you get into your kitchens and
 21   homes.
 22             A federal marketing order is an option. 


00217
  1   However, we want you to look at a program that is
  2   specific to the commodity as well as the regional
  3   diversity and risks that are included in that.
  4             Any success of a program should take into
  5   account the commodity food safety risks, the region,
  6   and growing cultural practices and processing
  7   practices.
  8             In regards to how the Food and Drug
  9   Administration plays an important role to all of this,
 10   the Taco Bell incident that occurred underscores the
 11   fact that FDA plays an important role in educating
 12   consumers and providing the public with being a
 13   reliable source for information.
 14             The media frenzy around that incident
 15   quickly jumped to conclusions.  Unfortunately, they
 16   did not hear the message loud and clear from the Food
 17   and Drug Administration.  
 18             I have to at this point commend the
 19   California Department of Health Services.  I was on
 20   several of the calls that they had with the media. 
 21   They specifically explained to the media that these
 22   were just preliminary indications regarding onions,


00218
  1   and that they were still looking at other commodities.
  2             Unfortunately, the media did not pay
  3   attention to that.  We believe that FDA needs to play
  4   a stronger role in stressing to the media the facts
  5   and the information. 
  6             We look forward to working further with you
  7   on this issue.  We look forward to providing consumers
  8   with a healthy product both in California, in the
  9   country, and around the world.
 10             Thank you very much.
 11             (Applause.)
 12             MR. GUZEWICH:  This is Jack Guzewich at FDA. 
 13   Thank you for that presentation.  Since you represent
 14   so many farms in California, I feel it’s appropriate
 15   to ask you the same question I’ve been asking others. 
 16   Do you think the growers in California understand
 17   about agricultural practices?  Do you think they are
 18   implementing them at this time?  
 19             The big question we are facing here is, do
 20   we need more standards or is this just a question of
 21   the standards we already have not being followed? 
 22   That’s the question we’re trying to understand.


00219
  1             MS. THOMPSON:  Right.  You know, we got that
  2   question at the very beginning of the outbreak because
  3   that was the main question is, does everyone
  4   understand the rules.  I think with the marketing
  5   agreement it really enforces the rules.  
  6             I will be honest with you, the marketing
  7   agreement and auditing process does not go into
  8   effect, I think the first audits are going to happen
  9   after April 23.  
 10             Today, I would say unfortunately what we are
 11   seeing from a lot of buyers are different ag
 12   practices.  I think they are focusing on those main
 13   areas, but they are slightly different.  
 14             After the 23d, I think you will see that you
 15   will have more people going by the rules.  I think
 16   they are implementing them.  Is everyone doing the
 17   exact same thing today?  I would say there is some
 18   question as to that.
 19             MR. BACA:  This is Joe Baca with FDA.  You
 20   mentioned the marketing agreement.  What are the
 21   consequences to the growers of not complying with the
 22   market agreement?


00220
  1             MS. THOMPSON:  How the marketing agreement
  2   works is it is actually focused on the handler signing
  3   up and the requirement of being a signatory to the
  4   handler, you can only buy from growers that adhere to
  5   good ag practices, and so they have to be audited to
  6   those good ag practices.  
  7             You cannot buy from a grower that is not
  8   adhering to those.  If they fail to adhere to it, then
  9   buyers will not buy from them as well.  You basically
 10   are out of the supply chain.
 11             MR. BACA:  Thank you.
 12             MR. LANDA:  Any other questions?
 13             MS. LEWIS:  This is Glenda Lewis with FDA. 
 14   Does transportation play a role in the marketing
 15   agreement.  I know you mentioned the suppliers and the
 16   handlers.  Is that aspect also being considered as a
 17   part of that?
 18             MS. THOMPSON:  It is.  What we have done
 19   right now is we have primarily focused, you know,
 20   we’ve had to bite this off in chunks.  You can’t do
 21   everything at once, and we’ve moved rather quickly in
 22   the amount of time that we have.  


00221
  1             The first chunk we bit off was on farm
  2   practices, and the next chunk will be processing and
  3   transportation.  That is why we really encourage FDA
  4   to play a strong role in reminding those industries
  5   that they also play an important part of this.  Just
  6   because you’ve handled one does not mean that you’ve
  7   handled all.  We do need  your help in reminding them
  8   that they also play an important role in this.
  9             MR. LANDA:  Anyone else?
 10             (No verbal response.)
 11             MR. LANDA:  Thank you.
 12             MS. THOMPSON:  Thank you.
 13             MR. LANDA:  It is now just a little after
 14   3:00.  We would like to take a short break and
 15   reconvene at 3:15, please. 
 16             Thank you.
 17             (Recess taken.)
 18             MR. LANDA:  Would everyone take their seats,
 19   please.  Our next speaker is G. Michael McCartney of
 20   QLM Consulting.
 21             (No verbal response.)
 22             MR. LANDA:  I stand corrected.  Our next


00222
  1   speaker is Alfred Murray from the New Jersey
  2   Department of Agriculture.
  3             (No verbal response.)
  4             MR. LANDA:  In the interest of moving things
  5   along, we will try to catch up with other people,
  6   assuming they are still here, but our next speaker is
  7   going to be Joe Rajkovacz, Owner-Operator Independent
  8   Drivers Association, Inc.
  9             MR. RAJKOVACZ:  Good afternoon.  My name is
 10   Joe Rajkovacz, regulatory affairs specialist for the
 11   Owner-Operator Independent Drivers Association. 
 12   Additionally, until a year ago, I spent over two
 13   decades hauling produce out of California back into
 14   Wisconsin and Minnesota.
 15             The association appreciates the opportunity
 16   to speak about conditions within the fresh produce
 17   industry that directly affect the safety of the
 18   products shipped for human consumption.
 19             Our more than 151,000 members operate over
 20   240,000 trucks nationwide.  An integral part to the
 21   supply chain is transportation.  Small business
 22   truckers and their drives are the overwhelmingly


00223
  1   dominant providers of fresh produce transportation.
  2             Focusing fresh produce safety narrowly on
  3   E. coli contamination clearly misses other significant
  4   entry points of foodborne pathogens that intuitively
  5   are implicated in fresh produce safety. 
  6             The agricultural industry attempt to thwart
  7   significant regulatory oversight through voluntary
  8   best practice guidelines related to food safety should
  9   be viewed with skepticism.  
 10             Best practices have been well known for many
 11   years, but economic considerations have trumped
 12   meaningful implementation.  An exposé carried by
 13   Dateline NBC on March 25 exposed poor conditions at a
 14   wholesale produce market in Los Angeles.  It was not
 15   shocking to most produce truckers.  We have been
 16   forced to live with filthy conditions like that for
 17   decades.  
 18             OOIDA had described similar conditions in
 19   our comments opposing an industry-push marketing
 20   agreement with the California Department of Food and
 21   Agriculture.  We are not fans of the marketing
 22   agreement, along with some others, primarily because


00224
  1   of its lack of inclusion in it and lack of
  2   transparency.
  3             Unsanitary and unsafe practices related to
  4   handling and shipping fresh produce is not limited to
  5   California.  It is a nationwide problem.  Significant
  6   numbers of shipping and receiving facilities around
  7   the country could have just as easily have been
  8   highlighted by reporters and hidden cameras.  
  9             The lack of sanitary bathroom facilities and
 10   hygienic conditions in which to work is all too common
 11   in the fresh produce industry.  Produce truckers are
 12   exposed regularly to bathrooms lacking running water,
 13   soap, and towels.  
 14             Portable toilet facilities that are only
 15   given scant attention are common.  These are often so
 16   filthy we drivers prefer to stand beside trucks and
 17   relieve ourselves.
 18             Even when modern, clean facilities are
 19   available, we will be denied their use because of
 20   deeply seated animosity against drivers.  Many
 21   shippers and receivers within the fresh produce
 22   industry exhibit a callous disregard for cleanliness


00225
  1   and sanitation procedures.
  2             The idea of maintaining a clean and sterile
  3   environment to minimize microbial contamination is
  4   given short shrift when compared to economic
  5   considerations.  
  6             Since much fresh produce is intended to be
  7   eaten in its raw form, minimizing human handling
  8   should be an obvious strategy to minimize potential
  9   microbial contamination associated with too much human
 10   contact.
 11             A common practice within the produce
 12   industry that is counterintuitive to minimizing
 13   excessive human contact places the truck driver as
 14   responsible for manually unloading and literally
 15   touching every box of produce coming off a trailer.
 16             We call it “fingerprinting a load.”  If the
 17   driver doesn’t do it, he hires a surrogate that we
 18   call a “lumper.”   This practice is purely economic in
 19   origin, that transfers warehouse labor costs to the
 20   trucker and compromises food safety.
 21             The use of recycled pallets wet or stained
 22   with animal blood, residue of previous chemical


