June 2000 In-Distribution Public )

Meeting )

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Pages: 1 through 88

Place: Washington, D.C.

Date: June 9, 2000

June 2000 In-Distribution Public )

Meeting )

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Washington Plaza Hotel

Franklin Room

10 Thomas Circle, NW

Washington, DC

Friday,June 9, 2000

The hearing in the above‑entitled matter was

convened, pursuant to notice, at 9:05 a.m.

APPEARANCES:

[MODERATOR]{.underline}

Tom Billy, Administrator, USDA Food Safety

and Inspection Service (FSIS)

[PRESENTERS]{.underline}

Catherine Wotecki, USDA Undersecretary for Food

Safety

Carol Seymour, Deputy Assistant Administrator,

FSIS Office of Field Operations

Phil Derfler, Deputy Administrator, FSIS Office of

Policy, Program Development and Evaluation

Krista Marting, FSIS Office of Policy, Program

Development and Evaluation

Mary Cutshall, Acting Director, FSIS Inspection

Systems Development Division

Jim Rutger, Minnesota Department of Agriculture

[AUDIENCE PARTICIPANTS]{.underline}

Bernie Scheier, American Association of Meat

Processors Caroline Smith DeWaal, Center for

Science in the Public Interest

Jill Hollingsworth, Food Marketing Institute

Stan Emmerling, North American Meat Processors

Association

Nancy Donley, Stop! Safe Tables Our Priority

Debra White, Food Marketing Institute

Mary Helms, North American Meat Processors

Association

Charlotte Kristin, Center for Science in the

Public Interest

Doug Saunders, Association of Food and Drug

Officials

[OTHERS PRESENT]{.underline}

Marlin Waller, Director, FSIS Human Resources

Division

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

(9:05 a.m.)

MR. BILLY: My name is Tom Billy and I\'m going to get this public
meeting started. We\'ve been asked by the television folks if we would
give our opening remarks from the podium so it\'s a little departure
from our normal procedure, but we\'re willing to accommodate that
request.

It\'s my pleasure at this time to introduce Dr. Catherine Wotecki, the
Undersecretary for Food Safety at the U. S. Department of Agriculture.
Dr. Wotecki is going to provide us her opening remarks to set the stage
for this important public meeting. Cathy?

MS. WOTECKI: Mr. Billy. Actually my remarks are going to be very brief
today as they usually are at these public meetings. I want to first of
all extend a welcome to all of you who devoted the time and energy and
thought to prepare for this meeting and also to say we look forward to
the contributions that you will be making during this meeting.

The comments and the ideas that you provide, even the questions that you
raise, are very important in framing the thinking of the agency as it
moves forward in developing its plans across the whole broad spectrum of
farm-to-table food safety for which the agency has responsibility.

I\'d like to add my words of welcome to Mr. Billy to all of you today
and to say that I look forward to hearing those comments and thoughts.
The meeting today is going to focus on the role that the Food Safety and
Inspection Service plays in the food delivery system after meat and
poultry products leave federally inspected establishments.

There are, as you can see from your agenda, a number of presentations
that people within the agency are going to be making to provide you with
background information about the current thinking of the agency about
its role in distribution of meat and poultry products.

Mr. Billy, the administrator of the Food Safety and Inspection Service,
will be moderator for the meeting and there will be plenty of time
during the meeting for questions and answers as well as an opportunity
at the end of the morning for a real interactive dialogue.

As I said, we look forward to these meetings because they do provide an
enormous amount of thought from those in the industry as well as the
general public about the role of the agency in food safety. So I look
forward to a lively discussion this morning. Thank you.

MR. BILLY: Again, it\'s a pleasure to welcome all of you to this public
meeting on in-distribution. In February of l995, when the Food Safety
and Inspection Service published its proposed rule on pathogen reduction
and HACCP, the agency presented this new food safety regulatory strategy
with six basic elements.

The first five elements address the need for the Food Safety and
Inspection Service, in conjunction with industry, to clearly define
minimum requirements for industry: to stimulate food safety improvement
by setting performance standards; to make industry responsible for
microbiological testing of their products; to foster scientific and
technological innovation; and to build the principal of prevention into
the inspection system.

Since that time both FSIS and industry have worked together to make
great progress in all five of these areas. And this strategy is working
to improve the safety of meet and poultry products nationwide.

We\'ve seen tremendous gains in terms of reducing pathogens in slaughter
and processing facilities. But we\'re not done yet. In addition to
continuing the progress already made in these five important areas, FSIS
must focus on the sixth element of that l995 strategy. And that is why
we\'re here today.

The sixth element states and I quote, \"FSIS must approach its food
safety mission broadly and address potential hazards that arise
throughout the food production and delivery system, including before
animals enter FSIS- inspected establishments and after meat and poultry
products leave those establishments.\"

We are here today to focus on what happens to meat, poultry and egg
products after they leave the plant. We must be sure that the work we do
within plants to ensure food safety is not undone once products leave
the plant.

We know that products can be mishandled and recontaminated in
distribution channels. Now, this isn\'t a new role for FSIS. For more
than 30 years FSIS has carried out a limited number of tasks in
distribution channels, including monitoring products as they move
through distribution, controlling adulterated products, detecting and
documenting violations of the law, and following up on consumer
complaints.

This work is carried out in full cooperation with state and local
authorities that share distribution. However, it has been limited to
approximately 15 to 20 percent of the time available from our small
consumer officer staff \-- excuse me, our small compliance officer
staff. That\'s our compliance officers that generally are charged with
enforcing our regulations. They were able to carry out this amount of
effort when they weren\'t carrying out other enforcement
responsibilities.

Now, we\'re not here today to debate whether FSIS should have a role in
distribution channels. Rather we are here to explore whether we can
improve on the approach currently in place, especially now that HACCP
has been implemented. We want to explore whether we can use inspectors
rather than compliance officers to conduct more activities in
distribution channels so that compliance officers can concentrate on the
more complex investigations and other enforcement activities.

We want to explore whether we can identify and rank hazards in
distribution channels so we can better focus our resources on the most
critical problems. We want to explore how all of us with jurisdiction in
distribution channels can best use our resources at the federal, state,
and local levels in a complementary manner. We want to explore whether
we can use information collected in distribution channels to help
evaluate whether in-plant HACCP plans are working to place safe products
in the consumer\'s hands.

And we want to explore whether some activities carried out within the
plant to address nonfood safety concerns may be best carried out while
the products are in distribution channels.

This project should be thought of as a learning process. We don\'t have
an approach in a system already designed to present to you today. We do
have some ideas, however, and we will share those ideas, that is, our
current thinking, with you today.

As we collect information and test new approaches, we will begin to
design a system that best protects the public health, using our existing
resources as wisely as possible. This is expected to include
establishing new federal regulatory requirements, such as performance
standards at some point in the future, which we will do through a
thoroughly public process.

In closing, we are committed to finishing what we set out to do \-- that
is, to develop a seamless farmed table food-safety system. This project
is an important part of that goal.

Industry deserves much credit for the successful implementation of HACCP
in meat and poultry plants, and we look forward to the same cooperation
from industry as we continue this important work. We also look forward
to working closely with the states and other regulatory authorities
towards the establishment of the seamless system. Thank you.

What I\'d like to do now is I\'ll go back to my seat and run through the
agenda and then we\'ll start the actual presentations. What we plan to
do now is provide some additional detailed information in terms of our
current or traditional approach to addressing the in-distribution
channels and then look at common questions and issues of concern to us
and others about this area of industry activity and then highlight for
you a number of the specific pilot projects that we\'ve embarked on,
including training some of our people, our inspectors, and our current
thinking in terms of other types of approaches we plan to look at in the
ensuing months.

To start this off what I\'d like to do is introduce Carol Seymour. She
is deputy assistant administrator covering the area of district
enforcement operations under our Office of Field Operations. Carol will
lay out for you our traditional approach to in-distribution. Carol?

MS. SEYMOUR: Thank you Mr. Billy. Good morning everyone. The objective
of this segment of our meeting is to give the participants a brief
overview of USDA\'s traditional roles that are carried out to monitor
the safety and labeling of meat and poultry products in distribution
channels, including our past and present capabilities and priorities.

Well, FSIS has been and remains focused on the very important and
difficult task of assuring the safety of products produced in federally
inspected plants. Our statutory responsibilities require that we
undertake a wide range of task in distribution channels.

Some of the work conducted outside inspected plants includes monitoring
products as they move through distribution, detecting and documenting
violations of law, following up on consumer complaints, and making
recall effectiveness checks.

Recent statutory amendments provide special requirements for monitoring
egg labeling and storage temperatures in distribution. Further, FSIS
compliance officers locate and control adulterated products that may
have been contaminated through such things as truck wrecks,
refrigeration failures, fires, and similar situations.

FSIS has long recognized that these kinds of activities can best be
accomplished through cooperative work with state and local authorities
that often share jurisdiction with us. For the purpose of today\'s
meeting we will concentrate on one aspect of this cooperative work, the
traditional work by federal and state compliance officers in food
distribution to conduct planned and random reviews of businesses that
are covered by the meat, poultry, and egg products laws.

To better describe these roles it\'s useful to see them in historical
context. In the early l960s, meat and poultry were separately regulated
and compliance activities were carried out by two separate groups called
the meat laws investigators and poultry regulatory officers.

Although these two units had significant differences in their methods,
they shared a common interest in monitoring distribution channels for
violations that could jeopardize food safety.

In the mid- to late l960s, four events occurred that led to changes in
the way USDA carried out our responsibilities for in-distribution.
First, the separate meat and poultry inspection programs were merged
into one unit and directed to merge their methods and their processes,
including their processes for enforcement.

Second, serious violations involving the diversion of inedible products
and uninspected horse meat into human food channels led USDA to conclude
that the so-called meat and poultry allied industries needed to be
systematically monitored and regulated. These allied industries include
businesses that dispose of animals that died on the farm and lice from
slaughter operations. Or the businesses handle similar materials that
would pose a high risk if they were diverted into human food.

Third, the acts were amended to establish the current system of federal
and state inspection and enforcement and a requirement that states have
equal-to laws and programs to ensure that they can enforce these laws.
If a state is unable to carry out these provisions, USDA is authorized
to designate the state as one in which federal inspection and
enforcement authorities fully apply.

Fourth, the same amendments to the laws that established the state
requirements also established new federal responsibilities and
authorities. Some of these changes were new prohibited acts for causing
products to become adulterated in distribution channels, detention
authority to block the movement of products as they move in commerce,
authority to regulate the transportation in storage of meat and poultry
products, a requirement that all meat and poultry dealers register with
USDA and maintain records of their transactions. USDA was authorized to
examine facilities and records maintained by businesses involved in
distribution of meat and poultry products.

USDA responded to these changes by, among other things, setting up a
small compliance staff to monitor the distribution channels and to
detect and document violations.

The staff was formed in l966 and has evolved over the years to its
present organizational structure, which includes two headquarters
divisions and 179 field compliance officers and supervisors.

