May 30, 2006

Docket Clerk

U.S. Department of Agriculture

Food Safety and Inspection Service

300 12^th^ Street, SW

Room 102 Cotton Annex

Washington, DC 20250

**[Re: Docket Number 04-026N]{.underline}**

**Salmonella Verification Sample Result Reporting: Agency Policy and Use
in Public Health Protection**

S.T.O.P.---Safe Tables Our Priority appreciates this opportunity to
comment on the above notice. S.T.O.P. is a national, not-for-profit,
volunteer health organization dedicated to preventing suffering, illness
and death due to foodborne illness by advocating sound public policy,
increasing awareness and education, and providing victim assistance.
S.T.O.P. was founded in 1993 in the aftermath of the Jack-In-The-Box *E.
coli* O157:H7 epidemic from ground beef in California and the Pacific
Northwest.

**The Impact of Foodborne Illness**

Foodborne disease is a serious public health issue and the cost to
American society is very high. The Centers for Disease Control and
Prevention (CDC) estimate that annually, 76 million people in the United
States suffer a foodborne illness; 350,000 are hospitalized; and 5,000
die. While everyone is at risk, the most vulnerable populations to
develop serious complications due to foodborne illness are children,
seniors, pregnant and postpartum women and individuals with a
compromised immune system.

Each year in the United States, there are approximately 1.4 million
cases of Salmonellosis that cause an estimated 400 deaths. According to
USDA's Economic Research Service (ERS), each of those cases costs an
average of \$2,126 in lost wages and medical costs[^1]. According to
another ERS report[^2], "Foodborne illnesses account for about 1 of
every 100 U.S. hospitalizations and 1 of every 500 U.S. deaths." In
fact, the ERS estimates that, each year in the United States, five
foodborne illnesses -- *Camploybacter, Salmonella, E. coli* O157:H7,
*Listeria monocytogenes* and *Toxoplasma gondii* - cause \$6.9 billion
in medical costs, lost productivity and premature deaths[^3]. These
estimates do not include many other foodborne illnesses, such as,
Norwalk virus - the leading cause of foodborne disease in the United
States - botulism, shigella, foodborne staph, and parasites. Nor does it
reflect any of the hidden costs that victims and their families suffer:
the cost of traveling to receive medical care, time lost from work
caring for sick children, lost leisure time, and pain and suffering.

Further, the acute stage of foodborne disease can be only the start of
the problem. The Food and Drug Administration (FDA) estimates 2 to 3
percent of foodborne illness victims develop secondary long-term medical
problems[^4] -- that is an estimated 1.5 million lingering health
problems per year. *Salmonella* is one of the leading predictors for
reactive arthritis, a painful, chronic and potentially debilitating
condition that causes joint inflammation. *Camplyobacter* is believed to
be a leading cause of Guillian-Barre Syndrome, an autoimmune reaction
that causes paralysis and kills between five and ten percent of its
victims. *E. coli* O157:H7 and other foodborne diseases are almost the
exclusive cause of HUS, the relentless condition characterized by
cascading organ failure. HUS can cause its victims, most of them young
children, to have seizures, strokes and heart attacks and many HUS
patients require spleenectomies, chemotherapy, repeated blood
transfusions, and even intestinal reconstruction. One-third of HUS
survivors will suffer life-long medical problems such as high blood
pressure, diabetes, kidney failure and brain damage. In fact, HUS caused
by *E. coli* O157:H7 is the leading cause of acute kidney failure in
children in the United States.

Clearly, besides the ethical/moral responsibility to provide consumers
with food free from disease-causing pathogens, there is a fiscal
argument for reducing foodborne illness and its resulting consequences.
The United States has a responsibility to its citizens to provide strong
regulatory requirements, coupled with strict inspection enforcement, for
all food products, but especially for those foods -- like eggs, meat and
poultry -- that carry heavy loads of microbiological pathogens.