00226
  1   shipments, and bug infestations is common.  Also,
  2   loading of clearly unsanitary trailers, improper
  3   loading of refrigerated trailers in violation of
  4   manufacturer specifications happens frequently.
  5             Last years outbreak of E. coli in spinach
  6   and the subsequent voluntary recall left many small
  7   business produce truckers with the financial
  8   responsibility to find dumping facilities for rejected
  9   product.
 10             It is a common industry practice to evade
 11   financial responsibility by leaving truckers holding
 12   the bag when dealing with recalled or rejected
 13   product.  We are their dumping ground.
 14             The lack of any mandatory assigned
 15   responsibility by the FDA during a recall indirectly
 16   allows rejected rotted, contaminated produce to enter
 17   the food supply chain.
 18             Produce truckers financial losses are under
 19   economic pressure to find the quickest dumping
 20   solution.  Dumping product at the back of a truck stop
 21   or along a highway is common.  Produce truckers have
 22   found that giving produce away to the general public


00227
  1   is an effective method to extricate ourselves from
  2   this Pandora’s box.  In a post-911 world, this is a
  3   recipe for disaster that will never contain any
  4   inadvertent or purposeful contamination of fresh
  5   produce.
  6             The produce industry has exhibited a
  7   historical lack of responsibility when dealing with
  8   the men and women charged with safely and efficiently 
  9   hauling America’s fresh produce.  It is hard to
 10   imagine a solution to fresh produce safety without
 11   intervention at the highest level of government.
 12             Thank you.
 13             (Applause.) 
 14             MR. GUZEWICH:  Thank you for that
 15   presentation.  This is Jack Guzewich with FDA.  I have
 16   one question.  We hear, not infrequently, anecdotal
 17   reports that truckers leave the West Coast and for
 18   economic reasons turn off the refrigeration unit on a
 19   truck until an hour or a half a day before they arrive
 20   at the destination and then they turn it back on.  Can
 21   you comment on that allegation?
 22             MR. RAJKOVACZ:  Yeah.  I read that in the


00228
  1   “San José Mercury News” this past year, and it was an
  2   individual from the California industry that said
  3   that.  It is an outrageous statement.  
  4             I am the one who is financially responsible
  5   for any claims related to that load based on
  6   temperature.  They put temperature recorders in these
  7   loads, and if that equipment is not maintained at the
  8   right temperature, that load is going to get kicked.
  9   I’m going to be the one that pays the claim.
 10             MR. ZINK:  Don Zink with FDA.  In my time in
 11   industry, I think I see much of what you were talking
 12   about.  I don’t have a feel for how prevalent it is,
 13   but I am familiar with loads that got left by the side
 14   of the road, and these things.  
 15             You say you’re often left holding the bag
 16   with recalled product.  Could you describe a scenario
 17   whereby a trucker, essentially, gets stuck with no
 18   place to go with a load of rejected product?
 19             MR. RAJKOVACZ:  One of the reasons that this
 20   happens is because the trucker -- in fresh produce it
 21   is almost always the buyer who pays the freight.  The
 22   trucker has a contractual relationship with the buyer


00229
  1   of the produce.  
  2             In the case of last fall, when the spinach
  3   was recalled, the buyers put the stuff back on our
  4   members’ trucks.  They have no contractual
  5   relationship with the shipper, so they ended up
  6   holding the bag, unless they of course got a lawyer
  7   and sued the shipper for reimbursement for the cost.
  8             MR. ZINK:  You show up at a destination with
  9   a load, and nobody will let you unload it?
 10             MR. RAJKOVACZ:  In the case of one of our
 11   members, he was not allowed to unload an entire load
 12   of spinach.  He had to haul it from Atlanta to
 13   Memphis.  We highlighted in our magazine, “Land Line.”
 14             That was the first place he could find a
 15   dump that would take it, and he had to manually unload
 16   the entire trailer into the dump.  All he was
 17   reimbursed was $200 for the dump tipping fee and none
 18   of his costs associated with transporting it from
 19   Atlanta to Memphis.
 20             MS. LEWIS:  This is Glenda Lewis, FDA.  What
 21   mechanisms do you have for maintaining the temperature
 22   control?  How is that handled on the trucks?


00230
  1             MR. RAJKOVACZ:  If I’m hearing you
  2   correctly, you are wondering how the temperature is
  3   maintained in transit?
  4             MS. LEWIS:  Yes.  What mechanisms are you
  5   currently using to assure that?
  6             MR. RAJKOVACZ:  Well, reefer units,
  7   obviously you turn it on and you set the temperature. 
  8   Many receivers, the buyers of freight, will demand to
  9   have temperature recorders placed on the freight that
 10   monitors in-transit temperature.
 11             Additionally, many new refrigeration units
 12   have built into them temperature recording equipment
 13   that, quite frankly, we truckers use as insurance
 14   against receivers who didn’t require a temperature
 15   recorder being placed on the load.
 16             In all the years that I hauled produce out
 17   of California, I would ask for a temperature recorder. 
 18   But if the buyer hadn’t requested it, I was refused it
 19   to be put on because it cost 25 bucks.
 20             MR. LANDA:  Thank you very much.
 21             MR. RAJKOVACZ:  You bet.
 22             MR. LANDA:  Our next speaker is


00231
  1   G. Michael McCartney, QLM Consulting.
  2             (No verbal response.)
  3             MR. LANDA:  Then, I guess our next speaker
  4   is Alfred Murray, New Jersey Department of
  5   Agriculture.
  6             MR. MURRAY:  Good afternoon everybody.  My
  7   name is Al Murray.  I serve as the assistant secretary
  8   of agriculture for the New Jersey Department of
  9   Agriculture.  
 10             I am here on behalf of Secretary Charles
 11   Kuperas as well as members of the New Jersey
 12   agricultural industry.  We are here to present New
 13   Jersey’s views on your important mission, to help
 14   enhance the safety of our nation’s food supply.
 15             Last September, New Jersey’s farmers,
 16   particularly our spinach farmers, faced a crisis.  As
 17   the fall harvest approached, the Food and Drug
 18   Administration advised consumers should not eat fresh
 19   or bagged spinach or mixed salad greens containing
 20   fresh spinach due to contamination by the deadly
 21   E. coli.  We all know that.
 22             Timing couldn’t have been worse for our


00232
  1   farmers.  The final irony for New Jersey came with the
  2   subsequent announcement that the contamination was
  3   limited to an area 3,000 miles away on the West Coast.
  4             This interconnectedness of the produce
  5   industry is primarily the reason why efforts to
  6   improve the safety of produce growing, shipping,
  7   processing, retailing must be uniform, appropriate,
  8   and attainable across the nation.
  9             Our produce growers, shippers, processors,
 10   and retailers must act in a unified, standardized way
 11   to ensure consumer confidence and to prevent fresh
 12   produce, which we all consider a part of the healthy
 13   diet, from being avoided by our nation’s consumers.
 14             Fruits and vegetables in New Jersey account
 15   for $262 million of our farm gate receipts annually. 
 16   Nationally, New Jersey ranks second in the production
 17   of blueberries, third in the production of peaches,
 18   and we are among the top ten states in the production
 19   of bell peppers, cucumbers, head lettuce, sweet corn,
 20   and spinach.  Clearly, we have a large stake in this
 21   issue.
 22             The cornerstone we believe in improving


00233
  1   produce safety is, in our view, third-party audits for
  2   the growers.  The three key tenets of this effort must
  3   be using the USDA third-party audit protocols,
  4   ensuring the cost of passing the audits does not
  5   exceed the farmer’s reach, and providing enough time
  6   to implement the standards.
  7             We suggest that the FDA and the USDA work
  8   together to devise a system that recognizes the
  9   differences in farm operation sizes, the unique
 10   qualities and methods for growing and harvesting
 11   fruits and vegetables, and differences in irrigation
 12   techniques.
 13             Although audits will differ based on these
 14   variations, the goals of these audits should remain
 15   the same.  A one-size-fits-all approach we think would
 16   be misguided, but a one-goal-fits-all is central for
 17   an effective auditing system.
 18             New Jersey’s recently formed Produce Safety
 19   Task Force has learned that growers and brokers are
 20   frustrated when produce buyers insist upon third-party
 21   audits performed by a private company specified by the
 22   buyer which adds an additional cost burden to our