These officers and supervisors report through the FSIS district offices.
The current district enforcement operations carries out many roles for
FSIS, but among our bedrock functions is the continuing systematic
monitoring of firms and individuals who are engaged in transportation,
storage, sales, and service of meat and poultry products.

This monitoring is carried out through the planned compliance reviews or
random compliance reviews. The planned compliance program includes
visits to approximately 11,000 businesses and individuals which are
considered high risk due to the inherent nature of their business or
their past history of compliance.

The following categories of businesses are covered: processors,
distributors, brokers, retailers, restaurants, transporters, custom
establishments, animal food establishments, warehouses, salvage
operators, renderers, 4-*D* establishments. These establishments, the
4-*D*, is people who handle dead, dying, disabled, or diseased animals.
And other businesses where meat and poultry and egg products are handled
are covered.

Planned reviews are scheduled, based on risk category. Compliance
reviews are conducted quarterly for firms or individuals in risk
category one. This category covers businesses that are suspected of
currently violating provisions of law or that engage in activities that
particularly lend themselves to placing unsound meat, poultry, or egg
products into human food channels.

Risk category two covers firms that were found to be violating within
the past twelve months or whose past operations demonstrate a constant
or intermittent risk of placing unsound food in human food channels.
They\'re visited semiannually.

Risk-category-three firms are visited annually. They include operations
that warrant continued planned coverage but that have not demonstrated
noncompliance in the last 24 months.

The planned compliance program includes both inspected and uninspected
businesses. It permits FSIS to track the movement of violators from
business to business and to increase the likelihood that repeat
violations will be detected. It is also used to monitor the terms of
probation or formal plea agreements as directed by the courts.

FSIS compliance officers also conduct randomly scheduled reviews in
distribution channels. These so-called random reviews are made when time
and travel funds permit compliance officers to visit a firm or location
not covered by the planned compliance program. Last year FSIS compliance
officers made approximately 34,000 random reviews. A random review may
include examination of facilities and products, discussion with the
employees of the business that are located on site, answering questions
or gathering information about the business or, occasionally,
documenting a violation and placing the firm into our planned coverage.

FSIS publishes its enforcement activities, including the distribution of
the full range of compliance actions on the FSIS Internet home page. For
this meeting, let me highlight a few statistics that are most relevant
from our recent annual report.

In fiscal year l999, compliance officers made 941 detentions totaling
over 20 million pounds of product. They monitored 55 product recalls
totaling over 40 million pounds of products and they initiated two
formal court seizures involving nearly 160,000 pounds of product. And
finally, they documented 2,370 violations.

Further, since an issue that\'s often discussed in relationship to IDI
is overlap with states, let me describe our current work plan agreements
now in place with 25 equal-to states for meat enforcement and 23
equal-to states for poultry enforcement.

In states that do not have these agreements, USDA has full authority for
enforcement and we often exercise that authority in cooperation with
county or local governments. But in those states where we do have formal
agreement, USDA shares the funding for state compliance programs.

The formal agreements provide for cooperative work planning, steps to
minimize or eliminate duplications of effort, joint sharing of
technology and information between FSIS and the individual states. State
compliance officers receive training managed by FSIS, right alongside of
federal compliance officers, at Sam Houston State University\'s Center
for Criminal Justice.

Both federal and state supervisors share information and refer cases to
their counterparts. Federal managers assist states in the most difficult
cases and we hand off investigations when state enforcement actions are
judged to be more expedient or effective.

Presently less than one-fifth of the compliance officer staff years are
devoted to planned and random reviews. The balance of the time is
devoted to documenting violations, controlling products, and a range of
other enforcement type work designed to deter violations and assure food
safety, both in-plant and in distribution.

Nonetheless, this percentage of planned and random reviews time is
significant because these reviews play a very important role in
educating meat and poultry handlers, assuring that we are able to detect
violations and deter continued or repeat noncompliance.

The plans to test in-distribution concepts provide, I think, a welcome
opportunity to find efficient and effective ways to increase this
coverage.

In closing, it should be pointed out that concerns have been raised
about what FSIS intends to do in relationship to compliance officers and
concerns that we\'re planning to replace compliance officers with
in-distribution inspectors. Ultimately it\'s hoped that in-distribution
inspectors may free up time at some locations so compliance officers can
concentrate on the more complex investigation and enforcement work.

Other presenters will explain the concepts that we\'re examining for the
future role of in-distribution inspectors in the farm-to-table
continuum. Thank you very much.

MR. BILLY: Carol, why don\'t you stay there for a second? We\'ve got a
few minutes and what I\'d like to do is provide an opportunity for
anyone that has a question of clarification. We\'ll get more into a
discussion after you\'ve heard all of the material, but if there\'s
something that Carol could clarify or amplify on, I\'d welcome that.

If you\'d like to raise a question, please state your name and your
affiliation.

MR. SCHEIER: Bernie Scheier (phonetic), American Association of Meat
Processors. I just had a question on one of the things you mentioned
there about the planned visits. I guess there was the one category that
there were no visits planned if there were no violations in the past two
years. So why are you doing visits and what kind of risks are you
looking for there?

MS. SEYMOUR: I\'m sorry, we do those visits generally based on the
nature of the work, the business that\'s being carried out, or they did
have a violation two years before. And eventually, if there are no
continuing violations we would drop them from our planned coverage.

But the question, for those of you in the audience, refers to our risk
category three. And those businesses are people who are kind of being
retired from the planned coverage.

They may remain in there for a period of time if the nature of their
operation is such that we think we need to visit them once a year. We
are doing it again because \--primarily because they handle products or
they\'ve had activities that would lead us to believe that they might
violate again.

MR. BILLY: Caroline?

MS. SMITH DEWAAL: Thank you. Caroline Smith DeWaal, with the Center for
Science in the Public Interest. I have two questions. The first is how
much of this oversight is in businesses with overlapping jurisdiction
with the Food and Drug Administration?

MS. SEYMOUR: We do \-- yes, that\'s a good question. I probably should
have mentioned that we do have what we call dual jurisdiction firms,
businesses that handle both FSIS-regulated and FDA-regulated foods. A
great deal of this is, in fact, in businesses that would handle both. We
are working very closely with FDA and when we do find violations in a
firm that is handling both meat and poultry products and, say, bakery
products or dairy products, we make a referral to FDA and we are working
on joint enforcement actions with them.

We have a couple that we hope will mature before too much longer, where
there will be a joint action through the U.S. Attorney.

MS. SMITH DEWAAL: Do you have any documentation on FDA\'s followup on
your referrals?

MS. SEYMOUR: We are getting documentation on that. I don\'t have any
yet. I think there is a report that recently came out from the agency.
Is that on our Web site? We may put something soon on our Web site to
report on that.

MR. BILLY: I believe it is, but if it\'s not, we can do so. It\'s a
joint report on the first year under this MOU.

MS. SMITH DEWAAL: My second question is about the 40 million pounds of
products that were recalled. How much of that is actually retrieved?

MS. SEYMOUR: Well, the 40 million pounds I refer to is actually
retrieved. That\'s an actual number of our records of what we were able
to confirm.

MS. SMITH DEWAAL: And what authority do you, the USDA officials have in
going out and actually getting that product and retrieving it, or
what\'s your role there?

MS. SEYMOUR: The role for recall effectiveness checks which I stressed
in my remarks \-- our compliance officers generally will verify about 10
percent \-- is that correct, Tom \-- about 10 percent of the consignees
that are identified of a firm that is recalling product \-- in other
words, the people that they have shipped to. They\'ll also, in our
random reviews and our planned reviews, will keep an eye out for that
product.

And one of the areas that we do look at is salvage operators. And we
make sure when compliance officers go in to a salvage operator, they are
very attuned to any product that may have been recalled but not
returned. We look at 10 percent of the consignees and if in fact we find
that there is still product out there, we would detain that product and
immediately move to get that product out of any distribution channels.

That happens very rarely, but we think its very important to verify the
recalls, to keep someone from \-- and it\'s often not the recalling
firm. It may be someone they sold to that may choose to not return the
product. So we want to keep a very close eye on that.

MR. BILLY: Jill?

MS. HOLLINGSWORTH: Jill Hollingsworth, Food Marketing Institute. Carol,
in your slide about the state enforcement programs, you mentioned the 25
meat agreements and the 23 poultry.

Can you explain what is the difference in the roles of FSIS and the
states in the states that have an equal-to program and those that do
not?

MS. SEYMOUR: Okay. In a fairly oversimplified \-- there\'s quite a few
differences, but for the purposes of our compliance and enforcement
work, in states that have equal-to programs, the state would \-- any
violation involving interstate movement of products would be under the
state authority solely. Any violation that might involve contamination
of previously inspected, federally inspected product that\'s moved in
interstate commerce, we would share jurisdiction. Any violation that
involved interstate commerce would be the federal jurisdiction.

MS. HOLLINGSWORTH: Is there any difference in the reviews \-- of the
planned and random reviews in one state versus another?

MS. SEYMOUR: Some states have more resources than others. In those
states that may have less resources, federal reviews would be the more
frequent thing and then we would hand those off to the states.

We encourage the states to have basically a planned compliance program
that would cover repeat violators and high-risk businesses exactly like
we do. And we\'ll share computer systems and records and forms and
reports. And as I say, we provide training if the state is interested in
doing that, we provide training for their COs right alongside with our
COs. So they hopefully will conduct basically the same kind of coverage
and share the information.

MR. BILLY: Stan?

MR. EMMERLING: Stan Emmerling, representing North American Meat
Processors Association. It appears that the in-distribution compliance
program is going to be much more expansive and broader based \-- that
seems to be what we are anticipating.

You mentioned you have about a 179 compliance officers. I have several
parts to the question. Do you anticipate hiring more, and does the \--
the 179 does not include the state people involved. If you add them all
together and you\'re working cooperatively, how many do you have in
total?

MS. SEYMOUR: I\'m sorry I don\'t know the answer. I should have looked
that up, but we\'ll certainly check on that and make that information
available. It wouldn\'t be twice that much, though, I can guarantee you.
Tom, do

you \-- I don\'t know if you have any statistics?

MR. BILLY: I don\'t know that off the top of my head.

MS. SEYMOUR: My guess is it would be something in the range of 250-300.

MR. EMMERLING: And you\'re intending to perhaps hire more? Do you have
any idea yet what you might be looking at there?

MS. SEYMOUR: Well, we\'ve had a steady increase over the last several
years in the number of compliance officers, as the budget permits.
Certainly we do know that there are certain parts of the country where
we are thin on coverage and we certainly want to fill those positions.

MR. BILLY: Stan, let me intercede just a second. Part of your question
will be addressed in the later presentations, but just to provide an
initial response, you\'ll learn that what we\'re exploring at least in
part is that some of the activities that have been carried out by
compliance officers \-- and keep in mind, Carol said that this is only
taking about 15 to 20 percent of their time \-- some of the activity may
well be carried out by an inspector instead of a more highly trained
compliance officer.

