January 13, 2000

Thomas J. Billy, Administrator

Food Safety and Inspection Service

U.S. Department of Agriculture

14th Street and Independence Ave., SW

Room 331-E

Washington, DC 20250

**CITIZEN PETITION**

**I.** **Introduction**

The Center for Science in the Public Interest (CSPI) and fellow Safe
Food Coalition members American Public Health Association, Consumer
Federation of America, Government Accountability Project National
Consumers League, and Safe Tables Our Priority urge the Food Safety and
Inspection Service (FSIS) to require companies producing ready-to-eat
meat and poultry products to test their plant environments and final
products for the presence of *Listeria* *monocytogenes (L.
monocytogenes).*

*L. monocytogenes* has become one of the most dangerous foodborne
pathogens in the U.S. food supply. According to the Centers for Disease
Control and Prevention\'s (CDC) most recent estimates, *L.
monocytogenes* has the highest rate of hospitalization among foodborne
pathogens and its case-fatality rate is second only to that of *Vibrio
vulnificus.* CDC estimates that 92 percent or listeriosis cases require
hospitalization and 20 percent result in death. Thus, although
listeriosis is rare in comparison to infections caused by such pathogens
is *Salmonella and Campylobacter,* it is a significantly more severe
infection and far more likely to cause debilitating illness or death,
especially in infants, pregnant women and their fetuses, the elderly,
and people with compromised immune systems.

Unfortunately, *L. monocytogenes* contamination of ready-to-eat meat and
poultry products has become all too common. Because such products may be
widely distributed before the contamination is detected, they can cause
large outbreaks of listeriosis. That tragic fact was brought to national
attention once again in late 1998 and early 1999, when a multistate
outbreak of listeriosis attributed to ready-to-eat meat products
produced at Sara Lee Corporation\'s Bil Mar plant caused 21 known deaths
and I 00 illnesses. In addition to that outbreak, there has been a rash
of recalls of ready-to-eat meat and poultry products contaminated with
*L. monocytogenes* in the past year. Clearly, the pathogen must be
considered a significant public-health hazard.

The federal government has long been aware of the danger posed by *L.
monocytogenes* in ready-to-eat products. Since 1989, FSIS has subjected
such products to the most restrictive standard \-- zero tolerance. In
other words, any amount of *L. monocytogenes* in a ready-to-eat meat or
poultry product renders it adulterated and subject to a voluntary
recall. The zero tolerance standard reflects a still-valid policy
decision, namely that the consequences of listeriosis are too severe,
and the available data regarding the pathogen\'s infectious dose and
other characteristics are too limited, to define a safe level of
contamination in foods that consumers need not further cook before
consumption.

Unfortunately, FSIS\'s resources to enforce the zero-tolerance standard
are insufficient to adequately safeguard public health. Currently, FSIS
relies on a small-scale random-sampling program in which government
inspectors annually test approximately 3,500 samples of domestic and
imported ready-to-eat meat and poultry products for the presence of *L.
monocytogenes.* When a positive sample is detected, the agency asks the
producer to initiate a recall of the affected product.

Despite the fact that FSIS\'s sampling program tests only a small
fraction of the ready-to-eat meat and poultry products produced in this
country, there is no requirement that the producers of ready-to-eat
products expand the effort to detect contamination by testing their own
finished products for the presence of the pathogen. Nor are companies
currently required to help prevent contamination of their products by
testing their plant environments for *L. monocytogenes* or an
appropriate indicator organism. The omission of such testing from
FSIS\'s food-safety program for processed-meat products endangers
consumers.

Mandatory microbial testing by the industry would improve the existing
regulatory program in two important ways:

-   It would broaden the safety net afforded by FSIS\'s limited random
    sampling program by significantly expanding the pool of products
    subjected to microbial testing and by extending testing to plant
    environments, where contamination could be detected even before it
    enters finished product. As a result, companies would be far more
    likely to uncover and address contamination problems before they
    cause consumer illnesses and deaths; and

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-   It would help plants to verify the efficacy of their required hazard
    analysis and critical control point (HACCP) plans and to identify
    when corrective actions are necessary.

As FSIS\'s experience with its meat and poultry HACCP/Pathogen reduction
rule for slaughterhouses demonstrates, carefully conceived
hazard-control plans combined with microbial testing for compliance with
pathogen-reduction performance standards can reduce contamination in
meat and poultry carcasses. Unfortunately, processed-meat plants are not
subject to the microbial-testing requirement.

Now, especially in the wake of the recent outbreaks and recalls due to
*L. monocytogenes* contamination, it is time for FSIS to move beyond the
slaughterhouses and to extend mandatory microbial testing to plants that
produce ready-to-eat meat and poultry products. Such testing should be a
required component of the hazard-control programs of all plants for
which *L. monocytogenes* is a hazard reasonably likely to Occur. Those
plants should be required to verify the efficacy of their HACCP systems
through scientifically valid microbial-testing regimens, as is currently
required for meat and poultry slaughterhouses.

Until a mandatory microbial testing regulation is finalized, FSIS should
require those plants that do not have an acceptable testing program
(including both environmental and final- product testing) to label their
products with a *L. monocytogenes* safe-handling statement that would
alert especially vulnerable consumers to the risks posed by contaminated
ready-to-eat meat and poultry products. That requirement would be
consistent with FSIS\'s recent advice to such consumers in response to
the Sara Lee outbreak and the recalls that occurred in early 1999.
Clearly, for at-risk consumers, foods labeled "ready to eat" may be
anything but. Labeling, as an interim measure pending finalization of a
microbial-testing rule, would better protect such consumers.

**II. Action Requested**

We request that FSIS require plants producing ready-to-eat meat and
poultry products to conduct microbial testing for the presence of
*Listeria* spp. or other indicator organisms in their plant environments
and for *L. monocytogenes* in their final products. We also request that
FSIS require ready-to-eat meat and poultry products that have not been
produced by a plant that incorporates microbial testing into its HACCP
verification program to bear a label alerting consumers that the
products may be contaminated and should not be eaten by at-risk
consumers without reheating. FSIS is authorized to take the proposed
actions under the adulteration and misbranding provisions of the Federal
Meat Inspection Act and the Poultry Products Inspection Act.

Because of the potentially fatal effects of *L. monocytogenes* and to
expedite development and implementation of the requested regulations, we
ask FSIS to promulgate them as an interim final rule and to defer risk
assessment and cost-benefit analysis until after publication of the
rule. Such action is authorized under both the Administrative Procedure
Act (APA) and the USDA Reorganization Act of 1994, Pub. L. 103-354.
Alternatively, if FSIS decides that it cannot promulgate the requested
regulations as an interim final rule, the agency should expedite
rulemaking to the greatest extent possible in order to protect public
health.

**III**. **Statement of Grounds**

> **A. Factual Grounds**
>
> **1.** **Foodborne Listeriosis Poses a Grave Public-Health Threat**
> *monocytogenes,* a gram-positive bacterium found in water, soil,
> silage, and other environmental settings, can contaminate a wide range
> of foods, including hot dogs, luncheon meats, and soft cheeses.\'
> [^1]Consumption of food containing *L. monocytogenes* can lead to
> listeriosis, a potentially deadly disease, in susceptible individuals.

Although listeriosis from contaminated food is less common than
infections caused by such pathogens as *Salmonella and Campylobacter,*
the consequences of listeriosis are far more severe than those of
salmonellosis or campylobacteriosis. According to the latest CDC
estimates, 92 percent of listeriosis cases require hospitalization (the
highest among foodborne pathogens),[^2] with an average hospital stay of
almost two weeks.[^3] *L. monocytogenes* also has the second highest
case-fatality rate among foodborne pathogens: approximately 20 percent
of patients with listeriosis die.[^4] Overall, 2,298 of the estimated
2,493 annual cases of foodborne listeriosis lead to hospitalization and
499 result in death.[^5]

Although as many as one out of eight Americans may be exposed to *L.
monocytogenes* each year,[^6] most people with healthy immune systems
can fight off the bacteria with few problems. Unfortunately, for those
at greatest risk of contracting listeriosis, including the elderly,
children, pregnant women, and people with compromised immune systems,
the outcome can be dire.

*L. monocytogenes* appears to be highly prevalent in raw meat.
Researchers have detected the pathogen in up to 77 percent of ground
beef and 95 percent of ground pork.[^7] *L. monocytogenes* also occurs
less frequently in processed meat and poultry products considered
"ready-to-eat," which are typically consumed without further cooking. In
its sampling program for ready-to-eat meat and poultry products, FSIS
has detected significant amounts of *L. monocytogenes* in a broad range
of products. Since 1989, FSIS testing has yielded positives in 5.7
percent of sliced ham/luncheon meats, 4.4 percent of small-diameter
sausages, 3.4 percent of salads and spreads, 3.1 percent of
roast/corned/cooked beef, 2.4 percent of cooked uncured poultry, 1.6
percent of large-diameter sausages, and 0.7 percent of jerky.[^8]

2.  **The Sara Lee Outbreak and Recent Large-Scale Recalls Demonstrate
    That More Must be Done to Protect Consumers**

The prevalence of *L. monocytogenes* in ready-to-eat meat products also
is reflected in the both the number and the magnitude of recent recalls
of contaminated products. Since January 1999, companies have recalled
over 32 million pounds of ready-to-eat meat products.[^9] Single recalls
have involved 30 million pounds of various ready-to-eat meat products
(distributed nationwide),[^10] over two million pounds of beef
franks,[^11] over 126,000 pounds of bacon chips (distributed in nine
-states),[^12] 78,000 pounds of chicken burritos (distributed by a
national airline),[^13] over 33,000 pounds of turkey franks (distributed
in six states),[^14] and over 28,000 pounds of luncheon meat
(distributed nationally).[^15]

Unfortunately, *L.* monocytogenes-contaminated products have caused
large outbreaks. The most recent example, a nationwide outbreak of
listeriosis caused by ready-to-eat meat products manufactured by Sara
Lee Corporation, resulted in 21 deaths (including six
miscarriages/stillbirths) and 100 illnesses in 22 states. [^16] The Sara
Lee outbreak shows just how widespread and devastating a single outbreak
can be. It also demonstrates that in the absence of microbial sampling
of ready-to-eat products, vast quantities of contaminated product can
escape detection and make their way to stores all around the country.