**Background**

1.  **The PR/HACCP Regulation**

The final PR/HACCP rule published on July 25, 1996, was the result of an
18-month process that included: seven information briefings; three
scientific and technical conferences; a two-day public hearing; six
issue-focused public meetings; a Federal-State conference; and a Food
Safety Forum chaired by (then) Secretary of Agriculture, Dan Glickman.
In addition, FSIS received approximately 7,500 written comments on the
proposal.[^5] The process was transparent and the participation of all
interested stakeholders was welcomed.

Members of S.T.O.P. committed prodigious amounts of personal time and
resources to participate in these meetings. We also submitted public
comments. We were disappointed that not all of our suggestions and
concerns were addressed and/or implemented in the final rule. [Hence any
new action must not weaken what S.T.O.P. already perceives as an
insufficient regulation to protect the public from unsafe meat and
poultry.]{.underline}

2.  ***Salmonella* Performance Standards**

The PR/HACCP system, which is rooted in sound science and statistical
quality control, relies on continuous control and monitoring of Critical
Control Points along the production process. Performance standards are
an objective measure for determining whether a plant's HACCP plan is
effective in pathogen reduction.

FSIS performance standards are based on the Microbiological Baseline
Surveys conducted in the 1990's. These surveys were designed to provide
national prevalences and levels of selected microorganisms in broiler
chickens, market hogs, turkeys, cows/bull, steers/heifers, ground beef,
ground chicken, and ground turkey. The microorganisms targeted were:
*Clostridium perfringens*, *Staphylococcus aureus*, *Listeria
monocytogenes*, *Camplyobacter jejuni*, *E. coli* O157:H7 and
*Salmonella*. Based on the results of these studies, the performance
standards were selected so that there is 80% probability that plants
operating at an acceptable level will have test results showing that
they have complied with the standard.

In the final PR/HACCP rule, pathogen-specific performance standards were
identified as an essential component and were intended to be revised as
the Microbiological Baseline Surveys were repeated to determine the
progress being made in pathogen reduction[^6]. Further, *Salmonella* was
identified as the first of many pathogen-specific performance standards
that would be used to determine whether a plant's HACCP plan is
effective. As stated in the directive, *Salmonella* was chosen as the
first target organism since it is a common cause of foodborne illness
and interventions/controls designed to reduce *Salmonella* levels are
believed to reduce other pathogen levels.

3.  **FSIS *Salmonella* Verification Testing Program**

In order to verify that establishments were achieving the *Salmonella*
performance standard, FSIS implemented the *Salmonella* Verification
Testing Program. Based on the performance standard for a product
category, FSIS personnel collect a designated number of samples that
constitutes a sample set. These samples are analyzed by FSIS
laboratories and the number of positive samples is compared to the
maximum number of positive samples allowed by the performance standard.
If the maximum number of positive samples is exceeded, a second and,
possibly, a third sample set are taken. According to the directive, FSIS
generally tests establishments once annually, unless the establishment
fails to meet the performance standard.

The *Salmonella* Verification Testing program is a strictly regulatory
program that was designed to determine if a particular establishment was
meeting the HACCP *Salmonella* performance standard at a particular
point in time. This regulatory program was not statistically designed to
measure the effectiveness of HACCP or estimate the level of *Salmonella*
in the food supply. The Verfication Testing Progam is flawed because it
is not statistically designed, samples different establishments from
year to year and samples are not randomly taken. Further compounding the
interpretability of the data is the fact that the program presents
unweighted percentages rather than weighted percentages. As a result,
[any]{.underline} inferences drawn about the effectiveness of HACCP
and/or the prevalence of *Salmonella* in the food supply are
inappropriate.

**Agency Decisions**

1.  **FSIS will add results from individual *Salmonella* verification
    sample tests to reports the Agency regularly makes to meat and
    poultry establishments.**

Allowing plants to know sooner that their process is out of control
certainly has a public health advantage. Posting this information will
provide an incentive to establishments to bring their process into
control quickly to avoid failing the sample set and the subsequent
further testing. However, the impact of this decision on the results of
the Verification Testing Program should not be overlooked.