Also the change to HACCP has put a further demand on the role of
compliance officers as it relates to slaughter and process facilities.
So there\'s a pull towards compliance work related to that, and if we
permit it, it could result in a reduction of this level of effort in
distribution.

And so what we\'re looking at is alternative ways of maintaining and
perhaps improving the effectiveness of our presence in distribution, and
that\'s what you\'ll hear more about in a little while. So maybe if you
keep that question in mind when we go through the rest of the
presentations, you\'ll get a sense of what we have in mind.

MR. EMMERLING: I for many years have been concerned you did not have
enough compliance people. And you know, you divide through and do the
arithmetic on 34,000 with 179 and you come up with about one a day.

The program you\'re talking about, if you\'re talking about other
consumer protections as well as food safety, you need to have, in my
judgment, a broader way of addressing that if you\'re trying to be
effective in the long run.

MR. BILLY: And that\'s \-- I think we\'ll get into that and then once
you hear it, I encourage you to come back and give us your view of how
you feel about what our current thinking is.

I\'d like to move on now. So thank you, Carol.

Next, it\'s my pleasure to introduce Mr. Phil Derfler. Phil is the
deputy administrator for the Office of Policy, Program Development and
Evaluation and he\'s going to talk about some of the common questions
and issues regarding this area of in distribution and hopefully dispel a
few myths in the process. Phil?

MR. DERFLER: Good morning. The national performance review suggests that
we do our stuff in a question-and-answer format that would help in the
clarity. And so, since as a speaker, I need all the help I can get, I
figured I\'d put my presentation in a question-and-answer format.

The questions actually reflect actual questions that we\'ve been getting
and concerns that we\'ve been hearing about the in-distribution program
and so that\'s what I want to try and address.

The first question is, what\'s the public health basis for assigning
inspectors to work in in-distribution channels? The recognition that
meat and poultry products need to be handled in a manner that will
ensure that they will not be rendered injurious to health as they move
from inspected facilities to the consumer and that the federal
government needs to engage in activities designed to ensure that that\'s
the case, is long standing.

Fifteen years ago, the national research council in its report, \"Meat
and Poultry Inspection: The Scientific Basis for the Agency\'s
Program,\" stated that \"An ideal meat and poultry inspection system
will ensure that adequate public health protection measures are located
throughout the food system, from animal production to the sale of the
food product.\"

The NRC, in its report, listed several factors that could affect the
safety of meat and poultry products after they leave the inspected
establishment. Included among these things were the microbial load in
the product at the time of shipment, air temperature and movement in
transportation vehicles and in storage warehouses, insect and rodent
control during storage, methods of loading walk-in refrigerators and
display cases, and cleanliness of items used in handling meat and
poultry products, including cutting boards, blocks, grinders,
tenderizers, and cooking utensils.

FSIS pointed out or pointed to the need for a farm-to-table system and
to the hazards that can arise as meat and poultry products move to the
consumer in its 1995 pathogen reduction HACCP proposal. FSIS stated that
its public health mandate requires that it work with the transportation,
distribution, and retail sectors to implement effective strategies to
prevent food safety problems. The agency pointed out that it was
exercising regulatory oversight of meat and poultry products in
transportation, storage, and distribution channels through the work of
its compliance officers and by working with the Food and Drug
Administration.

FSIS stated that if it put HACCP in place, it would consider how to
reconfigure its program or initiate new activities to increase the
effectiveness of its efforts to ensure that product remain safe after it
left the inspected facility.

In the pathogen reduction and HACCP final rule the agency reconfirmed
its commitment to a farm-to-table strategy. The agency stated that its
public health mandate requires that if effect a comprehensive strategy
to prevent foodborne illness and that its strategy would be based on
three principles.

First, those hazards that could result in foodborne illness can arise at
each stage of the farm-to-table continuum. Each stage presents a hazard
of a pathogen or other contamination and each provides opportunity for
minimizing the effects of those hazards.

Second, those in control of each stage bear a responsibility for
identifying and preventing or reducing the food safety hazards under
their control.

And finally, the agency\'s public health mandate requires that it
address hazards within each segment of the production and delivery chain
and that it implement or encourage preventive strategies to improve the
whole system.

Now that HACCP is in place and in effect in plan, FSIS has actually
begun to consider how best to configure the in-distribution portion of
its comprehensive strategy. Two factors will be particularly important
as the agency does so.

First, product from an inspected establishment that the agency finds is
not adulterated gets to bear the USDA mark of inspection. This mark acts
as a representation about the condition of the product. FSIS believes
that it has an obligation to verify that the handling of product as it
moves to consumers is such that the product appropriately continues to
bear the mark of inspection.

Second, under the agency\'s HACCP regulation, an official
establishment\'s HACCP plan is to be based on an analysis of the food
safety hazards that can occur before, during, and after the product
enters the official establishment. Verification activities focusing on
product as it moves in distribution can provide agency personnel both
inside and outside the producing establishment with insights as to
whether the establishment, as presented by its product, has developed an
adequate HACCP plan.

Both of these factors point to the need, based on food safety, to deploy
agency personnel to scrutinize the condition of product as it moves in
distribution. In addition, there\'s a third, nonfood safety factor that
supports this need.

The agency recently published an advance notice of proposed rulemaking
on how it should provide consumer protections other than food safety
protection. One concept that the agency advanced in that notice was the
possibility of shifting at least some of these other consumer protection
activities from in plant to in distribution so that the agency\'s checks
come closer to the consumers who will receive the product and so that
the agency\'s in-plant inspection force can concentrate on food safety.

For all of these reasons the agency believes that there is a significant
basis for it to deploy some of its inspectors to work in distribution.
But this raises the question of, why inspectors? Why not continue to
rely only on compliance officers?

The answer is that our tentative view is that reliance on inspectors to
assess the condition of product as it moves in distribution is
consistent with a fundamental shift effected by the implementation of
HACCP.

Before HACCP, the prime focus of the agency\'s efforts in distribution
was to find noncompliant product that had somehow slipped by the
agency\'s in-plant personnel and to take enforcement action against it.
Compliance officers were the obvious choice to do this work.

Now, however, plants are responsible for ensuring, subject to agency
verification, that the product they introduce in commerce is not
adulterated. Thus the agency\'s emphasis in distribution is to verify
that product that is moving in commerce is not adulterated. This is the
type of work that we are now assigning to inspectors. Only if the
inspectors find a problem would compliance officers need to be called
in.

One purpose of the in-distribution project is to determine whether this
shift makes sense in practice. The agency\'s goal is to ensure, as Ms.
Seymour said, that it does its work in distribution in as efficient and
as cost-effective manner as possible. To decide how best to do so, the
agency intends to explore various ways of doing in- distribution work,
from relying on inspectors to compliance officers to state and local
personnel and to personnel of other federal agencies, like FDA. We will
design our ultimate in-distribution strategy, based on what we learn in
the project.

Is the purpose of in-distribution inspection to find a place for
inspectors displaced by the models project or displaced from models
plans? The answer to this is no.

It\'s true that the institution of the implementation phase of the HACCP
implementation models project provided the occasion for FSIS to select
and train inspectors to work in distribution and to institute the
in-distribution project.

However, there is no continuing relation between the models project and
the in-distribution project. Each will proceed based on the findings and
developments in the particular project. For example, we\'re increasing
the number of models plans up to 30 and are considering proposing broad
changes in how we do inspection of the slaughter of young healthy
chickens.

Neither development will directly result in an influx of in-distribution
inspectors. The future of in-distribution inspection will be determined
by what happens in the in-distribution project, including among other
things the results of the work of the 11 in-distribution inspectors,
what we learn from the work that we intend to do with the state of
Minnesota, which Mary Cutshall will talk about later this morning, and
what we learned from an assessment that we intend to do of the hazards
that occur in distribution. Again, Ms. Cutshall will talk about that
assessment.

One related point. There have been questions as to whether consumer
safety officers will be used in the in-distribution project. Let me make
clear that the agency has no plans to do so. What, then, is the
relationship of the models project and in-distribution? As I said, there
is no continuing relation between the models project and the
in-distribution project.

Historically they were connected in that both grew out of the agency\'s
recognition that with the implementation of HACCP, there would be an
opportunity to reconsider how FSIS did significant aspects of its work.
The two projects were initially handled together by the agency and the
MOU with our union that provided that there could be up to 30 models
plans also provided for the selection and deployment of 11
in-distribution inspectors.

As work on the two projects proceeded, however, it became clear that
there was no reason to keep them connected. First, they focus on
completely different aspects of the agency\'s work. Moreover, the staff
working on the models project simply had no time for in-distribution.
The development of the in-distribution project has lagged as a result.
Therefore, we decided it would be better for both projects if we
separated them completely.

What establishments will in-distribution inspectors visit? Because the
work of the in-distribution project has lagged I don\'t really have a
definitive answer to this question today. The initial concept for in
distribution was that in-distribution inspectors would do the same
in-distribution work as compliance officers. We\'ve followed that
concept to date and as a result in-distribution inspectors are visiting
warehouses, distribution centers, and retail stores.

However, as I mentioned, FSIS intends to do an assessment of where the
hazards are in distribution. As that work clarifies things, we may
reconsider which facilities in-distribution inspectors visit.

Remember, however, that our goal is to configure our in-distribution
resources in a way that will increase their effectiveness in ensuring
the product remains safe after it leaves an inspected facility. Remember
also that the in-distribution project is not a facility inspection
program. Our interest is not in the facility per se but in the product
that bears the mark of inspection and in the conditions under which that
product is being held.

Now, what do I mean when I say that we\'re interested in the conditions
which the product is being held and not the facility? What I\'m saying
is that there\'s a big difference between walking into a supermarket and
checking the conditions in the meat display cabinet and in other places
where meat is being held, and on the other hand, doing a full inspection
of the whole store. FSIS in-distribution inspectors will be doing the
former and not the latter.

Why isn\'t FSIS\'s in-distribution inspection program redundant to state
inspection programs? We don\'t think there\'s redundancy because of the
differences in the focus of the two programs. FSIS\'s focus is on
federally inspected product and on the mark of inspection that that
product bears. The state\'s focus is on a lot of the facilities that are
in in-distribution. Thus, in the example I just gave, where FSIS\'s
focus is on how federally inspected product is being handled in the meat
department, the state\'s focus is on the entire store.

FSIS recognizes, however, that there can be some overlap between the two
efforts. That\'s why, as part of the in-distribution project, we are
working with the state of Minnesota in an effort to see how the agency
can integrate state inspection with its in-distribution inspection
efforts and to compare the input from state inspectors with that of its
own in-distribution inspectors.

Our efforts will be to minimize any overlap. In fact, depending on what
we learn, we may decide that in some states it will be appropriate to
rely on state personnel working with FSIS compliance officers and that
it is unnecessary to post in-distribution inspectors to that state at
all. But that is why we\'re doing the in-distribution project, to learn
how best to configure our resources.