The products implicated in the Sara Lee outbreak were all produced in
the company\'s Bil Mar plant located near Zeeland, Michigan.[^17]
Although the specific source of the contamination has not been
conclusively identified, CDC has tentatively concluded that the bacteria
were spread by contaminated dust particles stiffed up during replacement
of a refrigeration unit in the plant over the Fourth of July
weekend.[^18] Contaminated hot dogs from the plant apparently caused the
illnesses and deaths, although deli meats also may have been
involved.[^19] Illness onset dates for the outbreak were reported from
August 2, 1998 to February 8, 1999.[^20]

On December 22, 1998, Sara Lee initiated a voluntary recall of hot dogs
and other ready-to-eat meat products produced at the Bil Mar plant.[^21]
During its investigation of the outbreak, CDC isolated the outbreak
strain of *L. monocytogenes* from an opened and a previously unopened
package of hot dogs manufactured at the Bil Mar Plant.[^22]

Remarkably, the government\'s investigation revealed that the plant
should have been alerted \-- several weeks before the outbreak was first
detected \-- to a possible contamination problem on the very line that
produced the tainted products. According to the CDC official in charge
of the investigation, during the first six weeks after construction in
the plant the positive rate for *Listeria*-like indicator organisms on
hot dog production equipment climbed from 25 percent to 92 percent.[^23]
Unfortunately, the plant apparently did not respond to that clear
indication of a potential hazard by testing its final products for the
presence of *L monocytogenes*.[^24] Under current regulations such
testing is not mandatory.

Though the Sara Lee outbreak was notable both for the number of
illnesses and deaths involved and for its broad geographic scope,
neither of those characteristics should surprise those familiar with *L.
monocytogenes* and the processed-meat industry. Many factors contribute
to the potentially enormous magnitude of listeriosis outbreaks from
contaminated ready-to-eat products: the lack of information about
initial symptoms that would facilitate early detection, the long time
period between exposure and illness onset, and the huge production and
wide distribution of many processed-meat products.

The last factor has been made evident again and again by the numerous
recent recalls of products contaminated with *L. monocytogenes.* Many of
those recalls involved tens of thousands or more pounds of processed
products that had been distributed to broad regions of the country.
Although the recalled products are not associated with any broad-scale
listeriosis outbreaks, it is possible, given the volume and wide
distribution of the affected products, that they have caused illnesses
and miscarriages that went unrecognized.

FSIS can take concrete steps to prevent future outbreaks by requiring
producers of ready-to-eat products to test their products and plant
environments for the presence of *L. monocytogenes,* so that problems
are more likely to be detected before contaminated products reach
consumers. FSIS's current sampling program for *L. monocytogenes* in
ready-to-eat meat and poultry products is too limited to avert future
outbreaks of listeriosis.

**3. The Zero-Tolerance Standard for Listeria Monocytogenes in
Ready-To-Eat Meat and Poultry Products is Necessary to Protect
Consumers**

In response to a 1989 CDC report linking listeriosis to turkey franks,
FSIS introduced its zero-tolerance standard for *L. monocytogenes* in
ready-to-eat processed meats.[^25] By opting for the most stringent
standard possible, the agency ensured that products containing any
amount of the pathogen would be deemed adulterated and subject to
immediate recall. Under the zero tolerance standard, there is no
acceptable level of *L. monocytogenes* contamination for ready-to-eat
meat and poultry products.

The zero-tolerance standard, which also was adopted by the U.S. Food and
Drug Administration (FDA) for soft cheeses and other ready-to-eat
products, proved to be highly successful in its first few years of
implementation.[^26] Between 1987 and March 1992, FDA and FSIS initiated
voluntary recalls for 543 products from 132 firms because of
contamination with L. *monocytogenes*. [^27] In 1992, after a CDC
case-control study linked sporadic listeriosis with consumption of
delicatessen-counter foods and soft cheeses, recommendations for
avoiding exposure to *L. monocytogenes* were distributed, and the food
industry strengthened its efforts to minimize contamination of food with
the pathogen. A study examining listeriosis rates between 1989 and 1993
concluded that the zero-tolerance policy, along with various reforms
initiated by the food industry to respond to it, had succeeded in
reducing illness by 44 percent and deaths by 48 percent.[^28]

The zero-tolerance standard should remain in effect. The considerations
that led the government to implement the standard in the first place are
no less valid today than they were in 1989. Specifically, all of the
following still apply:

-   Listeriosis is a severe illness that has the highest hospitalization
    rate and the second-highest case-fatality rate among foodborne
    pathogens;

-   Once in food products, *L.* *monocytogenes,* unlike many other
    foodborne pathogens, can multiply while stored at refrigeration
    temperatures;

-   Ready-to-eat products subject to the zero-tolerance standard, such
    as deli and luncheon meats, are usually consumed without further
    cooking; even hot dogs are sometimes consumed without reheating;

-   The infectious dose for *L. monocytogenes* is not known, either for
    healthy consumers or for those who are at increased risk; and

-   Detection of the disease can be delayed because a long time can pass
    after exposure to the pathogen before the illness becomes apparent
    and because there is little information available about early
    symptoms.[^29]

Those considerations should lead FSIS to reject arguments by
meat-industry representatives that zero-tolerance policy should be
abandoned. Given the severity of listeriosis, current gaps in our
understanding of the pathogen\'s infectious dose, and its ability to
multiply during refrigerated storage, setting a \"safe\" tolerance level
in ready-to-eat meat and poultry products would be tantamount to
gambling with consumers\' lives. Instead, FSIS should continue to
enforce the zero-tolerance policy until reliable scientific evidence
shows that a less stringent standard would be equally protective of
human health. Such evidence currently does not exist.

> **4. FSIS Should Require that Plants Producing Ready-To-Eat Meat and
> Poultry Products Conduct Microbial Testing of Their Plant Environment
> and Final Products**

The Sara Lee outbreak and the recent recalls of *L.*
monocytogenes-contaminated ready-to-eat meat and poultry products make
it clear that FSIS must take further action to safeguard consumers. The
existing system, which relies heavily on limited random sampling of
final products by FSIS, has not kept contaminated products off
supermarket shelves. As things currently stand, the HACCP program for
ready-to-eat products is not truly preventive; all too often it takes
the detection of human illnesses to signal a flaw or breakdown in a
producer\'s *L. monocytogenes-control* systems.

FSIS could easily transform the HACCP program for ready-to-eat products
into a preventive food-safety system by mandating that meat-processing
plants conduct microbial testing for *L. monocytogenes* in both the
plant environment and in final products. Mandatory microbial testing by
the industry would serve three critical purposes: (1) it would enable
companies to verify that their HACCP systems effectively control *L.
monocytogenes* contamination in their products; (2) it would add teeth
to, and facilitate enforcement of, the existing zero-tolerance standard
for the pathogen in ready-to-eat products by dramatically increasing the
number and range of products sampled; and (3) environmental testing
would facilitate early detection of problems before products become
contaminated. FSIS should require microbial testing by companies without
further delay.

**a. Verification of HACCP Systems**

It is universally recognized that adequate verification is a core HACCP
principle.[^30] As FSIS explained in the preamble to its meat and
Poultry HACCP/pathogen reduction rule, \"\[v\]erification of HACCP plans
by establishments is designed to demonstrate that the HACCP plan is
accomplishing process control and resulting in the production of safe
food on a continuing basis".[^31] Because safe food is the bottom-line
demand of consumers, verification plays a crucial role in any HACCP
program.

FSIS took an important step in May 1999 when it confirmed that, absent
scientific evidence to the contrary, *L. monocytogenes* specifically
must be controlled for by plants\' HACCP plans because it is a hazard
reasonably likely to occur in ready-to-eat meat and poultry
products.[^32] CSPI welcomed FSIS's demand that plants reassess their
HACCP plans to ensure that they effectively address *L.* *monocytogenes*
contamination. Unfortunately, however, FSIS\'s action fell short because
the agency did not prescribe any meaningful verification mechanism for
assessing whether the plants' HACCP plans, reassessed or not, are
successfully controlling *L.* *monocytogenes* contamination on a
continuing basis. Without thorough and ongoing verification, it is
impossible to determine whether plants\' interventions against the
pathogen actually are working, leaving consumers without any assurance
that products are free from *L. monocytogenes.*

Microbial testing is the missing verification mechanism. Such testing is
a cornerstone of FSIS\'s HACCP/pathogen reduction rule for
slaughterhouses, which requires the industry to test carcasses for
generic *E. coli* while government inspectors conduct *Salmonella*
testing to determine whether the applicable pathogen-reduction
performance standards are being satisfied.[^33] According to FSIS data,
that program of mandatory microbial testing \-- with its built-in
incentives for plants to implement the most effective intervention
measures possible \-- seems to have contributed to a dramatic reduction
in *Salmonella* contamination levels in raw meat and poultry carcasses,
as well as a corresponding decrease in salmonellosis among
consumers.[^34]

Unfortunately, under the existing meat and poultry HACCP regulations,
microbial testing to gauge the efficacy of hazard-control programs is
mandated for slaughterhouses only. Manufacturers of ready-to-eat meat
and poultry products are not obliged to do so. As a result, there is no
meaningful way for the government to verify that plants\' HACCP plans
are effectively preventing *L. monocytogenes* contamination. Instead, as
the Sara Lee outbreak shows, problems come to light under the most
tragic of circumstances: illnesses and deaths among the consumers of a
manufacturer\'s products. Thus, without mandatory in microbial testing
in processing plants, HACCP is not an adequate hazard-prevention system
for ready-to-eat meat and poultry products.

