PUBLIC MEETING TO RECEIVE )

COMMENTS ON FSIS REGULATORY )

PROPOSAL CONCERNING READY-TO-EAT )

MEAT AND POULTRY PRODUCTS )

Pages: 188 through 323

Place: Washington, D.C.

Date: May 10, 2001

UNITED STATES DEPARTMENT OF AGRICULTURE

PUBLIC MEETING TO RECEIVE )

COMMENTS ON FSIS REGULATORY )

PROPOSAL CONCERNING READY-TO-EAT )

MEAT AND POULTRY PRODUCTS )

Federal Hall

The Washington Plaza Hotel

10 Thomas Circle

Washington, D.C.

Thursday,

May 10, 2001

9:08 a.m. - 2:28 p.m.

PARTICIPANTS

[From USDA]{.underline}:

MARGARET GLAVIN, MODERATOR, FSIS

DR. DANIEL ENGELJOHN, FSIS

DR. AMELIA K. SHARAR, FSIS

DR. DAVE PYBURN, APHIS

DR. HARRY WALKER, FSIS

PAUL UHLER, FSIS

FELIX J. SPINELLI, FSIS

PHIL DERFLER, Animal Science

STEPHEN CRUTCHFIELD, Economic Research Service

[Commenters]{.underline}:

DR. RAY GAMBLE, Agriculture Marketing Service

BETH BOCKMAN, National Pork Producers Council

LlOYD HONTZ, National Food Processors Association

DR. KATHERINE SWANSON, The Pillsbury Company

BERNARD SHIRES, American Association Of Meat

Producers

WILLIAM R. COLE, Techni Cal, Inc.

JIM HODGES, National Meat Canners Association

BOB DAIL, Dial Corporation

DR. DANE BERNARD, Keystone Foods LLC

[Commenters]{.underline}:

CAROLINE SMITH-DEWAAL, Center for Science in the Public Interest

CHARLOTTE CHRISTIN, Center for Science in the

Public Interest

KIM RICE, The American Food Institute

STAN EMERLING, North American Meat Processors

Association

[P R O C E E D I N G S]{.underline}

(9:08 a.m.)

MS. GLAVIN: Can I ask people to find seats, and may I suggest that
because we have a somewhat smaller group today that people might want to
move towards the front? This isn\'t church. You don\'t have to sit in
the back seat.

One announcement. I have a green glasses case. Fortunately, there are no
glasses in it. If this belongs to any of you, I\'ll leave it on the
table here. Just come and collect it. It\'s obviously for a prescription
pair of glasses. Someone might want to get it back.

This morning we have two topics. The first I believe is the Trichina,
the changes in the Trichina regulations, so we\'ll have a presentation
on that. My suggestion is we have our discussion on that prior to moving
into the second presentation on the canning regulations. Is that
satisfactory?

I\'ve lost my cheat sheet, so I\'m not sure who is leading off on the
presentation. Mimi? Mimi Sharar.

MS. SHARAR: Thank you.

(Pause.)

MS. SHARAR: Good morning. Today I\'m going to cover the section on
elimination of \-- for treatment of Trichina \-- . FSIS is proposing a
new rule under the provisions for the prescribed treatment of pork and
products containing pork to destroy Trichinellosis or Trichina under 761
ready-to-eat and not ready-to-eat products.

When this proposal becomes final, prescribed treatments for Trichina
will not be necessary because compliance with the performance standards
will eliminate all Trichina. At present, the regulations for treating
Trichina include freezing, curing, drying, fermentation in salt and
curing.

For heat treated products, the process achieves the proposed performance
standards for Salmonella. The practice should also eliminate Trichina.
The time and temperature for eliminating Trichina is lower compared to
the time and temperature in the compliance guidelines to achieve the 6.5
log reduction of Salmonella.

In salt cured, dried and fermented products, the lethality requirements
for Salmonella and also E. coli 0157:H7 for fermented products
containing beef are achieved, it is likely that Trichina will be
destroyed. However, there are no published studies comparing the
properties of Salmonella and E. coli 0157 to the destruction of Trichina
in those products.

Therefore, the Agency cannot state with absolute certainty that the
proposed lethalities for these products would also destroy any live
Trichina. Therefore, the establishment identifies Trichina as the cause
of \-- . The establishment is to ensure that the process used is
effective to eliminate Trichina.

The Agency does not prescribe treatment for Trichina in raw products
because they are customarily cooked thoroughly for safety at home by the
consumer end user. However, there are some raw products where the Agency
prescribes Trichina treatment. These are items that are raw, but may
appear to have been cooked because they contain ingredients such as
wine, other spices and curing agents that mask their appearance. Because
of their masked appearance, these products may be eaten rare or under
cooked. However, these products are raw and bear the safe handling
instructions on their label.

Trichina treatment provisions for these raw products are already
descriptive and are contrary to HACCP. Therefore, this proposal would
provide establishing the flexibility to determine whether \-- products
eliminate Trichina.

The establishment identifies Trichina as a hazard likely to occur in the
process. \-- for these products may provide \-- , which may be a term in
the \-- to be cooked or ready to be cooked and offer instructions for
fully cooking the products for safety.

The Trichina rule was first implemented by the Agency in the early
twentieth century. At that time, the most serious foodborne outbreak was
due to Trichina. Other bacterial pathogens were not fully characterized
or recognized at that time. Therefore, the Agency tests proposed \-- has
food regulations with regard to Trichina in order to protect public
health. Later on, as the bacterial pathogens were characterized and
recognized as causes of foodborne illness, the Agency has started making
policies on these bacterial pathogens to protect public health.

According to public surveillance of CDC, by the Center for Disease
Control and Prevention, there is a decrease in reported incidence of
Trichinosis from the years 1972 through 1997. During the reporting
period of 1972 to 1987, there were 128 outbreaks due to Trichinosis,
which comprised about five percent of the total foodborne outbreaks. In
1988 through 1992, there were ten outbreaks of Trichinosis comprising
0.5 percent of the total foodborne outbreaks.

From the reporting period 1993 to 1997, there were two outbreaks from
Trichinosis comprising 0.1 percent of the total outbreaks. There were no
death cases in all these reporting periods, and an interesting point is,
50 percent or less than 50 percent of the outbreaks were due to
ingestion of pork that\'s undercooked. The other 50 percent was caused
by other meat or other unknown sources.

Consumer surveys that were sponsored by both the Meat and Poultry
Hotline of FSIS and the industry shared the perception that pork may be
infected with Trichina continued to be a common food safety concern to
American consumers. So FSIS has some confidence that consumers would
cook this product thoroughly.

Recently, a pilot program for the National Trichina Certification
Program was started in August, 2000. This is a cooperative agreement
among USDA agencies, meaning APHIS, ARS, CSREES and FSIS. The National
Pork Producers Council and pork producers are \-- plants. Through this
program, pork producers and suppliers can be certified if they identify
the risk factors for Trichina infection on the hog farm and they
voluntarily adopt management practices that prevent and eliminate
Trichina infection in the farm environment. Dr. Dave Pyburn from APHIS
is here, and he is the coordinator for the National Trichina
Certification Program. He will give details if you need more details on
this program.

Establishments must address the hazard of Trichina in their HACCP plant
if they know that Trichina is a hazard that might occur. They have to
determine for ready-to-eat products if their process achieves a
lethality that meets a 6.5 log reduction of Salmonella. If they do that,
then they\'ll be able to eliminate Trichina also. They have to determine
especially for not ready-to-eat products or the masked products whether
they need a Trichina treatment. They have to determine when the pilot
project for Trichina certification is in full operation. They have to
determine whether Trichina or the pork products come from hogs that are
Trichina certified. They have to determine whether aside from safe
handling instructions for these masked products whether they need
cooking instructions for safety or they need conspicuous labeling in the
label.

Those are the outbreak cases. These are the provisions that are in the 9
CFR that are related to Trichina that would be eliminated if this rule
becomes final. Thank you.

MS. GLAVIN: Thank you. The people who are here supporting Mimi and who
also are able to answer questions that might arise are Paul Uhler and
Harry Walker from FSIS and, as Mimi mentioned, Dave Pyburn from APHIS.
Who is next? Paul, are you? Dave? Dave has a presentation. Thank you.

(Pause.)

MR. PYBURN: As Dr. Sharar mentioned, my name is Dr. Dave Pyburn. I\'m
with APHIS Veterinary Services. I\'m the national Trichina coordinator.
Trichina certification as a project has been ongoing for a number of
years, and it is a cooperative project between USDA and the various
agencies that Dr. Sharar mentioned, as well as the National Pork
Producers Council and the representation that they have for the pork
producers of the nation.

Something I would like to just start with off the top, and I don\'t have
an overhead for this, is she mentioned a declining prevalence within the
industry. Some of the most recent studies are from 1995. A study done on
the top 19 pork producing states by the Centers for Epidemiology and
Animal Health within USDA, basically found that the level of this
organism in market hogs and in sows together within the industry today
is .013 percent from that study.

In some studies that we have done since, especially in 1997 and 1998 in
hogs that came from Iowa, Minnesota and South Dakota, we tested over
220,000 market hogs in this study and did not find a positive. We double
tested all of these animals. We tested them both by serology, as well as
by the gold standard diaphragm digestion test. We couldn\'t find any.

In 2000, the Centers for Epidemiology and Animal Health is repeating
their swine study. They\'re going to look for the organism again, which
the results are not out yet. Quite frankly, though, it won\'t surprise
me if they don\'t find any this time around just with the way the
industry is going.

Why would that be? Well, you\'ve got to look at how the industry is
today compared to how it used to be when this was an issue. Previous to
the 1950s, this was a larger issue. More of the industry was structured
in such a way that this organism would most likely find its way or could
find its way into swine and into the pork that we eat.

In the 1950s, we had the enactment of the Garbage Cooking laws. It
wasn\'t directed at Trichina as an organism to deal with it, but in an
indirect way it did because the only way any warm blooded animal can
become infected with this organism is they have to eat the live larval
cyst and muscle tissue. If it\'s cooked, if it\'s frozen, if it\'s
cured, if it\'s irradiated, the cysts die. It\'s not at an extremely
high temperature or low temperature as far as freezing when the cysts
die.

Overall within the industry, too, since the 1950s, we\'ve had a
reduction of waste feeding operations as well. They\'re heavily
regulated. They have to cook, if they\'re going to feed waste. There are
some states where it is illegal to feed waste to swine. There is no
option to do it. When you look at the industry as a whole, it\'s less
than one percent of the commercial industry today, and it\'s shrinking.

Also within the industry when you look at how producers manage their
pigs, more so for swine health, but also for safety of their products
and economics on the far, we\'ve got much higher biosecure operations
today than we did even 15 years ago, and we keep advancing in this area.
We\'re really just now within the industry starting to take a look at
some science and research as it relates to biosecurity, so I think you
may see even in the next 15 years, greater advances in biosecurity that
will have an effect on all organisms, including Trichinosis.

Dr. Sharar mentioned some CDC work looking at human cases. There\'s a
graph that I got from Dr. Peter Shuntz at CDC who works with Trichina
for them. As you can see from the 1950s forward, a precipitous drop off
in the number of human cases.

I spoke with Dr. Shuntz about some of the more recent cases, more recent
numbers from CDC. On a yearly basis they get somewhere between eight and
15, somewhere in there, the number of individual human cases of
Trichinellosis that are reported to CDC. When you look at that, much
greater than half of those are not attributed to commercial pork.
Usually it\'s through the consumption of meat from wildlife.

I want to just clarify a little bit about the program that\'s been
mentioned in this regulation, as well as by Dr. Sharar. Within this
program, we go to the farm. First we go to the farm. We educate
producers on the good production practices as they relate to Trichina,
and then we come back to the farm.

An APHIS accredited veterinarian who has been further trained to do
auditing within this program comes back to the farm and looks to see
that in fact there are good production practices as they relate to
Trichina are in place. Those practices are such that it would be
extremely unlikely, if not impossible, for pigs to become infected with
the organism if they are in place. They do involve the documentation on
the farm to show they have been in place for a period of time and will
continue and do continue to be in place on the farm before and after the
audits.

Also as part of this program, at least in the beginning of this program
we\'re going to verify what we\'re doing within this program through
testing at the slaughter level, taking a statistical sample of the
national certified herd at each of the plants that are involved within
this program and test those animals for the organism, to be able to back
up what we\'re saying; the fact that these animals are not infected with
the organism.

I just wanted to put this up to reiterate or to kind of clarify a little
bit about the risk factors. The only way that any warm blooded animal
\-- pigs, humans, whatever it may be \-- can become infected with the
organism is through the consumption of live tissue cysts that survive in
muscle. That is the only way.

When you look at individual farms and how we do this within the program,
we boil it down to we have known risk factors on the farm, and then how
do we intervene. We have known interventions for the producers to put
into place on the farm. Our risk factors are, of course, feeding of
waste where it\'s legal, contact with rodents, and in particular for
this program, it\'s really not all rodents. It\'s more rats than
anything else. Exposure to infected wildlife or cannibalism. We have the
various interventions that you can see there put into place on the
program. We have educational materials on those interventions, and we
also have a structured audit to be able to tell that those interventions
are in place on farms.

As I said, within the program, up front is an educational process for
producers. Some of these are inherent good production practices that
already are occurring on farms. Some of the documentation and some of
the other things that have to occur to support the auditing within the
program, maybe isn\'t so inherent and maybe is not occurring on all
farms as of yet, so we have an educational process up front to let the
producers know here\'s what we need to do to control this organism in a
pre-harvest fashion. The producer and the herd veterinarian then work to
implement good production practices on the farm to decrease the ability
of the pigs to become exposed to the organism. The producer then within
this program, and this will be a national voluntary program. The
producer then requests that a qualified accredited veterinarian to come
out and do an audit to indeed ensure to APHIS and to the public that the
good production practices are in place on the farm.

Based on the audit then, APHIS grants certification to farms that have
all the good production practices in place. Certified pigs then will go
to slaughter with identification that they are from a certified site. A
certified pig will be processed separately, and their product will be
kept separately at the packing plant level if they are taken other than
from certified farms.

We also have the regular testing, as I said, within the plants to verify
what we\'re saying. We also have an oversight function within APHIS
where we have APHIS VMOs and state VMOs that have been trained to be
auditors for this program go out and do spot audits on a percentage of
these farms that have been certified. I\'ll be available for questions
if there\'s any further questions on the program.

MS. GLAVIN: Thank you very much. Are there other presentations?

MR. WALKER: Is here okay?

MS. GLAVIN: That\'s absolutely fine. This is Dr. Harry Walker from our
staff.

MR. WALKER: As she said, my name is Dr. Harry Walker. I\'m with FSIS
Office of Policy, Animal and Egg Production Food Safety Staff. What I\'d
like to do is continue with what Dr. Pyburn talked about with what
we\'re doing as we\'re moving from the hog production areas to the
slaughter house. That\'s one of the main functions that I have in Animal
and Egg Production. It is mainly a producers type organization, but
since this is slaughter we have a little bit of variation of the things
that we have to do.

The pilot project. We have two packing houses right now that are
involved, Swift & Company in Minnesota and FarmLife Foods in Iowa. Pigs
from the first Trichina certified sites will be delivered to the plants
sometime this summer, and the pilot will continue for at least a year,
and longer if necessary, to adequately test the hogs

\-- and proceedings.

If the pilot project is deemed successful, plans are to expand it into a
voluntary national Trichina certification program that will be available
to all pork producers and processors who wish to participate. In the
inspection procedures currently, FSIS does not oversee processors
through the process of maintaining certified status with regard to
Trichinosis. With these instructions and the Trichina pilot program,
FSIS is adding Trichina certified pork to its inspection procedures for
market hogs.

There are six points basically to what the inspectors will be doing in
the slaughter houses. One will be producer certification. Another will
be segregation of market hogs and pork products from Trichina certified
production sites. The third one will be validation of a certification
program by testing slaughter swine. A fourth will be reporting results
of testing. The fifth will be maintaining identity, and sixth will be
label claims.

Basically on producer certification, the inspector will certify by a
number of different methods that the hogs that are coming into the plant
are from a certified site, and then on the second point, the inspectors
will ensure that the hogs from the inspected sites are segregated from
hogs that come from non-certified sites, if that should be the case. I
would imagine that most of the plants will probably have only certified
hogs, but if they do have both, the provisions are there to keep them
segregated throughout the entire process.

The inspectors would also be observing the plants as they test the hogs,
or a certain percentage of the hogs. It is designed by a chart so an
adequate number are tested to ensure that they are Trichina free. If
some problems result, there\'s a procedure that you are to go back to
APHIS and let them know that this certified site is having some problems
so that they can be removed from the list.

Then, of course, maintaining identity. The IICs in these plants will
observe the establishment of records to ensure that for each sample
collected plant officials have maintained identity of the sample through
the Trichina identification number to the production site from which the
market hog originated. Finally, right now on label claims plants cannot
make label claims regarding Trichina certified pork on the pilot
project. In the future, label claims may be allowed in accordance with
FSIS labeling regulations.

That\'s all I have, but I will be available for questions. Thank you.

MS. GLAVIN: All right. At this point are there comments or questions
with respect to the Trichina provision, the Trichina control provisions
in the proposed rule? Yes? Can I get you to come to a microphone and
state your name?

MR. GAMBLE: My name is Ray Gamble. I have a prepared statement.

MS. GLAVIN: Terrific.