Finally, what standards will in-distribution inspectors apply? In the
short run, in-distribution inspectors, like FSIS compliance officers,
will apply the adulteration and misbranding provisions of the Meat
Inspection Act and the Poultry Products Inspection Act, and the FSIS
regulations applicable to product after it leaves an inspected
establishment. They will not be enforcing either the food code or local
laws.

In the future, FSIS intends to propose performance standards for the
handling of meat and poultry products as it moves in distribution.
However, this proposal is still in the early stages, very early stages
of development.

That concludes my presentation. I hope I\'ve answered some basic
questions about the in-distribution project.

MR. BILLY: Thank you, Phil. Again, if there are questions to get
clarification of what Bill\'s presented we\'d welcome them. Nancy?

MS. DONLEY: Nancy Donley, from Stop! Safe Tables Our Priority. I\'m a
little confused, Phil, maybe. When Carol Seymour gave her presentation
she said that states have to have equal-to programs, but then, here you
say that the difference between the state programs, that there\'s a
difference in focus. Can you \--

MR. DERFLER: Well, I\'m actually \-- Carol was talking, I think, about
state meat and poultry inspection programs and I\'m saying that states
have broader retail inspection programs, they work with the state and
local \-- and the state and local authorities cover that.

In some senses \-- in a lot of the concerns that we\'ve heard about the
in-distribution project, it\'s been the overlap between what it is that
we\'re going to do if we\'re going to send inspectors in retail stores.
And that\'s what I was focusing on.

Now, as we work through the in-distribution project \-- I mean, how we
work all this out is one of the questions that we need to deal with, but
that was what underlay what I said.

MR. BILLY: Now, let me say it a different way and maybe this will help
as well. Under the law, states can choose to have inspection programs
focused specifically on slaughter and processing facilities only, that
if they\'re equal to our program, that product can be marked and shipped
within the state. That\'s different than state responsibilities for
warehouses or retail stores or restaurants. And what we\'re talking
about today is the latter \-- the warehouses, retail, distribution
centers, that kind of thing.

And that\'s the area that our compliance officers have traditionally
focused in, and what Phil\'s talked about is how, in that latter area,
we could modify our current strategy to get a more effective result in
terms of food safety and other consumer protections.

MS. DONLEY: So those 25 meat plants and 23 poultry plants \-- or I may
have it reversed \-- in the states, that is for slaughter and processing
only, or are they also doing in-distribution functions?

MR. BILLY: Only. The cooperative agreements with us under our acts focus
only \-- those programs focus only on slaughter and processing.
Sometimes the same people also carry out other activities. But it\'s
under the state funds carrying out other authorities not provided for
under our cooperative program.

MS. SEYMOUR: If I could add, we actually do have separate agreements for
enforcement. We have inspectional agreements and enforcement agreements.
The states, if they have an inspection program, they also have to have
an enforcement program. If they do not have an inspection program we
don\'t sign these agreements on the enforcement program.

I can see it\'s a little confusing, but under our statutes you have to
have an equal law and that equal law has to have both an inspection
component and prohibitions for selling adulterated product or misbranded
product, that are much like our federal laws. So a state can\'t really
be equal to unless they inspect products and they take actions on their
violations that occur. So our cooperative work-plan agreements with the
states really cover more of the compliance kinds of activities for
criminal enforcement, documenting cases and prosecuting violators.

A good example, I think, that helps clear this up is, most states have
weights and measures people who may go to retail stores and check to
make sure the scales are accurate when you weigh your bulk foods and
things along those lines. And they have specific laws about that.
Occasionally weights-and-measures kinds of things bump into our food
safety and labeling laws, but very rarely. We don\'t anticipate getting
involved in weights \-- you know, is the scale accurate. But we
certainly would be getting involved in working with the states if there
were some kind of a widespread consumer fraud involving federally
inspected product. And so that\'s the kind of things we\'ll work out in
the pilot testing.

MS. DONLEY: Thank you.

MR. BILLY: Jill?

MS. HOLLINGSWORTH: Jill Hollingsworth, Food Marketing Institute. Before
my question, first of all I want to thank Tom and Carol for that
clarification, because I was concerned that the implication was that
only 25 states had programs for inspecting at in-distribution, and in
fact, all 50 states do. In some cases they may be equal to the food code
versus equal to FSIS regulations, but all states inspect
in-distribution.

Phil, I have a series of questions. First of all, the first one that
would help for clarification is, can you identify how many food
inspectors \-- the category of food inspector, how many of those people
are now called consumer safety inspectors and what is the difference?
How does a food inspector become a CSI, or is it just merely a name
change?

MR. DERFLER: I really don\'t know the answer to that question.

MR. BILLY: We do though. Hold on a second.

MR. WALLER: Hi, I\'m Marlin Waller. For consumer safety inspectors right
now, the change in classification took place after the full
implementation of HACCP. We have approximately 2,900 positions that are
now classified as consumer safety inspectors. They\'re the processing
inspectors, off-line slaughter inspectors. So that\'s the primary
difference. And also in the models plants now that \-- and also the
in-distribution inspectors are in the consumer safety inspector series.

MS. HOLLINGSWORTH: Is there any educational requirement or what is the
distinction? Why does one become the other?

MR. WALLER: The consumer safety inspector occupation does not have a
positive education requirement like the consumer safety officer, and
food inspector obviously does not have a positive education \-- that
means do not have to have a college degree. So we had \-- with the
change in the way that inspection is now being done under HACCP, we
think that the consumer safety inspectors series is more appropriate for
the way that we\'re approaching inspection now and that\'s why the
change occurred for processing and off-line slaughter jobs.

MS. HOLLINGSWORTH: And will slaughter on-line inspectors remain as food
inspectors and not CSIs?

MR. WALLER: Yes.

MS. HOLLINGSWORTH: Okay. My next question is, in one of your slides
where you identified the difference in the focus, where you said the
state focus was on the entire facility and FSIS was on federally
inspected product, it sort of sounds there like you\'re saying that the
states do not inspect federally inspected product. Can you clarify for
us, is there anything that an in-distribution inspector would inspect or
monitor that a state inspector does not already do?

MR. DERFLER: Well, I think I acknowledged that there is some overlap,
and that\'s why we\'re working with Minnesota to see how that works out.
The state inspector may well look at the conditions under which the meat
is being held. And that\'s what we\'re trying to work out with
Minnesota. Mary is going to talk about that, about what information we
would learn from that and how it would work.

But the mark of inspection, though, is uniquely ours, and right now, in
the lack of an interstate shipment or anything like that, only we would
be able to do anything with respect to that mark. And we take that very
seriously.

MS. HOLLINGSWORTH: Okay. And my last question is on the role in
distribution \-- when you talk about assessing the adequacy of the HACCP
plan, how will assessing the adequacy of the HACCP plan, when the
product is beyond the scope of the HACCP plan that is being enforced or
used by the plant, how will that differ than, say, a preshipment
verification?

It was our understanding that the preshipment verification was used to
ensure that the product in distribution in fact had been produced under
a valid HACCP program. What would be different in distribution?

MR. DERFLER: We anticipate that there may be developments in
distribution that reveal matters that the establishment had not
adequately anticipated in doing its hazard analysis. For example, I
mean, the one that sort of comes to the mind right now is listeria,
where what we\'ve learned recently is that some of the sell-by dates
that were being put on the product were based not necessarily on food
safety considerations and that there was the possibility of actual
listeria grow-out during that time.

That\'s one of the things that might be able to be determined by doing
inspections in distribution rather than simply relying on the work that
we\'re doing in the plant.

MS. HOLLINGSWORTH: Thank you.

MR. BILLY: And I might add, that would be something that isn\'t
currently being looked at by state inspectors specifically, but perhaps
that\'s something that we can address as well through this cooperative
effort with the states. Caroline?

MS. DEWAAL: Thank you Tom. It\'s Caroline Smith DeWaal with the Center
for Science in the Public Interest. Phil, a couple of years ago we did
some research that resulted in a report called \"Dine At Your Own
Risk,\" where we compared state, county, and local government adoption
of the federal food code which Jill Hollingsworth just referred to. It
is true that the states have major responsibilities for the oversight of
restaurants, food service, grocery stores. But the reality of that
system is that it\'s not even clear which body of government has the
responsibility in some instances. Sometimes it\'s the state, sometimes
it\'s the local government, sometimes it\'s the county government.

In addition, each one of these entities has to separately adopt
standards for the regulation of restaurants, food service, grocery
stores. Our report documented that there was huge variation in the
application of very basic food safety standards \-- things like cooking
temperatures for fish, for eggs, for meat, for chicken.

There can be huge variations around the country in how such basic
temperature standards as how hot to cook a hamburger. How the states
apply those and the county and local governments apply those in a
restaurant setting around the country can be highly variable.

We are also very concerned that state, county, and local budgets
fluctuate much more rapidly, and as a result we\'ve seen huge inspector
cuts that can occur very quickly at the state, county, or local level.
The people who are supposed to be doing this check of grocery stores,
restaurants, and things like nursing homes and school cafeterias may not
be there because they may have been cut from \-- or they may be being
used somewhere else because of budget cuts. So we strongly support
having another check on the system which would be represented by this
in-distribution program.

My question is, how is this program going to better ensure that we get
these minimum federal standards for meat safety \-- things like adequate
cooling temperatures, adequate holding temperatures, adequate cooking
temperatures. Is there a way that we can use this additional check on
the system to ensure that minimum standards are being applied, minimum
food safety standards are being applied around the country?

MR. DERFLER: Well I think the answer to your question has to be a
two-part answer. First of all, there has to be appropriate standards in
place, and we intend to look at that through the rulemaking we intend to
do on a performance standard. Plus, I mean, we work very closely with
the Conference for Food Protection to ensure that the food code is as
good and reliable a document as possible.

Once those things are in place, then the in-distribution inspection
system, however that ultimately is configured, is hopefully going to
provide monitoring.

MS. DEWAAL: But even if the food code is a strong document, if it is not
adopted in a particular jurisdiction, it\'s not meaningfully serving the
public. How will this program provide \-- let me just give you an
example from our report. Our data was collected, I think it\'s around
four or five years after the Jack-in-the-Box outbreak. And yet a third
of the jurisdictions that we surveyed still didn\'t enforce the minimum
cooking standard for hamburgers that we all knew had to be enforced to
prevent another Jack-in-the-Box-type outbreak.

How will this system ensure that even if a particular state or locality
hasn\'t adopted that cooking temperature, that you will be able to
enforce it? How are we going to ensure that these minimum safety
standards are being enforced around the country?

MR. DERFLER: Well, obviously the purpose of the in-distribution program
is to find the best way to do that. That may be in some circumstances
balancing what we do with the states, because the states are providing
viable enforcement. In some states it might mean that we do have a
bigger in-distribution program. I mean, it depends on what our resources
are going to be, what we learn as we do the program, and what the states
are doing.