00234
  1   growers.  
  2             With a national produce safety standard
  3   devised jointly among the FDA and the USDA and
  4   administered by the USDA, state departments of
  5   agriculture could work with our land-grant
  6   institutions to ensure that all growers seeking
  7   third-party auditing could afford an audit acceptable
  8   to buyers. 
  9             The third key element is ensuring that all
 10   producers have enough time to meet the requirements of
 11   third-party audit certification.  Infrastructural
 12   improvements, operational changes, employee training,
 13   and recordkeeping updates won’t be accomplished by all
 14   sizes of operations in the same amount of time.
 15             We believe national standards and
 16   third-party auditing cannot accomplish the goals of 
 17   uniform food safety unless the first level of
 18   production, farmers, buy into the program.
 19             New Jersey has mobilized quickly in this
 20   effort.  To date, our Department of Agriculture along
 21   with Rutgers University has trained more than 700
 22   farmers in food safety preparing them to go further in


00235
  1   the auditing process.  
  2             Also, not all produce commodities require
  3   the same safety measures.  Our Produce Safety Task
  4   Force recommends variations in the audits divided into
  5   three classes: tree and small fruit crops, on-ground
  6   crops, and underground crops.  Implementation should
  7   have three components: education, cost-share
  8   assistance, and research.  
  9             In education, any effective program must
 10   include a strong educational component.  This should
 11   and could include information on how farmers can work
 12   together to accomplish food safety goals.  
 13             It should include food safety training for
 14   farm employees and managers, education on implementing
 15   the auditing process, and instruction in maintaining
 16   clear and understandable production records.
 17             Cost-share assistance, we respectfully
 18   request that the Federal Government provide cost-share
 19   assistance to farmers whose financial position may
 20   stand in the way of achieving timely third-party audit
 21   certification.  This will facilitate wider food safety
 22   coverage throughout the system.


00236
  1             The need for research, as food safety
  2   technology advances, research is needed to enhance
  3   audit protocols and standards.  Any effective program
  4   must have research components that include the
  5   following: water quality and testing should be
  6   consistent and should be cost effective.
  7             Produce sampling in the field must employ
  8   uniform and attainable methods.  Traceback records,
  9   which I think everybody has been talking about today,
 10   they have got to be clear and understandable.
 11             In conclusion, you are faced with a great
 12   challenge to move the food safety of our economy to
 13   greater heights without negatively impacting the farm
 14   families and the small businesses who grow, ship,
 15   process, and sell this food.
 16             We believe that you must embrace the USDA
 17   standards with variations of protocols for different
 18   classes of produce, allow adequate time to implement
 19   these safeguards, and provide cost sharing and
 20   research to help the participants in the market chain
 21   obtain these goals.
 22             The job ahead is daunting, but we believe it


00237
  1   can be accomplished with the help of the FDA, USDA,
  2   state departments of agriculture, land-grant
  3   universities, and all those in the fresh produce
  4   marketing chain.  We enthusiastically offer the help
  5   of the New Jersey Produce Safety Task Force in your
  6   efforts.
  7             We believe that working together nationally
  8   as we have begun to do so in New Jersey along with all
  9   the appropriate agencies and segments of the market
 10   chain we can achieve produce safety standards to meet
 11   the high expectations of our nation’s consumers.
 12             Thank you.
 13             (Applause.)
 14             MR. GUZEWICH:  This is Jack Guzewich with
 15   FDA.  Thank you for that presentation.  Just one
 16   question.  On these third-party auditors, we’ve heard
 17   this question today earlier as well, how do we assure
 18   uniformity among these auditors so that it applies
 19   equally across areas?
 20             MR. MURRAY:  That’s something that we are
 21   calling for.  We would hope that all third-party
 22   auditors, whether they are private companies, whether


00238
  1   they be USDA certified, which in New Jersey our state
  2   employees that are inspectors that are part of the
  3   third-party auditing they are certified under the
  4   USDA.  They would all be uniform.  The standard of a
  5   farm passing would be at a rate that would be uniform
  6   across the board.
  7             MR. GUZEWICH:  How do we get there?
  8             MR. MURRAY:  That is what we are hoping you
  9   guys can show us.
 10             (General laughter.) 
 11             DR. SOLOMON:  This is Steve Solomon.  
 12             You are talking about the need for cost
 13   sharing.  Do you have some estimates what the costs
 14   are for third-party audits?
 15             MR. MURRAY:  That depends also, if a buyer
 16   requires a farmer to use a private company, we have
 17   heard estimates of $1,500 or $1,600.  Again,
 18   New Jersey’s farms are a lot smaller than a lot of
 19   people that are dealing.  A USDA audit provided by our
 20   inspectors can cost a farmer about $500 or so, so
 21   there is this cost savings if they go with the
 22   USDA-certified audit.  


00239
  1             The problem is a lot of buyers don’t request
  2   that.  They request an audit from a private company. 
  3   We feel that that’s unfair to the farmers who don’t
  4   have a say in who they can choose for this audit.
  5             That, again, is why we are calling for a
  6   standardized, across-the-board “This is the protocol
  7   you need to follow.”  Regardless of who does the
  8   audit, that’s the one they would have to meet.
  9             MS. LEWIS:  This is Glenda Lewis with FDA.
 10   In a world where money is not an issue and neither
 11   staff resources, you mentioned the USDA third-party
 12   audit system that is in place, is there any opposition
 13   to FDA doing the audit system, if we had the resources
 14   to do that?  Why did you specifically pick the USDA
 15   audit or another third party?
 16             MR. MURRAY:  Well, the USDA has the
 17   established program.  As a source of pride on
 18   New Jersey, we were the first state to actually be
 19   certified for our state inspectors to be under the
 20   USDA Program.  I don’t think the FDA has a
 21   certification program.
 22             MS. LEWIS:  We do not.  I just wanted to


00240
  1   clarify why specifically that one or any third party.
  2             MR. MURRAY:  I don’t think it would matter
  3   to New Jersey who does it.  I know that our produce
  4   inspectors are cross-trained to be third-party audit
  5   certified.  The fact that there are eyes and ears on
  6   the ground, particularly on the farms and processing
  7   and throughout the marketing chain in New Jersey, it
  8   makes for a good fit.
  9             MR. LANDA:  Thank you.
 10             Our next speaker is Greg, forgive this
 11   pronunciation, Drouillard  (pronouncing “dru-yard”),
 12   from Sunkist Growers.
 13             (PowerPoint presentation is in progress.) 
 14             MR. DROUILLARD:  Good afternoon.  My name is
 15   Greg Drouillard (pronouncing “dru-lard”).  I am the
 16   director of laser technologies at Sunkist Growers, and
 17   I want to discuss natural-light labeling, which
 18   happens to be a solution for this traceback problem
 19   that we are having right at the moment.  
 20             There is an inconsistency between where it
 21   comes out of the field and where it gets into the
 22   carton and from the carton, comingling.  We have a


00241
  1   solution to this problem.  In particular, it has
  2   positive implications for food safety and also the
  3   Bioterrorism Act.
  4             Essentially, the natural-light labeling
  5   system concentrates a beam of light which is precisely
  6   controlled to remove the pigment from the epidural
  7   layer of your produce.  It does not penetrate.  It
  8   only removes and is only accurate to the pigment.  
  9   That contrast is what you see as a label. 
 10   Essentially, sunlight grows your produce.  We use
 11   light to make the label, so it’s a non-contact system. 
 12             The premise behind the development of a
 13   natural-light labeling system was to provide the food
 14   industry and the consumer with an alternative to
 15   adhesive labels for food labeling.  Of the many
 16   advantages that the NLL system has offer, the most
 17   significant is in the area of enhanced food safety
 18   through traceability.
 19             The five most important elements of an
 20   effective traceability system are individual product
 21   identification certification.  It’s permanent; it’s
 22   nontransferable.  For example, nontransferable in


00242
  1   regards to a label in through a packing line, when it
  2   gets labeled, that label can transfer to another
  3   product throughout the system, somewhere in the
  4   system, or it can come off altogether and a label of
  5   some nonconsequence could get on a piece of product
  6   and you could identify it incorrectly.
  7             Another is a unique identification.  You
  8   would produce that unique traceability code, that
  9   right now is being implemented from the grower level
 10   and the carton level, you can transfer this code all
 11   the way through.  
 12             The system is capable of also storing this
 13   information for recordkeeping, so you can have
 14   instantaneous tracking.  If you have a problem, you
 15   can quickly get onto the system via the Internet or
 16   through any electronic measures and find out where
 17   that piece of product came from.  
 18             Even if that product was separated from the
 19   original carton it came from, it’s easy enough to
 20   actually put in the identifier and find out where it
 21   came from, so it’s not a problem if it’s not with the
 22   original carton it came with.