FSIS can address this shortcoming in the existing regulatory program by
mandating *L. monocytogenes* testing as a HACCP-verification mechanism
in all processed-meat plants. Such a requirement would better enable
both the federal government and the industry to identify problems in
plant HACCP plans ***before*** contaminated products ever enter the
stream of commerce.[^35]

**b. Enforcement of the Zero-Tolerance Standard**

While on paper the federal government\'s zero-tolerance standard for *L.
monocytogenes* in ready-to-eat foods appears to be a strong response to
a substantial public-health risk, FSIS enforcement of the standard is
too weak to afford consumers much protection against contaminated
products. As previously stated, FSIS enforces the standard by randomly
testing approximately 3,500 samples each year of both domestic and
imported ready-to-eat meat and poultry products for the presence of *L.
monocytogenes*.[^36] When a confirmed positive sample is found, the
agency asks the company to initiate a recall of all affected products
and publicizes the recall to inform consumers of the contamination
problem.[^37]

Obviously, that approach is extremely limited in scope. The 3,500
samples, not all of which are domestic products, account for only a tiny
fraction of the total yearly production of FSIS-regulated ready-to-eat
products that are subject to the zero-tolerance standard. While
additional testing by state regulators increases the number of products
sampled, absent a dramatic expansion in government sampling such
programs alone will never afford consumers an adequate level of
protection against contaminated retail products.

A truly effective enforcement scheme for the zero-tolerance standard
would augment government sampling with ongoing, systematic testing of
products from all processed-meat plants. The surest and most efficient
way to achieve such an expansion in the *L. monocytogenes* sampling
program would be to require that every plant test its own products,
using statistically valid sampling methods, for the presence of the
pathogen.

In addition to helping plants detect and correct contamination problems
before they can cause human illness, such a program would create a
documentary record of plants\' abilities to control the pathogen over
time. Evidence of repeated serious problems, as reflected in a plant\'s
paperwork, would provide a basis for aggressive agency action, including
plant closure where a serious threat to public health exists.

Mandatory testing by the industry also would greatly expand the pool of
available data on *L.* *monocytogenes* contamination in ready-to-eat
meat and poultry products. That information could help the government
and industry better identify and track contamination trends based on
product type, plant geographical location, seasonality, etc. The
expanded information base could also help to fill some of the data gaps
in the federal government\'s current quantitative risk assessment for
*L. monocytogenes*.[^38]

An additional important benefit of mandatory industry testing is that it
would encourage the meat-processing industry to develop and implement
effective interventions specifically aimed at eliminating *L.
monocytogenes* contamination. Because industry testing would increase
the likelihood of detecting contamination \-- resulting in more frequent
recalls and associated costs -companies would have a strong incentive to
introduce innovative, more effective interventions (such as cooking
packaged products a second time) or to redesign their post-cooking
systems to eliminate environmental exposure to the pathogen. The net
effect would be an industry-wide effort to improve the safety of
ready-to-eat products.

Finally, by making industry testing mandatory, FSIS would address a
disturbing development that has been reported in the press: the
unwillingness of some companies to test their products for *L.
monocytogenes* based upon advice from their lawyers.[^39] Clearly, some
in the industry prefer to remain willfully ignorant of a potentially
deadly problem and will not conduct microbial testing unless required to
do so by FSIS regulations. The agency should stop that unconscionable
practice by mandating microbial testing by all producers of ready-to-eat
meat and poultry products.

**C. Early Detection of Potential Contamination Problems**

In addition to mandatory microbial testing of final products, FSIS
should require plants to test their environments for the presence of *L.
monocytogenes* itself or, better yet, more prevalent indicator
organisms.[^40] As both FSIS and industry groups recognize, such testing
is a critical component of contamination-prevention programs for
ready-to-eat products.[^41]

Environmental testing can serve as an early-warning system for
contamination problems. Detection of *L. monocytogenes* or an
appropriate indicator organism alerts manufacturers that a particular
plant location or piece of equipment has become contaminated and may
threaten to contaminate products if the problem remains uncorrected.
Especially where the bacteria is found on surfaces that come into direct
contact with foods \-- or that may indirectly cause contamination to
spread to food by means of dripping water, dust particles, or the like
\-- plants should take immediate and aggressive action to determine the
source of the contamination and eliminate it. Unless comprehensive
environmental sampling is being conducted, such problems may not be
revealed until consumer illnesses are linked to contaminated products.

In Section 5(a) below, we describe what CSPI believes to be the
essential components of an environmental sampling program for *L.
monocytogenes.* FSIS should require that plants adopt programs that
include all of those components, or alternatives that yield an
equivalent degree of protection.

**5. Components of a Mandatory Microbial Testing Program for Plant
Environments and Final Products**

CSPI is not alone in emphasizing the importance of microbial testing in
preventing ready-to-eat meat and poultry products from becoming
contaminated with *L. monocytogenes.* In the wake of the Sara Lee
outbreak, both the federal government and the processed-meat industry
developed guidelines outlining effective measures that companies should
implement to eliminate *L. monocytogenes* from their products. Those
guidelines sounded a consistent theme: microbial testing of plant
environments is necessary to alert companies to potential contamination
problems in their plants, and final-product testing is a useful means of
assuring that control measures in the plant are effective in eliminating
*L. monocytogenes* from products.[^42]

The government and industry guidelines provide a solid foundation upon
which to build a set of mandatory regulations for environmental and
final-product testing. The guidelines share a number of common elements
that should be included in a mandatory microbial-testing program. Rather
than discuss all of the elements in detail, below we briefly outline
those that CSPI believes should be included in a mandatory program.

**a. Environmental Sampling**

Environmental sampling would serve as an early-warning system to alert
plants of a potential contamination problem. Accordingly, companies
should be required to test for the presence of *Listeria* spp. or
*Listeria*-like organisms, rather than *L. monocytogenes* itself,
because the indicator organisms are more likely to be found in the plant
environment and the test results are available more quickly.[^43]
Reliance on an appropriate indicator rather than the pathogen itself
should afford a greater degree of protection because the broader scope
of organisms detected by the test will minimize the likelihood of false
negatives.

Regulations also should require that plants devise an environmental
sampling scheme that includes both product-contact and
non-product-contact surfaces. Although plant surfaces that do not come
into direct contact with product are less likely to transfer pathogens
to foods, transmission can occur by indirect means (e.g., by means of
wheels on rolling bins or carts, dripping liquids, air-borne dust
particles, etc.). In addition, a positive test result on
non-product-contact surfaces can provide the earliest indication that
substantial amounts of *Listeria* have infiltrated the plant
environment, so that immediate measures can be taken to avert further
distribution of the bacteria in the plant.

Under a mandatory environmental-sampling scheme, testing should be
required to be done regularly, but on a random, statistically valid
basis so that problems will not inadvertently be overlooked. Companies
should be required to validate their microbial-testing programs to
assure the statistical significance of the results.

As the missed opportunity in the weeks leading up to the Sara Lee
outbreak shows, perhaps the most critical component of an
environmental-sampling program is the set of corrective actions that
must be followed when positives are detected. Companies should be
required to specify in their HACCP plans exactly how findings of
*Listeria* contamination in the plant environment will be dealt with.
FSIS should require that corrective actions be progressive; that is, a
positive result should trigger additional, more focused testing of the
plant environment and potentially contaminated product. For instance,
when non-product-contact surfaces test positive, regulations should
require that plants step up their sanitation measures,
product-contact-surface testing, and final-product testing.[^44]

In addition, trends toward an increase in environmental contamination
should be identified and subjected to further investigation. Where the
initial positive is obtained from a composite sample (that is, a sample
of multiple surfaces), additional, more localized sampling should be
required.

Detection of *L. monocytogenes* or indicator organisms on surfaces that
contact ready-to-eat foods should elicit a stronger response. At the
very least, regulations should require shut down, dismantling, cleaning,
and re-sanitization of all product-contact surfaces that test positive,
as well as additional testing to verify that the surfaces are
decontaminated. In addition, such a finding should trigger increased
testing of final products from the affected line, with retention of
product pending test results, until the situation is demonstrated to be
under control.[^45]

Finally, as with all aspects of a plant\'s control plan for *L.
monocytogenes,* the regulations should mandate that plants fully
document any contamination findings, including the reason for
contamination and steps taken to correct the problem and prevent future
incidents.[^46]

**b. Final-Product Testing**

Final-product testing for *L. monocytogenes* would serve two important
purposes: it would facilitate enforcement of the zero-tolerance standard
by greatly expanding the pool of products sampled, and it would enable
plants to verify that their HACCP plans are effectively controlling for
*L. monocytogenes* contamination. To achieve both objectives,
regulations mandating final-product testing should include the following
components:

-   The regulations should require that sampling be systematic \-- that
    is, performed regularly but on a random, statistically valid basis
    so that problems are less likely to escape detection;[^47]

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-   The regulations should mandate that product be retained at the
    facility until negative results are obtained, to better protect
    consumers and to obviate the need for massive recalls. In addition,
    because even extensive sampling may not prevent all contaminated
    product from entering commerce, plants should be require to define
    lot sizes appropriately, so that all potentially contaminated
    product can be identified and recalled if positive product is
    detected;[^48]