As stated earlier, the Verification Testing Program is purely regulatory
in nature and few inferences can be drawn from the data. However, the
Agency has, from time to time and sometimes inappropriately, used data
from the Verification Testing Program to make year-to-year comparisons
and to draw inferences about the prevalence of specific pathogens. By
informing establishments of results after each individual sample in a
sample set, establishments will be made aware that they are in danger of
failing a sample set and will be likely to take corrective action. It
should, therefore, be expected that the number of failed sample sets
will decrease. As a result, the Verification Testing Program will have
an inherent bias, and it will become even more important that the data
collected is not used to draw inferences about the prevalence of a
pathogen or trends over time.

In the past, FSIS has not informed an establishment until the sample set
is complete that they failed to meet the performance standard. This
policy allowed an establishment whose processes are out-of-control to
continue producing and distributing product to unsuspecting consumers.
In the interest of public health, an establishment should be informed as
soon as the maximum number of allowed positives for a sample set is
exceeded so that corrective action can be taken and a new sample set can
begin.

S.T.O.P. is pleased with this proposed change in policy as it represents
a shift in focus to that of public health. However, the impact of this
change on the interpretability and generalizability of data collected
from the Verification Testing Program is significant. As a result of
this change, the Verification Testing Program will, in essence, become
simply a tool for establishments to know when their process is not
meeting the *Salmonella* performance standard.

S.T.O.P. believes that this change will better protect public health as
long as the Verification Testing Program data is not used to make and/or
imply larger statements about the nationwide prevalence of *Salmonella.*

2.  **FSIS will post quarterly, nationwide data for *Salmonella*,
    presented by product class.**

Posting quarterly, nationwide data for Salmonella, by product class, is
not problematic as long as FSIS does not use the data to draw inferences
about trends over time (see discussion for Decision #1) or change its
sampling scheme based on interim results. The purpose of the
Verification Testing Program is to determine whether a particular
establishment is meeting the performance standard at a particular point
in time. It is very important that FSIS take extreme care in
interpreting and generalizing data collected from this program.

3.  **FSIS will classify *Salmonella* verification sample sets into one
    of three categories: consistent, variable, and highly variable
    process control.**

According to the proposed directive, Salmonella verification sample sets
will be categorized into one of three categories, defined as:

Category 1: Consistent Process Control for Salmonella Reduction. 50% or
less of the performance standard or baseline guidance.

Category 2: Variable Process Control for Salmonella Reduction. From 51%
of the performance standard or regulatory guideline to the performance
standard or baseline guideline.

Category 3: Highly Variable Process Control for Salmonella Reduction.
Greater than the performance standard or baseline guidance.

As stated in the proposed directive, the percentage of positive samples
in broiler chickens has been increasing since 2002. Due to proposed
change #1, classifying sample sets based on the degree to which the
performance standard is achieved may provide a more useful measure than
examining the percentage of sample sets that met/failed the performance
standard.

Also, given the number of products selected for testing -- along with
the large number of plants involved nationwide - the Agency may want to
consider expanding the number of categories so that it can more easily
oversee and report its findings.

4.  **FSIS will classify establishments into one of three categories
    that will dictate the frequency of *Salmonella* verification
    testing.**

According to the proposed directive, establishments will be classified
into one of three categories based on their past two consecutive
*Salmonella* verification sample set test results. Category 1
establishments are classified as having sustained good control by
achieving 50% or less of the performance standard on their past two
consecutive sample sets. In an effort to maximize limited resources,
these establishments would be tested at most once a year and at least
once every two years unless they are reclassified in the meantime as a
Category 2 or 3 establishment. Category 2 and 3 establishments will be
tested at least annually and more frequently, if needed.

There are several problems with the proposed classification of
establishments and the corresponding schedule for testing:

-   Since, in general, establishments are currently being tested
    annually, two consecutive sample sets that meet 50% or less of the
    performance standard is not sufficient to conclude that the plant
    has sustained good control.

-   Since Category 1 establishments may only be tested once every two
    years, there is no incentive for maintaining good and consistent
    control.