00243
  1             The next is tamper-proof.  “Tamper-proof”
  2   essentially means that in order to change this product
  3   or change the identifier you would have to damage the
  4   product in the first place.  The tamper-proof method
  5   is essentially damaging your product, if you try to
  6   remove the code to hide what you’re trying to do.
  7             The natural-light labeling system uses no
  8   consumables such as glue, plastic, paper, or ink to
  9   create the label.  The natural labeling system uses
 10   light to label the produce.  
 11             This system can print virtually anything,
 12   product and variety certification, organic or
 13   inorganic, PLU numbers, country of origin, and
 14   traceability information.  
 15             With respect to country of origin labeling,
 16   essentially the packer has to inventory all these
 17   labels.  If he brings in produce from the outside,
 18   from another country, he has to have labels with that
 19   country’s origin.  
 20             In fact, it is not a regulation at this
 21   time, but it was a cost, a significant cost, which may
 22   cause delay of the Food Labeling Act for


00244
  1   country-of-origin labeling.
  2             This method you can instantaneously change
  3   what country it came from.  If you had a lot, for
  4   example, a load of product that came from a different
  5   country, then typically you would have to wait until
  6   you get many loads to do this.  
  7             You could easily run that load as it came in
  8   and then switch right back to a domestic load.  It is
  9   not a problem with this system.  You could do so
 10   without having to deal with volume storing or peeling
 11   or maintaining or cleaning adhesive labels ever again.
 12             A “PLU code,” most of you are probably aware
 13   of a PLU code.  It’s the “price lookup code.”  It’s
 14   the typical information that the retailer uses to
 15   identify that piece of product.  That piece of product
 16   can be by weight or by quantity.  
 17             It’s just a matter of what that code means
 18   when they assign it at the retail level, even though
 19   it has been assigned already, what the product
 20   identification is.
 21             In particular, when we speak about
 22   “inorganic” and “organic” produce, you have an


00245
  1   appended “eight” or “genetic,” and I didn’t mention
  2   this, “genetically engineered.”  You can actually do
  3   that immediately without having to order more labels. 
  4   Also, the “nine” means “organically grown.”
  5             This is an example of a plum with the
  6   natural-light labeling label on it.  Features of it:
  7   it eliminates the high-cost associated with adhesive
  8   labels.  It eliminates consumer complaints of adhesive
  9   labels.  There is no waste byproducts.  
 10             Very little energy consumption, it is a very
 11   low-energy system.  It is a green product favorable to
 12   the environment because there is no consumable.  There
 13   is no waste product either, no tape or anything of
 14   that nature.  Traceability we mentioned; and no
 15   consumables to label the produce, again.
 16             We mentioned operational maintenance cost. 
 17   Typically, it costs manhours to maintain the labeling
 18   system, to change out the cartridges, and so on, and
 19   clean the equipment afterwards.  
 20             You don’t have this with this system.  This
 21   system has been designed to last 10 years without any
 22   significant overhaul.  If, for example, its 10-year


00246
  1   lifespan has ended, it is easy to maintain and to
  2   upgrade it for a very insignificant amount of money.
  3             Your cost of ownership has gone down
  4   immensely.  You have no overhead associated
  5   significantly with the system, other than the cost of
  6   the machine when you purchase it or lease it at the
  7   beginning.
  8             You also only require one head per lane.  I
  9   won’t go into great detail with that.  Essentially, it
 10   can coat on the fly.  If you had 10 different pieces
 11   of product and 10 different PLU numbers running at
 12   10 a second, it will label those all individually.
 13             Again, packers don’t have to deal with
 14   inventory overhead.  It does not affect shelf life. 
 15   It is capable of marking produce that previously
 16   adhesive labels couldn’t such as cucumbers, for
 17   example, potatoes, individual potatoes, if required.
 18             It can also, of course, date and time stamp
 19   the product lot code, batch code.  You can put
 20   virtually anything you would like on a piece of
 21   produce.
 22             I’m running out of time, so I’m going to


00247
  1   pass this.  Again, the advantages are traceability and
  2   also it prevents counterfeiting.  As Sunkist is aware
  3   and everybody is aware, there is significant
  4   counterfeiting that can take place outside the U.S. 
  5   This inhibits that because you have an identification
  6   code.  You can put that on there, that you can certify
  7   that that’s your product, and it hasn’t been changed.
  8             At this time we also have 56 countries from
  9   around the world accepting this technology, but also
 10   they import into the U.S.  At this time we also have a
 11   food additive petition that is presently in the FDA in
 12   which we are putting through -- well, we are waiting
 13   for acceptance so we can go ahead with this product.
 14             Again, here is another example of
 15   natural-light labeling.  This has the date.  Here is a
 16   green pepper.  The last was a tomato.  There is an
 17   onion, onion skins, and a cucumber, an avocado, an
 18   apple, and that’s it.
 19             Thank you.
 20             (Applause.) 
 21             MR. LANDA:  Don Zink with Food and Drug. 
 22   Two questions, you call this “natural light.”  What


00248
  1   exactly do you mean by “natural light”?  Is this very
  2   intense-focused white light?  Is it a laser light,
  3   et cetera?
  4             My second question is, what do you think the
  5   typical first-year cost would be for a packing house
  6   to implement this, say, a tomato packing house to
  7   implement this?
  8             MR. DROUILLARD:  Okay.  To address the first
  9   question, natural light, essentially the light that we
 10   use, which is a concentrated beam of light, it has a
 11   specific wavelength, only one wavelength.  It is
 12   10.6 micrometers.  That is an infrared labeling.
 13             Daily we are absorbing infrared.  In fact,
 14   we are absorbing it in this room right now from the
 15   light.  The infrared light that you are receiving now
 16   ranges anywhere from near- to far-infrared.  
 17             Essentially, it is what we deal with every
 18   day.  In this particular instance, we are using very,
 19   very low energy on the order of .675 watts of energy
 20   in order to produce this label.
 21             To address the cost, the cost issue,
 22   typically we talk about the return on your investment. 


00249
  1   It’s hard to nail that down, but I will try to give
  2   you an idea.  
  3             A typical packing house that has eight lanes
  4   of product and they may have one to three banks of
  5   labels will go through about $200,000 to $300,000
  6   worth of labels a year, not including the inventory
  7   carryover that they have to maintain.  They have to
  8   maintain that in a specified room at a temperature so
  9   the labels don’t lose their ability to adhere.  
 10             The other problem that they have is
 11   maintaining them.  You have to have someone always
 12   watching over the reels and clogging and such and then
 13   the cleanup afterwards.
 14             Trying to explain this, if you have this
 15   particular house, the return on the investment and the
 16   dollars that we have seen in that one example, they
 17   would see an immediate return somewhere in the order
 18   of $100,000 to $280,000, a return of not a loss but of
 19   a gain by going to this system. 
 20             If you had a smaller system, which would be
 21   a four-lane system, it could take anywhere up to two
 22   years to reclaim the cost.  But as we are preparing


00250
  1   the system, you can lease the system, which you can
  2   realize a return immediately.
  3             MR. ZINK:  But if you had a house that
  4   wasn’t labeling--?
  5             MR. DROUILLARD:  Sorry?
  6             MR. ZINK:  If you had a house that really
  7   wasn’t applying any kind of labeling at all--?
  8             MR. DROUILLARD:  If you were not applying
  9   labeling?
 10             MR. ZINK:  If you weren’t applying any kind
 11   of labeling at all and you wanted to purchase this
 12   system and put it in there, what would that cost?
 13             MR. DROUILLARD:  Well, if you were to lease
 14   the system, it’s going to range, and I’d hate to be
 15   quoted on it because we haven’t established -- well,
 16   we have established somewhat of a cost control on this
 17   -- it would be around $1,500 per lane, per head, per
 18   month, okay.
 19             MR. LANDA:  Thank you.
 20             Our next speaker is Charles Hall with the
 21   Georgia Fruit and Vegetable Growers Association.
 22             MR. HALL:  Thank you for the opportunity to


00251
  1   be here.  My name is Charles Hall.  I am executive
  2   director of the Georgia Fruit and Vegetable Growers
  3   Association.  
  4             Our association represents more than
  5   300 fruit and vegetable growers in Georgia and the
  6   Southeastern U.S.  Fruit and vegetable production in
  7   Georgia provides economic value to the state of more
  8   than $950 million at the farm gate.  
  9             In light of the recent foodborne illness
 10   outbreaks, food safety is at the forefront of our
 11   industry as we work to reinsure confidence in
 12   America’s food supply, particularly our fruits and
 13   vegetables.
 14             Our goal must continue to remain constant as
 15   we strive to reduce incidences of foodborne illnesses
 16   within the industry.  Food safety education has always
 17   maintained an important position in our association’s
 18   program of work.  
 19             In January 2002, our association was awarded
 20   a grant from the Georgia Department of Agriculture to
 21   develop and audit inspection procedure for our
 22   growers.  