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-   To help companies develop their microbial testing regimes, FSIS
    should publish detailed guidelines in conjunction with its
    regulations. Based upon data from the agency\'s decade-old random
    sampling program, as well as any relevant data from the federal
    government\'s ongoing quantitative risk assessment for *L.
    monocytogenes,* FSIS should advise companies about how best to
    sample the different types of products they produce;

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-   Final-product testing should be stepped-up when positive
    environmental samples are detected, though such testing should be
    conducted on an ongoing basis even when environmental testing yields
    no positives. As FSIS\'s current guidelines recommend, plants should
    be required to increase the sampling intensity for products that are
    exposed to the plant environment after cooking but before final
    packaging.[^49] In addition, trends toward repeated or increasing
    product contamination should be identified and corrected without
    delay; and

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```
-   The results of final-product testing, like those of environmental
    sampling, should be subject to stringent documentation standards.
    Among other things, companies should be required to record all
    findings and include a reason for positive findings and the steps
    taken to correct the problem and prevent future incidents.[^50]

**6. FSIS Should Take Appropriate Enforcement Action Based On Industry
Final-Product Testing**

FSIS should develop a program for taking enforcement action based upon
the results of industry testing for *L. monocytogenes.* Regulations
should require that companies alert FSIS immediately upon detection of
confirmed positives in finished-product samples. In response, the agency
should ensure that all affected products in the company\'s possession
are destroyed or otherwise treated to eliminate the pathogen, and that
all affected products that have already entered commerce are immediately
recalled.

Under that scheme, positive findings from industry testing would be
treated in the same manner as positives from FSIS\'s own *L.
monocytogenes* sampling program, as required under the zero-tolerance
policy. Regardless of who is doing the testing, all affected products
must be treated as adulterated and subjected to immediate recall.

In addition to an enforcement mechanism based upon the results of
industry testing, FSIS should develop a plan to carefully monitor, on an
ongoing basis, all environmental and final-product testing data from
plants producing ready-to-eat meat and poultry products. Such data would
provide a wealth of new information about the prevalence of the pathogen
in various types of products and the effectiveness of different control
measures used by processing plants. FSIS should regularly incorporate
the new information into the agency\'s overall *L. monocytogenes*
regulatory strategy.

Ongoing monitoring of the data from industry environmental testing is
necessary to avoid repeating a situation such as that which apparently
occurred in the Bil Mar plant, where no additional scrutiny of the
plant\'s processes was made despite a dramatic increase in environmental
contamination rates during the weeks leading up to the outbreak. FSIS
inspectors should be required to review environmental data to ensure
that such problems are rapidly detected and aggressively investigated
and corrected.

Moreover, the new regulations should authorize FSIS to take swift and
aggressive regulatory action where trends in plant-testing data indicate
a serious problem. If circumstances warrant \-- for instance, where a
plant repeatedly fails to produce *L. monocytogenes*-free product \--
the agency should be able (and willing) to close down the plant until it
demonstrates that it can gain control over its processes.

**7. FSIS Should Not Await the Outcome of a *L. monocytogenes* Risk
Assessment Before Mandating Microbial Testing**

Considering the risk to consumers, FSIS should take the regulatory
action requested in this petition now, without awaiting the outcome of
the federal government\'s ongoing *L. monocytogenes* risk assessment or
undertaking its own risk assessment for the pathogen. To be sure,
quantitative risk assessment eventually may yield insights into how best
to address the public-health threat posed by the pathogen. However,
given the abundance of data gaps and holes in our understanding of the
factors that contribute to the pathogen\'s ability to cause
illness,[^51] risk assessments are not likely to provide reliable data
to support rulemaking for quite

some time.

Meanwhile, enough currently is known about the pathogen to enable FSIS
to develop a meaningful regulatory response to the problem in the form
of required microbial testing in processed-meat plants. For instance,
there is no question that *L. monocytogenes* is capable of contaminating
virtually all types of ready-to-eat meat and poultry products sold in
the U.S. and that such foods can sicken or kill vulnerable consumers:
the Sara Lee outbreak and the recent large-scale recalls of contaminated
ready-to-eat products demonstrate that. In addition, available data show
that the pathogen, once found in such products, can continue to multiply
even at refrigeration temperatures, making it crucial to eliminate the
organism at the processing plant. Finally, it is obvious from the large
number of recent recalls of *L. monocytogenes*-contaminated products
that FSIS\'s current random-sampling program is not comprehensive enough
to keep huge volumes of potentially hazardous foods off the market.

Given all that is currently known about the public-health hazard posed
by

*L. monocytogenes* in ready-to-eat meat and poultry products, it is
clear that a well-designed

program of mandatory microbial testing in processing plants is necessary
to better protect consumers from the pathogen. Regardless of the
specific outcomes of the government\'s quantitative risk assessment,
mandatory industry testing will remain a key component of a
comprehensive strategy to prevent *L.* monocytogenes-contaminated
products from reaching consumers, because such testing is the surest way
to verify the efficacy of industry HACCP plans and to strengthen
enforcement of the zero-tolerance standard. FSIS therefore should take
immediate regulatory action to develop and implement a mandatory
microbial-sampling program, without awaiting completion of the federal
government\'s ongoing risk assessment or embarking upon its own risk
assessment.

Of course, FSIS should be willing to refine the mandatory
microbial-testing program to take into account any relevant data from
the risk-assessment process. Requirements for industry sampling should
be adjusted if scientifically justified by data obtained during risk
assessment. Moreover, if analysis shows that particular intervention
measures, plant designs, or other elements are particularly effective in
reducing the risk of *L. monocytogenes* contamination in ready-to-eat
meat and poultry products, FSIS should take steps to encourage \-- and
perhaps even mandate \-- adoption of such elements into plants\'
processes.

We emphasize that CSPI strongly supports the government\'s effort to
conduct a quantitative risk assessment for *L. monocytogenes.*
Especially in its early stages, that process will help to identify the
important data gaps that currently exist, and we encourage the
government and industry to sponsor and conduct additional research aimed
at elucidating the bacterium\'s pathogenic characteristics. However,
FSIS should not await completion of this lengthy process before taking
the common-sense step of requiring the industry to test its plants and
final products for the presence of the pathogen.

> **8.** **FSIS Should Maintain Its Random-Sampling Program for**
> **Listeria as an Additional Layer of Protection for Consumers** **and
> to Verify the Efficacy of Industry Testing Programs**

Implementation of a mandatory industry testing program for *L.
monocytogenes* should not spell the end of FSIS\'s existing
random-sampling program. Rather, FSIS should continue to sample final
products from plants on a random basis to ensure that industry programs
are working and to provide an additional layer of protection.

FSIS should, however, direct its limited resources to those plants and
products that pose the greatest risk to consumers. As data from both the
industry sampling program and the government\'s *L. monocytogenes* risk
assessment are analyzed, FSIS should revise its sampling program to
concentrate on the plants and products posing the greatest risk of *L.
monocytogenes* contamination.

FSIS has indicated that it intends to exempt from the government
sampling program those plants that conduct their own tests, using as a
model the agency\'s current *E. coli* O157:H7 sampling program under
Directive 10,010.1. CSPI agrees that such an approach eventually may be
appropriate, but we urge FSIS to refrain from exempting any plants from
random government sampling until the industry testing program is well
underway and the agency has had an opportunity to evaluate it. Rather
than wholly exempting certain plants from FSIS sampling, the agency
should instead concentrate its limited resources on those plants (and
products) that pose the greatest potential risk to consumers. The
comprehensiveness of a plant\'s testing scheme can be one factor in
determining whether FSIS should focus its attention on that plant or
elsewhere.

> **9.** **Pending Final Adoption of a Mandatory Microbial Testing
> Program, Ready-To-Eat Meat and Poultry Products Should be Required to
> Bear a *L. monocytogenes* Safe-Handling Label**

As FSIS advised consumers in the wake of the Sara Lee outbreak,
ready-to-eat meat and poultry products are not truly ready-to-eat for
people who are especially vulnerable to foodborne illness.[^52] Yet
those products are both labeled as ready-to-eat and bear a USDA shield,
creating the misimpression that they are safe to consume without further
cooking.

To protect at-risk consumers until the entire industry is required to
test for the presence of *L. monocytogenes* in plants and end products,
all ready-to-eat meat and poultry products should be required to carry a
safe-handling statement indicating that they could be contaminated with
the pathogen and therefore pose a potential health threat to infants,
pregnant women, the elderly, and those with weakened immune systems.

CSPI views such a labeling requirement merely as an interim measure
pending adoption of a final rule requiring microbial testing in all
processing plants, which, presumably, would lead to much safer food. In
fact, FSIS could exempt from the label requirement those plants that
voluntarily conduct microbial testing under a regime such as that
proposed in this petition, provided that it proves effective at
substantially lowering contamination rates.

**B. Legal Authority**

> **1.** **The FMIA and the PPIA Authorize FSIS to Mandate Microbial
> Testing of Plants Producing Ready-to-Eat Meat and Poultry Products and
> their End Products.**

The same legal authority that supports *E. coli* and *Salmonella*
testing in slaughterhouses under the HACCP/Pathogen Reduction rule
authorizes FSIS to require plants producing processed meat and poultry
products to conduct environmental and final-product testing for *L.
monocytogenes.*

As FSIS explained in the preamble to the final HACCP/Pathogen Reduction
rule, the FMIA and the PPIA give FSIS \"ample statutory authority\" to
promulgate microbiological testing provisions.[^53] The meat and poultry
inspection statutes mandate federal regulatory oversight of "unusual
intensity and comprehensiveness," and they provide the Secretary with
broad rulemaking authorities to implement them.[^54] As FSIS noted,

> \[flrom their inception, the meat and poultry inspection laws have
> recognized that sanitary conditions in establishments are critical to
> the safety and wholesomeness of the products being produced. Any
> product found to have been "prepared, packed, or held under insanitary
> conditions whereby it may have become contaminated with filth, or
> whereby it may have been rendered injurious to health" is adulterated.
> No product will be granted inspection or marked \"inspected and
> passed\" unless the sanitary conditions and practices required by the
> Secretary are maintained.[^55]

In the HACCP/Pathogen Reduction rule, FSIS invoked that authority to
require that slaughterhouses conduct and document tests for microbial
contamination. Such tests are FSIS\'s chosen means to measure how well
plant sanitation is working to prevent contamination of products.

