Talking Points for Philip S.
Derfler
Deputy Administrator
Office of Policy, Program Development, and Evaluation
for the Epidemiology Public Meeting
Atlanta, GA
January 29, 2002
You have just heard Dr. Wachsmuth talk about the public health
imperative that FSIS feels. I cannot emphasize enough how important
ensuring the public health is to all of us at the Agency. We consider
ourselves to be a public health regulatory agency. We are empowered to
ensure that the meat, poultry, and egg products in commerce are safe and
wholesome, as well as properly labeled, and we have a range of
regulatory tools available to us for making sure that this is the case.
The statement that FSIS is a public health regulatory agency bears
some analysis, however, because it holds the key for why we are here
today. To say that FSIS is a public health regulatory agency is to say
that it is the administrative agency that is charged with protecting the
public from harm from meat, poultry, and egg products.
Let?s deconstruct the statement a little further. As an
administrative agency, FSIS is a creature of Congress. Its powers are
limited to those that Congress has extended to it in the statutes that
the Agency acts to enforce. Thus, even though FSIS is the agency charged
with protecting the public health from harm from meat, poultry, and egg
products, it is not able to simply take whatever action it believes will
best serve the public health. FSIS does not get to choose from an
unlimited menu of options, with the right to pick the one that is most
protective. Rather, FSIS must look at the range of options that Congress
has authorized it to take and decide which, if any, is justified based
on the available evidence. Thus, the question is not what actions should
FSIS take; it is what action can FSIS take.
We need to turn, then, to the statutes under which FSIS works. FSIS
is charged with administrating the Meat Inspection Act, the Poultry
Product Inspection Act, and the Egg Products Inspection Act. Under these
statutes, FSIS is charged with inspecting
products before they enter commerce, deciding whether they should enter
commerce, and taking action if there is
reason to believe that the products may be injurious to health, or that
they are otherwise adulterated or misbranded. In this meeting, we are
really only concerned with adulteration, so my talk will focus on that
problem. I will explain what that term means in a minute.
FSIS has a range of tools to prevent products that may be injurious
to health, and thus may be adulterated, from entering commerce. It can
retain the product in the plant, withhold the mark of inspection from
the product so that it cannot enter or move in commerce, or suspend and
ultimately withdraw inspection at the plant.
Our focus today, though, is on what FSIS can do when it becomes aware
that product that has already entered commerce may present a threat to
the public health. The statutes that FSIS administers give it two
complementary courses of action. First, FSIS can detain the product for
up to 20 days. To detain a product, FSIS must have reason to believe
that the product is adulterated. In a detention, an FSIS compliance
officer goes to where the product is located and puts a
"detained" tag on product. Detaining a product means that the
product cannot be moved. During the period that the product is detained,
FSIS gets to develop and consider the available evidence and to decide
whether it will bring a seizure action against the product.
A seizure is an action in United States District Court by FSIS
against an article of food, that is, against a meat, poultry, or egg
product, on the grounds that the product was prepared, sold,
transported, or otherwise distributed in violation of the relevant law
and thus should be removed from commerce so that it will not reach
consumers. In a seizure, the Court takes control of the product until
the case is adjudicated. If the government prevails in this action, the
food is condemned and disposed of in an appropriate way, usually by
destruction. If not, it moves on to the consumer.
Now, the key to both detention and seizure is the government having
some reason to believe that the product is adulterated. All three acts
that FSIS enforces define when a product is adulterated. For simplicity,
I will focus on meat and poultry. The circumstances in which a meat or
poultry product is adulterated that are most relevant to our discussion
today are: if it contains an added poisonous deleterious substance, such
as a pathogen, at a level that may render it injurious to health if
consumed; if it is unhealthful, unwholesome, or otherwise unfit for
food; or if it has been prepared, packed, or held under insanitary
conditions whereby it may have been rendered injurious to health.
The point is that FSIS may detain and seize product if it has reason
to believe that the product is adulterated. The reason may not always be
a clear-cut case of a pathogen being found in a ready-to-eat product,
however. There may be, and have been, situations where FSIS finds that
it has reason to believe product in commerce is adulterated based on
epidemiological information or findings of insanitary conditions at the
producing plant. A full, reasoned discussion of these situations is our
expectation for this meeting.