00252
  1             This was started primarily because of
  2   third-party audits and the high cost to the growers
  3   for the third-party audits.  This was done in
  4   conjunction with the University of Georgia, the
  5   Georgia Department of Agriculture, and the Georgia
  6   Crop Improvement Association.
  7             The Georgia GAP Food Safety Program provides
  8   hands-on training and consultation to implement GAPs
  9   and standard operating procedures for on-farm food
 10   safety.  This training and consultation is followed by
 11   an inspection by a certified third-party auditor from
 12   the Georgia Crop Improvement Association.
 13             The scientific basis that the Georgia GAP
 14   Program has developed using the Food and Drug
 15   Administration’s “Guide to Minimize Microbial Food and
 16   Safety Hazards for Fresh Fruits and Vegetables”
 17   published in October 1998, the program focuses on
 18   eight areas in the growing and handling of produce to
 19   minimize and eliminate food safety risk.
 20             Although this is a voluntary program for
 21   Georgia growers, our goal is to reduce farm risk and
 22   ensure consumer confidence in Georgia produce.  As


00253
  1   several other industry associations have stated today,
  2   we believe there is a critical need here in our nation
  3   to develop basic principles that will develop and
  4   improve the confidence in a secure and safe food
  5   supply.
  6             These principles provide a basis for which
  7   the produce industry and the U.S. Government can
  8   develop a food safety policy framework.  The
  9   principles include, first, food safety standards must
 10   be consistent for produce grown anywhere in the
 11   United States or imported into this country.
 12             Consumers must have the confidence that
 13   produce grown in New York is just as safe as produce
 14   grown in Georgia.
 15             The same science-based standards that are in
 16   place with the Georgia GAP Program must be applied
 17   across the industry, if we are to be successful in
 18   maintaining consumer confidence.
 19             Secondly, to achieve consistent safety
 20   standards across the industry will require these
 21   standards to be mandatory with Federal Government
 22   oversight.


00254
  1             We believe that food safety standards must
  2   be based on sound science.  FDA, as the public health
  3   agency charged by law with ensuring the safety of the
  4   nation’s food supply including fruits and vegetables,
  5   should determine those safety standards in an open and
  6   transparent process with input from industry, the
  7   scientific community, academic researchers, consumers,
  8   and growers.
  9             Standards developed should allow for a
 10   commodity-specific food safety regulatory based on the 
 11   best available science.  Food safety regulations must
 12   have scientific flexibility to address the needs of
 13   different commodities in different geographic regions.
 14             I was very pleased to hear one of the
 15   speakers today say a one-size-does-not-fit-all
 16   approach is best way, because it is.  We cannot have a
 17   one-size-fits-all approach because it will not address
 18   the individual specific needs of different commodities
 19   within their own production and handling practices.
 20             Our association believes these three
 21   principles are very important as we try to reestablish
 22   the confidence, the American consumers’ confidence and


00255
  1   restoring their public trust in our fruit and
  2   vegetable industry.
  3             While a science-based, commodity-specific
  4   food safety regulatory policy is our most immediate
  5   need in our industry, we must not overlook the need
  6   for additional research to address many of the issues
  7   we face today.
  8             Many of the speakers have addressed this,
  9   but as an industry: we need a better understanding of
 10   ways to reduce E. coli in cattle, better ways to
 11   prevent contamination in the field, more effective
 12   risk reduction techniques after harvest and in the
 13   packing areas.
 14             The Georgia Fruit and Vegetable Growers
 15   Association strongly supports and will work with our
 16   congressional delegation to seek increased funding for
 17   food safety research.
 18             In addition, we will support and work
 19   diligently to seek increased research funding for
 20   specialty crops including our food safety needs in the
 21   2007 farm bill debate.
 22             In closing, I thank you for the opportunity


00256
  1   to present our views on this very important topic.  It
  2   is our association’s goal that we as an industry work
  3   together with government to ensure that American
  4   consumers have no fear of illness as they enjoy
  5   nutritious and healthy fruits and vegetables.
  6             Thank you.
  7             (Applause.)
  8             MR. GUZEWICH:  This is Jack Guzewich with
  9   FDA.  I think by now you know what my question is
 10   going to be.
 11             MR. HALL:  Yes, sir.
 12             (General laughter.) 
 13             MR. GUZEWICH:  I’ll ask it again, just in
 14   case.  Do you think Georgia growers understand the
 15   GAPs and are implementing them?
 16             MR. HALL:  I think, based on what growers
 17   you’re talking about, sir, within our blueberry
 18   industry we probably have 80 to 85 percent of our
 19   growers that are GAP certified and they are very, very
 20   prevalent and knowledgeable of that, the peach
 21   industry the same way.  
 22             When you move into the vegetable industry,


00257
  1   you go from a very small grower to a very large
  2   grower, so it varies from that.  I think most of our
  3   growers are much more knowledgeable than they were six
  4   months ago or certainly two years ago.  
  5             Most of what we have found, as we have
  6   worked with food safety and with our Georgia GAP
  7   Program, this is driven by what is demanded of the
  8   grower.  That’s why we feel like a mandatory program
  9   is necessary.  
 10             Most of the food safety issues and most of
 11   our GAP Program was initiated because our customers
 12   were saying, “You have to have a third-party audit.” 
 13   Without the customer saying you had to have a
 14   third-party audit, most of our growers wouldn’t have
 15   gone to that.  
 16             The larger ones would have, but the smaller
 17   ones would not have gotten to that point.  It has to
 18   be driven.  We don’t like to pay taxes.  We wouldn’t
 19   pay taxes if we didn’t have to.  A grower is not going
 20   to go through the process of being audited, if they
 21   don’t have to.
 22             MR. GUZEWICH:  Thank you.


00258
  1             MR. BACA:  I have a question.  This is
  2   Joe Baca with FDA.
  3             MR. HALL:  Yes, sir?
  4             MR. BACA:  I guess my question is a very
  5   basic one.  When these audits are conducted, is there
  6   any testing that is done?  I know that observations
  7   are made, but are there any samples taken?
  8             MR. HALL:  There are water samples taken. 
  9   It’s taken by the auditor or either our staff member
 10   that has worked with that grower.  We are basically
 11   providing a consulting and training operation, and
 12   then the Georgia Crop Improvement Association who also
 13   certifies seed in Georgia, the organic program in
 14   Georgia.  That’s why it has worked because they have
 15   the auditing background from that standpoint.
 16             MR. LANDA:  Our next speaker is Sally
 17   Greenberg with Consumers Union.
 18             MS. GREENBERG:  Good afternoon.  My name is
 19   Sally Greenberg.  I am senior counsel in the
 20   Washington Office of Consumers Union.  We are the
 21   nonprofit publisher of “Consumer Reports” magazine,
 22   with 4 million subscribers and “Consumer Reports


00259
  1   Online” with more than 2.5 million online subscribers.
  2             I appreciate today’s opportunity to
  3   participate in this public conversation with the FDA
  4   about the safety of fresh produce.  I must say I’m
  5   learning a lot from my fellow speakers.
  6             I am here today to bring you another
  7   consumer perspective.  You have heard from some of my
  8   consumer colleagues.  What we want to say from the
  9   Consumers Union and “Consumer Reports” perspective is
 10   that in the last 5 months along more than 200 unlucky
 11   consumers across 26 states ate spinach contaminated by
 12   a particularly virulent form or E. coli that killed as
 13   many as five and hospitalized more than 100 and
 14   sickened another 100.  
 15             This spinach disaster was quickly followed
 16   by a salmonella outbreak from contaminated tomatoes
 17   served at a restaurant which sickened 183 people in
 18   21 states.
 19             On the heels of this, came yet another
 20   E. coli outbreak from shredded lettuce at Taco Bell
 21   and Taco John’s restaurants that sickened another
 22   152 individuals.