MR. GAMBLE: As I said, my name is Ray Gamble. I\'m not currently with
the government, but I spent 20 years with ARS as a scientist in the
Agri-Service Center in Beltsville. During that time, part of my
responsibilities were to work in pre-harvest and post-harvest control of
Trichinella in pigs.

I\'ve done a lot of different things. I\'ve worked on diagnostics. The
commercial diagnostic test that\'s used in this program was developed in
my lab. I did a lot of work on pre-harvest control identifying risk
factors and validating programs. I\'ve been in from the beginning with
NPPC and FSIS. I\'ve done work with FSIS, and I see Carl back there, on
processed product regulations as far as curing and did some work with
Mimi and others on the freezing and cooking regs as well.

I also have some international involvement with Trichina in that I wrote
the OIU on regulations governing Trichina and Trichina control on an
international basis and worked with AMS currently on their export
program for Trichina, which does involve to some extent the regulations
that were in place because of \-- frozen and freezing processes as far
as export to Russia and some other export markets.

Lastly, and I\'ll mention this just towards the end here, I\'ve worked
with a group called the International Commission on Trichinellosis,
which has their own set of guidelines for control and in some ways draw
from these process regulations, so in fact these regulations haven\'t
really gone away. They\'re just translated into another form for the
international venue.

The comments that I had, and I\'ll read these and hope that they won\'t
be too boring. My experience in the ante-mortem and post-mortem testing
of pigs for Trichinella infection from 1981 through the present
documents that this parasite is essentially absent from the U.S. pork
supply.

I have a series of references. I\'ll turn this in when I leave, but
I\'ve referenced the NAHMS test from 1990 and 1995, which, as Dave
mentioned, found very, very low amounts of infections, and then we have
a large body of unpublished work as well testing pigs from 1993 through
2001 in which in one case, as Dave again mentioned, we tested about
221,000 pigs. In one study we found no positives. In another study,
which is ongoing, we tested about 23,000 pigs and found none positive.

In addition to that, this AMS program, which I\'ve been involved in
since about 1990, has tested literally millions of pigs annually. As far
as I\'m aware, we\'ve not found any positive pigs in recent years from
that program. Based on this very low incidence of Trichina in pork,
it\'s fairly clear that there really isn\'t any longer a need for
comprehensive processing regulations relative to Trichina. Therefore, I
would certainly support rescinding paragraph 318.10 regarding the
Trichina in processed products.

Again as was mentioned, CDC collects data on outbreaks of human
Trichinellosis, and these numbers have been very low in recent years and
primarily cases that have resulted from ingestion of infected game
meats, so pork is not really a problem as far as cases go to any extent.

However, it should be noted that Trichinellosis is a common disease in
many countries, and the U.S. was once one of these countries and
deserved the reputation as having a problem. Therefore, it\'s important
that we convey to our trading partners in fact that the U.S. has
determined that Trichinella really no longer is a threat to public
health, although we still need to do some of these processing
regulations \-- as I mentioned, freezing, for purposes of export to
Russia and some other countries.

We do have a committee on the International Commission on Trichinellosis
which has published guidelines for control of Trichinae in pork, as well
as horse meat, game meats and \-- horse meats in Europe. We have a
testing program in place for Trichina in horse meat, but this document
contains all those regulations relative to cooking and freezing that are
in 318.10.

As I mentioned, those will go in perpetuity as part of this
international guidelines book on Trichinosis that\'s published by the
ICT, and the tables that are included for freezing and cooking are in
that document.

Now, despite its rare occurrence in pigs in the United States, as Dave
mentioned, due to modern production systems, Trichinella does remain a
problem. It is possible for pigs to become infected in any area where
pigs are raised outdoors and regularly exposed to wildlife. There needs
to be an understanding within the industry that there is an occasional
risk that pigs can become exposed, particularly in pigs that are raised
in outdoor systems or where Trichinae has been reported to be endemic.
There are some publications that are cited in here which indicate areas
where we found Trichinella to be endemic in pigs. This information
should be clearly understood by pork packers and processors, and those
who are required to perform risk assessments should develop a HACCP plan
where necessary for this parasite, so we need to discuss that.

Related to this action, I wanted to mention another parasite which
really has not been discussed to much extent. In the discussion of
selection of reference organisms and the relationship of these organisms
to other potential hazards, the subject of Toxoplasma has received no
more than passing treatment. It was referenced briefly in the proposed
rule, but again only briefly.

This is surprising considering the fact that, one, the Centers for
Disease Control report Toxoplasma as the third leading cause of death
due to foodborne illness, behind Salmonella and listeria; two,
Toxoplasma is responsible for approximately 20 percent of all deaths
attributed to foodborne pathogens; and, three, the CDC estimates 50
percent of human cases of toxoplasmosis are foodborne in origin. I have
a citation here for that.

Toxoplasma poses a significant public health risk in pregnant women as a
cause of birth defects in congenitally infected fetuses and to
immuno-depressed or immuno-compromised individuals as a result of acute
or chronic latent infections. Human toxoplasmosis in the U.S. is
estimated to cost \$5.3 billion annually in medical costs, losses in
personal productivity and costs of special education and residential
care. An additional \$100 million in costs are attributed to medical
costs of toxoplasmic encephalitis in AIDS cases.

Toxoplasma has historically been associated with cats as the main source
of infection for humans. However, Toxoplasma can also occur as a
contaminant of pork and other commodity meats. Research is again cited
and has documented the occurrence of this parasite in pigs. Like
Trichinae, Toxoplasma infection rates are higher in pigs raised in
outdoor management systems. We have papers cited to that effect. These
findings suggest that raw, undercooked or improperly processed pork
might be a source of infection for humans, but further research is
needed to document this relationship.

Nothing is really known about Toxo infection in other meat and poultry,
although we do know that Toxo is an important abortifacient in sheep.
Additional research is needed to assess the prevalence of this parasite
in beef and chicken and the risk it poses to humans from these sources.

Despite the claims of the CDC on the relative role of foodborne
exposures in human toxoplasmosis, we know essentially nothing about the
relative role of meat and poultry versus environmentally contaminated
fruits and vegetables in human exposure to Toxo.

Methods are needed by packers and processors to assess the risk of
Toxoplasma in meat and poultry in their supply chains, and to take
subsequent steps to incorporate control in HACCP plans. If surveillance
is performed to identify hazards associated with meat or poultry and if
Toxoplasma is identified in raw product, the question arises how this
product might be handled, particularly if some product is intended for
sale as fresh product. FSIS might consider the implications of
identifying Toxoplasma as a contaminant of meat or poultry since this
parasite has not been previously addressed as a food safety concern.

Toxoplasma is inactivated in much the same way as Trichinae when
comparing cooking and freezing methods. The information that we present
regarding inactivation is relative to Salmonella and the increased
sensitivity of Trichina. Toxoplasma would fit in that category as well.
In both cases, the absolute thermal death point of Toxo and Trichinella
is much lower than reported for Salmonella and E. coli,

However, little is known about the effects of curing processes on
Toxoplasma. We\'ve done a lot of work on Trichina, but we know nothing
on Toxoplasma, which is a much more deadly parasite. Comparative data on
processing is needed for this parasite, particularly if production of a
safe product is predicated on meeting performance standards of
Salmonella. The assumption cannot be made that processing by curing to
meet Salmonella reduction performance standards will have the necessary
effect on the inactivation of Toxoplasma. Further research using
existing or proposed processing methods is needed to achieve this level
of confidence.

Basic biological differences between Salmonella and Toxoplasma eliminate
the use of certain treatments to achieve comparable results in reducing
risk in processed products. Any steps, for example, for surface
sterilization to reduce Salmonella numbers to meet performance standards
would have no effect on Toxoplasma. The only effective treatments are
those that are documented to inactivate the parasite, and those again
are cooking and freezing, and then those that would affect the carcass
throughout the treatment.

Lastly, I just have a couple of recommendations. Again, these are in the
statement. The first is to educate packers and processors regarding
possible risks for Trichinae in pigs raised in outdoor management
systems and take steps to minimize this risk. Certainly the
certification program is a major step in that direction as far as
minimizing risk. However, there is sort of an assessment whether it
would be included in the HACCP plan. I think that needs to be considered
from an educational standpoint, but also from a practical standpoint.

Support research to estimate the risk of Toxoplasma in pork and other
meats and poultry. We\'ve done a pretty good job of that so far for
pork, but there is essentially nothing about other meats and poultry,
and that really needs to be considered because Toxo can be a contaminant
of virtually any warm blooded animal. In particular, support is needed
for research on the prevalence of Toxoplasma in retail meats and
processes that inactivate the parasite.

Third, educate producers and packers regarding possible hazards
associated with Toxoplasma in meat and poultry. That again would be a
HACCP plan identifying what those risks would be. In particular, it\'s
important to make a distinction that contamination of raw product with
Salmonella and other microbes is not related in any way to contamination
with Toxoplasma, so the exposure risks are completely different at the
pre-harvest level at least.

When defining requirements for performance standards, consider the
differences between Salmonella and other bacteria and Toxoplasma.
Toxoplasma is a tissue dwelling parasite that is not impacted by surface
treatment. Therefore, methods to incorporate surface sterilization will
not affect Toxoplasma. Lastly, support further research to compare
non-thermal processes that inactivate Salmonella with lethality for
Toxoplasma in those \-- curing methods.

MS. GLAVIN: Thank you very much. Do you mind staying at the table just
for a minute in case people have questions for you? Are there questions
or comments? Mimi?

MS. SHARAR: Thank you, Dr. Gamble. Dr. Gamble is one of the leading
experts in the field of para-cytology (phonetic), especially in Trichina
research. We know that Toxoplasma is one of the pathogens of concern in
pork products, but research by Dr. Katula and Dr. Dube from ARS have
shown that heating and freezing treatment that is best for Trichina is
very effective toward Toxoplasma. As Dr. Gamble said, it\'s more
sensitive to heating and freezing than Trichina, so that will be covered
in this proposed rule that we have lethality for Salmonella.

In terms of research, we are aware that we are in need of research for
this ready-to-eat proposed rule, so we have proposed research comparing
the lethality of Salmonella and other pathogens of concern, including
Trichina and also Toxoplasma, for ready-to-eat products.

MS. GLAVIN: Okay. Any other questions? Thank you very much for that
presentation. It was very helpful.

Other comments or questions on the Trichina control provisions? Yes,
sir?

MALE VOICE: Jack \-- . Not on the control proposal, but about all
regulations that have changed, but as long as you\'re proposing to
change this one \--

MS. GLAVIN: Okay.

MALE VOICE: I think Dr. Sharar\'s last piece of film up there showed
Regulation 310 and other related regulations that would be done away
with. However, there are other publications by FSIS that relate to
Trichina control and the need for the use of certified pork. There are
directives and SID policy numbers on these topics and SID books for
products like Chorizo.

I would ask that if you\'re going to change this regulation or change
any of the other regulations that you go and find all the other
documentation that FSIS has in the field and remove that also.
Inspectors now have these FAIM computers where they can just punch in
something and a reference will show up. What I\'ve found is that while
regulations have been done away with, there are other references that
they can go back to, so I would ask if this is done away with that you
go through and find all the other references and do away with them, too.
Thank you.

MS. GLAVIN: Thank you. Very good point.

Other comments or questions? Yes? Can you come to the table, please?
Thank you.

MS. BOCKMAN: I\'m Beth Bockman with the National Pork Producers Council,
and we will be sending extensive written comments for this particular
section. I did want to provide a little bit more background as far as
the Trichina certification program and I think really express the
appreciation of the pork industry for the efforts that the USDA has
shown in helping move forward in food safety certification programs.

This program, which is in the pilot stages right now, started in 1993
through a lot of cooperation between APHIS, the Food Safety Inspection
Service, the Agricultural Research Service, the Agricultural Marketing
Service and Cooperative State Research, Education and Extension Service,
and it has required many pilot projects, many research projects, much
\-- development, development of tests, and has been a very good example,
I think, of the future type of programs that can be developed and then
can be adopted by the industry. I just wanted to express appreciation
for that work that\'s been ongoing since 1993.

MS. GLAVIN: Thank you. Other questions? Comments? All right. Thank you.
Thank you very much for those presentations. We will move on to the
section of the regulations or the provisions of the regulations
governing commercial sterile canned product. Paul Uhler\'s presentation
is actually the commercially sterile canned product presentation.

MR. UHLER: \-- products are addressed in two subparts \-- . Those
subparts are \-- address poultry products. Those regulations are \-- .
\-- processes, the forward process \-- biological, physical and chemical
hazards from developing in a HACCP plan. However, establishments do not
have to \-- food safety hazards associated with microbiological
contamination if the product has \-- . This exception is contained in
Section 2(b)3 of the HACCP regulations.

\-- this exception, the Agency recognized that the \-- regulations were
based on HACCP concepts to provide for the analysis for food processing
systems and controls through \-- . However, \-- performance standards
are finalized.

\-- to a single category of meat and poultry products is inconsistent
with FSIS\' other regulatory missions to grant the industry maximum
flexibility and define the industry\'s responsibility and accountability
for the safety of meat and poultry products.

However, while it may appear that the current exemption for the industry
for the flexibility to \-- HACCP plant must still comply with the
regulatory requirements. Therefore, the change in the standards is no
longer making the regulatory language consistent with that \-- .

FSIS\' proposal \-- lethality performance standards \-- regulatory
standards \-- . FSIS is also proposing to revise the requirement \-- .
\-- current regulations \-- requirements and those that overlap the
HACCP regulations. FSIS will continue to train \-- supervisors. In other
words, the proposed changes should not affect current industry practice.

The food processing \-- commercial sterility. However, commercial
sterility addresses both food safety and non-food safety forms of
contamination. Therefore, FSIS is proposing lethality performance
standards designed to kill pathogens and prevent growth of pathogens \--
in the commercial sterility standard.

In the first performance standard, FSIS is proposing a requirement to
establish a process for reducing \-- . In the second performance
standard, FSIS is proposing to require \-- factors other than the
thermal process to prevent the multiplication of C. botulimon. For these
products, \-- process reduction of C. botulimon.

As additional performance standards, FSIS is proposing a specific
requirement that \--. This requirement is consistent with the existing
commercial sterility definitions in Section \-- of the FDA regulations.

\-- commercial sterility is safe, but it may not be stable.

FSIS considers the commercial sterility standard to be appropriate,
among other reasons, because the Agency is obligated under the statute
to \-- . The Agency\'s current \-- regulations are intended to assure
\-- products are not adulterated.

The proposed commercial sterility requirement \-- commercial sterility.
The process delivers \-- destruction with the more heat resistant
organisms, such as clostridium sporgenes.

FSIS is proposing a \-- quantitative standard for commercial sterility.
\-- quantitative standards necessary, such as a 5 log reduction,
clostridium sporgenes, just for an example. \-- container protects the
product \-- . If the container \-- stable. \-- contaminated product. If
the product is adulterated and becomes \-- , that is an economic
concern. C. botulimon becomes a public health concern.

For this reason, FSIS considers \-- seal requirement. FSIS is proposing
that the seal be airtight to protect the contents of the container from
the entry of microorganisms. FSIS also recognizes commercial sterility
can be achieved other than by the thermal process. Therefore, the
definition of commercial sterility has been expanded to include those
processes in the definition or the proposed definition of commercial
sterility \-- added to the current definition.

The commercial sterility requirement is the product must be processed to
achieve commercial sterility. The container in which the product is
enclosed must be hermetically sealed so as to be airtight to protect the
contents and the container against injury from microorganisms during and
after processing.

Several industry groups and other interested parties have expressed
reservations concerning replacement of the existing regulations for
fully processed commercially sterile performance standards. The
complexity of the process, the condition of the \-- have been cited as
reasons for maintaining existing prescriptive regulations.

Significantly, FSIS is proposing to retain the training requirement for
all operators of processing systems for commercially sterile poultry
products and it will continue to be issued under the direct supervision
of the person who is associated with school instruction. It is generally
recognized that it is adequate for the training of supervisors of
canning operations.

There are many changes regarding the definitions. With the certified
product and the time to certify the product, if it\'s longer than 24
hours it must be validated. In the current regulations, it requires a
processing authority to approve a longer time period.

Commercially sterile and hermetically sealed has replaced canned product
in the current regulation. FSIS specifically invites comments as to
whether and in what form the existing requirements for fully processed
commercially sterile meat and poultry products should be retained. If
the Agency does replace the current requirements, we propose firmer
standards and plans to issue a revised version of the current
regulations as to requirements for industry. And a copy of these
compliance guides is on the table in the lobby.

In summary, the proposed rule defines the performance standard for food
safety, defines the standard on adulteration, continues the training
requirement, encourages flexibility and motivation, \-- the requirements
and removes overlap with HACCP requirements. Thank you.

MS. GLAVIN: Thank you very much. Lloyd, did you want to make a comment
at this point?

MR. HONTZ: I did have \--

MS. GLAVIN: Do you want to give your name for the reporter, please?

MR. HONTZ: Lloyd Hontz with the National Food Processors Association. I
do have some prepared remarks I would like to give, but maybe it\'s
appropriate to ask some questions about the information that was just
presented, and the Preamble discussion.

MS. GLAVIN: All right. That\'s fine. That\'s fine. Are there questions
for Paul Uhler at this point on the presentation he has made on what is
included in this proposal? You had one. Now there\'s a method to your
madness.