-   It is unclear under what circumstances an establishment would be
    reclassified. After an outbreak? After one case of serious disease
    or death? After a specified number of hospitalizations? After a
    specified number of NR's during regular inspection?

-   Other factors, such as production level, plant size and facility
    activity, are not considered when classifying establishments. Using
    only two consecutive *Salmonella* verification sample sets to
    classify establishments is a rather simplistic approach and ignores
    several other very important risk factors.

It is essential that FSIS take a proactive, not reactive, role in
preventing pathogenic contamination of meat and poultry products. It is
important to provide establishments with an incentive to achieve
sustained control of their processes, but it is equally important to
provide an incentive to maintain that control. While decreasing testing
to once every two years provides an incentive to establishments to
initially achieve sustained control, the Agency is not providing
incentive for establishments to maintain that control in the one to two
years of no testing. This is analogous to knowing that, once you see a
traffic officer, you will not see another one for 100 miles. This type
of enforcement effort by police does not create an incentive to obey the
speed limit after you have seen a police officer. Smart law enforcement
offices know this and have adjusted by sometimes placing a second or
even third police officer a little further down the road. Similarly,
there is no incentive to maintain good control over the entire two year
period. Minimally, there should be random testing, even if in smaller
numbers. In conjunction with the random testing, establishments should
be encouraged to demonstrate continued control by contracting with the
Agency to voluntarily report all internal test results to FSIS on a
regular, scheduled basis.

Establishments that have higher risk of experiencing pathogenic
contamination ought to be tested more frequently than those with less
risk of pathogenic contamination. Careful consideration must be given in
determining the number of categories needed to create effective control,
as well as clearly defining how the Agency will classify establishments.
Incentives must be provided for both achieving and maintaining good
control. Clearly, this proposed change is a step towards risk-based
inspection, and as such, this policy change could be viewed as a model
for future efforts. As a result, any decisions regarding the
implementation of this policy change should be made in conjunction with
the ongoing risk-based inspection discussions.

5.  **FSIS will provide a new compliance guideline particularly related
    to the broiler chicken industry containing information that FSIS has
    found to be relevant to the control of *Salmonella*.**

Given the limited amount of information provided on the contents of the
new compliance guideline, S.T.O.P. cannot comment on its appropriateness
at this time.

6.  **FSIS will obtain more timely *Salmonella* serotype information for
    each positive test result from its verification program, pursue
    sub-typing of the *Salmonella* found, and publish annual aggregate
    results for serotypes.**

On February 24, 2006, the CDC reported on a 2004 multi-state outbreak of
*Salmonella* Typhimurium that was associated with eating ground beef,
caused 31 illnesses and resulted in 9 hospitalizations. The illnesses
occurred in nine states and the District of Columbia between August 11,
2004 and October 2, 2004. The outbreak was identified after a review of
PFGE patterns submitted to the National Molecular Subtyping Network for
Foodborne Disease Surveillance (PulseNet) database. Upon investigation
by the state health departments, CDC and FSIS, it appeared that the
outbreak was associated with ground beef purchased at a national retail
chain that originated from three processing plants and, ultimately,
their common supplier. Since *Salmonella* is not considered an
adulterant in food and the plants involved seemed to be in accordance
with current FSIS production guidelines, no recall or public warning was
issued, even though there were documented cases of illness associated
with a specific food product. Millions of American consumers were put at
risk for serious foodborne illness due to consuming this tainted
product, yet the overseeing agencies did little to protect the American
public.

Despite the fact that no recall or public warning was issued, this case
demonstrates the importance of obtaining timely *Salmonella* serotype
information. State health departments, CDC, FDA and FSIS need to work
together, using sub-typing, such as pulsed-field gel electrophoresis
(PFGE), to identify potential outbreaks and focus their combined
resources in a thorough epidemiologic and product tracing investigation.
As a result of this type of collaboration, FSIS will be better able to
identify the mechanisms and possible sources of *Salmonella*
contamination; in addition, FSIS will be better able to determine if its
regulatory requirements are adequate and appropriate, and identify
potential new interventions for reducing *Salmonella* in meat and
poultry.