The agency\'s authority to use microbial testing to evaluate plant
sanitation is not limited to slaughterhouses, but extends to meat and
poultry processing facilities as well. Section 45 3 (g)(4) of the PPIA
and § 601 (m)(4) of the FMIA, which define as adulterated any poultry or
meat product that has been prepared, packed, or held under insanitary
conditions, apply to all processed products.[^56] Likewise, § 456 of the
PPIA and § 608 of the FMIA, which direct USDA to prescribe rules and
regulations for plant sanitation and forbid inspectors from marking
products as "inspected and passed" if they are prepared under insanitary
conditions that render them adulterated, apply to plants producing
ready-to-eat products.

In addition to the foregoing provisions of the FMIA and the PPIA, each
statute contains a general provision that supports the actions requested
in this petition. Both the FMIA and PPIA include provisions that grant
the Secretary broad authority to promulgate rules and regulations
"necessary to carry out the Act\[s\]."[^57] F SIS relied upon these
provisions when it promulgated its HACCP/Pathogen Reduction Rule and
they are equally applicable here.

> **2.** **The FMIA** **and the PPIA Authorize FSIS to Mandate
> Safe-Handling Labels for Ready-to-Eat Meat and Poultry Products That
> May Be Contaminated with *L. monocytogenes***

FSIS\'s authority to require safe-handling labels on food products
derives from § 601(n)(12) of the FMIA and § 453(h)(12) of the PPIA.
Under those provisions, a food is misbranded if it does not bear, in
addition to the official inspection legend, \"such other information as
the Secretary may require \... to assure that \[the food\] will not have
false or misleading labeling and that the public will be informed of the
manner of handling required to maintain the product in a wholesome
condition.\" Thus, both the FMIA and the PPIA give the agency discretion
to require labeling in addition to the official inspection stamp *See
American Public Health Ass'n v. Butz,* 511 F.2d 331, 335 (D.C. Cir.
1974).

In the early 1970s, USDA declined to invoke that authority to require a
warning label on uncooked meat and poultry products, a decision that was
upheld by a federal appellate court. *See Butz,* 511 F.2d at 331-335.
However, it is important to recognize that in *Butz* the court merely
found that the agency is not *obligated* by statute to require a
safe-handling label on meat products that may contain microbial
contamination; the decision does not preclude the agency from
reconsidering the safe-handling-label issue and deciding to exercise its
discretion differently in the future. In fact, FSIS has since revisited
the question and, in 1994, promulgated a rule requiring raw meat and
poultry products to bear safe-handling instructions.[^58]

Given the serious health threat posed by *L.* monocytogenes-contaminated
processed-meat products, especially to those consumers most susceptible
to foodborne illness, FSIS should again exercise its discretion under
the FMIA and PPIA to require labeling information in addition to the
official inspection stamp. The agency has already issued a brochure
alerting consumers to the risk of listeriosis from ready-to-eat products
and has advised especially vulnerable consumers to avoid eating such
products unless they can be reheated to steaming temperatures.[^59] FSIS
should, as an interim measure pending finalization of the
microbial-testing regulations requested in this petition, require that
the products themselves bear such a safe-handling statement, as
authorized by § 601(n)(12) of the FMIA and § 453(h)(12) of the PPIA.

> **3. FSIS Should Promulgate the Requested Regulations as an Interim
> Final Rule Without First Completing Notice and Comment, Risk
> Assessment, and Cost-Benefit Analysis**

Ready-to-eat meat and poultry products contaminated with *L.
monocytogenes* pose a serious, immediate threat to human health. FSIS,
the agency responsible for protecting consumers from hazardous meat and
poultry products, has a duty to respond to that threat by taking
*immediate* regulatory action, without pursuing an unnecessarily lengthy
rulemaking process. Under ordinary circumstances, the agency must comply
with procedural requirements under both the Administrative Procedures
Act (APA) and the USDA Reorganization Act of 1994, including the use of
notice-and-comment rulemaking and the completion of a risk assessment
and cost-benefit analysis before issuance of a new rule. However, both
acts provide for exceptions to those requirements for circumstances such
as those present here, where the new regulations would address an
imminent threat to public safety and any delay in rulemaking would be
contrary to the public interest.

FSIS should avail itself of those statutory exceptions and promulgate
the requested regulations without first providing the public with notice
and an opportunity for comment and before completing a full risk
assessment and cost-benefit analysis. The agency should first adopt the
regulations as an \"interim-final rule,\" which would become binding
upon publication (or shortly thereafter), and subsequently provide for
public comment and complete its risk assessment and cost-benefit
analysis.[^60] As explained below, FSIS is authorized to take such an
approach under both the APA and the USDA Reorganization Act of 1994.

> **a. The Requested Regulations Satisfy the \"Good Cause\" Exception to
> the Administrative Procedure Act\'s Requirement for Notice and
> Comment**

The APA provides that full notice-and-comment rulemaking is not required
when an agency \"for good cause finds (and incorporates the finding and
a brief statement of the reasons therefor in the rules issued) that
notice and public procedure thereon are impracticable, unnecessary, or
contrary to the public interest.\" 5 U.S.C. §553(b)(B). The good cause
exception \"is an important safety valve to be used where delay would do
real harm.\" *United States Steel v.* *EPA,* 595 F.2d 207, 214 (5th Cir.
1979). According to the legislative history of the provision,
\"\'impracticable\' means a situation in which the due and required
execution of the agency functions would be unavoidably prevented by its
undertaking public rule-making proceedings.\" S. Rep. No. 752, 79th
Cong., 1st Sess., at 16 (1945). As one court has held, determining
\"impracticality\" requires \"analysis in practical terms of the
particular statutory-agency setting and the reasons why agency action
could not await notice and comment.\" *American Transfer &* *Storage
Company v. ICC,* 719 F.2d 1283, 1295 (5th Cir. 1983).

There are numerous instances in which courts have upheld an agency\'s
decision to invoke the \"good cause\" exception and issue a rule without
providing for notice and comment where a delay would threaten public
safety or the environment. *See, e.g., Hawaii Helicopter Operators*
*Ass\'n v. FAA,* 51 F.3d 212, 214 (9th Cir. 1995) (good cause exception
satisfied in view of \"the threat to public safety reflected in an
increasing number of helicopter accidents\"); *Northern* *Arapahoe Tribe
v. Hodel,* 808 F.2d 741, 750-52 (10th Cir. 1987) (good cause exception
satisfied in view of urgent need for hunting regulations where herds
were threatened with extinction); *Northwest Airlines-v. Goldschmidt,*
645 F.2d 1309, 1321 (8th Cir. 1981) (good cause exception satisfied in
view of urgent need to allocate landing slots at major airport).

The rationale underlying those decisions, that compliance with
time-consuming procedural requirements would "do real harm" by delaying
implementation of urgently needed regulations to safeguard public
health, is equally applicable here. *L. monocytogenes*-contaminated meat
and poultry products pose an imminent threat to public health, having
very recently caused a major outbreak that resulted in 21 deaths and 100
illnesses. Repeated large-scale recalls of such products demonstrate
that the problem is not under control, jeopardizing the health of
consumers throughout the country. Under such circumstances, any delay in
requiring the processed-meat industry to test its plants and final
products for the presence of *L. monocytogenes* would pose a serious
threat to public safety. Clearly, the exigent circumstances necessary to
satisfy the APA\'s good cause exception are present.

> **b. The Requested Regulations Present a Situation In Which Regulatory
> Analysis is \"Not Practicable Because of Compelling Circumstances\"
> Under the U.S. Department of Agriculture Reorganization Act of 1994**

Under § 2204e of the USDA Reorganization Act of 1994, USDA must complete
a risk assessment and cost-benefit analysis for each proposed major
regulation that relates to human health, safety, or the environment. 7
U.S.C. § 2204e. That section does provide an exception, however: when a
risk assessment and cost-benefit analysis is \"not practicable because
of compelling circumstances,\" an explanation can be provided in lieu of
a full analysis. *Id.* at § 2204e(b)(1).

USDA\'s Office of Risk Assessment and Cost-Benefit Analysis, which has
been in operation for only five years, has yet to exempt a proposed rule
from the regulatory-analysis requirement. Nevertheless, CSPI asserts
that the rulemaking requested in this petition readily satisfies the
exemption. The imminent public-health threat posed by *L.
monocytogenes-*contaminated ready-to-eat meat and poultry products
presents the "compelling circumstance" needed to justify the
promulgation of regulations without undertaking a full risk assessment
and

cost-benefit analysis.

The Sara Lee outbreak demonstrates that many ready-to-eat meat and
poultry products are widely distributed and, if contaminated with *L.
monocytogenes,* can kill or sicken hundreds of consumers throughout the
country. Ominously, the numerous recalls that have been undertaken since
the Sara Lee outbreak \-- some involving millions of pounds of *L.
monocytogenes*-contaminated product \-- show that the pathogen remains
prevalent in processed-meat products and that many plants are not
effectively addressing the problem under their HACCP plans. Luckily, so
far the recalled products apparently have not sickened or killed any
consumers. But it is reasonable to expect that, absent immediate
adoption of the regulations requested in this petition, consumers\' good
fortune cannot continue indefinitely, and that a new deadly outbreak of
listeriosis will produce another national tragedy.