MR. HONTZ: Lloyd Hontz with the National Food Processors Association.
Paul, I was looking at the Preamble discussion of commercial sterility.
Let me tell you that in the discussion it talks about current practice,
but on some occasions in delivering the thermal process, the times and
temperatures to achieve commercial sterility may not be attained, but
indeed the heating time is more than enough to protect it from \-- I\'m
talking here about a practice in some cases of incubating some product
under those conditions to determine if the product is stable and then
allowing the product to be released.

Later in the Preamble discussion where it states that the proposed
commercial sterility requirement \-- there is something that says, would
have to ensure a reduction or inactivation of foodborne organisms
sufficient to guarantee commercial sterility, if there\'s even an intent
here that processors would no longer be able to operate under the
current practices, which would allow release of product which might not
have met commercial sterility requirements, but has indeed exceeded the
minimum health requirements.

Another question or an observation is that in many cases the thermal
processing authority, which we believe is a very, very integral part of
the current regulations, the processing authority would be experienced
in the background and in many cases has and will continue to make
determinations that products which may have only slightly failed to meet
the commercial sterility requirement would not even need to be incubated
before it could be released.

I was wondering if the proposal suggests any different strategy for this
area of thermal processing?

MR. UHLER: For the processing \-- processing environment \-- and the
need for certain poultry products

\-- . That preceded the implementation of HACCP in all establishments,
so it\'s similar \-- . The process has to be validated, so \--

MR. ENGELJOHN: This is Engeljohn. Just to follow up on what Paul said, I
would say there is no limitation within the proposed rule that would
restrict the use of a processing authority and that authority providing
documentation to the plant, which would be part of the record so that
the plant would keep documenting wider processes that were safe and
validated.

MR. HONTZ: Lloyd Hontz again. My question is whether you\'re utilizing
the process and whether there\'s an intent by the Agency to disallow the
marketing of product that may not have met the commercial sterility
requirements, but is above the minimum health requirements.

MR. ENGELJOHN: This is Engeljohn again. Could you give me maybe a little
more background on what the product would be that doesn\'t meet
commercial sterile today, that\'s released into the marketplace? Does it
have refrigerated statements on it? What exactly does it say today in
those situations?

MR. HONTZ: It would not require anything like that. It would be your
typical canned meat product, which perhaps has a certain commercial
sterility \-- . It\'s discussed in the Preamble language. It says a
product that is \-- processing and necessary to protect health, but less
than necessary for commercial sterility is safe, but it may not be safe.

It talks about in certain cases the processor might distribute that
product for some period of time in containers, which could indicate
economic standards of the product. They would not be appropriate for
marketing. They would be used and discarded, but the remainder of the
product would be released into the marketplace. It would be processed
and delivered at somewhat less than required for commercial sterility.

MS. GLAVIN: Did you want to jump in?

MS. SWANSON: Yes, just to provide a clarification. This is Katie
Swanson. For example, you\'ll have a stated time process that the plants
are supposed to produce against, and perhaps they have a processing \--
associated with that. The process that is given to the plant is
supported by data that the thermal processing authorities have in hand.
They might look at the deviation that was submitted to them, do a very
technical assessment as to whether or not it still provides the
assurance that they need that we\'re not producing and sending product
out that\'s going to provide extensive spoilage in the marketplace. So
it might be something less than the authorized process given to the
plant, but more than the likes of their data suggests would present a
problem.

They might take that information, couple it with \-- detection tests,
incubated samples or even 100 percent sort and say we have seen no
spoilage that is evident other than that related to a canning defect.
Based on that information, we\'ll release it. We\'re not talking about
shipping product that we think is going to spoil in the hands of the
consumer. It\'s just that the assumptions that they make when they
develop those processes are under worst case situations \-- the highest
fill, the lowest head space, the greatest viscosity, et cetera \-- and
that is not the average. If you put all of that together, it\'s not
something that you can clearly delineate in your HACCP plan with regard
to corrective action. It\'s something that takes a highly competent,
trained processing authority who\'s been working on this for years to
make that judgment.

Under what we have under the guidance of HACCP, that flexibility
seemingly disappears; albeit maybe not intended to have that happen, but
it very well could disappear. I think that\'s the crux of what you\'re
talking about.

MR. HONTZ: That was very helpful.

MR. ENGELJOHN: This is Engeljohn. I would say that there was nothing in
the proposed ruling intended to change the status quo on that issue. If
there are language issues with regard to the way we\'ve written the
standard that would make that more clear so that it would continue to
provide that. We would clearly like to have some guidance on what
language that would be, but I would say there was no intention to change
those provisions.

MR. DERFLER: Let me just ask Mr. Hontz a question. Is there a provision
in the current regs that specifically authorizes what you\'re talking
about, or is this a process that\'s kind of grown up under the regs?

MR. HONTZ: Lloyd Hontz again. I believe it\'s just practice. It\'s
through practice.

MS. SWANSON: In some respects \-- Katie Swanson \-- it might be industry
practice, but there is a need for a thermal process authority, and the
thermal process authority is the one that has to review these
deviations. That is covered.

MS. GLAVIN: In the regs.

MS. SWANSON: In the regs.

MR. DERFLER: Okay.

MS. SWANSON: So it is current. That\'s the need for a thermal process
authority provision.

MS. GLAVIN: Okay. From the nods I\'m getting over here, I assume that
that will be in your written comments?

MS. SWANSON: Yes. It already is.

MS. GLAVIN: Okay. Other clarifying questions before Lloyd makes his
comments? Yes?

MS. SWANSON: Related to the thermal process authority concept, is it the
intent of the new regulations to negate the need for a thermal process
authority? There are currently thermal process authorities there, but
there are people who might think they\'re one, but might not be, and so
are the regs as intended supposed to allow for other people to be able
to make these technical changes?

MR. ENGELJOHN: This is Engeljohn. I would say the intent of the reg is
to make it as flexible as it can be with regard to what the
establishment will use to validate or provide the validating
documentation for the safety of their process. If that requires them to
have a processing authority that they will get services from, that is
what they can do.

It doesn\'t limit their activity, but it also doesn\'t require one,
which would be what would be the current reg. It doesn\'t limit that,
but it certainly would allow for the use of processing authorities as
the supporting role for the plant\'s HACCP plan.

MS. GLAVIN: Okay. Thank you. Someone over here? Yes? Could you state
your name when you come to the microphone? Thanks.

MR. SHIRE: Bernie Shires. If you want to have a processing authority
standard, what other types of individual organizations would you be
thinking about since you propose to remove this from the regulation?
Process authority.

MR. ENGELJOHN: The intent of the proposal was to allow the establishment
to establish their HACCP plan and to have the adequate documentation to
show that they have a validated system, so that would be a determination
that the plant would use as to what rigor they would employ to assure
that.

MS. GLAVIN: Other questions before we move on? Yes?

MS. SWANSON: I have a question related to requirements for validation.
Under the current HACCP regs, frequently when validation is done it is
done with the specific hazard of concern or the pathogen of concern.
With regard to thermal process validation, this is not the case.
Clostridium botulimon is not put into containers of product and tested
to assure that they are inactivated.

My question is how will the Agency assure that or is it the intent of
the Agency to require those validations, and how will they assure that
if they don\'t want to specifically require the use of C. bot
validations how will they be able to communicate this as a difference
from other parts of the HACCP regulation?

MR. ENGELJOHN: I would say that the Agency\'s intention in terms of
proposing this performance standard based rule would be that the
establishment would need to have on file what its documentation would
be, how they\'ve identified their hazards and what it is that they\'re
going to do to ensure that the product is safe. I don\'t view that
differently than what they do today. If you could give me a little more
clarity as to what you\'re seeking on that, maybe I could respond to
that.

MS. SWANSON: Well, frequently if we get requests to demonstrate some of
the time, temperature and activation studies, and they want to make sure
\-- the inspectors might want to see Salmonella or how many strains of
Salmonella did you use, and those kinds of studies. When we discussed
the lethality standards for Salmonella just earlier in this
presentation, very pointed questions about well, did you use Scot-A for
listeria or, you know, how many strains were there and how many times
did you replicate. That is part and parcel of validating lethality
studies for many of the microbial systems.

That is just simply not the case for Clostridium botulimon. We tend to
develop processes based on what you need for commercial sterility
because it far exceeds Clostridium botulimon, yet the regulation is to
control

C. bot.

I have somewhat of a concern that once a change is made to something
that has been in place for many, many years that it\'s so different than
the approach that HACCP has used in other situations, people will start
looking for similar types of data, and they just don\'t exist.

Additionally, and I\'m getting comments so I\'m going to ask some
questions here, but additionally current HACCP regs require
reverification of the HACCP plan on an annual basis or with every
verification. The processors are validated extensively when they\'re set
up, but they\'re not revisited on an annual basis from a thermal process
perspective.

We review changes as they come along and make a technical judgment as to
whether or not there is an impact. But something as simple as changing
from one starch supplier to another, at the same percentage, can change
the impact on those products.

I just want to make sure that the Agency understands the magnitude and
the complexity of the things that they\'re trying to change in light of
the fact that a very effective system has been in place for years and
has demonstrated a lack of \-- .

MR. SHIRES: Katie mentioned something that sparked a little bit of an
idea here in terms of, if we transition from where we are now to a
\"HACCP\" and performance standard mode on canned foods, there are
frequent formulation changes, et cetera. Processes may change. For
example, one may have five processes on the same product as
alternatives.

I\'m curious as to how you would envision that fitting into HACCP. You
may be setting up a system which is much more burdensome in trying to
make it more simple. Your paperwork burden is going to go way up in
terms of reassessment of the plans for each process that is now a \--
process or each \-- .

I hadn\'t thought of that aspect of this before, but that could be very
cumbersome. That\'s just a comment.

MR. ENGELJOHN: I would respond just particularly to the comments that
you submit when you flush that out as to some of those issues. I would
in part compare this to what occurs with irradiation processes in which
there currently is defined, there are requirements for defined criteria
that have to be there.

Now, within the irradiation regulations that we have in place today we
have seen more prescriptive requirements there than what we do for
general processing categories. So if there are similarities between
existing irradiation regs and the canning regs, that would be something
I think we\'ll go back and look at to see the additional requirements
that we put there which involve more clarity as to specifying any
changes and so forth through required certain activities.

We\'ve gone in this proposal to the very general performance standard
statement without considering some more prescriptive provisions other
than requiring that a person be trained, which is one of the components
for irradiation.

There may be a need to look at some added descriptive requirements to
this performance standard. If you could maybe flush that out a little
more as to the specifics, that would be very helpful to us.

MS. GLAVIN: Any immediate questions? I\'m not trying to shut this down,
believe me. What I\'m going to suggest is that if there are a few more
questions we get those on the table now and before we move on to the
presentations, because there are a number of people signed up, we take a
short break. Questions?

MS. SWANSON: One more question, and that\'s related to thoughts in the
Agency on prerequisite programs. I know that that\'s not something that
is frequently addressed within USDA. Would some of the provisions
related to the equipment that is used for thermal processing is a very
good example of the need for a prereq program. When you\'re establishing
a process it\'s specific to the line. You do temperature distribution
studies within retort (phonetic) vessels, for example, to determine
where the cold spots are.

This is not something that is easily captured within a HACCP plan
because it\'s not done every day. It\'s done at a certain point in time
and then when equipment changes are made. When you remove the equipment
portions and requirements from the regs, all of a sudden those
requirements seemingly disappear, and they are essential to delivering
the process that you need on each and every can that goes through. Is
there a consideration that you might have some recognition of the
prerequisite program?

MR. UHLER: Won\'t the equipment be covered in the validation system \--
wouldn\'t that be covered?

MS. SWANSON: It would be covered during that initial validation, but the
ongoing check is not something that would be able to \-- that\'s easily
amenable to doing in your HACCP plan.

MS. GLAVIN: Question?

MR. DERFLER: This is Phil Derfler. The only thing I\'d add is we have
pending before the Agency a petition from the industry. One of the
issues that it raises is the issue of prerequisite programs. The
petition \--

MR. COLE: \-- someone who spent 25 years in the Food and Drug
Administration as an investigator, who spent a lot of time on the plant
floor doing inspections of food processors, both national and
international.

I think the concern that Katie and Roy and Dane are voicing here is that
if you transfer a regulation, okay, which has a very clear cut
definition of commercial sterility, and by definition of commercial
sterility it mandates destruction of bot. It mandates the destruction of
Clostridium botulimon right now by definition.

You\'re going to have an awful lot of work that needs to be performed on
the basis of the annual reevaluation of the HACCP plan whereas today the
situation in the plant is that a lot of work goes into basically
establishing the schedules and the processes and validating the
recording systems through temperature distribution studies. Then a
careful eye is kept, or supposed to be kept on the process by plant
management to make sure, A, nothing changes with respect, okay, to the
process itself.

Katie mentioned the example of going from one starch supplier to another
starch supplier. There are a myriad of different issues that are
involved here. On the weak \-- side, if you have a plant engineer who
runs out of gate valves on the vertical scale retort side, and decides
to replace it with a globe valve, not understanding, you know, the
significance of what that means in a line, okay, so this is basically
the way this is controlled today.

They do not redo the \-- on an annual basis. They do not do the
temperature distribution on an annual basis. Basically it has not been
necessary. It does become necessary, as David said, and there should be
control provisions in place for that.

If the process is being thought to be changed, you\'re supposed to
contact the process authority. If you\'re thinking of changing something
to your retorting system, you\'re supposed to contact the process
authority. If this moves to HACCP, it looks like what\'s going to have
to be done, regardless of whether it\'s necessary or not, on an annual
basis. I think this is the source of a lot of concern here.

MS. GLAVIN: All right. I declare a break. Let\'s try to keep it to about
ten minutes. Thank you.

(Whereupon, a short recess was taken.)

MS. GLAVIN: All right. What I will suggest is that we start moving into
some of the comments that people are prepared to make and intersperse
that with questions, since I suspect the presentations will trigger
additional questions and discussion.

Lloyd, sometime way back earlier this morning I offered you the
opportunity to make a presentation. Would you like to proceed?

MR. HONTZ: Yes, I would.

MS. GLAVIN: Thank you.

MR. HONTZ: Thank you, Maggie. I am Lloyd Hontz from the National Food
Processors Association. I do have some prepared remarks. They will take
about five minutes to cover, and I promise to cover them in less than
half an hour.

MS. GLAVIN: Thank you.

MR. HONTZ: Thank you for this opportunity to comment on one important
element of the FSIS proposed rule setting performance standards for
ready-to-eat food. For a host of reasons, the National Food Processors
Association vigorously approves of the FSIS plan to remove the existing
canned regulations from the Code of Federal Regulations and to replace
them with performance standards.

In our reading of the Preamble to this ruling, we find no discussion of
a public health basis for this change. This is not surprising since the
existing regulations have been exceptionally effective in minimizing
public health problems associated with canned foods. In that regard, I
noted at the end of Mr. Billy\'s opening remarks from the technical
conference on Tuesday, the desire for science based processes with
proven performance. If I remember correctly, Mr. Billy also said that
the one true measure of success of regulatory food safety methods is the
reduction of foodborne illnesses. If this is so, then the FSIS canned
food regulations have been truly successful.

Unlike some of the other ready-to-eat food categories in which new
approaches for enhancing food safety are still being developed, we do
not believe that the proposed changes to the canned food segment of the
meat and poultry industry will yield public health benefit. In fact, we
fear that a very opposite result can occur.

I would also note that the proposed changes appear to be very likely to
require significant economic expenditures for validation of those
processes that are already exceedingly conservative and whose adequacy
has been validated by many, many years of production of safe products.
Again, we would note that no public health benefit would accrue from
such expenditures.

Before going further, I would like to offer a brief review of the origin
of the canned regulations, which have had the strong support of the
canning industry for more than 30 years. I will show how the change
surely would introduce unnecessary competition for processors who also
produce FDA regulated canned foods and/or export their products to other
countries. As was suggested, the proposed changes could adversely impact
the very envious safety record of this food industry segment.

Following a food poisoning incident in 1971 in which the failure to
properly apply a heat process to commercially canned product led to
fatal consequences, the National Canners Association, now the NFPA,
petitioned the FDA to publish new regulations to address the problem.
Elements of this major new program were designed to control the primary
food safety hazard associated with canning operations; that being the
survival of scores of Clostridium botulimon which could then germinate
and produce the deadly botulism toxin in the anaerobic environment of
the \-- can.

Consumption of even small amounts of this potent toxin in the absence of
practical administration of antitoxin can quickly lead to paralysis and
death of any consumer, not just those who might be immuno-compromised or
in some other special risk category.

In addition to new emergency \-- requirements that provided FDA with a
basis for enforcement, the plan called for good manufacturing practice
regulations applicable to formerly processed low acid foods packaged in
hermetically sealed containers. These PNPs were published and made
effective in January of 1973.

At a time long before hazard analysis and critical control point became
a household term, these canning regulations were based upon HACCP
principles. Utilizing knowledge gained over a period of more than 60
years as the art of canning was converted into a science, experts from
the NCA and its member companies carefully analyzed the various steps in
the canning process and identified those whose proper performance was
essential to the manufacture of safe product.

In a cooperative effort with FDA, the most important features of various
retorting systems, the essentials of thermal process establishment by
recognized processing authorities and special parameters for container
closure were identified as mandatory requirements to document that, as
denoted as shells in the regulation.

Monitoring and record keeping requirements to document that factor is
critical to the final process, and prescribed procedures for corrective
action when process deviations occurred were also required elements of
the regulation.