7.  **FSIS will conduct baseline studies for *Salmonella* and other
    pathogens and indicator organisms among specific product classes.**

S.T.O.P. is pleased that FSIS has undertaken and will continue to
undertake new Microbiological Baseline Surveys for *Salmonella* and
other pathogens and indicator organisms.

The Microbiological Baseline Studies, which were conducted in the 1990's
to estimate national prevalences for selected foodborne pathogens and
used to establish performance standards for HACCP in 1996, were flawed
in their design and scope, especially in regard to ground meat products.
Some of the problems include grossly inadequate sample sizes and lack of
testing during summer months when levels of pathogens are known to be
higher.

In any study, a statistically-designed sampling scheme is critical to
ensuring the validity, interpretability and generalizability of the
study results. The first step is clearly identifying the study
objective(s) and population of interest. The sampling and data
collection methods should then be clearly defined, taking into account
potential factors, such as seasonal variation, and consistent throughout
the study. In addition, it is crucial that the resulting samples are
randomly selected and representative of the population of interest.
Further, the sample size matrix selected for each study should be
statistically justified using power calculations.

In 2003, the National Academies of Science report, [Scientific Criteria
to Ensure Safe Food]{.underline}, recommended that new Microbiological
Baseline Surveys be conducted on a regular basis. The report also
recommended that the new surveys be designed to 1) allow comparisons of
the new baseline and previous baseline results and 2) correct the
sampling deficiencies of the original baseline studies. In order to
further reduce foodborne suffering, illness and death, it is crucial
that FSIS follow these recommendations, repeat the baseline surveys in a
timely manner and use this new data to establish tighter performance
standards that will result in increased process control.

**Further Agency Considerations**

1.  **FSIS will post *Salmonella* verification sample set results on the
    Agency website, identified by establishment name and number.**

USDA's Economic Research Service's report on *Product Liability and
Microbial Foodborne Illness* identifies three economic incentives most
likely to result in the production of safe food: market forces, food
safety laws and regulations, and product liability. Posting *Salmonella*
verification sample set results on the Agency website along with the
establishment name and number is one mechanism to provide one of these
economic incentives: market forces. As cited in the proposed directive,
providing information about the process control performance of
establishments related to Salmonella will enable further processors to
make informed purchasing decisions. This, in turn, provides an
incentive, through market forces, for the meat and poultry slaughter
industry to invest in food safety innovation and seek to attain
consistent control for *Salmonella*.

2.  **FSIS will consider inspection modification based on industry-wide
    performance and demonstration of process control.**

The goal of HACCP is to achieve, sustain and improve quality control of
meat and poultry products in terms of pathogenic contamination. Critical
to the success of HACCP is statistical quality control. In other words,
the collection, analysis, and interpretation of data is critical to
assessing the adequacy and effectiveness of process controls.

Central to statistical quality control is the reduction of variation in
the process to achieve consistent control. Every process has some degree
of variation, some of which is random. Eliminating all non-random
variation will help achieve statistical quality control. This requires
the following: 1) identifying a method of process measurement, 2)
establishing acceptable levels of variation that are indicative of
process control and 3) monitoring the process over time to identify
unexpected process variation. When control limits -- or performance
standards -- are exceeded, the process is considered to be not in
control and process adjustments must be made. As processes achieve
sustained control over time, process improvements can be made that will
further reduce variation and, in terms of HACCP, reduce pathogenic
contamination. As this happens, the control limits -- or performance
standards -- are tightened.