CSPI contends that this imminent threat constitutes the \"compelling
circumstances\" necessary to permit FSIS to adopt the requested
regulation without first completing a full regulatory analysis. FSIS
instead should publish the regulations as an interim final rule and
provide an explanation for its rulemaking as contemplated under §
2204e(b)(1) of the USDA Reorganization Act.

**c. If FSIS Believes That It Cannot Promulgate the Requested
Regulations As an Interim Final Rule, It Should Take All Steps Necessary
To Expedite Adoption of the Regulations**

If FSIS concludes that it cannot promulgate the requested regulations
without first pursuing notice-and-comment rulemaking and completing a
risk assessment and cost-benefit analysis, the agency should commence
the requisite rulemaking immediately and finalize the regulations as
quickly as possible. Resources from other, less pressing regulatory
activities should be reassigned to the development of the requested
regulations, and all necessary components of the rulemaking process
should be undertaken simultaneously, rather than sequentially, to
eliminate any delay in the process. FSIS should also inform the Office
of Management and Budget that exigent circumstances demand rapid review
and approval of the rule.

In addition, if the agency does not publish the requested regulations as
an interim final rule but instead undertakes a lengthy rulemaking
process, it should take immediate action to require safe-handling labels
on all ready-to-eat meat and poultry products as an interim measure to
protect consumers.

**III. Conclusion**

The events of the past year make it clear that ready-to-eat meat and
poultry products contaminated with *L. monocytogenes* pose a serious
health threat, especially to older people, infants, pregnant women, and
others who are most vulnerable to foodborne illness. The Sara Lee
outbreak leaves little doubt that the pathogen is among the most
hazardous in the food supply. And as the huge recalls of *L.
monocytogenes*-contaminated products continue unabated, consumers are
left to wonder not whether, but when and where, the next deadly outbreak
will occur.

Unfortunately, the existing regulatory system fuels, rather than allays,
that concern. Because the mandatory microbial-testing provisions of
FSIS\'s highly touted HACCP program do not extend to processors of
ready-to-eat products, it is unlikely that contamination problems will
be detected before large volumes of tainted products are distributed to
supermarkets. Nor can consumers be sure under the existing system that
the federal government is adequately verifying the continuing
effectiveness of companies\' *L. monocytogenes*-control processes.

FSIS can easily address those dangerous shortcomings in the existing
regulatory program by developing a mandatory microbial-testing rule
based upon the recommended practices in the agency\'s \-- as well as the
industry\'s \-- guidance documents. By requiring companies to test both
their plant environments and their final products, FSIS would transform
the HACCP program for processed-meat products into a truly preventive
food-safety system. CSPI urges the agency to take that step without
further delay, before another outbreak of listeriosis claims more lives.

**Appendix**

**FSIS 1999 Recall Listings:**

**Ready-to-Eat Meat Products Contaminated with *Listeria***

+-----+-------------+-----------+------------+------------+---+-----------+
| **  | *           | **L       | *          | **Amount** | * |           |
| Dat | *Company/** | ocation** | *Product** |            | * |           |
| e** |             |           |            | **(lbs.)** | D |           |
|     | **Esta      |           |            |            | i |           |
|     | blishment** |           |            |            | s |           |
|     |             |           |            |            | t |           |
|     |             |           |            |            | r |           |
|     |             |           |            |            | i |           |
|     |             |           |            |            | b |           |
|     |             |           |            |            | u |           |
|     |             |           |            |            | t |           |
|     |             |           |            |            | i |           |
|     |             |           |            |            | o |           |
|     |             |           |            |            | n |           |
|     |             |           |            |            | * |           |
|     |             |           |            |            | * |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 1   | Oscar Mayer | Madison,  | luncheon   | 28,313     |   | Na        |
| /15 |             | WI        | meat       |            |   | tionwide, |
|     | Foods Corp. |           |            |            |   | Puerto    |
|     |             |           |            |            |   | Rico,     |
|     |             |           |            |            |   | S         |
|     |             |           |            |            |   | ingapore, |
|     |             |           |            |            |   | Bermuda,  |
|     |             |           |            |            |   | Aruba,    |
|     |             |           |            |            |   |           |
|     |             |           |            |            |   | St.       |
|     |             |           |            |            |   | Martin,   |
|     |             |           |            |            |   | Dominican |
|     |             |           |            |            |   | Republic  |
+-----+-------------+-----------+------------+------------+---+-----------+
| 1   | Bosell      | C         | sliced ham | 349        |   | PR        |
| /22 | Foods       | leveland, |            |            |   |           |
|     |             | OH        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 1   | Thorn Apple | Forrest   | various    | 30 million |   | Na        |
| /22 | Valley      | City, AR  | re         |            |   | tionwide, |
|     |             |           | ady-to-eat |            |   | Inte      |
|     |             |           | meat       |            |   | rnational |
|     |             |           | products   |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 2/2 | Culinary    | Chicago,  | chicken    | 26,975     |   | N         |
|     | Foods       | IL        | burritos   |            |   | ationwide |
+-----+-------------+-----------+------------+------------+---+-----------+
| 2/5 | B.B. Meat & | Be        | hot dogs,  | 1,545      |   | WA, OR,   |
|     | Sausage     | llingham, | brockwurst |            |   | AK        |
|     | MFG, Inc.   | WA        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 2   | Ba Le Meat  | Chicago,  | Head       | 2,600      |   | NY, PA,   |
| /17 | Processing  | IL        | Cheese     |            |   | IL, MN,   |
|     | &           |           |            |            |   | NC, MD,   |
|     | Wholesale,  |           |            |            |   | MA, GA,   |
|     | Inc.        |           |            |            |   | CA, TX,   |
|     |             |           |            |            |   | FL        |
+-----+-------------+-----------+------------+------------+---+-----------+
| 2   | Lowell      | Fi        | franks,    | 4,460      |   | GA,AL     |
| /18 | Packing     | tzgerald, | smoked     |            |   |           |
|     | Company     | GA        | sausages   |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 3/2 | Culinary    | Chicago,  | pasta with | 1,923      |   | IL, NY    |
|     | Foods, Inc. | IL        | sausage    |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 3   | P           | W         | franks     | 18         |   | NJ        |
| /18 | hiladelphia | estville, |            |            |   |           |
|     | Foods, Inc. | NJ        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 5   | White       | Will      | bologna,   | 16,392     |   | SC, NC,   |
| /14 | Packing     | iamstown, | ham,       |            |   | VA, NY,   |
|     | Company     | NC        | salami,    |            |   | NJ        |
|     |             |           | etc.       |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 5   | The Alpine  | H         | weisswurst | 60         |   | PA        |
| /28 | Wurst &     | onesdale, |            |            |   |           |
|     | Meat House  | PA        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 6/1 | Valley Meat | Valley    | weiners,   | 150        |   | ND        |
|     | Supply      | City, ND  | fr         |            |   |           |
|     |             |           | ankfurters |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 6/4 | Real        | Chicago,  | skinless   | 1,285      |   | IL        |
|     | Sausage     | IL        | franks     |            |   |           |
|     | Company     |           |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 6   | Redondo's   | Waipahu,  | fr         | 9,620      |   | HI        |
| /18 | Inc.        | HI        | ankfurters |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 7/2 | Marburger   | Peru, IN  | bacon bits | 135,906    |   | IA, MT,   |
| 7-8 | Packing     |           | and bacon  |            |   | WA, NE,   |
| /16 | Inc.        |           | pieces     |            |   | TN, TX,   |
|     |             |           |            |            |   | KY, OR,   |
|     |             |           |            |            |   | IL, OH,   |
|     |             |           |            |            |   | AL, OK,   |
|     |             |           |            |            |   | MI, WI,   |
|     |             |           |            |            |   | NC, FL,   |
|     |             |           |            |            |   | MN, UT,   |
|     |             |           |            |            |   | MS        |
+-----+-------------+-----------+------------+------------+---+-----------+
| 7   | Dearborn    | Dearborn, | ham        | 200        |   | MI        |
| /29 | Sausage     | MI        |            |            |   |           |
|     | Co., Inc.   |           |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 7   | Gerrity's   | Kingston, | hot dogs   | 200        |   | PA        |
| /30 | S           | PA        |            |            |   |           |
|     | upermarket, |           |            |            |   |           |
|     | Inc.        |           |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 7   | Loeffer's   | Trenton,  | roasting   | 200        |   | NJ        |
| /30 | Gourmet,    | NJ        | sausage    |            |   |           |
|     | Inc.        |           |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 8   | Medina &    | San Juan, | chiorzios  | 1,640      |   | PR        |
| /26 | Medina      | PR        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 8   | Gaspar's    | D         | sausage    | 3,720      |   | RI, MA,   |
| /27 | Sausage     | artmouth, |            |            |   | CT        |
|     | Company,    | MA        |            |            |   |           |
|     | Inc.        |           |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 8   | Foster      | Li        | turkey     | 33,710     |   | CA, TX,   |
| /27 | Poultry     | vingston, | franks     |            |   | UT, WA,   |
|     | Farms       | CA        |            |            |   | NV, OR    |
+-----+-------------+-----------+------------+------------+---+-----------+
| 9/9 | Verl's      | Freder    | chicken    | 240        |   | PA        |
|     | Salads Inc. | icksburg, | salad      |            |   |           |
|     |             | PA        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 10  | Marathon    | Bronx, NY | beef       | 2,100,000  |   | N         |
| /13 | E           |           | franks     |            |   | ationwide |
|     | nterprises, |           |            |            |   |           |
|     | Inc.        |           |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 11  | Couch's     | Garfield  | hot souse  | 47         |   | OH        |
| /11 | Sausage     | Heights,  | meat       |            |   |           |
|     |             | OH        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 11  | Abe's Cajun | Sulphur,  | smoked     | 1,270      |   | LA, TX    |
| /12 | Boudin,     | LA        | sausage    |            |   |           |
|     | Inc.        |           | (pork and  |            |   |           |
|     |             |           | beef)      |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 11  | Uncle Louie | Kahului,  | hot dogs   | 312        |   | HI        |
| /12 | Sausage Co  | HI        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 11  | Hy-Vee      | R         | lunchmeat  | Unknown    |   | MN        |
| /12 | grocery     | ochester, |            |            |   |           |
|     | store       | MN        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 11  | Sophie's    | C         | cooked     | 130        |   | OH        |
| /15 | Choice      | leveland, | smokies    |            |   |           |
|     | Meats       | OH        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 11  | Robbins     | St        | hot dogs   | 1,020      |   | GA        |
| /17 | Packing Co. | atesboro, |            |            |   |           |
|     |             | GA        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 11  | P.J.'s Inc. | B         | polish     | 800        |   | MD        |
| /19 |             | altimore, | sausage    |            |   |           |
|     |             | MD        |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 1   | J.L. Miller | York, PA  | beef       | 4          |   | PA        |
| 2/2 | and Sons    |           | franks     |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 12  | Foodarama   | Linden,   | sliced     | 900        |   | NJ        |
| /14 | Su          | NJ        | luncheon   |            |   |           |
|     | permarkets, |           | meats      |            |   |           |
|     | Inc.        |           |            |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+
| 12  | Hannelore   | Hu        | Foie gras, | 80,000     |   | Na        |
| /29 | Gourmet     | ntington, | other      |            |   | tionwide, |
|     | Foods, Ltd. | NY        | pate-type  |            |   | Canada    |
|     |             |           | products   |            |   |           |
+-----+-------------+-----------+------------+------------+---+-----------+