In addition to the mandatory requirements, other advisory or recommended
practices intended to ensure compliance with the required features were
included and specified in the regulations as \"shoulds.\" This strategy
allowed industry flexibility to achieve a desired goal by alternative
approaches.

Meanwhile, several incidents and one death from commercially canned meat
and poultry products occurred in the early 1970s. FSIS procured a
canning regulation of its own in 1976, but never went further with it.
In September of 1981, the NFPA petitioned FSIS to establish further
manufacturing practice regulations that prescribe detailed thermal
processing requirements for canned meat and poultry products which would
enhance consumer protection, reduce the cost of inspection, achieve
consistency in the FDA regulations and ensure fair and predictable
enforcement by USDA. NFPA urged the Agency to abandon its earlier
proposal as it had significantly mis-marked for comparability with the
original FDA ruling, which had been modified itself in 1979.

On April 12, 1984, FSIS published their proposed ruling in response to
the NFPA petition. I find some of the Preamble language to be
informative to our discussions today. The Preamble stated that the
decision to pursue the proposal was in consideration of our petition
and, I quote, \"the Department\'s desire to provide maximum consumer
protection by the most efficient means possible.\"

Later in the Preamble it was noted that among the several alternatives
available, the option to develop comprehensive canning regulations, and
I quote, \"was selected because it would accommodate advanced technology
and would strengthen controls over canning operations to the degree
deemed necessary to provide increased assurance of safety and sterility
of canned products.

\"Also, the development of regulations which are not \-- the proposed
CODEX Elementarius Code of Hygienic Practice for Canned Foods and which
closely parallel existing FDA regulations would serve to promote
standardization and unity in national and international regulations.\"

Finally, it was noted that the requirements and recommendations \-- in
the proposal are generally recognized by the industry as essential to
good canning operations, and they have been widely adopted. When FSIS
published its final rule for canning establishments in December of 1986,
they included a Preamble statement that, \"This regulation will reduce
the risk of public health hazards associated with improperly processed
canned product.\" It became effective six months later.

To conclude the historical perspective, the canning regulations
promulgated by FDA and FSIS resulted in a unique cooperative effort
between the canning industry and the sister agencies to address a very
serious public health concern, Clostridium Botulimon. These HACCP based
regulations are widely regarded as the first and perhaps the most
successful application to date of the principles of HACCP.

The FSIS proposal to remove the from the Code of Federal Regulations
these industry supported regulations and to replace them with
abbreviated performance standards seems to overlook this unique
background. While NFPA and its members are certainly supportive of
appropriately designed and achievable performance standards, we believe
that the severity of the hazard addressed by the existing canning
regulations justifies their continuance. The primary justification for
the proposed change is to make the requirements for this industry
segment consistent with those for other meat and poultry products.
Overlooked is the fact that it would create disharmony with the
requirements of the FDA and the recommended Code of Practice of the
CODEX Elementarius Commission. As previously noted, these were
significant reasons for publishing comprehensive regulations in the
first place.

Most of our members who manufacture canned meats and poultry products
also produce FDA regulated canned foods. We argued long and hard for
consistent regulations between the agencies as the requirements for the
production of safe canned goods are the same for both types of products.

Another stated justification for the proposed change is to provide
greater flexibility for industry to produce safe product in the most
efficient manner. While the original FSIS canning regulations were
indeed somewhat restrictive, over the past 15 years many changes have
been made both at the request of industry and of the Agency\'s own
volition, to eliminate unnecessary requirements such as those that
require approval of alternative procedures that can be documented
scientifically to achieve the same end result.

Indeed, the Agency has eliminated the many requirements in the original
rule for a mandatory prior approval of partial quality control or PQC
programs \-- . After a lengthy effort, we were able to gain regulatory
alternatives to the HACCP incompatible requirement for mandatory ten-day
incubation of canned products. While a few additional changes along this
line could be made, these can easily be accomplished with minor
amendment to the existing regulations. The drastic action proposed by
the Agency was certainly not required for this purpose.

We note that the Agency very recently released its proposed version of
guidelines for industry. While we haven\'t had the opportunity to
carefully compare these with the existing regulations, it appears that
the sole change has been the conversion requiring \"shalls\" to
recommended \"shoulds.\" Just as we objected when the initial FSIS
proposal converted many of the FDA\'s recommendations to requirements,
we find this proposal to make all of the provisions advisory to be
unconforming.

Indeed, in those guidelines they would not be suitable for regulatory
enforcement nor compliance purposes. Processors, especially new ones or
very small ones, would have no basis for knowing which of the
requirements are essential in CODEX and which are merely examples of
acceptable practices. Such a situation would seem to us to invite
problems.

On the other hand, if inspection personnel are finding fault with the
procedures of a processor who did not follow all of the provisions of
the guidelines, the industry could rightfully argue that the Agency was
attempting to enforce a guideline, a practice to which we have
frequently objected in the past.

One of the most troubling elements of the Agency\'s proposal is the
elimination of the codified provisions for developments by processing
authorities, which in our mind introduces the possibility of
inappropriate processes and procedures, especially once again by new or
small processors. Our recommendation is for the Agency to delete the
canning regulation from the rest of the regulatory proposal. At a later
date and within a separate docket if it could, undertake some relatively
minor refinements out of the existing regulations. Certainly the Agency
could combine and recodify the current separate requirements for meat
and poultry into a single section.

Other modifications to eliminate any lingering restrictive requirements
along the lines of the document we shared with the Agency in 1997, could
also be considered at that time. Indeed, we believe that it is time for
us to take another look at those recommendations provided four years ago
with an eye toward making sure that they reflect the current situation.
This would be in addition to our request of a further extension of the
comment period on this proposed rule.

As we have aptly demonstrated over the past 20 years, we are more than
willing to work with the Agency to ensure the continued safety of the
products in this food industry segment. I appreciate this opportunity
for comment. We intend to provide more input in written kind at a later
date. Thank you.

MS. GLAVIN: Thank you very much. What I\'d like to do is if anybody has
any questions for Lloyd to raise them now, but to hold the discussion
until we have maybe two other proposed comments prepared. Are there any
questions at this point for Lloyd? Okay. Jim? Jim Hodges?

MR. HODGES: I think it would be our preference that Bob go ahead, and
then I\'ll finish up our testimony.

MS. GLAVIN: Okay. Bob Dail?

MR. DAIL: My name is Bob Dail, and I work for the Dial Corporation. We
make the Armour brand of canned meat and poultry products. We are the
second largest producer of canned meat and poultry products in the U.S.
The Armour brand first appeared in the marketplace in 1867, and our
first canned product was placed in the marketplace in 1879. Product
safety is our highest priority in this business, and the reason for that
is that we believe that Clostridium botulimon is in a class by itself
among food pathogens. You don\'t have to be elderly, immuno-compromised,
an infant, for bot toxin to be fatal. None of the other organisms listed
in this proposal represents this level of threat to the public health.

At the request of the industry, the current USDA canning regulations are
very similar to those promulgated by FDA in the early 1970s. Together,
these regulations have been spectacularly successful at protecting the
public health from botulimon fatalities. The Agency states a part of its
motivation for proposing the performance standards is the recent
incidence of foodborne illness caused by adulterated meat and poultry
products. None of these incidents was caused by adulterated canned
foods. Consequently, we see no public health basis for including the
canning industry in this proposal.

The Agency states that additional motivation for the proposal was its
desire to move away from command and control type regulations. While we
generally support this philosophy, in this instance we think it is
inappropriate because its threat to public health is so significant. I
tell the management of my company that this is like making injectable
drugs. You cannot make a mistake.

Further, to provide a modified form of the current regulations solely as
guidelines with a selection of critical control points left to the
processor potentially invites disaster. We think this is particularly
true for smaller processors that do not have in-house technical people.

While most of the food products that the Dial Corporation produces are
regulated by USDA, we do make some FDA regulated products. Right now
when we comply with one set of regulations, we are essentially complying
with the other, and we are also in compliance with the recommended Code
of Practice and the CODEX Elementarius for our international sales. To
us, it makes no sense for all these regulations and recommendations to
have the same philosophical basis.

The Agency also states that it has a need to have objective, measurable
pathogen reduction. Our interpretation of this for the canning industry
is that microbial destruction genetics obtained by a thermal \--testing
will be required because this is the only real way to scientifically
demonstrate that you have a 12 log reduction of Clostridium botulimon
spores.

We view this as burdensome and unnecessary for the following reasons.
First, the alternate processes used for low acid canned foods utilize FO
values that significantly exceed 12-D. The reason for this is a
requirement that spores and all thermal heat resistant organisms be
destroyed to prevent economic spoilage.

Consequently, the need to know the process level which scores 12-D is
only useful in the event of process deviation, and even then it\'s not
required because we\'re allowed to rework or reprocess the product.
Therefore, we find the requirement to define and \-- the specific 12-D
levels for a wide range of meat and poultry products to be unnecessary.

Second, there are very few places the industry can turn to generate \--
data because the handling of Clostridium botulimon spores requires
licensing by Centers for Disease Control and Prevention. Also, the
equipment and the expertise required to do the testing is unique, which
makes it quite expensive.

Because this adds little or nothing to ensuring product safety for the
reasons just given, we view it as burdensome. To summarize this point,
the requirement to validate measurable pathogen reduction will require
an expenditure of money, time and human resources with no added safety
benefit for the consumer.

In regard to listeria testing, there is simply no scientific basis for
including the canning industry in the proposed rule and listeria testing
provisions. There is no chance that any vegetative organism can survive
a retort process, and listeria is not a first process contamination
organism for canned foods. Therefore, we think the canning industry
should not be included in this requirement. Otherwise we will be forced
to rewrite our HACCP analysis to include listeria as a hazard reasonably
likely to occur, which would then be destroyed in the retort process,
along with all the other vegetative organisms, which the whole thing
would become nothing then but a paper exercise. So the rhetorical
question is why make us do that?

The Agency has requested whether and in what form the current
regulations should be retained. From all of the discussion provided
above, we think it makes the most sense for the thermal process
commercially sterile foods to be excluded from this proposal and to
remain under the current regulatory structure. Changes made over the
past few years to eliminate prior approval requirements have made the
current regulations less restrictive. Speaking as a representative of
the second largest producer in the United States, we are quite satisfied
with them.

We think changing for the sake of consistency with other FSIS regulatory
initiatives is insufficient reason for change, given the current
regulations have been so effective in an organism this virulent. We
strongly urge the Agency, as strong as we can, to adopt this viewpoint
as well. Thank you for hearing our comments.

MS. GLAVIN: Thank you. Before we move on to Jim\'s concluding comments
on that presentation, are there questions for Bob? Okay. Jim?

MR. HODGES: Thank you, Maggie. I am Jim Hodges, and today I\'m
representing the National Meat Canners Association. The National Meat
Canners is the national trade association representing processors and
suppliers of shelf stable meat and poultry products.

NMCA was founded in 1923 to promote the interests of the canned meat
industry in the United States. NMCA members include companies of all
sizes from regional processors to large, multi-client operations. Our
members were instrumental in helping USDA develop the current canning
regulations that are in place today. Therefore, the proposed rule to
replace the existing regulations for thermal processed commercial
sterile products with the performance standards has a direct and
substantial effect on our members and the industry.

NMCA, like MFPA, opposes the section of the proposed rule that would
significantly change the manner in which thermally processed
commercially sterile products are regulated. NMCA sees no compelling
reason or rationale or need to make the wholesale changes described in
the proposed rule.

The existing rules and procedures for canned foods have been remarkably
successful in protecting the public health against the threat of
foodborne illness and death caused by Clostridium botulimon. The
Preamble to the proposed rule states that FSIS action is compelled by
the recent outbreak of foodborne illness related to the consumption of
adulterated RTE meat and poultry products. However, none of the
referenced foodborne illnesses involved thermally processed shelf stable
products, which is a testimonial to the efficacy of the current
regulations in assuring the safety of these products.

Furthermore, Clostridium botulimon toxin is one of the most lethal
foodborne toxins known. The virulence of the Clostridium botulimon
organism is unparalleled. Therefore, it is entirely appropriate and
desirous that detailed regulatory requirements such as those currently
codified in the Code of Regulations are necessarily prescriptive to
control this significant public health threat.

We applaud the Agency\'s desire to provide the industry with more
regulatory flexibility, but the production of commercially sterile shelf
stable food products presents unique challenges that require specific
procedures and controls to prevent a potential catastrophic outcome.

FSIS cannot justify replacing the existing regulations simply on the
belief that the current rules are inconsistent with other FSIS
regulatory initiatives. The existing canning regulations have been
validated over time as effective in safeguarding public health.
Replacing these proven regulatory standards with an untested regulatory
approach based on performance standards cannot be justified.

Protection of the public health should be FSIS\' first priority.
Replacing the existing canning regulations with less prescriptive
performance standards, potentially threatens public health by creating
unnecessary confusion and uncertainty in the industry.

Section 430.5 of the proposed rule describes the performance standards
an establishment must meet to achieve regulatory compliance. But the
proposal is silent regarding the nature and scope of documentation a
plant must have to demonstrate compliance with that performance
standard.

Presumably, FSIS will make the final determination regarding regulatory
compliance based on the evidence that a company presents to the Agency,
but the company will not have the benefit of knowing the threshold of
proof required by FSIS. This regulatory approach that requires an
establishment to prove that it is producing products that are not
adulterated places the industry in an untenable and precarious position.
Less industry guidance and more Agency discretion is a prescription for
creating, not solving, problems.

Additionally, the proposed rule adds new burdensome requirements by
mandating producers to thermally process commercially sterile products
and address food safety hazards associated with microbial contamination
under HACCP plans. Presently, establishments producing canned meat and
poultry products do not have to address microbial hazards in their HACCP
plan if the product is produced in accordance with the existing canning
regulations.

This exemption is permitted because sufficient microbial lethality is
achieved to assure product safety. NMCA does not support the notion that
performance standards should replace the existing canning regulations
and requests that the current exemption be retained.

Finally, the proposed rule is incompatible with regulations applicable
to the production of thermally processed commercially sterile foods
other than meat and poultry products. Several manufacturers produce
products in the same plants that are regulated by FSIS and FDA. FDA
regulations codified under 21 CFR, Part 113, govern the production of
thermally processed low acid foods packaged in hermetically sealed
containers other than meat and poultry products.

These regulations are very similar to the existing regulations codified
in 9 CFR, Part 318 and Part 381, that govern meat and poultry products.
The proposed rule would significantly alter the rules for producing meat
and poultry products, thereby creating two vastly different regulatory
regimes for foods that have virtually identical food safety hazards.
FSIS has provided no rationale to justify this regulatory disparity.

In summary, the proposed rule to change the way thermally processed
commercially sterile products are regulated is unnecessary, burdensome
and not justified based on the exemplary food safety record of the
industry. As you have heard in my testimony and in comments previously
given prior to mine, the canning industry is unanimously opposed to
promulgating the rules that have been published in the Federal Register.
We believe the proposed wholesale changes to the existing regulations
are unwarranted and respectfully request FSIS withdraw sections of the
proposed rule that pertain to thermally processed commercially standard
products. We appreciate the opportunity to comment on this important
proposal. Thank you.

MS. GLAVIN: Thank you. Are there other people with prepared comments at
this point? I have Dr. Gamble\'s name on this list, but I believe he
made his comments on the Trichina. I suspect that was his intention.
Okay. We\'re open for questions and further discussion. Dane?

MR. BERNARD: Thank you. Dane Bernard, Keystone Foods. At this point
you\'re probably what you did to deserve this verbal barrage. Let me
from my perspective, having been associated with canned foods for most
of my career, try to explain a little bit about why the response is what
it is. I noted to Dr. Engeljohn earlier that it\'s as if you\'ve touched
the Holy Grail.

MS. GLAVIN: Or the third rail.

MR. BERNARD: Or the third rail \--

(Laughter.)

MR. BERNARD: \-- as the tag line goes. It\'s almost like changing a line
in the Bible talking about changing this rule. Why is that? It would
seem that we should welcome the opportunity for more flexibility and
less rigidity in our world, but I think part of the reason is canned
foods are pretty much boilerplate. It\'s easy. You just put it in a can
and seal it right, cook the heck out of it, and it\'s okay.

Despite the fact that it looks like a fairly easy thing to do, it\'s a
relatively sophisticated technology, and the reason we don\'t have a
record of recent problems is because of the factors that need to be
addressed in successfully implementing this technology are addressed in
those rules.

The difference between, for example, a gate valve and globe valve \--
they both work. You can drain a retort with either one, but the flow
characteristics of those two valves are different, and the reason that
one is prescribed and the other not is because you need to know how they
function. It\'s those nuances that are addressed in the regulation that
I think people fear would be lost if we change those rules. The
successes that we have are the result of basically hard won battles.

One of the projects that I\'m working on is the history of food safety.
And with Dr. Turps (phonetic) from CDC, my contribution is an
investigative review of the history of canned foods, so I\'ve been
digging back through some of the old literature. It\'s surprising how a
lot of what we have arrived at today in the regulations basically came
about and people paid for it, unfortunately, with their lives to learn
some of those hard learned lessons, which has all been distilled down
into those regulations.

I began my career before final implementation of FDA\'s canned food
rules, but after they were finalized. They were adopted, but not yet
implemented. A lot of people who are here remember those early days of
implementation. It was tough getting a lot of this up and running and
getting it successful. With the publication rule and implementation
rule, we were not successful for years after that rule was published. As
a personal note, being the laboratory person at the time about all we
did when I started with that organization, which was then National
Canners, was examinations on spoiled canned goods trying to find out
why.