00260
  1             Consumers are understandably confused and
  2   they are angry.  They are angry that eating leafy
  3   green vegetables and other produce can make them sick
  4   and can even kill them.
  5             Consumers Union believes that the time for
  6   voluntary industry guidelines have long past. 
  7   Clearly, the FDA’s voluntary approach to regulation of
  8   fresh vegetables has utterly fail to make them safer.
  9             We believe the FDA must assume the authority
 10   and be given the staff to effectively mandate good
 11   agricultural practices or “GAPs” for every farm and
 12   hazard analysis, critical control point, or HAACP
 13   Programs for every processor including thorough and
 14   regular inspection programs, effective traceback
 15   systems, third-party audits, and rigorous enforcement
 16   standards.
 17             The leafy green industry in particular has
 18   brought dangerous products to market too many times
 19   for consumers to believe that it will suddenly meet
 20   voluntary standards.  For many consumers, it’s just
 21   safer to stop buying leafy green vegetables, health
 22   diet notwithstanding.


00261
  1             In the absence of strong FDA mandates to
  2   regulate the produce industry, growers in states are
  3   stepping in to fill the void.  As I was on vacation
  4   last week, I opened up “The Palm Beach Post” and saw
  5   an article about which the subject was addressed by
  6   Mr. Brown today of the Florida Growers Association.
  7             What he told us and what I read in that
  8   article was that in Florida where more tomatoes are
  9   grown than in any other state, the growers there are
 10   backing a bill to require mandatory state inspections
 11   and traceback systems.
 12             As for the California growers voluntary
 13   agreement with the state officials there.  We joined
 14   with the trucker who spoke today.  We are not fans of
 15   that agreement because it lacks transparency and
 16   because there is no public input and for a host of
 17   other reasons.
 18             Simply put, if the produce industry ever
 19   hopes to regain consumer trust, it must be regulated
 20   by an authority other than itself.  The safety of the
 21   food we buy is a fundamental expectation of consumers,
 22   and the Government must use its standard-setting,


00262
  1   investigative and enforcement powers to see that this
  2   expectation is fulfilled, nor should safety be used as
  3   marketing tool when it comes to food.  
  4             Safety should not be something that
  5   consumers must search out and possibly pay extra for,
  6   for a variety of reasons, including that would leave
  7   poor consumers and poor communities at risk.
  8             Now is the time for the FDA to do everything
  9   in its power including seizing adulterated products as
 10   authorized by Section 402 of the Food, Drug, and
 11   Cosmetics Act and establishing HAACP Programs on farms
 12   as authorized by Section 361 of the Public Health
 13   Services Act, all to ensure the safety of produce.
 14             Further, Congress must step forward and
 15   fully fund the FDA, giving the Agency the resources
 16   and staff to effectively enforce mandatory authority
 17   over this industry.
 18             Former FDA Official William Hubbard wrote
 19   last year in “The Washington Post” that the Agency’s
 20   food inspections have dropped from 50,000 in 1972 to
 21   about 5,000 in 2006, a 90 percent reduction
 22   inspections.


00263
  1             He also said that U.S. food processors are
  2   inspected on an average of every 10 years and that the
  3   chance of a food product from overseas being inspected
  4   is infinitesimal.  Hubbard explained that for years
  5   the FDA’s budget has remained essentially flat while
  6   new responsibilities have been piled on.  
  7             I want the FDA officials here to know that I
  8   and other consumer groups spend a lot of time in
  9   Congress.  One of the things that we continue to do is
 10   ask Congress to increase the FDA’s budget commensurate
 11   with its expanded responsibilities.
 12             To recap, the central components of
 13   regulation ought to be GAPs for all farms and HAACP
 14   Programs for all processors; written food safety plans
 15   showing how producers will comply with GAPs;
 16   third-party audits; traceback systems that include
 17   package identifiers so that each item can be traced
 18   all the way back to the field in which it originated;
 19   FDA inspections at least yearly, made possible by
 20   increased funds from Congress; and FDA enforcement
 21   that has teeth.
 22             I leave you today with a couple of


00264
  1   hundred-million-dollar questions from the consumer
  2   perspective.  The first one, why is the FDA only
  3   suggesting and recommending safe practices for the
  4   fresh produce industry and not requiring them despite
  5   numerous incidences of contaminated fresh produce
  6   reaching the marketplace and harming and even in some
  7   cases killing consumers?
  8             Secondly, how many more deadly outbreaks
  9   must there be before FDA’s “should” becomes a “must”
 10   and their suggestions, recommendations, and current
 11   thinking become rigorous, mandatory oversight by a
 12   credible government watchdog that is well funded and
 13   adamant about protecting the food supply and public
 14   health?  
 15             While we are waiting for credible answers to
 16   these questions, consumers’ health and safety hangs in
 17   the balance.  I thank you.
 18             (Applause.) 
 19             MS. GREENBERG:  Did I get a pass?
 20             MR. LANDA:  Yes.
 21             MS. GREENBERG:  Thanks.
 22             MR. LANDA:  Our next speaker is


00265
  1   Robert Gravani with Cornell University.
  2             MR. GRAVANI:  Well, good afternoon.  Thank
  3   you very much for the opportunity to speak with you
  4   today.  Although I am director of the National Good
  5   Agricultural Program that’s housed at Cornell
  6   University, we have 25 states’ worth of collaborators
  7   out there at mostly land-grant universities.
  8             Today, the comments that I will make will
  9   represent my views and the views of my colleague
 10   Ms. Betsy Bihn.  We certainly heard a lot today about
 11   regulation and certainly the concern out there about
 12   regulation is that small and medium growers are very
 13   concerned.  
 14             They are concerned about the metrics, many
 15   of which are based on old science, and they are
 16   certainly concerned about the issues of compliance. 
 17   They are concerned about who will enforce those
 18   regulations, and that’s a key issue that we need to
 19   face today.  
 20             Do we have enough people who are properly
 21   trained to go out there and enforce those regulations
 22   should we pass them?  Would regulations be the best


00266
  1   use of financial resources given all of the current
  2   needs we’ve heard here today?
  3             I want to call your attention to the
  4   excellent presentations we heard this morning, one in
  5   particular by Dr. Jim Rushing a colleague and
  6   collaborator from Clemson University.  
  7             There is a lot of wisdom in Jim’s
  8   statements.  I’m going to follow up on some of those
  9   points, because when you’re next to last most of your
 10   good ideas have already been presented.
 11             Basically, let’s look at some things.  The
 12   current FDA guidance is not always followed, Jack.  A
 13   lot of growers are unaware of the standards and
 14   expectations. 
 15             This might not be the largest growers in our
 16   country, but it certainly represents a number of
 17   growers.  We and our collaborators throughout those
 18   25 states have conducted numerous GAPs workshops for a
 19   variety of commodity groups and growers throughout the
 20   country.  However, there are still people who are
 21   unaware of the standards and the expectations and are
 22   not implementing GAPs.