MR. BILLY: Okay. Thank you very much. I\'m going to now call a break and
I\'d like you all to try very hard to be back here at 10:30.

(Whereupon a short recess was taken.)

MR. BILLY: Another area that we wanted to share some information with
you on is to give you the sense of he kind of training and evaluation
functions that we\'re currently making available to our in-distribution
inspectors. We think it will help communicate some of our current
thinking and, obviously, again provide opportunity to ask any questions
and clarification.

With us this morning to present this material is Krista Marting. She is
with the Office of Policy, Program Development and Evaluation. Krista?

MS. MARTING: Thank you. Good morning everyone. As you have already heard
this morning, we have started to explore how resources will conduct
in-distribution activities as part of the agency\'s farm-to-table
strategy.

To start the process, 11 in-distribution inspectors were assigned to
four locations in the United States to conduct specific in-distribution
activities. This initiative was designed to provide information about
how to best focus resources to address food hazards after meat and
poultry products leave inspected establishments.

This morning I\'ll be providing you with a brief update on the 11
in-distribution inspectors, the training that was provided to them, and
I will also briefly describe the ongoing evaluation process that is
underway.

Earlier this year 11 in-distribution inspectors and their respective
supervisors were trained to carry out in-distribution activities in four
locations. Five in-distribution inspectors were assigned to the
Philadelphia, Pennsylvania, area. We actually have two in South
Philadelphia, one in North Philadelphia and two in Hatfield,
Pennsylvania. Three in-distribution inspectors were assigned to the
Minneapolis, Minnesota, area. We have one in Minneapolis, one in St.
Cloud, and one in Austin. Two in-distribution inspectors have been
assigned to Harrisonburg, Virginia, and one has been assigned to
Guntersville, Alabama.

The training that was provided to the in-distribution participants
consisted of four different components: an orientation, introductory on
the job, formal, and followup on the job training.

The orientation session lasted two days and was conducted January 19th
and 20th in each of the four district offices. This training consisted
of an overview of the activities that the in-distribution inspectors
would be performing. I will discuss these activities in the next slide.
At this orientation session, in-distribution inspectors were paired with
a compliance officer who served as their mentor throughout the remainder
of the training program.

Following the two-day orientation session began a two-week introductory
on-the-job training session. This lasted from January 24th through
February 4th. During this OJT session, inspectors accompanied their
mentor compliance officers and observed the compliance officers
performing the assigned activities.

Next there was one week of formal training. This took place from
February 7th through the 11th in our Philadelphia district office. At
this training session the inspectors were taught the specific components
of each of the assigned activities and also how to complete the
paperwork that was associated with each of the activities.

Following the formal training we had a followup on-the-job training
session that, again, lasted two weeks. This was February 14th through
the 25th. During this OJT session, inspectors went out again with
compliance officers but instead the inspectors assumed the lead in
performing the assigned activities while the compliance officers
observed and provided the necessary guidance and input as needed.

Following this two-week OJT session the in-distribution inspectors began
working independently, contacting their appropriate supervisor for
guidance as needed. The initial training activities that the
participants were trained to perform include conducting reviews \--
these are the planned and random reviews that Carol Seymour discussed
earlier \-- conducting the recall effectiveness checks, investigating
consumer complaints, collecting E. coli samples, and liaison activities.

I\'ll give a brief description of the last three since the first two
we\'ve already discussed earlier. Investigating consumer complaints
simply involves talking to the consumer who has submitted a complaint,
just to gather information about the product, and it also may involve
going to the store where the product was purchased, to gather additional
information.

Collecting E. coli samples actually doesn\'t need an explanation so I
won\'t do that. Liaison activities \-- this simply involved the
communication that is needed between the in-distribution inspectors and
FSIS enforcement personnel and state and local government officials as a
result of performing all of these activities.

A formative evaluation of the in-distribution inspection program is
planned. A formative evaluation takes place during the program\'s
operation and focuses on providing useful information to program staff.
The purpose of the evaluation will be to determine if the program is
working as intended, identify any problems the participants are having
as they carry out their duties, identify any additional training needs,
and to assess the differences in how the project is working in the four
different geographic areas.

The evaluation process will be continuous, to allow adjustments to be
made as necessary. The evaluation team will collect information from all
participants at various intervals, using surveys and interviews.
Information will be used to address study questions, identify
improvements, and note recommendations for continued success.

An initial evaluation was conducted shortly after the training and
focused primarily just on the training. This evaluation recommended that
additional training be provided to address the varying levels of
knowledge and experience among the in-distribution inspectors. Project
leaders are currently exploring different options for providing the
additional training to some of the in-distribution inspectors to address
these variances.

In addition to the formative evaluation, project leaders have
established an open line of communication with all participants to allow
for continuous feedback and improvement.

And that\'s it for me. I have the shortest of all presentations.

MR. BILLY: Thank you, Krista. Are there any questions for clarification?
Anyone? Okay, thank you very much.

The next presentation is going to be made by Mary Cutshall. Many of you
know Mary as the person that provided some very important leadership,
helping the small and very small plants implement HACCP.

Mary is now also focusing her energies in helping us develop the
concepts and approaches that Phil described in very general terms in his
presentation. Mary now will give you a little more in-depth thinking in
terms of these ideas, so that may well prompt some further questions on
your part. Mary?

MS. CUTSHALL: Thank you. Good morning. I hope, as Mr. Billy said, that
some of the things that I talk about this morning will bring together
the information that Carol has presented, that Phil has presented, and
that Krista has presented and give you a little bit more idea about what
our concepts and our thinking is. And I want to stress at the outset
that what I\'m going to be talking about is our current thinking and our
concepts, because this is an ongoing process of development for us at
FSIS.

You heard this morning where we began with the in-distribution project
and about the role that compliance plays in assuring that food is safe
in an in-distribution environment. Through this project we are not
creating a new activity within in-distribution channels as you\'ve
already heard. This activity has already been established through our
compliance program and under our current authorities.

Rather, what we want to do is explore new ways to look at assuring food
safety through the distribution channels as part of our farm-to-table
commitment. Thus, as Mr. Billy said earlier this morning, we are not
debating about the need for presence in distribution but how we can best
carry out our food safety and other consumer protection responsibilities
at this point in the farm-to-table continuum.

Today I want to discuss our current thinking and the ideas that we will
test, and I want to stress the word \"test.\" The emphasis for the
future of this project is on determining conditions that exist in the
distribution chain under which inspected products are held that may
constitute food safety hazards and how to address them, using the
resources available to us at FSIS, the federal levels, state levels and
local levels.

I\'m going to go about this in sort of a who, what, where, when, and why
format as a way of organizing the information that I\'m going to present
to you today. And that follows with sort of our presentation all
throughout the morning.

I\'m going to begin with \"who.\" And the idea that I will discuss and
the ideas today involve the 11 inspection program personnel that are
currently in place for this project. I\'m also going to discuss
cooperative agreements that we hope to establish and that we are
establishing with state and local jurisdictions as part of our focus on
partnerships. And I\'m going to talk more about cooperative agreements
later in my talk.

When we talk about \"what,\" we want to talk about what the
in-distribution inspectors will do. For the duration of this project we
will test the concept of having in-distribution inspectors conduct
verification activities to ensure the safety of federally inspected
products, meat, poultry, and eggs after they leave the plant and are in
distribution channels.

This is a central point that I think Phil Derfler made earlier is that
we are going to be focusing on food safety for federally inspected
products in distribution channels. This is a new type of verification
activity for FSIS inspectors. Currently our inspection forces focus on
verifying in plant the food safety for inspected products and
facilities.

We\'re also going to be collecting information, and this is a big part
of our effort. We\'re going to be using this for several purposes. First
we\'re going to collect information to help us develop a system for
determining how to target our verification activities, based on food
safety hazards that will be identified in distribution. Second, we\'re
going to be collecting information to determine if we can link this
information to the adequacy and the efficacy of in-plant HACCP plans.

Let me discuss these in a little bit more detail. What we\'re going to
be doing with verification is focusing on food safety aspects of product
during handling, transportation, and distribution. The 11 individuals
that are in place will visit businesses not to make, as Phil said,
traditional facility-focused inspections but to verify the safety of
federally inspected products within these channels.

In a few moments I\'m going to talk about a hazard ranking system that
we propose to utilize that will serve as a basis for guiding our
verification activities. We believe that a measured and methodical
approach composed of determining food safety hazards and directed
performance of inspection activities in distribution will aid us in
making decisions regarding where, when, and how hazards can best be
addressed through an out-of-plant approach to in-distribution to make
determinations regarding compliance with food safety regulatory
requirements.

We also intend to address other consumer protection concerns through
verification activities in distribution, but food safety will remain our
priority. When we talk about what we\'re going to do, I mentioned
information collection.

At this point in time we at FSIS are not aware of any systematic reviews
that define what specific hazards are found in distribution channels and
how the specific hazards can be weighed or ranked. Because of the
scarcity of specific data, this project will involve determining through
the use of a systematic method where the hazards most likely to affect
food safety occur in this continuum.

We will be using the 11 in-distribution inspectors to collect
information that can assist us in making these determinations. FSIS will
explore using the Brian model, a method that\'s been published by Dr.
Frank Brian and presented to the World Health Organization. This model
has been specifically developed with foods of animal origin in mind. It
takes into account differing factors and the factors that constitute
hazards and it allows a ranking or a hazard coefficient to be attached
to each of these particular parameters.

In this case, the parameters that we would be looking at ranking and
evaluating would be: (a) the process \-- for example, grinding, frozen
storage, or food service preparation; (b) the hazard posed by the
specific type of firm or business involved; and (c) the hazard posed by
the amount of product produced. When I talk about this last parameter,
this would help us predict the impact on a population if there were a
foodborne illness outbreak associated with a particular type of
business.

All these factors are accumulated together and you can come up, using
this method, with a hazard coefficient for a particular type of
business. The use of this type of model can very effectively allow us to
make determinations about where verification should occur and allow us
to document our findings over time.

As we make these determinations, the in-distribution inspectors will use
these guidelines that we have developed to determine where they should
make verification visits. This activity will be directed through OPPDE
in conjunction with field operations, the district managers, the circuit
supervisors, and the in-distribution inspectors.

Another aspect of what we will be doing when we are collecting
information is to evaluate in plant HACCP programs. We envision that
verification and distribution channels will allow us a way of providing
more information and feedback on the adequacy and efficacy of in-plant
HACCP plans in our inspected facilities.

As I said, we hope to be able to use this information in a continuous
feedback so that we can supply our in-plant inspection personnel with
information that we have gleaned through our in-distribution activities.

We plan to develop a system to be able to look at this information,
although at this time we are not sure exactly what the system will look
like as we are collecting information as the project will continue. But
we will explore our options during the duration of this project to be
able to \-- of where we may be able to do this type of activity that
Krista mentioned, the sampling of ground product for 0157:H7.