Over the next ten years after finalization of that rule, that book of
business, if you will, of spoiled canned goods went down. I personally
relate that to the success over time of understanding those regulations
to the point where they became steady state and common practice. The
industry understood what was in those rules, and the inspectors in the
field understood what was in those rules, and were able to inspect
according to those rules and get good results. And the industry was able
to understand and comply with those rules.

These were not easy times. They were difficult times, but we\'ve
forgotten now that we did have problems with canned goods at one time. I
think what you\'re hearing now as a universal response is that people
who were part of that were, and I think rightly so, proud of their
successes and feared that the problems that we had are only asleep and
that they could be back.

We\'ve seen an erosion, I think, of commitment to safety of canned
goods. FSIS at one time had a canning group, which is no longer. FDA\'s
expertise in canning is probably gathered in this room. That\'s how few
people there are left because we haven\'t had problems, and we all know
money follows problems.

I think there\'s a fear that changing the rule itself will be a further
erosion of the fabric that supports the safety of this technology. I
think as an emotional issue, that\'s kind of what you\'re hearing.
We\'ve heard a lot about what we don\'t like about the rule, what
changes might bring, but at a gut level, we\'re talking about looking at
successes that we\'ve had, why we\'ve had them and fear that we may be
further undoing the reasons for that success.

Thanks.

MS. GLAVIN: Thank you. That was very helpful. Other comments or
questions? Thank you. My helpers are over here telling me that there\'s
someone behind me.

MR. COLE: William Cole with Techni-CAL again. On the advice of my
colleague, Mr. Bernard, I switched to decaf during the break. I think
one of the things that you\'re hearing from the people that made the
presentations today more than anything else is that low acid canned
foods as we generically refer to them are not your typical ready-to-eat
foods. They are in an extremely unique category. Let me give you an
example from my FDA career of how unique at least the Agency looked at
this class of foods as being. I was initially trained in a two-week
course on HACCP inspections, most of which was in the performance of low
acid canned food inspections, in 1973 under those instructors who worked
for the Pillsbury Company. Pillsbury was early into this type of food
safety control.

Okay. Once a certain core of investigators like myself were trained, we
went out, and we did inspections of the low acid canned food industry.
Something that is also not known to a lot of people, is that we had a
voluntary HACCP program involving six different categories of frozen
heat-and-serve type foods.

For a number of years our investigators such as myself got more and more
experience basically in evaluating the basic principles behind the
establishment of the thermal process, behind delivery of the thermal
process, documentation of delivery, as well as container entitlement.

Now, the uniqueness of this was pointed out by virtue of the fact that
when the FDA upgraded their program, their compliance program, for the
inspection of store pharmaceuticals, they realized that they didn\'t
have a very large base of trained investigators to go in and actually
look at the processes that would be \-- from the standpoint of the
establishment of those processes.

They actually sent in initially investigators who had been trained to do
canning inspections because they had this basic background. So there was
a recognition on the part of the Food and Drug Administration at that
particular point in time, I think, of the uniqueness of the canning
industry. I think before FSIS decides that they want to shift thermally
processed low acid foods over into the rest of the category of
ready-to-eat foods, you need to take a look, a very hard look, at the
uniqueness of this industry and the potential problems that can occur by
considering it to be a category of foodstuffs like any other
ready-to-eat.

As I said, I think some of the comments that have been presented today
more or less voice support to this and demonstrate I think a real
concern.

MS. GLAVIN: Thank you.

MR. DERFLER: It\'s Phil Derfler. Let me ask the question that Bill\'s
comment raised. When I was at FDA, everybody talked about the canning
regs as the HACCP regs. You know, that was the first model for the HACCP
regs before we moved into HACCP for seafood and infant formula and a
couple other places.

The question that I have is we\'re really not talking here about
necessarily moving the canning provisions into other ready-to-eat foods.
We\'re talking about integrating the canning provisions into the HACCP
rule because there\'s the exception in 417.2. My question is if this is
essentially a HACCP program, and that\'s kind of I think what Bill just
talked about, why is it so hard to do that?

MS. SWANSON: Katie Swanson. I\'ll take a stab at answering that. Because
we do have facilities that have HACCP regulated products and not HACCP
regulated products.

We at Pillsbury look long and hard at how we can capture the information
that we currently gather for thermally processed products in a HACCP
format. There was a desire by some to have consistency within the
company, more the types of things that you\'re talking about, and it is
based on the same thought process to define what can go wrong and how
can you prevent it.

As you define the processes and products that we produce, the format
that you envision for HACCP where you have the seven columns with all of
these things delineated across, just aren\'t amenable to documenting all
of the things that you have to do with thermally processed products.

Because of that, we have captured HACCP as a prerequisite program within
Pillsbury because it\'s not just here\'s the step, here\'s the process,
here\'s the hazard, here\'s the control. It\'s more all of that is done,
and here\'s your authorized process, guys. Here\'s the particle size you
need to do. Here is the time, the temperature, the pressure, et cetera,
all on one page. It\'s just a heck of a lot easier to communicate to the
plant, the expectations and requirements if you do it in that format.
And there\'s all of that underlying don\'t change the valves on the
retorts and make sure you have your heat penetration done. It\'s just a
more effective way to manage it.

MR. DERFLER: Let me just ask you to clarify something that you said. You
said HACCP has a prerequisite program. Do you mean low acid canned foods
is a prerequisite?

MS. SWANSON: No. Yes. Thermal process is a prerequisite program \--

MR. DERFLER: Okay.

MS. SWANSON: \-- under our HACCP program for those plants that can
products.

MR. DERFLER: Okay.

MS. SWANSON: We have products that are FDA regulated. We have seafood
products that are in a can on the same lines that do USDA products. So
we\'ve got to manage all those things.

MR. DERFLER: Thank you.

MS. GLAVIN: Jim?

MR. HODGES: Phil, it might help to answer your question in a very simple
way. If you look at almost all of the regulations in USDA prior to the
publication of the canning rules, they related to a finished product
standard of some form, in some form or another. When the canning rules
were published, that was the first time that we started to try to
regulate the process, not the product, and that\'s the reason that
they\'re called HACCP regs because we\'re regulating the process, not
regulating the product.

MR. DERFLER: Thank you.

MS. GLAVIN: Charlotte, did you have a question?

MS. CHRISTIN: Yes. Hi. Charlotte Christin from CSPI. I had a question
for Katie, and actually it is in regards to, if things are regulated or
done through prerequisite programs, our concern would be whether the
Agency has access to documentation. Could you address the issue of
Agency access to documentation?

MS. SWANSON: Katie Swanson. With regard to thermal process regs, yes.
They have access to the records. If they ask for anything with regard to
our thermal process records, we give them the records.

MS. CHRISTIN: Charlotte Christin again from CSPI. One of the concerns
with prerequisite programs that we have is the Agency\'s access to
documentation and I guess the concern about if this were managed under a
prerequisite program such as the issue with the rest of the HACCP
program. I mean, one of the things that the Office of Inspector General
said in his report last June was that he was concerned that the Agency
didn\'t have access to all of the information that might be included in
the Prerequisite Program, and a concern about things being left outside
of HACCP.

MS. SWANSON: But with regard to thermally processed products, they are
covered by the regulations, by different regulations. Because of that,
that issue does not exist. They are accessible.

MS. GLAVIN: Dane?

MR. BERNARD: Dane Bernard, Keystone Foods. I\'d like to comment on that
as well. We don\'t have that issue if the canned food rule stays in
place. You have that issue if we transition HACCP. Let me give you a
good example. The canned food rule requires seam examinations. This is
when you cut the can down you make various measurements, and you make a
judgment call as to whether that seam construction \-- this is more in
terms of whether it is accessible.

Where that falls if we transition to HACCP, I mean, it\'s covered
broadly, but whether it lands in a HACCP plan or whether someone wants
to call it a prerequisite program I don\'t know, and that\'s assuming
we\'re going to put can seam examination in as a critical control point.

I don\'t know sitting here what kind of critical limits I would put on
that because of the judgment of what is a good and bad seam is an expert
operation because there are several measurements that we can make on a
judgement call judgement call to say this is okay. There are guidelines,
but there are nothing that I recall as critical limits.

You\'re also required to add a germicide to the cooling water, and there
are guidelines on how much. There is nothing I would call a critical
point in that. So by transitioning this into HACCP there are several of
those issues that now become what I would call the \-- that I\'m not
sure we would like to open that Pandora\'s Box.

MS. GLAVIN: Thank you, Dane. As usual, you cut to the heart of the
matter. Thank you. Okay. Are there questions or comments on this section
of the proposal? We will close with that comment.

Our next area to cover, which is scheduled this afternoon, but I suggest
we move ahead as we thought we might, is the economic impact of the
proposed regulations and the cost benefit data needs that the Agency has
with respect to moving to a final regulation.

I\'d like to ask Phil Spinelli from our Office of Policy, Program &
Development Evaluation to present this issue. Phil was the lead on
putting together the economic and cost benefit information for the
proposed regulation.

(Pause.)

MR. SPINELLI: Is the microphone on? Everybody can hear me? Very good. My
name is Phil Spinelli. I\'m currently with the Agency, and I have the
pleasure to try to assemble as much information as I could as to the
regulatory impact assessment for the proposed ready-to-eat rule.

What I would like to cover today is five topics. I\'ll first give you a
brief overview of the regulatory impact analysis and impact assessment
framework where this information fits into the regulatory framework.
I\'ll spend most of my time on the preliminary estimate on the industry
costs, particularly the impact of the higher performance standards and
the mandatory testing of the listeria species.

I\'ll try to break those costs down to give you some idea of the cost
impact on small entities, and I\'ll spend a fair amount of time on the
preliminary estimate of social benefits and then finally compare those
industry costs with possible social benefits.

Moving quickly to the purpose of the regulatory impact assessments,
there are three \-- as I see them; the estimate of potential social
benefits and costs, the proposed options. We also identify and assess
regulatory alternatives. This material is in the proposed reg and
economic impact material, and what I will be going with and presenting
also in the appendix of that proposed rule. Hopefully this provides a
framework for public comment and further improvement.

Now, along these lines, what I have tried to do is I tried to take some
of the comments that were made yesterday, and I recognize that there are
people that are particularly motivated to look into the assumptions that
were made. This is a means to better flush out some of the data needs
whereas our particular need in this analysis, and I\'ve worked with my
colleagues in FSIS and other agencies to try to get a better handle on
this thing. As you can imagine, it was quite an effort, and it will
continue to be.

I have a limited number of copies, but for those that are particularly
motivated I would like you to follow along. What I did is also provide
in my speaker notes a lot more detail that you might be able to respond
to.

Just to finish off on some of the bigger picture here of the regulatory
impact analysis, one job really is to try to establish a baseline of the
industry\'s behavior and also on the benefits side, the consumer side,
and then try to forecast or estimate to the best of my ability the
regulatory induced changes in industry practices that might come about
with the proposed rule, and create a scenario which incorporates this
impact of the changes in the industry and the health benefits, and then
compare those two.

In that light, I\'d even like to refine that or boil that down into even
simpler jargon that I would like you to view as a focusing device.
Hopefully I\'m going to take the material that I\'ve gleaned here in the
last two or three days, and other material, and try to focus that so our
policy makers can make a more informed judgment and policy.

I would like you to follow along as best as you can and focus on any
comments that you can make that would help me better identify how to
clarify any of the materials I present in the larger framework and then
the specific estimates; any clarifying comments on those two points, the
general framework and then my general estimates. Afterwards, I\'d like
to open it up then for others and myself, if appropriate, to address
your concerns, your comments on maybe better estimates that I might be
able to use, more informed data, knowledge, information.

In that light, let me go right into the preliminary assessment of the
performance standards. On the impact of the performance standards, as
well as on testing, the general framework is I look at the direct cost,
and then I look at indirect costs. The indirect costs are more the
unintended consequences of the rule, the economics that cause spill over
effects, or extranalities. These aren\'t intended. We need to recognize
them, the possibility. We need to quantify those as best as we can.

The first thing we do with the impact of the performance standards is we
try to estimate how many firms might be potentially affected by this
provision and in what ways. In direct costs, there might be some one
time initial costs in validating the processes in order to assure that
the performance standards are being met. They might also include any
equipment costs in processing those food items, cooling them down,
whatever. Then there\'s also some recurring costs that might directly
impact the firm in additional processing, longer times, higher
temperatures, other processes, irradiation and what have you.

The number of firms in this industry that I have identified that might
be potentially affected are roughly one-third of the firms in what I
classify as the Group 1, Subgroup 1, and Group 1, Subgroup 2 and 3.
Those are the fermented dry and summer sausage producers, salami, dried
beef and pork product producers, salt cured country hams and one-third
in the sausage and meat and poultry patty industry.

The reason I say that is because assuming that the other folks producing
similar products are already complying with the roast beef rule, and
that\'s why that assumption was made. What that does in the analysis is
cuts the number of establishments down to roughly 50 in the first group
and 25 in the second group. You can see that in your notes as you go
through that. That would be data need number one. If I could
particularly address some data concerns, that would be a valuable piece
of information. I would welcome your comments later.

You\'ll see in Section 2 down below there we have to get the number of
products that these folks are going to produce and how many potential
production processes might need validations to see if they\'re obtaining
the performance standards. To do that, there is a whole host of
assumptions as well.

The large firms in Group 1, Subgroup 1, produce 30 items, small produces
ten items, and the very small firm category five. You\'ll see similarly
down in Group 1, Subgroup 3, similar assumptions. Somewhat different,
but we figure that \$5,000 cost to validate those processes. That\'s how
we arrived at the first year \-- cost.

The first year recurring costs again in 75 firms through census date
estimated that they produce roughly 441 million pounds, and another
crucial piece of information I assumed was these processes would amount
to about a one cent per pound additional cost on each product. That
would include all equipment costs for higher temperatures and so forth.

I said there were direct, and then there\'s going to be indirect costs,
too, in the general framework. In the indirect HACCP performance
standards, I would like to know more about the potential impact on
short- and long-term rejection rates. These firms expect that their
rejection rates will go up after an increase in time and temperature or
whatever new processes, but in the long term maybe those rejection rates
would go down and be a benefit.

Speed lines. I would be interested in knowing if a lot of these meat
patty plants have a stainless steel conveyor belt. Would they be
required to slow down those speeds, as opposed to increase temperatures
or a combination of both? What would that do to their annual production
level? This would be an unintended effect that would reduce their
profits, their volume of production and thus their profits.

What would be the impact of recalls? Product quality. Product shrinkage.
You can see in the speaker notes there, one example that was submitted
to us was the potential shrinkage in meat patties. That might be a
sizable loss for particular products.

In summary, the direct costs, and I believe the previous slide said at
this time there are no indirect cost impacts that were estimated. I
simply did not have enough information to base any of those on. I would
welcome any comments along those lines.

We have right now a preliminary direct cost impact first year, \-- costs
in the validation process of those processes is \$2.72 million with an
annual recurring cost of \$4.41 million for a total first year impact
cost of a little over \$7 million. That\'s just on the performance
standards alone.

Now going back to the testing provisions, as Dr. Engeljohn explained
yesterday it\'s an either/or proposition. We look at the decision by a
firm to go and elect to go modify their HACCP plan to incorporate a
critical control point addressing Lm contamination or instead go with
the actual testing of product contact surfaces.

The way I went about trying to get a handle on this component of the
reg, to the best of my information \-- NFTA did a survey last year, and
we did our survey assessment about a year ago \-- putting together some
thoughts and making some assumptions as an economist, and I\'m allowed
to do those types of things.

Currently 50 percent of the large establishments have a CCP incorporated
into their HACCP plan that addresses Lm concern. What I propose is that
or forecast is that 100 percent of those plants would like to develop
and incorporate a CCP addressing Lm in their HACCP plan. I\'ll show you
in a minute what my logic was there. There again, that\'s another
critical piece of evidence that I would like to have, as well as these
other assumptions. For small, I assume right now about a third of the
firms currently have a CCP addressing Lm contamination. That would go up
to 50; very small ten, and that would go up to 20 percent.

If you do the math with the number of firms that I\'m dealing with, it
appears that we would have and switch over, and that\'s in your speaker
notes as well, 257 firms that would elect to take this option. Again, I
used roughly a \$5,000 estimate to modify their HACCP plan. That might
be high. It might be low. I saw estimates ranging from \$2,000

problem to \$20,000. Any comments that you might have concerning that
estimate would be helpful.

Again, some of the logic that I used, and I welcome any suggestions
here. As I looked at the requirements that are applied with the proposed
rule, if you look at the large plants with six lines per establishment
is what we estimated or thought would be representative of large firms
times the four times per month requirement to test, 24 tests per month.
We have a cost for testing that we could do in our little survey was
\$35 a test, not \$6 or \$8. As Dr. Tompkins was saying it would be as
an in-house test, so there\'s another piece of evidence that would be
very helpful. If you multiply that out, the \$35 times 24 tests per
month times 12 months a year, that would impact large firms a little
over \$10,000 an establishment. Again, their option as opposed to that,
they would be looking at \$5,000 to incorporate a CCP into their HACCP
plan. Similarly with the requirements times the cost that I used, and
that\'s also in your speaker notes in the handout. Those are what it
would imply for small and then the very small establishments.