00267
  1             Third-party audits, and there are a ton of
  2   companies that are out there auditing farms, but there
  3   is no standardization in the audit forms.  Multiple
  4   audits are often done on the same farms at great
  5   expense, for what reason, auditing the same things.
  6             We have heard a lot about this today.  There
  7   are no standard audit training programs for auditors. 
  8   Yes, the USDA has a very good mentoring program and
  9   audit procedure system program where investigators
 10   certainly go through and mentor with experienced
 11   inspectors, et cetera.  Let me give you a case in
 12   point.
 13             We got a call from an irate grower at one of
 14   our GAPs workshops and he said, “I got dinged because
 15   I didn’t wash my produce.”  His produce was onions. 
 16   Okay?  Does that tell you something about standards of
 17   audits and auditors?
 18             Some food safety standards out there are
 19   based on non-food safety related research.  Think
 20   about irrigation water standards, which are a real
 21   tough one to get our arms around.  
 22             We are looking now at recreational water


00268
  1   standards to be applied to irrigation water standards. 
  2   Clearly, we have got some issues out there on the
  3   research side.
  4             I think, and I commend all the groups out
  5   there who are really looking very at those research
  6   gaps, no pun intended.  We need to identify those
  7   areas that are most important that require research,
  8   and we need to support these financially.
  9             I want to publicly mentioned Fresh Express
 10   who put up $2 million unencumbered and brought
 11   together a group of scientists to allow them to write
 12   an RFP and give that money away to researchers who
 13   could, in a very short period of time, come up with
 14   some answers in one year.  You will see some materials
 15   about that released next week.  
 16             I think we need to continue to support those
 17   levels of research.  We need to continue to
 18   consistently support education and training programs
 19   for growers.  
 20             While these are done intermittently based on
 21   competitive grants for two or three years at a time,
 22   we really need to consistently support education and


00269
  1   training for all growers, large and small and medium
  2   throughout the United States, not in just selected
  3   states.
  4             We need to understand, as many of the
  5   speakers previously have mentioned, that diverse
  6   production and distribution channels for different
  7   types of produce, from different geographical areas
  8   and certainly commodity-specific documents are
  9   important.
 10             We have got to recognize that there are many
 11   small and medium operations providing fresh fruits and
 12   vegetables in the U.S. that reach an awful lot of
 13   consumers. 
 14             With that, I want to thank you again for the
 15   opportunity to say a few words today.
 16             (Applause.) 
 17             MR. GUZEWICH:  Do you want to answer my
 18   question?
 19             MR. GRAVANI:  Ask it again, Jack, because I
 20   want to have another crack at it.
 21             (General laughter.)
 22             MR. GUZEWICH:  Okay.  Lest Bob you feel left


00270
  1   out -- this is Jack Guzewich with FDA -- Bob, do you
  2   think growers are implement and understand GAPs?
  3             MR. GRAVANI:  Jack, I think it’s a little of
  4   both.  I think just a lot of people out there who have
  5   an inconsistency in terms of their knowledge of GAPs,
  6   but I also think there are some implementation issues
  7   out there.  
  8             As Caroline mentioned this morning, we did a
  9   growers survey in 2002 and 2003, reported out in 2004. 
 10   There was still a lot of people, despite all our
 11   efforts and hard work and all the materials on our
 12   great website that we make available, people still are
 13   in some cases clueless about what we are addressing. 
 14   That’s important.  We need to have, that’s why I say a
 15   consistent education and training effort nationally,
 16   not just in selected states. 
 17             MR. LANDA:  Mike Landa.  What do you think
 18   accounts for that, to use your word, “cluelessness”?
 19             MR. GRAVANI:  I think that some people as
 20   many speakers previously have described is that “We’ve
 21   always done it this way.”  To go back to Jim’s
 22   Rushing’s comments, “We’ve always done it this way. 


00271
  1   We’ve never had a problem.  So why should we spend
  2   this time, labor, and manpower recordkeeping issues to
  3   address these issues.
  4             We need to impress upon these folks the
  5   reasons why we need to do this.  Obviously, the
  6   recalls and the illnesses and deaths are a great way
  7   to get people’s attention, certainly.
  8             DR. SOLOMON:  Steve Solomon, FDA.  We are
  9   having these issues you described here domestically. 
 10   What do you think the approach should be
 11   internationally?
 12             MR. GRAVANI:  I think education and training
 13   internationally, too, and I commend the JFSAN/FDA
 14   consortium for conducting programs in a number of
 15   countries.  I think we need to take the next step and
 16   continue to provide some good, science-based metrics
 17   now.  I agree with Jim.  
 18             If we look at the data and we look at what
 19   we are asking people to do, we can’t answer a lot of
 20   the questions.  We really need to provide them with
 21   better science and more information about how to
 22   comply and how to reduce the risk on the commodities


00272
  1   that we are talking about here today.
  2             Thank you very much.
  3             MR. LANDA:  Thank you.
  4             (Applause.) 
  5             MR. LANDA:  Our next speaker is Jenny Scott
  6   with Grocer Manufacturers/Food Products Association.
  7             MS. SCOTT:  Good afternoon.  My name is
  8   Jenny Scott and I’m vice president of Food Safety for
  9   the Grocery Manufacturers Food Products Association,
 10   which represents the world’s leading food, beverage,
 11   and consumer products companies.  
 12             We promote sound public policy and champion
 13   initiatives that serve to protect the safety and
 14   security of the food supply through scientific
 15   excellence.
 16             Thank you for the opportunity to provide
 17   comments on the safety of produce from the perspective
 18   of processors who use produce as an ingredient and who
 19   produce fresh-cut produce products for retail and food
 20   service as well as those who are customers and provide
 21   produce to the consumer through food service
 22   operations.


00273
  1             FDA posed questions in a number of areas,
  2   and I only intend to comment briefly on a couple of
  3   them.  First, we commend FDA for having these public
  4   meetings as they bring to light how much we really
  5   don’t know about the safety of food grown on the farm
  6   and controlling pathogens in those products.
  7             FDA developed its final guidance on good
  8   agricultural practices in 1998.  In it’s good
  9   guidance, there is a lot of discussion about what else
 10   needs to be done.  One of the things we do need to do
 11   is to determine the extent to which good agricultural
 12   practices for fruits and vegetables have been properly
 13   implemented.  Procedures to verify compliance need to
 14   be established.
 15             Second, the produce industry needs to work
 16   together to share food safety best practices for
 17   production and processing.  They need to embrace the
 18   concept that food safety cannot be a competitive
 19   issue.  
 20             The produce industry, including growers and
 21   processors, needs to be proactively developing and
 22   utilizing technologies and processes that create


00274
  1   sufficient interventions in reducing or eliminating
  2   food safety hazards to ensure the safety of fresh
  3   produce.
  4             Currently, many U.S.-based organizations are
  5   working on establishing guidelines or standards
  6   relative to good agricultural practices, to
  7   manufacturing practices, and audit programs for
  8   produce growers and processors.  We have a long way to
  9   go in these.  
 10             We need to have harmonized, HAACP-based good
 11   agricultural practices based on the best science
 12   available; although, there will be some
 13   commodity-specific aspects.
 14             It is going to be more productive to have a
 15   single set of best good agricultural practices for the
 16   growers in the industry to use.  These good
 17   agricultural practices need performance criteria
 18   against which compliance could be measured, and these
 19   need to be widely vetted and agreed upon.  As you have
 20   heard here today, we have a long way to go in
 21   attaining those appropriate criteria.
 22             This would be an ideal project to take to


00275
  1   the National Advisory Committee on Microbiological
  2   Criteria for Foods and put it on a fast track.  A lot
  3   of people think that the committee takes years to
  4   finish their deliberations on things, but they can
  5   work quickly when they are given the resources to do
  6   so.
  7             One of the questions posed in “The Federal
  8   Register Notice” about this meeting was, “What new
  9   federal actions, if any, are needed to enhance the
 10   safety of fresh produce?”  
 11             FDA should move forward with its
 12   modernization of its current good manufacturing
 13   practices and pay particular attention to produce in
 14   this regulation and include provisions that apply to
 15   produce commodities where needed.  
 16             This could include a requirement that
 17   produce be produced under good agricultural practices. 
 18   Another regulatory action deals with recordkeeping
 19   procedures which should provide accurate tracing both
 20   forward and backward along the supply chain.
 21             FDA already requires the ability to track a
 22   product one step forward, one step back and thus apply


00276
  1   all along the food chain.  We suggest that FDA host a
  2   public meeting to exchange ideas on what is possible
  3   in tracing produce throughout the food chain.  We have
  4   heard a little bit of that today, but there is a lot
  5   more out there that can be applied.  
  6             It does have to be recognized that for many
  7   products tracking to particular fields may be very
  8   difficult due to comingling.  It is not possible to
  9   completely avoid comingling in the way we do business
 10   today.
 11             FDA should also host a meeting to explore
 12   microbiological testing related to produce.  It would
 13   address such questions as: what is the role of
 14   indicator organisms?  How do you obtain representative
 15   samples from fields?  What do you sample in the field? 
 16   When is the best time to sample a field?  What’s an
 17   indicator of a problem in water testing?  When should
 18   water be tested?  
 19             There are lots of questions, and this may be
 20   another issue for the National Advisory Committee on
 21   Microbiological Criteria for Foods.
 22             One final federal action relates to