Phil mentioned listeria and shelf life. These are the kinds of things
that we can make both verifications and collect information on in
federally inspected product in distribution that can allow us to look at
the efficacy and adequacy of in-plant HACCP plans that are addressing
hazards as they do not relate to in the plant but, as the regulation
says, after the product has left the plant.

We talk about when \-- Krista mentioned to you that the final phase of
the initial training was completed in March of 2000. So we\'ve had these
11 individuals out there for the past few months. We agree that we need
to take a more focused approach and we have determined that that focused
approach is going to be on food safety and federally inspected product
\-- verification of that food safety through the in-distribution
continuum.

As Krista also mentioned, we will be doing ongoing and continuous
evaluation throughout the term of this project. We have made a
commitment to the process of exploration and analysis to determine the
most effective approach to in-distribution as part of our overall
farm-to-table food safety strategy.

As was mentioned earlier by, I believe, Caroline and Phil both, where we
will be conducting these activities is a pretty broad spectrum. There
are a number of different types of businesses that we will be
considering for verification activity. Cold storage, warehouses, retail
stores, salvage operators, brokers, institutions, restaurants,
renderers, animal byproduct manufacturers \-- I think you\'re all pretty
much familiar at this point with the gamut of options that we have that
we can explore.

How are we talking about doing some of these verifications and
collecting information? After we determine who and where and when would
perform these verifications, we also want to look at how those
verifications would be performed. Our verification activities will be
based upon, as Phil mentioned, performance standards, and those are
performance standards that not only will be developed in the future but
performance standards that currently exist in our regulations.

And we will also be looking at incorporating our HACCP systematic
methodology for determining food safety and distribution, based on
defined hazards as we have evaluated those and determined those, using
the methodology that I have mentioned.

We could also focus on specific growth levels and control of growth for
targeted pathogens in respective processes that have been identified, as
well as products, and the conditions that may lead to increased food
safety hazards presented by that increased pathogenic growth.

Temperature abuse is one example and, I think, a common example that
everyone is familiar with that may occur in distribution channels. Our
inspectors will look at product to verify whether there are conditions
that may render the product adulterated or misbranded. I think
mishandling is another pretty common example of this.

We talk about the different types of verifications and at this point I
know the issue came up about, what is it that the in-distribution
inspector is going to be doing that\'s a little bit different.

I\'ve tried to lay this out for you, based on information collection,
being able to tie things back to the HACCP plan, but one of the things
that we are absolutely committed to is having in-distribution inspectors
take a proactive role. As I said, when you\'re looking at HACCP plans
and doing feedback to the plant, that\'s a proactive role.

We also want them to be interactive. We\'ve talked about the fact that
we want to form cooperative agreements. We know we\'ll be dealing at the
state, local and other federal level, so that we will have inspection
personnel in distribution that will have a very active interactive role
with other agencies.

And the third piece, as I mentioned, is information collection so that
we can make methodical determinations about where, what we want to do
with this project in the future.

Another aspect of how we want to go about in-distribution development is
to work cooperatively with state, federal and local jurisdictions in
order to use existing resources effectively and efficiently. The
cooperative approach is one that we strongly believe in and we believe
it will help assure effective oversight along the distribution continuum
without necessarily overlapping resources.

We would like to use memorandums of understanding and cooperative
agreements for this purpose. It is possible that in states where
there\'s a well-functioning cooperative relationship with FSIS \-- Carol
mentioned a number of states. We know we have other activities going on.
If we have a functioning, cooperative relationship with FSIS, then FSIS
may make determinations about a lesser need for a presence in those
areas in distribution channels.

This we hope to be a large part of the information that we can gather
during the project and part of the lines of communication that we can
help become well established and well defined over time. These efforts
we believe would be beneficial for federal, state, local jurisdictions,
FSIS, consumers, and any other interested federal agencies.

So far as you\'ve heard mentioned this morning we do have a project in
place with Minnesota and we\'re working on developing a cooperative
agreement. This project utilizes state inspection personnel and we are
working on developing effective lines of communication so that our
people within the state of Minnesota and Minnesota\'s people can work
cooperatively to assure that without overlap we are all ensuring the
safety of federally inspected product.

We believe that this is a model that can be used in other states to
assure communication between FSIS, compliance, and state and local
inspections. We\'ve also had discussions with Virginia and Alabama
where, as you\'ve heard Krista mention, three of our other IDI
inspectors are located.

I know the question always comes up and so I\'m going to answer it very
forthrightly about enforcement actions and how we would handle
violations. The in-distribution inspectors will be operating under the
provisions of the meat and poultry acts and the associated regulations
when making determinations on findings as a result of their
verifications. Obviously, as part of our responsibility to assure safe
product, if violations are found, action will be taken. In such cases
compliance will be notified through the district office and a compliance
officer will assume responsibility, as is the case today. This is also
true in the case of suspected violations.

In all these cases, whether violations are found, whether suspected
violations are found, or where ongoing verification activities are
performed, all of this information will be continued to be fed back
through headquarters to Office of Policy to make determinations and
evaluations, and also through field operations channels.

I mentioned briefly earlier about other consumer protections. We are
looking at a different approach to assuring other consumer protections
in the distribution channels. And this will be a component that \--
we\'ll address ways we can more effectively use our resources to look at
other consumer protection in distribution. We believe that there are
some activities that are currently being carried out in the plant that
could be more effectively and/or efficiently carried out in distribution
channels.

One of the examples that we use for this type of activity is
nutrition-labeling audits. These now occur in the plant environment and
we envision that this could more effectively occur in the distribution
chain to allow us to gather this information.

I also mentioned evaluation, which is a big part of what we\'re going to
be doing as part of this project. We really envision that we are going
to continuously be collecting information and evaluating that
information in order to focus our efforts for verification in the best
way that we can. The information gathered from these verifications will
be evaluated by The Office of Policy to help further refine the focus of
how, what, when, and where we will be performing verifications.

The evaluation function for each aspect of our information gathering is
going to be based on the information that\'s gathered and will be
adjusted on an ongoing basis. This is not going to be a static type of
activity for us.

The evaluation results will consist of hazard determinations, the
in-distribution inspectors\' feedback, sampling results, and feedback
from our cooperative agreements with our state and local partners. This
information will be analyzed to determine the most effective ways to
approach in-distribution and to determine what conclusions can be drawn
about the effectiveness of in-plant HACCP plans and controlling food
safety hazards after product has left the inspected facility.

In closing I just want to reiterate that we\'ll be looking at different
approaches by gathering information, analyzing this information on an
ongoing basis throughout the project, and then making judgments about
the most effective approach based on what we learned.

In all that we do, we\'re planning on taking a measured and methodical
approach, focusing that, and using HACCP pathogen reduction principles
in our verification. We expect that the results of our in-distribution
activities will allow us to create a cycle that will feed back to the
activities conducted in inspected plants as well as in distribution
channels.

We plan to continue to communicate our thoughts regarding the
information that we develop as a result of all these efforts, in future
public meetings. Thank you.

MR. BILLY: Thank you very much, Mary. Are there any specific questions
for Mary and the material she sent in?

MS. WHITE: Yeah, I\'m Debra White with the Food Marketing Institute, and
I have a question that relates to other consumer protections which
follows up on something that Phil Derfler said as well. I was wondering
if you could explain why the agency believes it\'s more effective to
look at other consumer protection issues after the product has left the
plant and therefore there is no longer an opportunity to correct the
issue.

You mentioned nutrition labeling. If we take as an example, say, a
sausage that\'s packed at the plant that gets some sort of nutrition
labeling, once its left the plant and goes into the distribution channel
and into retail, if it\'s incorrectly labeled, it\'s sold to the
consumer. The consumer then no longer has a remedy. Isn\'t it more
effective to look at that issue before the product leaves the plant and
gets to the consumer?

MS. CUTSHALL: I think there\'s sort of two answers to that question. The
first is that, as I stressed, everything that we\'re going to be looking
at we\'re going to be looking at in an evaluated format and we may find
that that may not be the most effective way to do it.

But the other thing to keep in mind is, even though that is not a
function for food safety, it also ties into our capability to look at
what\'s happening in the inspected establishment and to make some
determinations about maybe where we need to focus back in the inspected
establishment.

MS. WHITE: But I guess I still don\'t understand why it would be more
effective to do that in the distribution stream than it would be to take
care of it before the product leaves the plant.

MS. CUTSHALL: I don\'t think any of us really know the answer to that
question and that\'s why we\'d like to explore it.

MS. WHITE: But you have no basis to believe it would be more effective,
is that what you\'re saying?

MS. CUTSHALL: No, I say that we don\'t have any basis to make a
determination one way or another and we\'d like to explore that option.

MR. BILLY: Phil?

MR. DERFLER: This is Phil Derfler. The first thing I\'d say is, like I
said before, we have a proposal out there. We specifically raised this
question as one that we\'re asking for comment on. I think we also
discuss in there some various other scenarios about \-- where we\'re
looking at the possibility of, it might be better to use our resources
closer to the consumer \-- some of the net weight things that you might
look at, for example. There\'s other examples. But we\'re interested in
your comments and the quickest way to do it right now is to provide them
in the other consumer protection docket.

MS. WHITE: And that\'s what I had planned to comment, to the docket, so
you\'ll definitely have our comments there, but I thought it was
appropriate to bring

up \--

MR. DERFLER: No \-- I\'m not saying no.

MR. BILLY: Nancy?

MS. DONLEY: Nancy Donley from Stop! Just a question about these
partnerships and then the \-- any MOUs. Is there any financial or
economic arrangement with state \--with these partnerships? Will \-- if
they\'re using state resources \-- will they be reimbursed in some way,
shape, or form?

MS. CUTSHALL: At this time, no, we are not looking at a reimbursable
relationship, although I certainly wouldn\'t want to speak for Mr. Billy
and rule any options out.

MR. BILLY: Okay. Go ahead.

MR. HELMS: Marty Helms, North American Meat Processors Association. You
talked about identifying some hazards in distribution and I would
encourage the agency to look back at the Research Triangle Institute
report. I think that\'s a very valuable document, specifically as it
relates to this issue, because it brought up a number of both retail
food service concerns and potential hazards that existed. Which brings
me to a point that in January, as we looked at the retail exemption in
January, NAMP (phonetic) was \--

and in our comments on retail exemption, you\'ll notice there too we
refer to the RTI document.

We were a little concerned that a retail establishment, although it
would be pass-through product, does not have the same control in selling
the possibly food service and even giving them an opportunity to put
together distribution to food service establishments from a retail
grocery store chain as opposed to a federally inspected establishment.

On pass-through product, I understand that it\'s not quite the concern
that it is with processed product until that product is returned to the
retail grocery store. I think that returns is a concern that needs to be
addressed as we move forward. Thank you.

MR. BILLY: Okay. Thank you.

MR. SCHEIER: I have two questions actually. The first one, do you have
any feeling at this point as to \-- depending on what happens in the
development of this

program \-- as to when this would actually start, when you would make
the shift and this would \-- in terms of personnel, when this program
would get underway?