In total, when you have the number of plants and deduct the 257 that
would foreseeably go into the HACCP plan modification, that leaves 835
that would be open for testing. Those testing costs over the industry
would be \$1.75 million a year.

Now comes some of the more interesting items, some of the things that
were touched upon yesterday. I must say I gained some insight yesterday
and particularly on Tuesday. But we\'re interested also in identifying
the indirect costs.

In the testing area, they\'re very similar to the performance standards,
rejection rates, impact on recalls for quality. Perhaps the testing
would not affect line speeds and shrinkage as much, but we were
concerned, as was commented on yesterday, on the potential impact of
increased testing and detection of Lm and what that may imply for
testing all occurrences, disposal of product and the storage capacity
question.

Unfortunately, I did not have a lot of data on these sorts of things. I
was wondering what the audience member who did a \-- envelope
calculation and what he thought it would cost his plant for just a small
increase in the number of tests on hold kind of occurrences. This would
be very valuable information. Particularly with small operators and very
small operations, this would be a particular concern.

There was one indirect impact, though, that I did venture out to try to
quantify, and that had to do with the need for production adjustments in
order to eliminate any listeria species contamination that would have
been detected by the increased amounts of testing.

These production adjustments are along the same lines as much of the
discussion on Tuesday; increased sanitation efforts, redirection of the
processes, these sorts of things that firms can do. All the way up to
the last speaker today talked about actually incorporation of
post-lethality treatments for products.

One of the basic assumptions here is that I would assume that a large
number of plants will not incur any additional costs due to the testing.
I would imagine they would not have a serious contamination problem.
Now, why did I assume that? I assure you that what I tell you now is
previous knowledge of what Dr. Tompkins said yesterday, but it is
amazing how similar some of the numbers are. I never talked to him
before, never met him before yesterday.

He did give me an estimate of about 85 percent of the plants for the two
years of data that he had that of the plants that he had looked at about
85 percent of the plants did not have an occurrence of more than two
consecutive positive Lm finds.

That stuck in the back of my mind because one of the first things I did
when I came to the Agency was I looked at some of the microbiological
survey data, and for the one year that I looked at, and this is
alternatives, and I\'d like to further explore this. I looked at the
initial positive finds, and then I also looked at the firms that were
found to get a negative within five consecutive time period tests after
that period of time, in what\'s called a follow up test.

Looking at that data, it appears that about 85 percent of the ones that
had an initial one or two follow ups in our microbiological survey data,
about 85 percent of the plants it appeared, cleared up their listeria
problem promptly. So different data but roughly similar kind of
magnitudes.

Why is this important? I\'m going to have to try to predict on if you
have had increased testing what\'s the likelihood of finding a firm
that\'s going to have a chronic problem and what\'s their most likely
remedy sources and what\'s that going to cost them.

This is a post \-- . Roughly 85 percent I assume would not incur any
additional cost. And from the tentative data from the FSIS
microbiological survey data it appears that another seven percent will
have a number of follow up tests, and they would most likely run into
some important modifications that would cost them some money.

To the best of my knowledge, the type of increased sanitation, the
operation of sanitation efforts, this sort of thing, I estimate about
\$2,000 per line cost. Seven percent of those firms or of the industry I
think works out to be 104 \-- it\'s on your speaker notes there \--
would incur those kinds of costs.

Another seven percent would incur one-tenth of one percent of gross
sales. They would have a more serious Lm problem and maybe have to
realign drains, production processes, these sorts of things. That cost
estimate came out of the literature in the early 1990s and is documented
in the preamble or the appendix.

That leaves roughly one percent then that would have a chronic listeria
problem and would elect to drop out of ready-to-eat production. This is
something that you should note on the general framework. The numbers
\--or if this framework is faulty, I would like to get comments on
those.

If you multiply those numbers out, we have a

one-time production adjustment cost. Those are the firms at seven
percent and the additional seven percent. They would need to fix their
plant. They would have to take steps to clean up their listeria
contamination problem to the tune of about \$2.5 million.

Add that also to the one-time cost to the folks that modify their HACCP
plan at \$1.2 million, as we talked earlier. The subtotal for one-time
costs is \$3.78 million, and then they have this recurring testing cost.
On the testing program, we have a first year impact of \$5.53 million.

The total impact of the performance standards and the testing, if we add
those two together, to validate the performance standards is \$2.72
million; to modify your HACCP and put a critical control point
addressing Lm contamination, \$1.29 million. The production adjustment
we just talked about. You get a subtotal of \$6.5 million. That\'s the
way it\'s broken up between the two provisions.

We have to add onto that a return cost, the increased processing cost
related to the performance standard of \$4.41 million, in addition to
the testing cost of \$1.75 million. So your total first year cost impact
is \$12.66 million about evenly distributed between the two provisions.

Similarly, the cost impacts. The first year, all the costs, \$5.53
million related to testing; performance standards, \$7.13 million.
Again, that total is \$12.66 million for the first year, and the
recurring costs then thereafter are \$6.16 million per year.

Over the two years I established a baseline. I explain that in the
appendix. In today\'s dollars, \$68.1 million. Over ten years as taking
those future values and bringing them to the present, \$48.3 million.

If you haven\'t had a chance to look at the appendix and the impact on
small entities, this might give a little bit of a flavor in the
aggregate what those costs translate into and the incidents on the
different size firms. There\'s also quite a bit of data in the appendix
on the specific product groupings that were used so you can get a better
idea perhaps on a particular industry\'s particular product type.

Just for a real global snapshot, we have 32 percent of the plants that,
since we\'re using census definitions and numbers, would be classified
as very small plants employing less than ten, ten or less employees.
They may absorb 15 percent of the total impact. The number of small
firms are a large chunk of the folks in the industry. Fifty-nine percent
of the firms absorbed roughly 54 percent of the impact that I\'ve
identified up until now with mostly direct costs. Large firms. Nine
percent of the firms, but they absorbed 31 percent of the impact.

That makes perfectly good sense when you look at the processing, the
additional processing that\'s associated with the performance standards
as item based. When you look at the testing, for the most part that\'s
item based as well.

There is some additional data in the speaker notes here and what that
might imply for a typical small firm, very small firm and large firm,
from each of the provisions that might pertain to their situation.
Basically with the performance standards, the potential impact on those
75 firms, those very small firms within the group, roughly \$40,000 a
year, small firms a little under \$90,000 a year, and the large firms
\$630,000 a year just on the performance standards. It\'s very difficult
to get some of these bigger picture type numbers out to you. I know it
probably would be more meaningful, but given the diversity of the
products and size of the plants and what might pertain to them, it\'s
difficult.

I think I\'ve made quite a bit of comments there on what kinds of data
and data gaps exist on the cost side. I\'d like to look now on the
demand side, the consumer side. I want to specifically limit this. My
benefits discussion at this time is really limited to the improved food
safety that\'s possible and spurred on by the verification testing for
Lm. I would be welcome to receive any comments from you.

The logic on the testing benefits that I\'ll be discussing are simply
that increased testing hopefully and theoretically would imply that we
would have a decreased probability of contaminated product going out
through the commercial channels, less contaminated product and fewer
instances and deaths.

We have to ask ourselves some very, very tough questions, and I know
there was a lot of discussion in the last two days about a lot of these
topics. They\'re very difficult ones to address. Be that as it may,
they\'re important for any kind of analysis.

This is very preliminary, and I want you to keep that in mind. I would
very much like to receive any comments on any specific estimates, but
particularly when we move to the comments on maybe perhaps better
estimates for other ways for going about this thing. I\'d be
particularly interested to hear your comments.

The best thing that I\'ve come across and most people in the industry
use is Dr. Mead\'s study from CDC. He\'s estimated about 2,500 listeria
cases were associated with about 500 deaths from all sources in the
U.S., so therein lies the first major hurdle of what is attributable to
the consumption of meat and poultry products. A \$64,000 question. In
fact, it\'s been such an inflationary time since that was first said,
it\'s probably worth a whole lot more than that.

Also, once you\'ve established that, what is attributable to actions at
the plant? What could actually be feasibly reduced at the plant by
actions taken at the plant? What\'s the impact of other measures? We\'ve
heard lots of other measures. This would be private sector initiatives,
as well as regulatory induced or facilitated.

We heard some scientists talking about the incorporation of additional
secondary inhibitors in certain products, these kinds of things, so we
would want to try to adjust and account for those, the benefits of those
other measures.

If we know those first three, are we confident then? Do we know enough
about the effectiveness of the measures that will be taken by the plants
in response to increased listeria testing?

There are some other questions on the rate of beneficial impact. Do you
get this impact overnight? Is there a flood of benefits over time?
There\'s the whole question of how to monitor all these benefits. We
have an additional speaker to address those issues from the Economic
Research Service this afternoon.

Let\'s first try to address that first issue. We have two estimates
linking meat and poultry products to Listeriosis. The first one is the
recent draft of the FDA/ FSIS risk assessment, and they ranked relative
risk across many food products.

While we feel there is an FDA/FSIS risk assessment, when I started in on
this project, I had to piece together two independent studies by Dr.
Mead and Dr. Olson down at CDC. Linking those two studies I feel will
give a little about perhaps cases and deaths, but we have to recognize
that I\'ve made some tenuous assumptions in order to do that, and I hope
to be very clear and transparent how that came about so I don\'t give
any false impressions of precision or anything like that. I don\'t want
to do that.

All right. Let\'s look at the FDA risk assessment, the FDA/FSIS risk
assessment. If you\'ll look at that data, it would suggest or it does
suggest to me anyway that over 65 percent of the cases and deaths are
attributable to ready-to-eat meat and poultry products. A huge
proportion, over 90 percent of that proportion, was attributable to deli
meats. The remainder was attributable to deli salads, hot dogs, pate,
\-- and sausages.

So the bottom line on the FDA/FSIS risk assessment is if you apply those
estimates to Dr. Mead\'s numbers you get roughly 1,660 cases of
Listeriosis resulting in 331 deaths per year. That would be directly
attributable to the consumption of meat and poultry products.

Dr. Olson had made another study earlier on, and she looked at the
transmissions of different diseases, Listeriosis being one of \-- excuse
me; total foodborne diseases and attributed eight percent of total
foodborne diseases to the meat and poultry products, so if you can make
that leap from total foodborne diseases, Listeriosis, which is a jump,
and apply those to Dr. Mead\'s number of annual cases and deaths, you
get 167 cases and 35 deaths per year, roughly a tenfold decrease. The
FDA is a tenfold increase.

Okay. Now, if you have the notes there\'s quite a bit of assumptions,
quite a few assumptions that go into this slide. I\'ll try to walk you
through it as best I can so you\'ll know what\'s involved in the
numbers.

The unadjusted Mead-Olson and draft FDA/FSIS risk assessment study. The
FDA/FSIS study are the higher range and the Mead-Olson. A combination of
those two studies are on the left. Remember, I had on the other slide
that we have to identify some kind of a reasonable assumption on the
flow of benefits. In your speaker notes, you\'ll see I assume a five
percent benefit accruing the first year, ten, 15. Additional comments on
this estimate would be helpful.

If you apply those numbers then to both sets of raw data you come up
with average annual cases over ten years at 87 to 863 possible case
reductions, cases that could possibly be reduced from the testing
provision, given those initial numbers and the benefit stream. That
implies a death reduction that would be possible of 18 to 173.

Now, what I did is I tried to then be as conservative as I possibly
could and address those for some of those factors that I\'ve identified
that we don\'t have very good estimates of and that we would be
particularly interested in getting your opinion on. I adjusted those.
This adjustment is for what can be controlled at the plant. I made an
estimate that about 60 percent of what occurs could be possibly
controlled at the plant. I can go into that. I can clarify that if you
need what was that based on. That might perhaps elicit more clarifying
comments on your part that could clarify this part of the analysis.

If you accept that, to develop a feasibility set then one could say how
many cases then could you reasonably reduce from actions taken by the
plant. The total pie that\'s possible is 50 to 496 cases that could
possibly be reduced, and that implies about a ten to 99 death reduction
per year average over the ten years. Now, that\'s the total pie. We all
know that the internal combustion machine, what you put into it you
don\'t get that transmitted 100 percent. There\'s all kinds of losses.
We would assume the same thing. A benefit is not going to be 100 percent
effective. I failed to come across in the literature what kind of
reasonable assumption could be made on the percentage of that feasible
set that could be reduced due to program effectiveness.

For illustrative purposes, this is 50 percent. Even if you assume that
50 percent of that bigger pie could be reduced, then you\'ll come down
with a possible case reduction of 25 to 248. Associated with that is
five to 50 death reductions. You may want to keep in mind that five to
50 death reductions per year.

Let\'s summarize what we have on the cost side and on the consumption
side here. First, your costs are a little under \$13 million. The
recurring costs, annual costs of increased production, processing and
testing to the industry, \$6.16 million. The cost over ten years is a
little shy of \$7 million.

Benefits in lives saved. When you have a five to 50 on an average annual
basis over ten years, that is your five to 50 deaths avoided. That\'s
highly dependent on your assumption of what is the percentage of total
Listeriosis cases and deaths attributable to meat and poultry products,
the percent that is attributable to plant actions or what could be
effectively reduced at the plant, the impact of other regulatory actions
and other actions that are spurred on through the private sector to
better address listeria contamination. And then the effectiveness of the
measures that would be taken by clients in response to the testing
provisions.

You can see that my focusing tool is that general framework, and I\'m
trying to pick up pieces of information from everywhere I can. If you
were sitting here the last two days, I think you can appreciate some of
the ranges on the cost side and on the benefits side that I have to put
through this viewer in order for our policy makers to capture the
essence of the impact both on the cost and the benefit side.

When I summarize the major costs and benefits of the rule, and I don\'t
believe my colleague from ERS is here right now, but this afternoon he
may be able to put more of the benefit side, the cases and deaths
avoided, more into a better focus and the monetary side. But from my
preliminary data it would suggest that the benefits far exceed the
costs.

Of course, you have to recognize that this is preliminary, particularly
on the indirect cost side that we\'ve really heard much about the last
two days that we\'ve been aware of that we would like to quantify, as
well as qualify. We know these things exist. These would be important
pieces of information. Of course, we seek additional data and comments
on costs and benefits.

I would open up the comments, and if I could move down then to comments
that would pertain to your need for me to clarify the framework that I
presented in the material?

MS. GLAVIN: Phil, I\'m going to suggest that given that it is 12:15 and
that we have an ERS presentation that will also be of use for a
discussion, that we break at this point unless somebody needs to ask a
question right now.

Let\'s try and keep it just to a couple of questions and then discussion
when we have more information on the table.

MS. SMITH-DEWAAL: Maggie, it\'s Caroline Smith-DeWaal from CSPI. I
appreciate you recognizing me. I have to go. I\'ve been asked to give a
briefing to the House Appropriation Committee members at 1:00 p.m., so I
won\'t be here this afternoon.

MS. GLAVIN: Okay.

MS. SMITH-DEWAAL: This is my one shot.

MS. GLAVIN: Okay.

MS. SMITH-DEWAAL: Of course, Charlotte will be here all afternoon.

MS. GLAVIN: She will eagerly represent you.

MS. SMITH-DEWAAL: Very well. The one thing I will need clarification on
perhaps after lunch is the issue of the Olson study. I have never seen
an assessment that says that meat is only responsible for eight percent
of foodborne illnesses. I have notes of the CDC outbreak data that has
outbreaks linked to food sources, so it doesn\'t include outbreaks where
there are unknown food sources. In that listing, 20 percent of the
outbreaks are linked to meat and poultry products.

Now, I can do another assessment \-- I don\'t have it with me, and I\'ll
include it in our comments \-- that includes the case percentile linked
to meat and poultry products linked to outbreaks. But I will get you
that data. I\'ve never seen anything so low. We also believe that 20
percent figure is low compared to FoodNet data on Campylobachter. That
is just one point.

The other thing is, in the indirect impacts, you haven\'t thought about
lawsuits. The reality here is that these illnesses are terribly
devastating. When they occur, about 90 percent of the people are
hospitalized, and 20 percent die.

I have, and I will submit for the record, the *Washingtonian* magazine
article from July, 2000, in which a woman with no high risk who didn\'t
meet any of the high risk criteria ended up with bacterial meningitis
and with chronic effects, with very severe effects. Two other women,
both of whom have independently called me, had miscarriages as a result
of that pate outbreak.

I\'d like to submit this statement of Lisa Lee, who lost twins as a
result of the Sara Lee outbreak. Her babies she lost 20 weeks into the
pregnancy, and they were named Andrew and Alicia. And Mary Winkerstorff,
who also lost her pregnancy at four and a half months. I would like to
submit these as actual examples.

The thing that I need hopefully for you to think about is the issue
which is very much \-- it may not be part of what the economists think
about, but it\'s certainly what the lawyers think about when they see
cases like this.

There are issues around when a life is lost due to listeria, it is not
only an economic detriment to the person who died. It is a serious
tragedy for the people who survive. There is loss of companionship
issues, for a miscarriage loss of potential, the potential child, the
potential life that was going to be. This is a tragedy for the family,
and in legal terms we talk about issues of pain and suffering that
accompany that kind of a loss. That also goes to if you survive, but you
have a chronic outcome.

I think you should consider this. I can see this is not complete because
this is the first time I have seen one of these cost/benefit analyses
where there are no benefits enumerated. I mean, you talk about them, but
there\'s no number. We can debate the cost of a life. I mean, you know,
there\'s lots of vehicles for doing that, but I think you need to add in
one more thing. There is a benefit to the industry to not have these
very devastating lawsuits and loss of corporate reputation.