00277
  1   training, which is an essential component to ensure
  2   proper implementation and execution of good
  3   agricultural practices.
  4             FDA should mandate in its modernized GMPs
  5   that every farm should have at least one person with
  6   good agricultural practice training who is responsible
  7   for oversight of operations.  Records of training
  8   should be maintained.  
  9             To most effectively minimize the risk of
 10   future foodborne disease outbreaks and improve
 11   consumer confidence in fresh produce, knowledge and
 12   technology gaps must be filled.  
 13             Federal monies should be dedicated towards
 14   this research as well as towards the extension
 15   programs that provide outreach and training to
 16   growers, packing houses, processors, and the workers.
 17             Partnerships among industry, government, and
 18   academia, in particular through the land-grant
 19   university system offer the best opportunity to
 20   develop practical solutions.
 21             It is equally important that substantive
 22   consumer outreach programs be conducted and enhanced


00278
  1   to emphasize the importance of proper food handling. 
  2   We recognize that this will take funding, and that’s
  3   why as part of the Coalition for a Stronger FDA, we
  4   support significant and sustained funding increases
  5   for FDA’s Foods Program.  We intend to do all we can
  6   at GMA and FPA to work with all stakeholders to
  7   enhance the safety of produce in the United States.
  8             Thank you.
  9             (Applause.)
 10             MR. LANDA:  Questions?
 11             (No verbal response.)
 12             MR. LANDA:  You get a pass.
 13             I think we have one more speaker, a person
 14   without indicated a desire to speak earlier today,
 15   Jill Hollingsworth from the Food Marketing Institute.
 16             MS. HOLLINGSWORTH:  Thank you.  First, I
 17   want to thank FDA for having this public hearing; and,
 18   secondly, I want to apologize to the panel for making
 19   you stay five more minutes.  I’ll try to do it really
 20   quick.
 21             I’m Jill Hollingsworth.  I’m the vice
 22   president of food safety for the Food Marketing


00279
  1   Institute.  We are the trade association that
  2   represents the retail food stores.  Our membership
  3   includes a little over 1,500 supermarket chains,
  4   independent-operator grocery stores, and also the
  5   wholesale companies that supply to them.  Our
  6   membership represents over 75 percent of all retail
  7   food store sales in the United States.
  8             Retailers are in a unique position in the
  9   food chain.  On the one hand, we meet and greet
 10   customers, the consumer, every day -- oftentimes,
 11   24 hours a day, 7 days a week.
 12             On the other hand, we also have the
 13   purchasing power.  We actually are purchasing agents
 14   for the consumers, and we can use that position to
 15   influence suppliers of the food chain.
 16             We realize that retailers, in fact, can be a
 17   catalyst for change and for improvements, and we have
 18   seen this.  There are numerous examples of where the
 19   retail food industry has actually brought about
 20   changes, for example, requiring test-and-hold programs
 21   for ground beef and even changing animal welfare
 22   standards.


00280
  1             We also work closely with our supplier
  2   partners.  To that end, we have supported all of the
  3   work that the leafy-green initiatives have achieved so
  4   far such as the metrics, the marketing orders, and
  5   other similar efforts to improve these products.  
  6             We also applaud FDA and the states for their
  7   continued effort on improving GAPs and GMPs, but we
  8   feel they just haven’t gone far enough.  We are
  9   looking at past experiences, ground beef and seafood,
 10   to try to learn lessons from the past and move forward
 11   with the leafy-green industry.
 12             One of the things that we want is a
 13   HAACP-based, leafy-green guidance.  We have
 14   established one under a retail-owned program called
 15   Safe Quality Food or “SQF.”  
 16             Recently, a group of industry stakeholders
 17   and scientists convened to do a complete risk
 18   assessment of the leafy-green products from harvesting
 19   through processing.  
 20             Yes, we know some people will say you can’t
 21   use HAACP because there aren’t always CCPs, but
 22   certainly the methods and the techniques that are used


00281
  1   in a HAACP-based program and the risk assessment
  2   efforts that can be applied to any food commodity have
  3   worked very well in assessing the leafy-green
  4   industry.
  5             We have incorporated all of the work that
  6   has been done in the past, the good agricultural
  7   practices and manufacturing practices.  We will also
  8   be able to incorporate any regulatory standards should
  9   they be developed.
 10             But, again, the SQF standard will go
 11   further.  We know we don’t have all the science, we
 12   wish we did, but we can’t tell consumers that they are
 13   going to have to wait until we have more science.  We
 14   have to do what we can do now with the science that we
 15   have.
 16             One of the things we have done in the SQF
 17   Program is include rather stringent verification and
 18   validation steps.  Yes, we will expect there to be
 19   microbiological sampling and testing of the product,
 20   but that data will serve us in many ways.  
 21             Not only can that microdata be used to
 22   validate whether a supplier’s food safety plan is


00282
  1   actually working, but it will also help us establish a
  2   baseline, one of the things the scientists keep
  3   telling us is the missing piece.  Against that
  4   baseline we will be able to truly measure if we are
  5   making continuous improvements.  
  6             As a retailer-owned standard, one of the
  7   nice things about SQF is that we can avoid all of the
  8   conflicts that are inherent in many of the industry’s
  9   other driven standards.
 10             We can also make changes quicker, certainly
 11   quicker than the federal government.  We know they try
 12   to make changes quickly, but they do have a lot of
 13   regulatory procedures they have to abide by. 
 14   Additionally, we think we have a better plan for how
 15   to conduct audits. 
 16             SQF is not just an audit program.  It is
 17   actually an international certification program.  Only
 18   accredited certification companies are allowed to
 19   perform the audits.  
 20             The certification companies must be
 21   accredited by an international body such as ANSI,
 22   UCAS, or a similar program.  All of the auditors must


00283
  1   be trained.  They must be registered with sQF and they
  2   must demonstrate competency in the product that they
  3   are going to audit.  In other words, we don’t let meat
  4   auditors go onto a farm and look at spinach.
  5             Also, because SQF is an internationally
  6   recognized program already, we are able to use it in a
  7   number of other commodities and in any country around
  8   the world.
  9             Already many products around the world in
 10   Chilé, Mexico, and other places are already being SQF
 11   certified.  We believe that the SQF Program and the
 12   guidance we have developed for leafy greens will move
 13   us in the right direction, the direction of food
 14   safety, safer products, safer leafy greens, and
 15   greater consumer confidence in the products we sell at
 16   retail.
 17             Thank you.
 18             (Applause.) 
 19             MR. GUZEWICH:  This is Jack Guzewich with
 20   FDA.  I get to ask my question to ask my question one
 21   more time.  
 22             (General laughter.) 


00284
  1             MR. GUZEWICH:  Since, Jill, you’re involved
  2   in SQF, do you have any impressions on the
  3   implementation and understanding of GAPs in
  4   agriculture in the U.S. internationally?
  5             MS. HOLLINGSWORTH:  As far as what is
  6   currently being done, one of the first things we do in
  7   the SQF Program is we require the company to compare
  8   the program they have in place now with the SQF
  9   standard and identify what GAPs they have in between
 10   the two.  
 11             We have found that particularly in fresh
 12   produce there is quite a bit of difference, a lot of
 13   companies that have not implemented GAPs, certainly
 14   very few of them who have gone far enough to do
 15   validation and verification of the steps they are
 16   using.
 17             MR. GUZEWICH:  Thank you.
 18             MR. LANDA:  Thank you.
 19             MS. HOLLINGSWORTH:  Thank you.
 20             MR. LANDA:  Well, that concludes the
 21   presentations by our speakers this afternoon.  I would
 22   like to thank them as well as the people who presented


00285
  1   this morning.  I would like to thank you for coming
  2   and staying with us all day.  It’s been a long day.  
  3             I would like to thank Juanita Yates, who as
  4   the top of the stairs there, and her stairs for taking
  5   care of the logistics.
  6             (Applause.) 
  7             MR. LANDA:  Finally, I would like to
  8   encourage you and remind you that the docket is open
  9   to June 13 and to encourage you to submit comments,
 10   information, data.  
 11             There obviously isn’t a five-minute limit on
 12   that, but more importantly I suppose there is no page
 13   limit, so you can submit as much information as you
 14   like.
 15             Thank you again.  This concludes the
 16   proceedings today.
 17             (THEREUPON, at 4:30 p.m., the meeting was
 18   concluded.)
 19                           * * *
 20   
 21   
 22