\*Sources: Food Safety and Inspection Service, USDA, "1999 Recall
Reports." (Available at
<http://www.fsis.usda.gov/OA/recalls/recdb/rec1999.htm>\>Internet)

*Food Safety Net* (Available at
<http://www.extension.iastate.edu/files/fscurrent/>\>Internet)

[^1]: U.S. Department of Agriculture, Food Safety and Inspection
    Service, \"Listeria monocytogenes Contamination of Ready-to-Eat
    Products; Compliance with the HACCP System Regulation and Request
    for Comment,\" *Federal Register,* Vol. 64, No. 101 (1999), p. 28352
    \[hereinafter cited as *FSIS HACCP Reassessment* *Notice\];* U.S.
    Food and Drug Administration, Center for Food Safety and Applied
    Nutrition, *\"Listeria* *monocytogenes,\" Foodborne Pathogenic
    Microorganisms and Natural Toxins Handbook,* available at
    \<http://vm.cfsan.fda.gov/\~mow/chap6.html\>lnternet.

[^2]: Centers for Disease Control and Prevention, National Center for
    Infectious Diseases, \"Food-Related Illness and Death in the United
    States*,\" Emerging Infectious Diseases,* Vol*.* 5, No. 5 (1999),
    available at
    \<http://www.cdc.gov/ncidod/eid/vol5no5/mead.htm\>lntemet, Table 3
    \[hereinafter cited as *CDC Foodborne Illness* *Estimates*\].

[^3]: Council for Agricultural Scienceand Technology, *Foodborne
    Pathogens: Risks and Consequences*, Task Force Report, No. 122
    (1994), p. 45 \[hereinafter cited as *CAST Report*\].

[^4]: ^?^ Jordan W. Tappero, *et al.,* \"Reduction in the Incidence of
    Human Listeriosis in the United States:

    Effectiveness of Prevention Efforts?\" *Journal of the American
    Medical Association,* Vol. 273, No. 14 (1995), p.

    1118 \[hereinafter cited as *Listeria Prevention Efforts\]; CDC
    Foodborne Illness Estimates,* Table 3.

[^5]: *CDC Foodborne Illness Estimates*, Table 3.

[^6]: *CAST Report*, p. 44

[^7]: *CAST Report*, p. 34 (citing Jeffrey M. Farber, *et al*.,
    "Microbiological Quality of Fresh and Frozen Breakfast-type Sausage
    Sold in Canada," *Journal of Food Protection*, Vol. 51 (1988), pp.
    397-401.

[^8]: U.S. Department of Agriculture, Food Safety and Inspection
    Service, *Listeria Guidelines for Industry* (May 1999)
    (unpublished), p. 4 \[hereinafter cited as *FSIS Guidelines* for
    Industry\].

[^9]: ^?^ U.S. Department of Agriculture, Food Safety and Inspection
    Service,\" 1999 Recall Reports,\" available at
    \<http://www.fsis.usda.gov/OA/recalls/recdb/rec1999.htm\>lnternet. A
    list of recalls of FSIS-regulated ready-to-eat foods is provided in
    the Appendix to this petition.

[^10]: ^?^ Food Safety and Inspection Service, USDA, \"Thorn Apple
    Valley Listeria Recall\--Update and Amended List,\" January 28,
    1999, available at
    \<http://www.fsis-gov/OA/news/99-rc-05.htm\>lnternet.

[^11]: Food Safety and Inspection Service, USDA, \" 1999 Recall
    Reports,\" October 13, 1999, available at
    \<http://www.fsis.usda.gov/OA/recalls/recdb/rec1999.htm\>lnternet

[^12]: ^?^ Food Safety and Inspection Service, USDA, \" 1999 Recall
    Reports**,\"** July 26, 1999, available at
    \<http://www.fsis.usda.gov/OA/recallls/recdb/rec1999.htm\>Internet.

[^13]: \"Chicken Burritos Recalled for Listeria,\" *Food Safety Net,*
    February 6, 1999. Culinary Foods, a subsidiary of Tyson Foods,
    recalled about 78,000 pounds of chicken burritos.

[^14]: Food Safety and Inspection Service, USDA, \" 1999 Recall
    Reports,\" August 27, 1999, available at
    \<http://www.fsis.usda.gov/OA/recalls/recdb/rec1999.htm\>lnternet.

[^15]: Food Safety and Inspection Service, USDA, \"1999 Recall
    Reports,\" January 15, 1999, available at
    \<http://www.fsis.usda.gov/OA/recalls/recdb/rec1999.htm\>lnternet.

[^16]: ^?^ Centers for Disease Control and Prevention, \"Update:
    Multistate Outbreak of Listeriosis,\" *Press Release* (March 17,
    1999), available at
    \<http://www.cdc.gov/od/oc/media/pressre1/r990114.htm\>lnternet
    \[hereinafter cited *as Sara Lee Outbreak Press Release\].*

[^17]: *Sara Lee Outbreak Press Release.*

[^18]: \"CDC Finds Listeria Caused Outbreak Caused by Airborne Particles
    in Processing Plant,\" *Food Chemical News,* Vol*.* 1, No. 25 (July
    14, 1999), p. 704; Alison Young, Jeff Taylor, and Janet L. Fix, \"A
    Killer in

    Our Food: Special Report,\" *Detroit Free Press,* (August 26, 1999),
    p. 12 \[hereinafter cited as *Detroit Free Press Report\].*

[^19]: *Sara Lee Outbreak Press Release.*

[^20]: *Ibid.*

[^21]: *Ibid.*

[^22]: *Ibid*; Centers for Disease Control and Prevention, \"Update:
    Multistate Outbreak of Listeriosis \-- United States, 1998-1999,\"
    *Morbidity and Mortality* *Weekly Review*, Vol. 47, No. 51, (1999),
    p. 1117.

[^23]: Remarks of Dr. Paul S. Mead, Centers for Disease Control and
    Prevention, at the 1999 Meeting of the International Association of
    Milk, Food, and Environmental Sanitarians (August 23, 1999);
    *Detroit Free Press Report* (August 23, 1999), p. 2.

[^24]: Detroit Free Press Report (August 23, 1999), p. 2.

[^25]: *Listeria Prevention Efforts, p*. 1118.

[^26]: Remarks of Thomas J. Billy, Administrator, Food Safety and
    Inspection Service, before the World

    Congress on Meat and Poultry Inspection (June 10, 1997), available
    at \<www.fsis.usda.gov/oa/speeches/1997/

    world.htm\>lntemet.

[^27]: United States Department of Agriculture, Food Safety and
    Inspection Service, and United States Department of Health and Human
    Services, Food and Drug Administration, *Preventing Foodborne
    Listeriosis* (992), p. 5.

[^28]: *Listeria Prevention Efforts*, p.1121.

[^29]: ^?^ "U.S. *Listeria* \'Zero Tolerance\' Policy is Being Reviewed:
    Vanderveen," *Food Regulation Weekly*, Vol. 1, No. 30 (1998), p. 12
    (quoting John Vanderveen, U.S. Food and Drug Administration, who
    described the factors that contributed to the zero-tolerance
    standard).