I mean, we know what happened with Bill Marr and the Sara Lee
Corporation, but that can happen to many other companies. Cargill
recently experienced a similar recall. I think that there are benefits
on the corporate side, and you need to consider in addition to the
economic value of the life that is lost, the loss to the family. That
should be an additional consideration.

We would be happy to ask the many women and families who have contacted
us following losses like these to submit letters talking about what that
pain and suffering is like if you would like to go through that analysis
as part of your analysis, but I think without that, I mean, it\'s
clearly something that\'s going to come up if this reg isn\'t
implemented, if things continue as they are and if the companies get
sued. They are going to pay pain and suffering losses every time they
have to settle one of these cases or when they go to Court. These can be
huge. I think that\'s a real gap in your analysis so far. Thank you.

MS. GLAVIN: Thank you for that, Caroline. I\'m sorry that you will not
be able to be here for the rest of the discussion. We will return at
1:30 to complete our discussion on this topic.

(Whereupon, at 12:30 p.m. the meeting in the above-entitled matter was
recessed, to reconvene at

1:30 p.m. this same day, Thursday, May 10, 2001.)

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[A F T E R N O O N S E S S I O N]{.underline}

(1:37 p.m.)

MS. GLAVIN: We\'re getting down to the hard core attendees at this
meeting. What I propose to do is ask Steve Crutchfield from Economic
Research Service to make his presentation because I think that will
inform the discussion of both Phil\'s and Steve\'s presentations. I
think that would be the most useful way to do that. Steve, are you
ready?

MR. CRUTCHFIELD: Sure. I\'m Steve Crutchfield, and I\'m an economist
from the USDA\'s Economic Research Service. I\'m head of the Diet Safety
and Health Economics Branch. What our group does is we look at a variety
of issues related to food safety, diet and health issues. Our task is
basically to put numbers on things.

The sort of work that we do and have done over the years has been to
look at in the case of foodborne illnesses looking at what sort of costs
foodborne illnesses impose on society. When people get sick from things
like listeria,

E. coli 0157:H7 and so forth that imposes a cost on society, and our
group has been working actively for a number of years to measure what
some of those costs are.

The second part of my job is to work with agencies like Food Safety
Inspection Service. When a rule is proposed, or some action is taken
designed to address a public health issue such as listeria in
ready-to-eat products, what we do is take some of our economic analysis
tools and answer the question, what are some of the benefits associated
with these rules, because ideally what we want to have in the end is a
situation where the government society expends resources to address a
problem, in this case listeria. We want to ensure that the benefits of
whatever we do are at least hopefully greater than the cost of whatever
it is we\'re trying to achieve. I\'ll give a brief overview, and I
apologize for not being here this morning to hear Phil\'s remarks. I had
an advance peak at his slides.

The issue here is a new RTE rule to prevent premature death from
listeria. What we did at ERS is we started with some of the assumptions
that were given to us by FSIS that I understand Phil ran through this
morning. Estimated cases prevented at 25 to that should be I believe 248
rather than 48, estimated deaths prevented between five and 50, and an
estimate of some of what the costs of this rule might be at \$68 million
over ten years, which is \$48 million is present value terms. This is
what the cost of this proposed rule might be.

What we were asked to do is address what some of the benefits of the
rule might be. I\'m an economist. I have a Ph.D. from Yale, and I cannot
start a talk without going \'assume the following.\' Economists are very
fond of making assumptions, and much of what I\'m going to be talking
about today will depend and flow directly on the assumptions we made
during this analysis.

Running through them in no particular order, the first is that all of
the cases of Listeriosis that are associated with this rule, the cases
prevented from this rule, will require hospitalization. I checked with
my experts, and we just don\'t have any good idea of the total round of
cases of listeria, how many end up in the hospital, so we\'re assuming
that all of these cases of listeriosis will require hospitalization. We
will be assuming that five percent of the cases are moderate and 95
percent severe. This is data that we got from working with the Centers
for Disease Control and their FoodNet active surveillance system.

The third assumption is we\'re only going to be considering adult
illnesses and death, not perinatal or maternal deaths. What I\'m saying
here is the economic analysis is not going to include an analysis and
benefits of preventing deaths of unborn children. Economists get very
squeamish and squishy when asked to put a value on the premature death
of an unborn child, so for the sake of not getting into that moral and
ethical quandary we\'re only going to be considering adult illnesses and
deaths. Keep in mind that\'s going to mean that some of our benefit
estimates are going to be lower than they otherwise would be if I as an
economist have a good way of dealing with that issue.

Finally, the last assumption is the effectiveness of the rule in
preventing cases will increase over a ten year period. It\'s not
realistic to assume that if the rule were enacted say on July 1 that a
year from now the rule would be 100 percent effective and all of the
deaths and illnesses that we\'re talking about here would be immediately
prevented. So in our analysis we phased in the benefits of the rule by
accounting for the fact that it will take some time for the rule to take
effect.

There are two types of benefits we\'re going to consider here. One is
just the out-of-pocket medical costs associated with cases of
listeriosis. As I said, we assume that 25 to 248 cases require
hospitalization, and of those 20 to 198 cases the patient will survive.

Based on estimates done partly by Tonya Roberts at ERS and also by my
colleague, Paul Franzen, who is at ERS, we\'re setting the medical costs
associated with hospitalization from listeriosis. For mild cases it\'s
about \$10,300; for severe cases \$28,300.

For the medical costs of the cases prevented, if we take 20 cases and
again go through this each year for ten years, just if you add up ten
years it\'s \$4.4 million in nominal terms. In present value terms,
accounting for the fact that future dollars ten years out are worth less
than they are now, \$2.9 million in present value terms. For the more
severe assumptions that there would be 248 cases of listeriosis
prevented by this rule, the benefits would be \$44.2 million in nominal
terms or \$29 million in present value terms.

Again, the assumptions we\'re working with are the large numbers of
cases of listeriosis come from an FDA risk assessment. The small numbers
of illnesses and deaths prevented come from some work that\'s been done
by the FoodNet people, Paul Mead at Centers for Disease Control, and
extrapolating from that to what prevention of illness might be
associated with this particular rule.

The next issue we have to deal with is what is the value of a life. In
my Agency and the economists I work with and economists generally have
spent a lot of time worrying about that particular issue. How do you put
a value in dollar terms on somebody who dies from any cause, whether
it\'s a foodborne illness, a traffic accident, an unsafe product or what
have you?

The approach economists have taken is they\'ve looked at the wages which
are paid to high risk workers. The idea here is if you pay people enough
money, they will voluntarily undertake risks to life and health in
exchange for money.

The predominant research in this area is kept exclusively at Harvard
University. What they\'ve done is they\'ve looked at high risk
occupations \-- bridge builders, tunnelers, perhaps fishermen in the
Gulf of Alaska and what have you \-- and they\'ve looked at the amount
of extra money that has to be paid for people to voluntarily undertake
risky occupations. Based on statistical analysis of the data, they found
that if you pay these people enough money, between \$5 million and \$6
million, that will pay the extra wages that these people in these high
risk occupations have. It results in an expectation of one extra
premature death.

If you look at enough people in these risky occupations and you have an
expectation of one premature death, you have to pay them \$5 million to
\$6 million. In the literature it\'s been called the value of a
statistical life. This \$5 million to \$6 million figure has been used
throughout the federal government to look at the benefits of regulations
which prevent premature death. It\'s been used by the Consumer Product
Safety Commission, the Environmental Protection Agency to look at health
risks from pollution. It has been used by the Department of
Transportation to look at prevention of deaths from traffic accidents
and so forth.

One of the problems that we at ERS have with this particular approach,
though, is you look at the people whose values were considered;
predominantly middle-aged, healthy construction workers, predominantly
males. They would expect to lose about 36.5 years of life from these
fatal accidents from on-the-job injury.

That may not be particularly relevant for foodborne illness cases
because some of the susceptible populations, for example, might be
elderly people who would only lose a few years of life or very young
people who might lose more than 36.5 years of life. We\'ve developed a
procedure which adjusts this \$5 million to \$6 million figure downwards
for deaths that occur later in life and upward for deaths that occur
earlier in life.

For the sake of expediency and time, I\'m going to go through this very
quickly. The two scenarios we dealt with were five premature deaths
prevented and 50 premature deaths prevented. Cost per death when you
account for the age at which death occurs, and we do this by using data
on the percentage distribution of people who die from listeriosis.
There\'s a fairly large clump in the elderly range and a fairly large
clump early in life. Again, I\'m not dealing with premature death from
unborn children.

We have a clump of deaths out there later in life, which is why the cost
per death is \$4.8 million rather than \$6.1 million is the average the
EPA uses now. If you look at this over ten years and again phasing in
the effectiveness of the rule so that the benefits start accruing in the
out years and not immediately, the ten year total is \$55.1 million in
nominal terms or \$36.5 million in present value terms for the low
estimate of premature deaths prevented and about \$500 million present
value for the larger estimate of 50 premature deaths prevented.

At this point, if you put this in the context of the cost estimates that
were presented earlier I believe it was \$48 million present value terms
over ten years so the bottom line is do the benefits of this rule exceed
the cost? Well, it depends, as always, on the assumptions you make.

The low estimate of \$36.5 million for the five deaths prevented per
year over ten years is a little bit less than the expected costs of the
rule. If you believe that the rule would prevent more deaths, if it
would prevent 50 premature deaths again stretched out over ten years,
the benefits of the rule are \$500 million compared to \$48.2 million
for the cost.

At this point, the question is do benefits exceed cost? My guess as a
professional economist is probably yes. I would suspect that the
benefits of the rule would likely be greater than the costs, and that\'s
for two reasons. One, as I said, I\'m not attaching any benefits to
prevention of deaths of unborn children. If you believe that has a

non-zero value, which I ethically believe that it does \-- I\'m just not
prepared to estimate it yet \-- then that means the benefits would be
greater than I presented here.

Also, to be consistent with the cost analysis which was stretched out
over ten years, I limited myself in this analysis to just looking at
benefits over ten years. One would presume that the rule is going to
stay in place longer than ten years. If we start looking at years
outward past year ten, the benefits stream from years ten through 20 is
greater than the cost stream in years ten through 20. So as the rule
progresses past ten years in implementation, then the benefits grow
faster than the costs. So I think in the long run, again, there\'s
evidence that the benefits in the proposed rule would be greater than
the costs. I believe that is the end of my discussion.

MS. GLAVIN: Thank you very much.

MR. CRUTCHFIELD: Would you like me to take questions now, comments?

MS. GLAVIN: What we\'ve been doing, and you may choose to stand there if
you want, but we\'ve been being informal and being at the table and
letting people comment and ask questions as they like.

Questions either for Phil Spinelli or for Steve Crutchfield on their
presentations, what they included in their work, what their assumptions
were, where they came from? Any questions? Charlotte?

MS. CHRISTIN: Charlotte Christin from CSPI. The first question I have
would be, did I hear you correctly that EPA uses an estimate of \$6.1
million?

MR. CRUTCHFIELD: I believe that\'s correct. The reason I\'m a little
hazy here is that originally what happened with these labor market wage
studies is there was a range of \$4 million to \$7 million, and Congress
a number of years ago picked a midpoint.

The original studies where this methodology was thought up were back in
the past. The actual dollar depends upon picking up and updating for
inflation, so I apologize. I did not check with my colleagues at EPA to
see what exact value they\'re using, but I believe it\'s around \$6.1
million to \$6.5 million.

I believe this approach is also used in the arsenic in drinking water
rule. I\'m not going to comment on that. I know that\'s \-- . That shows
you that this approach has been used elsewhere to value health risks.

MR. DERFLER: Phil Derfler from Animal Science. Maybe you explained this,
but you only talk in terms of deaths, and maybe that\'s \-- , but what
about illnesses prevented even if you don\'t quantify them by the rule?

MR. CRUTCHFIELD: I\'m sorry. I closed down the presentation. Earlier in
the presentation I did present an estimate on the hospitalization costs
associated with the cases of listeria, and that was around \$4 million.

MR. DERFLER: But that wasn\'t enough to push the benefits, even the
lowest of the benefits, over?

MR. CRUTCHFIELD: You\'re talking about \$10,000 to \$30,000 per case,
and you\'re talking at most 248 cases.

MR. DERFLER: Isn\'t it 2,500 cases?

MR. SPINELLI: I didn\'t hear the question.

MR. CRUTCHFIELD: The question was why are the benefits just associated
with measuring the cost of treating the illnesses, forgetting the value
of death. They appear to be fairly low since we used 248 cases as a
maximum number.

MR. SPINELLI: Right. Right.

MR. CRUTCHFIELD: You multiply that by \$30,000 per case, and it\'s not
very large.

MR. SPINELLI: Yes. I guess I wanted to clarify one thing, something that
might be confusing. On page 17, the estimates on that page is \$55.1
million. The cost that\'s associated with just the \-- is \$21.3
million. The \$68.1 million over ten years represents both the cost \--
and the performance standards.

As I said, I am open for comment as to how to better quantify the
benefits from the performance standards, but at this time there were no
benefits that were quantified at this time. I would welcome any
suggestions or comments on how to better quantify those benefits.

MS. CHRISTIN: This is Charlotte Christin from CSPI. Is there any way you
can look back at the analysis you used for the HACCP rule and perhaps
get some values for Salmonella reduction from that?

MR. CRUTCHFIELD: Salmonella reduction? This

was \--

MS. CHRISTIN: I\'m speaking in terms of the Salmonella performance
standard. If we only are talking about benefits from reductions in
listeriosis deaths among adults, there are lots of issues, but one of
them being why are we not talking about benefits from reduced illnesses
due to Salmonella and 0157:H7 specifically in fermented beef?

I mean, if the rule is much larger, why are we not looking at the
benefits of the larger rule?

MR. CRUTCHFIELD: If somebody were to give me estimates of how many cases
of Salmonella or E. coli 0157:H7 cases would be associated with this
particular \-- , we could do a similar sort of analysis that would make
the benefits greater. I was just strictly addressing myself to the issue
of listeria.

MS. CHRISTIN: Okay. So you are looking for data on Salmonella and
0157:H7?

MR. CRUTCHFIELD: Yes. The analysis that I presented here for listeria we
have done for other illnesses caused by other pathogens. If you go to
our website, which is www.ers.usda.gov, and look for food safety, we
have a number of presentations where we\'ve gone through exactly this
sort of approach to measure the costs associated with 0157:H7,
Salmonella and other pathogens as well.

In theory, here\'s a request for information. If somebody can give us
information as to how this rule could potentially reduce cases of
Salmonellosis or 0157:H7 then we could do this sort of analysis for
those pathogens as well.

MS. RICE: Can we get a copy of your presentation? Is that going to be
available on your website?

MR. CRUTCHFIELD: I can\'t promise when it will be available on the
website. Probably the quickest thing would be just send me an e-mail,
and I\'ll send it to you.

MS. RICE: Okay. The second question is to follow up on the last one.
Have you done anything on perfringens or bot; Clostridium perfringens as
it relates to this particular rule and the products associated with it?

MR. CRUTCHFIELD: Not associated with this particular rule. We\'ve done
some research in the past on Clostridium. That information is available
on our website. It\'s an older publication. We have not updated that
cost estimate in the last few years. What was the other one?

MS. RICE: Perfringens, Clostridium perfringens and clostridium
botulimon, both associated with these products.

MR. CRUTCHFIELD: Not associated with these particular products, no.

MS. GLAVIN: Bernie?

MR. SHIRES: Bernie Shires from AAMP. We\'re going to be making comments
in written form on some of these issues after today, but I just wanted
to direct something to Phil. You asked for a lot of information that may
not be there. I guess one thing I\'m wondering about a little bit would
be the number of plants that you\'ve taken into your sample. I\'m not
sure if, for example, plants that are under state inspection, equal to
state inspection programs, have been figured in as part of this because
they also have to be involved in this if and when this rule is passed.

Now, most of the figures we\'ve seen, I guess there\'s about 6,500
federal establishments more or less, maybe a few less than that, and
about 2,500 state inspected establishments in 27 states. These are
plants that are under what we call equal to inspections, so they carry
out the same regulations that the USDA does.

Most of these plants, virtually all of these plants, are I\'d say small
or very small establishments. Of that percentage, a good percent of them
are very small. Of all those, a higher percentage are involved, and I
don\'t have the figures with me now, but a higher percentage of those
kinds of plants are involved in processed products production because of
what they do, making large numbers of products. I wonder if they were
taken into account when these plant numbers were estimated because I
just get the feeling that with the number of plants that you\'re talking
about it may be on the low side in terms of plants that are going to be
affected by the rule.

MR. SPINELLI: I will definitely agree. They are certainly on the low
side. The reason I used the figures that I did is that it was the best
available \-- and it came from the Census, so 1630 firms in total, are
FSIS internal data \-- at least the products that I identified.

\-- maybe 6,500, so any kind of data that you have or any source of data
that I could get my hands on that would identify the number of plants,
the type of products that they produce and their volumes would be very
helpful.

MR. SHIRES: Yes. I don\'t want to give an incorrect impression. When I
said 6,500, I think that\'s the number of USDA plants under USDA
inspection. That\'s not to say that all of them make processed products.

MR. SPINELLI: Right.