According to the PR/HACCP final rule, FSIS would repeat the
Microbiological Baseline Surveys periodically and, over time, adjust the
performance standards downward. According to the proposed directive,
FSIS will consider allowing inspection modification based on
industry-wide performance and demonstration of process control. FSIS
further gave the example of allowing broiler and hog industries to study
the effect of increasing linespeeds if there were an industry-wide
demonstration of good, consistent control of *Salmonella*. Clearly, this
type of incentive will encourage industry to work together to achieve
good, consistent process control and invest in food safety innovation.
However, inspection modification cannot happen in the absence of
improving statistical quality control. Once an industry achieves
consistent process control, the performance standards must be
re-adjusted to reflect the new norm. If industry can demonstrate that
process changes, such as increasing linespeeds, will not impact their
ability to maintain process control and meet the adjusted performance
standards, then it may be appropriate to consider such changes.

In recent years, several interventions -- including reduction of
linespeeds -- have resulted in better process control and the reduction
of pathogenic contamination of foods. Modifications of these
interventions should only be considered in conjunction with adjustment
of performance standards and evidence of improved process control and
pathogen reduction. In order to meet the public health objective of
reducing foodborne illness, the Agency and industry must strive for
improvement, not just maintaining status quo.

**Conclusion**

To date, *Salmonella* remains behind schedule for meeting the Healthy
People 2010 targets for pathogen reduction. While there has been some
level of decrease, *Salmonella* has stubbornly held its ground as a
\"problem pathogen,\" and the really bad news is that many *Salmonella*
strains have developed multi-drug resistant capabilities.

Some of these strains, like *Salmonella Newport* *MDR-AmpC*, spiked
alarmingly from 1999-2003. Fortunately, according to the 2004 and 2005
FoodNet data, *Salmonella Super 9* has leveled and slightly decreased
over the past two years, and while that is good, this gain has been
offset by the five-fold increase in *Salmonella enteriditis* in broilers
for the 2005 FoodNet data. Not only is *Salmonella enteriditis*---which
has been heavily associated with eggs, not broilers---increasing, it is
also showing resistance to clinically important drugs for treating human
disease.

In addition, when you look at the overall trends in *Salmonella's*
multi-drug resistant development, there is a significant increase in the
number of strains that are becoming drug resistant---currently the CDC
is reporting that 14+ strains of *Salmonella* are showing drug
resistance to one or more clinically important drugs. For example, some
*Salmonella* strains have gone from 0% resistant to 7% resistant to
quinalones, which is the class of drugs most commonly used in treating
adults with *Salmonella* infections. (Quinolones are not used to treat
children because the drug may damage cartilage formation.) Clearly, the
challenges that *Salmonella* is presenting to food safety goals is
formidable. Further research, as well as increased oversight---including
testing at all poultry and meat production establishments---are
essential if this dangerous pathogen is going to be contained to the
limits set out in Healthy People 2010.

Over the years, S.T.O.P. has steadily maintained that using the best
science available to reduce pathogens in food is a paramount public
health objective. Thousands of Americans suffer and die each year due to
serious foodborne disease. [FSIS must, as mandated, seek to protect
public health by providing strong regulatory requirements, coupled with
strict inspection enforcement.]{.underline}

Respectfully submitted,

Barbara Kowalcyk

President, Safe Tables Our Priority

[^1]: Economic Research Service, USDA. *Foodborne Illness Cost
    Calculator*, [www.ers.usda.gov]{.underline}

[^2]: Buzby, Frezen, and Rasco. Food and Rural Economics Division,
    Economic Research Service, USDA. Agricultural Economic Report No.
    799: *Product Liability and Microbial Foodborne Illness.*

[^3]: Buzby. Food and Rural Economics Division, Economic Research
    Service, USDA. *Children and Microbial Foodborne Illness.* Food
    Review, Vol 24, Issue 2.

[^4]: Frezen. Economic Research Service, USDA. *The Economics of Food,
    Farming, National Resources and Rural America,*
    [www.ers.usda.gov]{.underline}

[^5]: "Improving the Safety of Meat and Poultry: Background on a
    Science-based Strategy for Protecting Public Health", page 3. (July
    25, 1996)

[^6]: [The Pathogen Reduction/HACCP Final Rule]{.underline}, Federal
    Register, Vol. 61, No. 144 (Jul 25, 1996)