[^30]: *See, e.g.,* U.S. Department of Agriculture, Food Safety and
    Inspection Service, \"Pathogen Reduction; Hazard Analysis and
    Critical Control Point (HACCP) Systems; Final Rule,\" *Federal
    Register,* Vol. 61, No. 144, (1996), p. 3 8817 (citing HACCP
    Principle No. 7: \"HACCP systems must be systematically verified\")
    \[hereinafter cited as M*eat and Poultry HACCP Final Rule*\]; Food
    and Drug Administration, \"Procedures for the Safe and Sanitary
    Processing and Importing of Fish and Fishery Products; Final Rule,\"
    *Federal Register,* Vol. 60, No. 242, (1995), p. 65129
    (\"Verification is one of the seven commonly recognized HACCP
    principles.\"); National Advisory Committee on Microbiological
    Criteria for Foods, *Hazard Analysis and Critical Control Point
    System* (March 20, 1992); \"Hazard Analysis and Critical Control
    Point Principles and Application Guidelines, *J.* *Food Protect*.,
    Vol. 61, No. 6, (1998), pp. 762-775; Food and Agriculture
    Organization of the United Nations, Food Safety Through HACCP \--
    The FAO Approach, *Food, Nutrition Agriculture*, Vol. 15, available
    at \<http://www.fao.org/docrep/v9723t/v9723t0e.htm#haccp
    principles\>Internet.

[^31]: *Meat and Poultry HACCP Final Rule,* p. 38827.

[^32]: U.S. Department of Agriculture, Food Safety and Inspection
    Service, "Listeria monocytogenes Contamination of Ready-to-Eat
    Products," *Federal Register*, Vol. 64, No. 101 (1999), pp.
    28351-353.

[^33]: *Meat and Poultry HACCP Final Rule*, p. 38837-854.

[^34]: U.S. Department of Agriculture, Food Safety and Inspection
    Service, \"Progress Report on Salmonella Testing of Raw Meat and
    Poultry Products,\" *FSIS Backgrounder,* (October 1999), available
    at \<http://www.fsis.usda.gov/OA/background/saimtest4.htm\>lnternet;
    U.S. Department of Agriculture, Food Safety and Inspection Service,
    \"HACCP Implementation: First Year Salmonella Test Results: January
    26, 1998 to January 25, 1999,\" *FSIS Backgrounder,* available at
    \<http://www.fsis.usda.gov/OPHS/salmdata.htm\>lnternet; Centers for
    Disease Control and Prevention, \"Incidence of Foodborne Illnesses:
    Preliminary Data from the Foodborne Diseases Active Surveillance
    Network (FoodNet) -- United States, 1998," *Morbidity and Mortality
    Weekly Report*, Vol. 48, No. 9 (1999), pp. 189-193.

[^35]: Contrary to the assertions of some in the industry, mandating
    microbial testing is not tantamount to dictating critical control
    points. Microbial testing serves as a means of verifying the
    efficacy of HACCP plans and a regulatory tool for enforcing the
    zero-tolerance standard; plants would remain free to design their
    own HACCP plans and sampling programs \-- including the
    identification and management of critical control points \-- to
    account for the unique features of their operations.

[^36]: U.S. Department of Agriculture, Food Safety and Inspection
    Service, "FSIS Action Plan for Addressing *Listeria monocytogenes*,"
    *FSIS Backgrounder*, (May 1999), p. 2.

[^37]: Ibid., pp. 2-3

[^38]: The federal government\'s *L. monocytogenes* risk assessment is
    discussed in greater detail in Section III (A)(7) below.

[^39]: Marian Burros \"Experts Concerned About Return of Deadly Bacteria
    in Cold Cuts,\" *New York Times,* (March 14, 1999), p. 23.

[^40]: Whether companies test for *Listeria* spp. or other organisms as
    an indicator for *L. monocytogenes* contamination, their test
    methodologies should be fully validated. *FSIS Listeria Guidelines,*
    p. 5. The indicator organisms and tests should be chosen carefully
    to ensure that false negatives do not occur.

[^41]: ^?^ *FSIS Listeria Guidelines,* pp. 5-7, 9-11; National Food
    Processors Association, *Guidelines to Preventing* *Post Processing
    Contamination from* Listeria monocytogenes, *First Edition,*
    (unpublished), April 1999, pp. 13-16 \[hereinafter cited as *NFPA
    Guidelines\];* North American Meat Processors, *et al., Guidelines
    for Developing Good* *Manufacturing Practices (GMPs), Standard
    Operating Procedures (SOPs) and Environmental Sampling/Testing*
    *Recommendations (ESTRs): Ready-to-Eat (RTE) Products,*
    (unpublished), April 1999, pp. 13-20; ConAgra Refrigerated Prepared
    Foods, *ConAgra Refrigerated Prepared Foods' Current Strategy* for
    Listeria monocytogenes, (unpublished), Updated May 19, 1999, pp. 2-4
    \[hereinafter cited as *ConAgra Strategy*\].

[^42]: ^?^ FSIS\'s own guidelines state, \"Establishments with limited
    resources should establish end product sampling as their top
    priority, followed by product contact surface/non-product contact
    surface testing.\" *FSIS* *Listeria Guidelines. p.* 5. NFPA\'s
    guidelines explain the importance of environmental sampling as
    follows:

    An environmental monitoring program is necessary to assess the need
    for additional pathogen control measures for products that may be
    recontaminated by *L. monocytogenes*. Industry experience has shown
    that an ongoing monitoring and control program that uses *Listeria*
    species \... as an indicator of potential *L. monocytogenes*
    contamination not only reduces the possibility of finding *L.
    monocytogenes* in finished product but other pathogens as well.
    Industry experience also shows that reentry of *Listeria* spp. Into
    the production environment cannot be reliably prevented. Thus,
    ongoing monitoring to detect the organism in the environment is
    necessary.

    *NFTA Guidelines*, p. 13. NFPA's guidelines also state that random
    final-product testing "may be used to verify that the *L.
    monocytogenes* control/monitoring program is effective in preventing
    product contamination." *Id.*, p.15.

[^43]: *NFPA Guidelines*, p. 13; *ConAgra Strategy*, p. 2.

[^44]: *FSIS Listeria Guidelines*, p. 6; *NFPA Guidelines*, p. 15

[^45]: *ConAgra Strategy*, p. 2.

[^46]: *FSIS Listeria Guidelines*, p. 6.

[^47]: CSPI recognizes that even a carefully conceived final-product
    testing program cannot guarantee that contamination problems will be
    detected before distribution of the affected product, due in part to
    limits in current detection methods and the pathogen\'s ability to
    grow even while refrigerated. However, mandatory final-product
    testing by the industry should significantly decrease the likelihood
    that contaminated products escape detection, as compared to the
    existing FSIS sampling scheme.

[^48]: *NFPA Guidelines,* p. 15 (stating that "\[all sampled lots should
    be held until the laboratory results are available.").

[^49]: *FSIS Listeria Guidelines*, p. 7

[^50]: *Ibid*., p.6.

[^51]: ^?^ During presentations at the September 23, 1999 meeting of the
    National Advisory Committee on Microbiological Criteria for Foods,
    various government personnel involved in the *L. monocytogenes* risk
    assessment noted the following data gaps, among others:

    very limited data on consumption levels of beef, pork, and poultry
    ready-to-eat products;

    difficulty in correlating *L. monocytogenes* serotypes with the
    magnitude of risk for listeriosis in susceptible populations;

    few human epidemiological studies of listeriosis outbreaks meeting
    quantitative requirements for the risk assessment;

    extremely limited dose-response data from relevant animal studies;
    and

    available host-susceptibility data is from studies that reflect
    extreme immunological scenarios (e.g., knockout mice).

[^52]: ^?^ That fact is reflected in FSIS\'s advice to especially
    vulnerable consumers:

    > People at risk for listeriosis, their family members, and
    > individuals preparing food for them should \... \[r\]eheat until
    > steaming hot the following types of ready-to-eat foods: hot dogs,
    > luncheon meats, cold cuts, fermented and dry sausage, and other
    > deli-style meat and poultry products. \... *If you cannot reheat
    > these* *foods, do not eat them.*
    >
    > U.S. Department of Agriculture, Food Safety and Inspection
    > Service, \"FSIS Action Plan for Addressing *Listeria
    > monocytogenes," FSIS Backgrounder*, (May 1999), p. 3 (emphasis
    > added).

[^53]: *Meat and Poultry HACCP Final Rule*, p. 38851.

[^54]: *Ibid.*

[^55]: *Ibid*. (quoting 21 U.S.C. §§ 453(g) and 601(m)).

[^56]: Section 453(g)(4) of the PPIA applies to all \"poultry
    products,\" which are defined in § 453(f) as including \"any product
    which is made wholly or in part from any poultry carcass or part
    thereof.\" Similarly, § 601 (m)(4) of the FMIA applies to all \"meat
    food products,\" which are defined in § 601(j) as \"any product
    capable of use as human food which is made wholly or in part from
    any meat or other portion of the carcass of any cattle, sheep,
    swine, or goats." Thus, both § 453(g)(4) of the PPIA and § 601(m)(4)
    of the FMIA apply to ready-to-eat products.

[^57]: 21 U.S.C. §§ 463,621.

[^58]: U.S. Department of Agriculture, Food Safety and Inspection
    Service, \"Mandatory Safe Handling Statements on Labeling of Raw
    Meat and Poultry Products; Final Rule,\" *Federal Register,* Vol.
    59, No. 59, (1994), pp. 14528-540.

[^59]: U.S. Department of Agriculture, Food Safety and Inspection
    Service, Listeriosis and Food Safety Tips (Brochure), May 1999.

[^60]: *See* Michael Asimow, \"Interim-Final Rules: Making Haste
    Slowly,\" *Admin. L. Rev.,* Vol. 51, (Summer 1999), pp. 703-744
    (describing numerous administrative agencies\' use of interim-final
    rules as a pragmatic tool to "strike a compromise between a
    perceived need for immediate adoption of a rule and the values of
    public participation and regulatory analysis").