MS. CUTSHALL: Well, as I said, we have the 11 IDI inspectors out there
now, so as far as we\'re concerned, the program is underway and we\'re
continuing to explore options.

MR. DERFLER: I think, you know, we\'ve just started and are looking at
some of the concepts that we\'re talking about within the last couple of
months with the decision to separate the two projects and so we intend
to move these things as quickly as we can. But right now, we have
in-distribution inspectors who are doing work that is similar to the
work traditionally done by compliance officers.

MR. SCHEIER: So you\'re basically saying pretty much that the program
has started, that you\'re kind of going to ease into it or develop it
and see how things go along and make changes when necessary \-- those
kinds of things?

MR. DERFLER: And as we develop the concepts that Mary talked about, yes,
and we can get them out to the field.

MR. SCHEIER: Okay. The other question I wanted to ask \-- I had wanted
to ask you when you were up there, but I can ask you or Mary, it
doesn\'t matter \-- and it has to do with the way this program is set up
vis-à-vis traditional inspection. The way that the states and counties
and municipalities inspect, if you want to use that word, retail stores
and groceries is very different from the way that USDA and state
equal-to programs do it, for a number of obvious reasons, but one of the
differences, obviously, is the frequency.

And I guess what I\'m wondering is, in what you see in terms of the
inspection being done under this program by inspectors instead of
compliance people, is it going to be closer in terms of frequency to
what states and counties and municipalities do, or would it be closer to
the way traditional inspection is carried out, or somewhere in the
middle? Do you have any feel for that at all?

MR. DERFLER: I think the answer is, not at this point. I mean, part of
it is how we do it. Part of the idea of what we\'re trying to work with
Minnesota is, if they in the course of the work that they\'re doing
discover problems with federally inspected product, then they\'re going
to let us know about it and then we would do followup.

So to the extent that that\'s a model that we follow in at least some
jurisdictions, it\'s going to be in the kind of frequency that they do.
To the extent that we have our in-distribution inspectors doing it, then
it\'s going to be dependent on the number of inspectors we have, the
nature of the task that we\'ve defined for them \-- those sort of
things. So I think at this point it\'s hard to give you a definitive
answer and it may well vary, depending on what we learn as we go through
the project.

MR. SCHEIER: So it could be different locations, you could have
different areas, you could be doing different frequency, different
amount \-- that sort of thing?

MR. DERFLER: But ultimately, the goal is to have as efficient and
effective program as possible.

MR. SCHEIER: Thank you.

MR. BILLY: Jill?

MS. HOLLINGSWORTH: Jill Hollingsworth, Food Marketing Institute. We were
previously told, but I need to get this clarified since I know there has
been some change in the thinking as this program has evolved, that there
will be no total increase in the inspector workforce. That the
in-distribution CSIs will come from the total pool of inspectors that
you currently have. Is that still correct?

MR. BILLY: Uh-huh.

MS. HOLLINGSWORTH: So the workforce itself is not increasing? And one of
the concerns that we have as retailers is that we\'re concerned about
what appears, anyway, to be a shift from a prevention mode to a
detection and reactionary mode. Verifying HACCP and safety of products
when they\'re already in the hands of consumers is very stressful for
us. We would like more assurances that the preventions are being
enforced, that the HACCP programs at the point where the CCPs exist and
the corrective actions are taken, that that is not diminished, that
those inspectors are not being taken away from that duty and put out
looking for the problems after they occur.

That almost seems a reversal to the old way. And we would like to
encourage the agency to, if anything, enhance and assure that the
products leaving federal establishments are in fact produced under HACCP
systems that have been verified and not get into this reactionary
recalling product from the hands of consumers saying, oh, well, we just
found out that the system wasn\'t working.

MR. DERFLER: This is Phil Derfler. What I was trying to say is that we
are trying to go into a preventive mode and some of the work done by
in-distribution inspectors would only enhance the work that\'s done in
the plant. As we develop our communications channels between the
in-distribution inspectors and the feedback back to the plant, the focus
on the federal mark of inspection \-- we believe that that\'s going to
do exactly what you said and that it\'s ultimately going to enhance,
throughout, the farm-to-table spectrum.

MR. BILLY: Jill, I\'m a little puzzled with something you said, and
maybe you could elaborate. I didn\'t hear anything said this morning
about doing inspections of product that\'s in the consumer\'s hands.
I\'m puzzled by that statement.

MS. HOLLINGSWORTH: Well, our concern is that by the time products are
already into distribution in retail and restaurant, at least a large
portion of that product will have already been sold, consumed. By the
time test results come back, the product will have been distributed, and
our concern is, we would like to have an assurance that the foods, when
they come to a retail store, are already as safe as they can be.

Now, we\'re certainly not saying we don\'t accept our obligation, and
we\'re not trying to shy away from inspection enforcement at retail.
What we don\'t want to do is see a shift away from in-plant preventions,
with reliance on detection after the product has already left. And
there\'s no recourse for corrective action once the product is in
distribution unless it can be recovered and returned.

MR. BILLY: Nancy?

MS. DONLEY: Nancy Donley from Stop! I agree with some of the comments
that Jill has made, that we too share the concern that we can\'t \--
that the prevention area, that what takes place, the inspection that
takes place in both the slaughter and processing levels can\'t be
weakened through any change in shifting inspection into the in-
distribution channels. So I think that the agency \-- I urge the agency
to be very, very careful and monitor closely that if anything seems to
be shifting at the processing level, that adjustments be made
immediately.

I just want to verify one other point, and that is that \-- a comment
that Bernie had made earlier \-- is there going to be any \-- first of
all, FSIS in distribution and in retail is in no way, shape, or form
going to replace anything that states are doing on their own, states and
local. Am I correct in that?

MR. BILLY: Yes.

MS. DONLEY: Okay. So this is going to be just an enhancement of those
programs, which I think is a very good thing because the state programs
right now are very uneven programs so I like the idea very much of
having some federal oversight in these areas.

And then lastly, is FSIS going to monitor somehow that states then
don\'t try to rely on the federal government to be able to use you as a
fallback position and, when their budgets get cut, to necessarily cut
these \-- that\'s a concern of ours as well. There\'s got to be some
sort of a monitoring of \-- let\'s make sure that ultimately the public
is best protected, that one isn\'t assuming, okay, I can rely this way
or that way.

MR. BILLY: Very good points. Stan?

MR. EMMERLING: Stan Emmerling, representing North American Meat
Processing Association. I just would also like to reinforce some of the
prevention comments that were made by Jill Hollingsworth. It almost
appears \-- and though I support this in-distribution aspect that
you\'re going on \-- I think it\'s necessary and it\'s certainly part of
the whole process \-- it\'s almost cart before the horse because some of
these problems are starting before it even reaches the slaughter floor
\-- in other words, on the farm, and we keep talking farm-to-table
continuum and we haven\'t given up that concept, but we don\'t start
with it and that\'s really the beginning. So the prevention aspects
would minimize some of these things that you\'re trying to do on the in-
distribution. Those are more like Band-Aid approaches when the problem
starts way before that.

With respect to some of the things in the in- distribution \-- and I
didn\'t hear any of that and I don\'t know whether you\'ve thought about
it, but are you contemplating more testing, like, for species or
ingredients with this down, you know, on the in-distribution level, is
that something that\'s going to be moved out of, say, in-plant testing
further on down the line? How are you going to catch up with some of
these things that you\'re trying to address if you\'re moving them out
of the inspected establishments?

MR. DERFLER: This is Phil Derfler. We\'re going to do the best job that
we can. I mean, what you\'re talking about is other consumer
protections. To the extent that we take ground beef samples in
distribution, we\'re going to look at species as well as the E. coli
0157:H7. I mean, we\'re going to try and develop a system that provides
the best protection that it possibly can.

MR. EMMERLING: Well, with respect to the E. coli, if you\'d do that
earlier it wouldn\'t be necessary to do it later, which is the
prevention aspect of it.

MR. BILLY: One other thing I would add is, we\'re sponsoring a national
meeting in early September that focuses on animal-production food
safety. It\'s being held in Kansas?

MR. DERFLER: St. Louis.

MR. BILLY: St. Louis. And it will be a description of all the efforts
that we\'ve been putting forth working cooperatively with the states and
the producer organizations over the last several years. There have been
significant gains in that area. They\'ll be highlighted, as well as
where the current work is being done, including research. So I think
you\'ll find general agreement here that there\'s room for improvement
on the farm end. And we\'ll learn at that conference and there will be
proceedings published from that, what progress has been made, how it\'s
being applied, and more importantly, where the current work is being
done. It is important that there be a balanced focus across the
farm-to-table spectrum.

Now Cathy would like to make some comments.

MS. WOTECKI: Thank you, Tom. I wanted to reflect both on the comments
that Jill Hollingsworth made and also that Nancy Donley made about
prevention and prevention of foodborne diseases. If I understood at
least some of the premise of your assumption, Jill, it seemed to be that
prevention should occur earlier in the system than at retail.

And if I understood part of the premise of your comment, Nancy, it was,
does the agency have the resources to carry out additional
responsibilities beyond the role that they now play in inspection in
plants. And I wanted to talk a little bit about prevention and the
antecedents for the approach that\'s being talked about now, because I
think you\'re both raising very important questions.

If you go back to Phil Derfler\'s presentation, he has a quote from an
Academy study in 1985 that we all look back to as being the antecedent
to the current HACCP program. And it makes the point that the ideal
inspection system will ensure adequate public protection measures
throughout the food system, from animal production to the final sale of
the food product.

The approach that the agency has built on that actually has been a
farm-to-table model because it also has had a very strong information
and educational component to the public about their roles and
responsibilities as well in protecting themselves.

But what we\'re talking about today is premised on not diminishing the
agency\'s role and responsibilities in the areas where it traditionally
has worked but also addressing conceptually not only its legal
authorities but also the additional protections that, given the current
resources, could be applied in distribution. And all of that is
important for prevention. So I just wanted to make clear that we\'re not
backing away from a historical role. We strongly believe that prevention
begins at production and goes all the way through to the point of
preparation that occurs either commercially or in the home. But what we
can address and are specifically addressing today is this concept of
adequate public protection throughout the inspection system.

MR. RUTGER: I\'m Jim Rutger and I\'m with the Minnesota Department of
Agriculture. And I\'m here to give a little bit of comment from the
state\'s perspective.

We\'re very excited and we go on record as supporting the IDI program.
It\'s been an exciting program, it\'s a good program. Farm to table is
very important for the state of Minnesota. One thing I think that we all
need to recognize here, though, is it\'s not one agency here. It takes
all agencies with concurrent jurisdiction, from farm to table, to
protect that.

It\'s a situation where, when we were going through the training with
the IDI training, the state had a very large commitment to this. Indeed
it was the state\'s dollars that sent three of our individuals to this
training. It was state dollars that sent me here today. I\'m here on
behalf of the state of Minnesota to tell you that we are committed to
this. We have a staff of 83 people at this Department of Agriculture in
Minnesota, including a state equal-to program, a food inspection
program, and a dairy inspection program.