MR. SHIRES: Especially when you get to the small and the very small, the
numbers may be higher. At the same plants, having been factored into
this obviously, a high percentage of that would relate to processed
products. That\'s going to have to be part of this as well.

MS. GLAVIN: I think Phil\'s point is that to the extent that you can
provide him data that he can use, that would be terrific.

MR. SHIRES: That\'s what we plan to do.

MS. GLAVIN: You\'re more likely to have that data.

MR. SHIRES: Yes. We\'ll give you that data.

MS. GLAVIN: Great.

MS. CHRISTIN: Charlotte Christin from CSPI. Do you have any data to
address the cost to industry from recalls from litigation, from costs of
attorney\'s fees associated with outbreaks or recalls?

MR. CRUTCHFIELD: Not with this particular rule, but I \-- responding. We
have just completed a report, which is being released either today or
tomorrow, which looks at product liability and cases of foodborne
illness and does a statistical analysis trying to establish a
relationship between the nature and severity of the food poisoning or
foodborne illness case and the result of a jury verdict and jury award.
If you want to meet up with me afterwards and give me your card, I\'ll
arrange to mail you a copy, or it will be available on our website
within a few days.

MS. CHRISTIN: That would be great. Thank you.

I also will put a copy in the record of a *Food Processing* magazine
report that talks about some of the costs associated with the Sara Lee
outbreak. They spent \$76 million just to cover the cost of the recall.
Thorn Apple Valley spent between \$1 million to \$7 million on its
recall. The only reason those costs were lower or one of the reasons the
costs were lower was because the products were already code expired.

As you can see, there are some real costs associated in addition to loss
of goodwill. It really does benefit industry to have a strong regulation
in place because a lot of times consumers aren\'t going to remember the
name of a specific company, but they\'re going to remember the type of
product.

It inures to the benefit of industry to have a strong regulation in
place, and I think that it will strengthen this proposal to have an
accounting for those costs in the economic analysis.

MR. SPINELLI: That\'s a good point. I appreciate it.

MS. GLAVIN: Other questions and discussion?

RON: Ron \-- . Just a point of clarification.

Steve, I believe you were looking at the benefits. You were looking at
the reduction in listeria illnesses and deaths associated with the
testing provision in the rule. Is that correct?

MR. CRUTCHFIELD: That\'s right.

RON: Right. Okay. But when you were comparing that with costs, the costs
covered all the provisions in the rule?

MR. CRUTCHFIELD: Yes.

MS. GLAVIN: Does everyone now understand how these people do their
analyses? Charlotte?

MS. CHRISTIN: I\'m sorry. I didn\'t want to hog the mike, but I guess I
will. A question about your inability to estimate the cost of fetal
death. Tonya Roberts from ERS had done some important work in the early
1990s, and she was able to place a value on that. Are you able to
incorporate some of her earlier analysis into this analysis?

MR. CRUTCHFIELD: Tonya Roberts works for me, so, yes, I\'m aware of
that. The work that she had done I believe was in the case of Toxoplasma
\-- , although there may have been some others.

MS. CHRISTIN: listeria?

MR. CRUTCHFIELD: listeria as well.

MS. CHRISTIN: Yes.

MR. CRUTCHFIELD: Let me give you a little bit of the philosophical
debate about this. When we were going around updating some of our
estimates and costs associated with all foodborne pathogens, the
question is how do you place a value on a premature death.

There have been some economists who have argued that the premature death
of an unborn child does not have a cost because that was never a person
and that if the family wanted to replace that, they could have another
child, as one economist put it to me in a Toxoplasma conference.

We could go through and assume that the death of an unborn child would
be statistically equivalent in cost terms to the death of say a
one-year-old or somebody who would expect to lose 73 point something
years of life. But it\'s just the procedures among economists is that
there is no universally acceptable approach for that particular moral or
ethical issue of how you handle the fact that the child was unborn at
the time the fetal death occurred.

Another thing we\'re doing at ERS and trying to get a handle on this is
looking at not only deaths of unborn children, but what happens when you
have learning disabilities or severe mental retardation. In earlier
approaches we valued that in terms of long-term acute care, giving extra
education costs. In other words, we\'re recognizing these costs exist,
and if we were to prevent deaths of unborn children then there would be
a benefit associated with that.

In the past, Tonya and I kind of argued about whether or not we should
include these costs. Basically because I spent some time looking at
this, I just felt uncomfortable professionally standing up and saying
here\'s exactly what the cost of the death of an unborn child is because
the economics profession hasn\'t really come to any closure on the
appropriate use of that value.

MS. CHRISTIN: Do you think that your new research on the values placed
at time of litigation would perhaps give you some costs that you could
use in this?

MR. CRUTCHFIELD: From what I recall of the report that I mentioned
earlier, I don\'t know. I\'d have to check. I don\'t think there\'s more
than two or three cases that Dr. \-- looked at in her study where the
nature of the lawsuit was that an expectant mother contracted a
foodborne illness and then lost her unborn child. There may be some
cases in there, but I don\'t think that there would be enough evidence
from the data to make a reliable inference.

The other thing I\'ll caution about using sort of litigation case
studies from the legal profession is one of the things that Jean Wesby
found in her research is that when a defendant company has a
particularly weak case; that is, they may face a non-zero probability
condition in having to pay both compensatory and punitive damages, they
tend to settle out of Court. What happens is, a lot of times it\'s when
these cases are settled out of Court we as economists have no way of
knowing what the settlement was because in many cases the parties are
bound to confidentiality.

That was one of the problems that we had in that particular research
project. A lot of the cases were settled out of Court, so we didn\'t
know what the jury verdict would have been, and we didn\'t know what the
settlements actually were. I hope that answers your question.

MS. CHRISTIN: I do think that it\'s difficult in the time of a
Republican Administration to think that there might not be a value
placed on a lost life, and I think that other agencies do look at issues
such as this. I think that for companies that face these problems, they
have to have their own experts help them make decisions about the values
of these lives when they think about litigation strategies, when they
think about settlements. I understand it\'s not an easy question. I
understand there are a lot of assumptions involved. I do think, however,
if we\'re going to truly be able to evaluate this rule it\'s important
that we include those things.

I also think we do have fetal deaths, but we also have newborns who
survive and face meningitis and other serious illnesses. I\'m not sure
why we don\'t have more information about that included in the analysis.

MR. CRUTCHFIELD: That\'s a good question. I\'ll go back and as the final
rule making goes forward, see if we can come up with some more
information to provide as the final rule goes forward.

MS. CHRISTIN: We\'ll try, you know, with whatever we can find. We will
be sure that \--

MR. CRUTCHFIELD: Again, if you have information or know of sources of
information that would help us, please let us know.

MS. CHRISTIN: Great. Thanks.

MS. GLAVIN: Other questions? You wanted to make a presentation?

MR. SHIRES: Yes.

MS. GLAVIN: Thank you.

MR. SHIRES: Bernie Shires with AAMP. I just want to make a few brief
comments. As I indicated before, we\'re going to be submitting detailed
written comments about the proposal, including answers to a lot of
questions that we\'ve been asked to provide answers to over the last
three days. We plan to do that in the spirit of helping this process
along.

I\'ll just say briefly that AAMP, the American Association of Meat
Processors, is an international trade association. We have members in
all 50 states, Canadian provinces and several foreign countries. Our
members include meat and poultry processors, slaughterers, wholesalers,
retailers, caterers, as well as suppliers and consultants to the meat
industry.

While we have a few large establishments as members, most of our members
are small and very small businesses. A high percentage of them are
family owned and operated establishments. In addition, there are 35
state meat processing associations affiliated with us, and most of their
members, virtually all of their members, are small and very small
businesses as well, so we represent a fairly large segment of the small
and very small meat and poultry processing industry.

As I said, we\'re going to be submitting detailed comments, as well as
answers to questions that you raised during these discussions. But from
talking to our members and doing some preliminary survey work, we can
say now that if small and very small processors of ready-to-eat products
would have to follow this rule as it was written today, it would
probably force many of them out of the ready-to-eat business or at least
to consider getting out of that business.

As you know, many small and very small processors make a wide variety of
products, especially in this processed products area. For those who are
not convinced that they might be better off giving up making these kind
of products, many might, on the other hand, be forced to take another
attack; that is to stop making that wide variety of products and limit
themselves to only a few.

Unfortunately, this would greatly hurt the strength of these processed
product small manufacturers because their strength in marketing, their
strength in their markets, really comes from the diversity of products
that they do, as well as specialty and ethnic type products. Their
strength is the niches they work in. For this to be taken away from them
would cause these businesses obviously serious harm.

In listening to the discussion over the last couple days, we see great
problems with finding meaningful HACCP plans, including critical control
points, that small and very small plants can afford and then implement.
A lot of this I think came from the discussions, the excellent
discussions that were held on Tuesday, which was more of a scientific
discussion. Those discussions and the possibilities that were pointed
out, many of these possibilities would carry very large price tags. At
this point, we don\'t see how a lot of these small folks would be able
to do this.

In my discussions that I\'ve had with colleagues in other trade
associations, similar problems exist, and other problems, for that
matter, exist for large establishments. The specter of \-- HACCP plans
has been raised several times, plans that would fulfill regulatory
compliance, but not really do anything as far as solving the problem
with listeria. Obviously that\'s not something that industry or USDA
wants to get into at all.

We\'re also concerned about what we don\'t see, I guess would be the way
to put it, as viable corrective actions that could be taken as part of a
HACCP plan to control listeria by small plants.

The alternative SSOPs, the testing, will cost a great deal of money, and
we feel more than what has been estimated in the estimates that have
been in the rule so far. There was discussion about holding and testing
for large plants. \'Hold and test\' also affects small plants as well in
a different way. It causes great problems for plants in that for most of
the product produced is going to customers. The product is already
spoken for. They don\'t have the ability to hold large amounts of
product.

We think that whatever is eventually decided or made as a rule, USDA
really needs to take a leadership role in working with AAMP and with the
other trade associations to provide help to the small and very small
plants in complying with this rule or the other rules formulated. These
things should include process validation, as well as ways for the small
and small plants to comply with performance based standards.

There would need to be very clearly laid out guidelines for processors
we think, maybe technical assistance to small and very small plants
similar to what was done during preparation for HACCP. If you remember
back then, the small and the very small plant HACCP technical training
program began as part of discussions with USDA about how things could be
done to help these plants. In fact, the very first technical sessions
were held in AAMP\'s offices by USDA. Possibly small and very small
plants will then cooperate with larger plants to formulate means of
complying with the listeria rule.

The other possibility which happened during HACCP was to get the land
grant universities involved. We worked with a lot of those folks to
begin with. Get a lot of the animal science and microbiological
departments at those universities involved.

To answer a couple of questions that were raised yesterday, though,
we\'ve already started moving ourselves in some areas. AAMP is right now
in the process of producing a video with the help of our plant members
and science consulting members and universities on how to do a testing
program in a small plant and even the possibility of small plants doing
it with their own equipment. Those such things are possible, and that\'s
something we want to do as part of a video.

The other part of this would deal with how to \-- plants in a way to
prevent listeria, how to do a good job \-- plants. AAMP has offered
several seminars on dealing with listeria and process validation, and
we\'re setting up more seminars as well.

There have already been discussions at our association about acting as a
facilitator to negotiate with laboratories that are supplying and
consult members of our association to negotiate for costs that small and
very small plants would be able to afford, so this is something that\'s
already been started.

The other thing I wanted to mention was the question about the
guidelines. The guidelines that the Agency published came out late last
week. I haven\'t had a chance to look through them very well yet, so
I\'m not going to say anything about them other than to say that it
would be helpful in the future when the guidelines are published that we
can get a hold of them as soon as possible so that we can run them by,
so we can get them to the members of our meat inspection committee and
our science committee and people at the universities so they can give us
some feedback on them. That would be very helpful.

I\'m just going to mention one thing in passing that may create a few
chuckles around the table. There is nobody from field operations here. I
don\'t see anybody anyway. Oh, there she is. Okay. I didn\'t see you
there.

It might be of interest to you to know that on one USDA survey, and I
won\'t say where it is, the inspectors were going to plants and telling
everybody they were going to be enforcing this new rule within a week or
so, the rule being the USDA listeria rule. Don\'t worry. This was taken
care of at the district office level. I just want to emphasize that it
never should be said that program employees at USDA don\'t want to do
their jobs.

In closing, I guess I\'d like to say that industry and USDA share a
mutual goal concerning listeria. I guess I think our mutual goal is to
make sure that it isn\'t in the food that the industry produces. And
that consumers don\'t eat food and then get sick with listeriosis.

At this point, we\'re going to provide as much information as we can,
and I hope to have more discussions with people in the Agency about what
exactly they would need to be helpful from our neck of the woods, so to
speak. At this point, I guess the way the rule is laid out today we
don\'t see that the rule as proposed by USDA is the way to accomplish
those goals, and hopefully we can go over the next one, however long it
takes. We\'ll be able to achieve those goals through changes and other
modifications.

Thank you.

MS. GLAVIN: Thank you. That was very helpful. It would be particularly
helpful to the extent that you can be specific about what are the
provisions that, for example, might cause a plant to stop producing a
product or to stop making ready-to-eat product and even more useful if
you could go beyond that and suggest alternatives that would achieve the
goal without that negative impact. I know that\'s easier said than done,
but the more specific you can be the more useful it is.

MR. DERFLER: Phil Derfler from Animal Science. The guidance material is
drafted. We tried to get it available so we\'d have it for this meeting,
but you can take a look at and give us comments on it.

MR. SHIRES: Oh, I understand that. We\'re going to do that. We talked
about it a while back. It just seemed as if it would have been helpful
if we could have it at that time, too, but we\'re certainly going to do
that now. We\'re going to give this to our people.

MR. DERFLER: Mimi and Paul and a lot of other people worked very hard on
that.

MR. SHIRES: Oh, I know. I\'m not throwing any stones. I know that
everybody worked hard to get it done and to get it out. It\'s just
unfortunate with the timing the way it was that we weren\'t able to do
that, and that it wasn\'t able to be done.

MS. GLAVIN: Okay. Other comments or questions? Stan?

MR. EMERLING: Stan Emerling representing the North American Meat
Processors Association. I was listening to the conversation and I just
have some thoughts which \--

MS. GLAVIN: Can you stay closer to the microphone?

MR. EMERLING: Sure. I\'m sorry. I just jotted down some thoughts, which
\-- conversations here, but I would assume \-- . Regardless of the \-- ,
I don\'t think any of us want to produce product that can cause illness
or death.

I think the moral question here is whether the law can accomplish what
\-- types and correlations of listeria and bacteria, the illness causing
illness and side effects. I really think the question is whether the
information should be approached through testing of the performance
standard without the regulatory implications would be a first step that
should be taken, after which we have that information that could be
conveyed and put all together and then see what we should do.

It just seems that if we know what\'s causing the illness, it\'s Lm. But
we\'re not sure of its correlation to where it comes from \-- the
environment \-- if we could come up with some of those answers before
trying a new regulation \-- six months or whatever it may be. It\'s just
a philosophical question \--

MS. GLAVIN: Thank you, Stan. Anything more? Charlotte?

MS. CHRISTIN: Charlotte Christin, CSPI. I understand the point that Stan
is making. I think that the problem is the deaths and illnesses
continue.

It\'s been more than two years since the Sara Lee Bilmar outbreak. We
have continued to have recalls. We have continued to have more deaths
and illnesses. At some point you\'ve got to stop banging your head
against the wall and figure well, maybe I should change my approach.

I think one of the reasons why we were so pleased that the Agency was
able to move this proposal forward is to see that there has been
progress on this. This is one of the reasons we submitted a petition. We
were anxious to get some sort of change. We don\'t want to keep banging
our heads on the wall, and we don\'t want to keep seeing deaths and
illnesses.

MS. GLAVIN: Thank you. I sense that we are about wound down. I don\'t
want to cut anyone off who has additional questions or comments. Thank
you, especially for you who stayed until the very last.

I have found this to be a very useful several days. I think the level of
discussion has been extremely high, and there\'s an enormous amount of
good information shared and an enormous amount of real effort to address
what we all agree is a problem. Thank you.

(Whereupon, at 2:28 p.m. the meeting in the above-entitled matter was
concluded.)

CERTIFICATE OF REPORTER, TRANSCRIBER AND PROOFREADER

[Public Meeting to Receive Comments]{.underline}

Name of Hearing or Event

[N/A]{.underline}

Docket No.

[Washington, D.C.]{.underline}

Place of Hearing

[May 10, 2001]{.underline}

Date of Hearing

We, the undersigned, do hereby certify that the foregoing pages, numbers
[188]{.underline} through [322]{.underline} , inclusive, constitute the
true, accurate and complete transcript prepared from the tapes and notes
prepared and reported by Marcia Logan, who was in attendance at the
above identified hearing, in accordance with the applicable provisions
of the current USDA contract, and have verified the accuracy of the
transcript (1) by preparing the typewritten transcript from the
reporting or recording accomplished at the hearing and (2) by comparing
the final proofed typewritten transcript against the recording tapes
and/or notes accomplished at the hearing.

[5-10-01]{.underline}

Date Karen Stryker

Name and Signature of Transcriber

Heritage Reporting Corporation

[5-10-01]{.underline}

Date Lorenzo Jones

Name and Signature of Proofreader

Heritage Reporting Corporation

[5-10-01]{.underline}

Date Marcia Logan

Name and Signature of Reporter

Heritage Reporting Corporation