Remember we are talking about action against product that has been
distributed in commerce. That means that a single lot of product may be
dispersed to tens or hundreds of locations, and that there only may be a
small amount of the product in any one place, or it may even have been
distributed to the consumer. In such circumstances, detention and
seizure may not be practical. FSIS has only about 175 compliance
officers. There is a limit to what they can accomplish. It would be
extremely difficult for them to identify all the places where the
product is likely to be and to get to all those places to detain the
product. If a product has been associated with an outbreak of disease,
however, it is necessary to find a way to get it out of commercial
channels as quickly as possible.
To deal with the problems presented by distributed product, FSIS and
FDA have developed the concept of a recall. Earlier I tried to emphasize
that FSIS is a creature of Congress and of the authorities that Congress
extended to it. Although there is no explicit authority to request a
recall in the Meat Inspection Act or the Poultry Products Inspection
Act, the concept does tie back to the statutes, as I will explain. What
a recall is is a voluntary action. FSIS asks the company that introduced
the product into commerce to take action to remove the product from
commerce. If the firm agrees, it contacts its consignees and asks them
to collect the product and remove it from commerce as quickly as
possible. The collection effort may include notice to the consumer
through a press release, shelf statement, or even direct contact, to
return the product to the store at which they purchased it.
A recall obviously can be a quick and efficient way to remove product
that there is reason to believe is adulterated from commerce. It is in
the interest of the company to recall product because it helps the
company limit its product liability and to minimize negative publicity.
It also saves FSIS resources, and, most importantly, it helps to protect
the consumer from product that could cause serious illness or other
adverse effects.
When FSIS asks a company to recall a product, there is the implicit
threat that if the company does not, FSIS will institute detention and
seizure against the product. It is this implicit threat that ties the
recall back to the statute. This threat means, though, that before FSIS
asks for a recall, it must have some reason to believe that the product
is adulterated, and thus that there is reason to believe that FSIS would
prevail in a seizure action should it be necessary to bring one.
So, what kind of evidence should FSIS have if it is going to ask a
firm to recall a product? Certainly, there are circumstances in which
the adulteration is clear?If laboratory results show that ground beef
contains E.coli 0157:H7, or that a hot dog contains Listeria
monocytogenes, the adulteration is obvious. The product is likely to be
injurious to health. There is a reasonable possibility that at least
some of the people who eat it are going to get sick.
But what about when ground beef is associated with an outbreak of HUS,
presumably because of E. coli O157:H7, but there are no laboratory
findings of E. coli O157:H7 in the product? What is the significance of
epidemiological evidence in the face of nonconfirmatory lab results?
When can it be reasonably said that there is an association between
illness and a product and thus that, on the strength of the
epidemiological evidence, the products may contain a pathogen or be
unhealthful? When does the association established by epidemiological
evidence provide reason to believe that a product is adulterated and
thus justify a request for a recall?
These are the questions that we will be considering over the next two
days.
Let me reiterate Dr. Wachsmuth?s answer to a basic question: Do we
care about public health? You bet we do! Yet it is important to
recognize that the same statutes that empower us to act to protect the
public health also restrain that power. We can?t just request a recall
because it seems like the right thing to do. We have to be ready to back
the request up with action, and quite frankly, we have to be confident
that we will prevail if we do act.
Thus, the questions that we want to get to at
in this meeting are: How can FSIS effectively use epidemiological
evidence and other public health tools to ensure that the public health
is protected against meat and poultry products that are in commerce and
that have caused, or are capable of causing, harm? And what we can learn
from epidemiology and from other public health tools in the face of
laboratory results that fail to establish a smoking gun?
We are also hoping for insights and your views on other related
questions. For example, how should FSIS, and for that matter CDC, the
States, and the producing plants, weigh epidemiological data in their
decision making? How can all levels of government best take advantage of
cooperation from companies in this effort? When, how, and to what extent
should FSIS share with companies non-confidential epidemiological data
that it has received? When is an in-plant investigation or an
environmental assessment warranted?
The answers to all these questions are important because they will
help FSIS as it develops its thinking on the role epidemiological
evidence should play in its efforts to protect the public health and to
ensure that adulterated meat, poultry, and egg products that enter
commerce are removed as quickly and as effectively as possible.
Thank you for your attendance, for your participation, and for your
help. I know I speak for all of us from USDA when I say that we look
forward to the discussion of these issues at this meeting.
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