We heard a lot of comments here today about uneven playing fields in
some of the states and we recognize that that does occur. One thing for
Minnesota \-- and I can only speak for Minnesota but I have to assume
that it is the situation for many other states and local jurisdictions
as well \-- Minnesota has the food code in place. In fact, one of the
things about our food code that differs from the federal code, the
federal code says, compliance with law, and it\'s silent on what that
law is.

Minnesota addresses five chapters of federal regulations that have been
adopted by the state of Minnesota as its own regulations. Indeed, we
enforce EPA, Food and Drug Administration, National Marine Fishery, and
USDA regulations as our own. Our staff is trained by the USDA, by the
FDA, and National Marine Fishery Service in HACCP. We have state
statutes in place which address and connect us to the Food and the Drug
and Cosmetic Act, the Wholesome Meat Act, and several other federal
acts, including FIFRA and the Interstate Milk Shippers Act.

Minnesota has a real commitment here in this program and to this. The
states have a role to play here, and it\'s a big role. It\'s the role
\-- one of communication, of partnership, of making a safe food product
for all of our citizens. One thing where we differ, however, from USDA
is that we feel that in those states that opt to take this program, that
have the resources and the commitment and the regulations in place, that
we be allowed through cooperative agreements, memorandums of
understanding, to go forward with this program and to carry it out.

Indeed, the citizens of this country and the citizens of Minnesota
expect the best bang for the buck for the tax dollars out there. In
those states that don\'t have those resources, we feel that USDA should
commit their resources there and allow the states to do the work where
we have the resources committed there.

Our staff holds numerous licenses which attest to our credentials. We
hold several USDA licenses in egg inspection. We hold licenses in school
lunch, state equal-to program. Many of our staff have commissions with
the Food and Drug Administration. We have licensing with National Marine
Fisheries to do lot inspection and HACCP inspection.

So at least in Minnesota you have an agency that vests the abilities of
all three of the major federal food inspection agencies in one location.
Indeed, our sister agency, with the Minnesota Department of Health and
the Minnesota Department of Agriculture, and our delegated agencies,
where we delegate to the county and local authorities, require that they
adopt our food code and, like I said, our food code references back to
the Food, Drug, and Cosmetic Act. It goes back to the United States Code
on food regulations. It goes back to title 9, title 7, title 50, title
40. Those are state regulations.

Mr. Derfler commented about cooperation, working together, and overlap
of jurisdiction. Indeed, if we go into a food establishment and we find
uninspected product or a misuse of a federal inspection seal, the state
of Minnesota also feels that that\'s a violation. And through concurrent
jurisdiction, it\'s not only a federal violation, it\'s a state
violation.

We have a staff of 27 food inspectors, 8 equal-to meat inspectors, 20
dairy inspectors, a compliance staff of 5, and an assistant attorney
general assigned to our agency to protect consumers in the state of
Minnesota for food product. And so we take this very seriously and we
honestly believe that, in those states that can make this level of
commitment, that we be allowed to do a partnership and that we take the
resources that the USDA would extend in those states and utilize them
where a state perhaps doesn\'t have the resources. In return we would
ask that the USDA supply us with training, they\'d supply us with
insight, give us the support that we need to carry out our program so we
get on an even playing field.

In addition to that, the Department of Agriculture has a full laboratory
staff, including microbiological, chemical, food safety or food
chemistry, and pesticide work that we\'re capable of doing. Our agronomy
unit holds many accreditations with EPA on that. Our laboratory is
certified by Food and Drug, certified by USDA, certified by EPA.

So many of the states are capable of doing this. Give us a chance to do
it. Thank you.

MR. BILLY: And I would just add to that I think that what Jim has
presented gives you a good sense of why Minnesota is one of the states
we wanted to explore this in and work together because to the extent
that we can take advantage of the kind of commitment and activities that
you\'ve just heard about, we can learn a lot from that in terms of where
we might fit in and how best to fashion a cooperative approach. So it\'s
recognizing what Minnesota is bringing to the table that is part of the
motivation for us to carry out part of this project in that state as
well as in several other states. Who\'s next? Yes, please.

MS. KRISTIN: Hi, I\'m Charlotte Kristin from the Center for Science in
the Public Interest. We certainly want to applaud the efforts of
Minnesota and other states who are working so hard to ensure food safety
within their states. However, sadly that\'s not the norm.

Caroline Smith DeWaal earlier in this meeting mentioned our \"Dine at
Your own Risk\" study. That looked at 45 state, county, and local
jurisdictions and looked at their food inspection and food code
activities. The food code recommends that restaurants be inspected twice
a year.

And when we talked to those 45 jurisdictions, we found that 67 percent
of them, two thirds, thought that they met or exceeded the food code
recommendations. Unfortunately, when we actually verified their data, we
found that less than half of them did. So while states believe that
they\'re doing a good job and they\'re trying to do a good job, they
don\'t have the resources or the ability to fulfill that commitment.

In addition, when you look at the FDA\'s record on inspections, the
average inspection of an FDA plant is once every eight to ten years. In
fact, the high risk plants are only inspected annually. Therefore, CSPI
fully supports this plan and thinks that there is a definite need for
USDA to be pursuing this. Thanks.

MR. BILLY: Thank you. Bernie?

MR. SCHEIER: I wanted to make more of a brief comment than a question at
this point. I wanted to say to Nancy and people from the consumer groups
that we certainly, I\'m with the American Association of Meat
Processors, we certainly don\'t advocate weakening inspection at the in-
plant level. But we do think that increasing scrutiny at other levels,
including prior to that, on the farm, and after that, in distribution,
is a good idea. At AAMP we\'ve had a long-standing position, and which
we\'ve made the agency aware of many times, of supporting inspection of
food and meat and poultry products where the risk exists.

And there are situations that exist today where products are being
processed in retail and grocery at various levels, pretty much the same
thing that\'s being done in plant. And the risks are virtually the same.
And yet the inspection is not. And so our feeling about this is that
this is a good idea generally.

We\'ll be interested in more specifics about it, but we really support
this initiative the agency is taking because inspection has to happen
where the risks exist. And if there are risks \-- for example, if things
can happen to products once they leave the plant, at the retail or at
the restaurant level, then there needs to be some examination there so
that those things can be dealt with. Thank you.

MR. BILLY: Thanks, Bernie. Yes.

MR. SAUNDERS: Doug Saunders with the Association of Food and Drug
Officials. First off I would like to thank FSIS for conducting this
public meeting today. I think there has been a significant amount of
misinformation floating around with respect to the IDI project as well
as other items and I think this public meeting will go a long way
towards dispelling that misinformation.

AFDO does strongly encourage continued efforts to eliminate any
duplication or overlap not only between states and federal agencies but
also between states and local government agencies and any other overlap
that might exist.

Additionally we strongly encourage the continued efforts to efficiently
utilize all of the available resources that are out there with respect
to food safety and to the development of effective partnerships or
cooperative agreements between states and local governments, between
states and federal government. And we look forward to continuing an
effective relationship with FSIS towards development of a truly seamless
food safety system.

MR. BILLY: Thanks, Doug. Yes. Okay, Jill?

MS. HOLLINGSWORTH: Tom, if I\'m correct in understanding \-- there was a
report that was published along with a *Federal Register* announcement
and it was on your Web site. It was a report on the in-distribution
inspection pilot, the November document.

And today\'s information is certainly appreciated because it\'s much
clearer for us, but it is somewhat different from what\'s in here. And
it\'s my understanding this has been taken off the Web site now. I
certainly couldn\'t find it anymore as of this week, so I\'m assuming
it\'s been taken off. But when we filed comments back in March of \`99
it was based on that information. Will there be a new opportunity to
comment on the new approach that you\'re taking, because we\'re not sure
that our comments are actually as relevant or accurate on the old system
as they would be on this one, and we\'d like a comment on this new
system also.

MR. BILLY: The answer is yes. Phil?

MR. DERFLER: We intend to provide a comment period with every public
meeting that we have. Now, I don\'t remember the specifics of the
notice, whether we actually said that. We certainly \-- that\'s our
intention. We always do that and we meant to do that here.

MS. HOLLINGSWORTH: Okay. Good. Thank you.

FEMALE VOICE: Will there be a new proposal sort of like the written
report that was provided before or are the presentations and what
you\'ve handed out going to be the extent of what the agency has?

MR. DERFLER: The presentations represent what we have so far. But we\'re
working on it.

MR. BILLY: Other comments or questions? Okay, let me provide a brief
wrap-up. First I\'d like to thank all of you for being here and
participating. Those that have provided comment or suggestions we
welcome them, and as we stated several times, we do listen and we factor
into our thinking the thoughts and other information that you share with
us. I\'d like to reiterate the importance of addressing food safety in
distribution and repeat the quote that Phil Derfler used on one of his
slides from the National Academy of Sciences l985 report on the
scientific basis of the meat and poultry inspection program, which was
that, \"An ideal meat and poultry inspection system will ensure that
adequate public protection measures are located throughout the food
system, from animal production to the final sale of the food product.\"
In terms of the next steps, we intend to use the information that we\'ve
been provided from you today, your thoughts and suggestions, as we go
through this project, including development of the performance standards
that were referred to earlier.

We also plan to continue the effort working with Minnesota and other
states and local authorities in terms of developing new kinds of MOUs or
cooperative agreements as we learn how or most appropriately to approach
that kind of partnering. We also plan to continue the public process. As
we mentioned, there will be an opportunity for public input and we plan
to have further public meetings as we learn more and build on the work
that we\'re doing.

I believe the discussions here today have been good discussions and
hopefully cleared up some misunderstandings and created a better general
understanding of our current thinking. And we think this kind of
dialogue is important as we move forward and we plan to continue it in
the future. So thanks everyone for coming.

(Whereupon, at 11:45 a.m., the meeting was concluded.)

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CERTIFICATE OF REPORTER, TRANSCRIBER AND PROOFREADER

[June 2000 In-Distribution Public Meeting]{.underline}

Name of Hearing or Event

[N/A]{.underline}

Docket No.

[Washington, DC]{.underline}

Place of Hearing

[June 9, 2000]{.underline}

Date of Hearing

We, the undersigned, do hereby certify that the foregoing pages, numbers
[1]{.underline} through [87]{.underline} , inclusive, constitute the
true, accurate and complete transcript prepared from the tapes and notes
prepared and reported by [John DelPino]{.underline} , 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.

[6-9-00]{.underline}

Date Dot Fleshman

Name and Signature of Transcriber

Heritage Reporting Corporation

[6-27-00]{.underline}

Date Helen Burlingame

Name and Signature of Proofreader

Heritage Reporting Corporation

[6-9-00]{.underline}

Date John DelPino

Name and Signature of Reporter

Heritage Reporting Corporation