**Center for Foodborne Illness Research & Prevention (CFI)**

**P.O. Box 206 Grove City, Pennsylvania 16127**

**Phone: 724-458-0767**

December 17, 2008

United States Department of Agriculture

Food Safety and Inspection Service

1400 Independence Avenue, SW

Room 1175, South Building

Washington, D.C. 20250

Docket No. FSIS-2008-0035

**Re: USDA Public Meeting on October 14-15, 2008 in Washington, D.C.:
*Control of E. coli O157:H7: Addressing Sampling and Testing
Methodologies, Compliance Guidelines, and N60 Labeling***

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

The Center for Foodborne Illness Research & Prevention (CFI) appreciates
the opportunity to comment on the United States Department of
Agriculture's Food Safety & Inspection Service (USDA/FSIS) public
meeting held October 14-15, 2008 in Washington, D.C., to solicit input
on the control of *E. coli* O157:H7 through sampling and testing
methodologies, compliance guidelines and N60 labeling.

CFI is a national, nonprofit health organization dedicated to preventing
foodborne illness through research, education, advocacy and service.
Founded in 2006, CFI hopes to lead America in creating innovative,
science-based solutions for the food challenges of the 21st Century.
CFI's programs and activities are designed to develop better food
protections for all Americans. CFI believes that federal, state and
local government, as well as farmers; food
processors/distributors/retailers; medical providers; educators; policy
makers and consumers share the responsibility of building an environment
that promotes food safety throughout the farm to fork continuum. No one
sector can achieve this goal alone, so CFI is committed to collaboration
in its efforts to improve food safety.

These are CFI's initial comments on the topics presented at the two day
meeting and should not be considered complete.

***[Background]{.underline}***

Foodborne illness is a serious public health issue that causes an
estimated 76 million illnesses, 325,000 hospitalizations and 5,000
deaths each year in the United States. USDA's Food Safety and Inspection
Service (FSIS) is charged with the oversight of the safety of meat and
poultry products in order to protect public health.

*E. coli* O157:H7 has a significant impact on public health, especially
for children, the elderly, and individuals with compromised immune
systems. According to CDC, each year there are an estimated 73,000 *E.
coli* O157:H7 infections,[^1] resulting in 2,000 hospitalizations and 60
deaths,[^2] most of which are caused by hemolytic uremic syndrome
(HUS).[^3]

Given the potential severity of illness and threat to public health,
USDA declared *E. coli* O157:H7 an adulterant in ground beef in 1994,
mandating that this pathogen is not allowed at any detectable limit.
Over the past 14 years, other products, such as trim and tenderized
roaster steak intended for ground beef production, were also required to
adhere to this standard of zero tolerance. Products found to be
contaminated with *E. coli* O157:H7 are required to be diverted and/or
removed from retail markets.

In 1996, Pathogen Reduction / Hazard Analysis at Critical Control Points
(PR/HACCP) was adopted by USDA/FSIS to provide consumers with higher
assurance that meat, poultry and egg products were being monitored using
robust, scientific methods. To meet that end, USDA/FSIS developed and
implemented microbiological testing programs to identify contaminated
products, monitor process control, characterize the microbiological
quality of meat and poultry products, and evaluate the effectiveness of
prevention strategies and inspection programs. Under the PR/HACCP
system, FSIS established the following microbiological testing programs:

1.  *Salmonella* Verification Testing to assure that raw meat/poultry
    end-products meet a national performance standard before being
    allowed into commerce;

2.  *E. coli* O157:H7 Verification Testing of selected raw beef products
    to assure that product contaminated with this adulterant is not
    allowed into commerce;

3.  *Listeria monocyctogenes* Verification Testing of ready-to-eat (RTE)
    products to assure that product contaminated with this adulterant is
    not allowed into commerce;

4.  Microbial testing using generic *E. coli* to assure that standard
    sanitation operational procedures (SSOPs) are maintained.

Data collected from these FSIS Microbiological Testing Programs have
been used as the basis for public policy and as a means for assessing
the public health impact of foodborne illness.

Initially, PR/HACCP resulted in a reduction of pathogenic contamination.
Implementing SSOPs was fundamentally accepted by all food stakeholders
and efforts were put forth to improve them. On the other hand, the
Salmonella performance standard and end product testing were challenged
in the federal courts on the grounds that USDA did not have the
authority to enforce its Salmonella performance standard for
meat/poultry products since Salmonella was not considered an adulterant
in meat and poultry products. After these two court cases (*Supreme
Beef*, 2001 and *Nebraska Beef*, 2003), the reduction of pathogenic
contamination stalled. However, in 2001, immediately after the ConAgra
recall, there were some encouraging signs for better control, but in
subsequent years, those gains were not sustained.

In 2007, FSIS observed an increase for meat/poultry recalls contaminated
with *E. coli* O157:H7, and there were nine beef-related foodborne
illness outbreaks. Now, in the third quarter of 2008, FSIS maintains
that this trend is continuing, and that the Agency is particularly
concerned about the number of outbreaks of foodborne illness that are
being linked to contaminated meat/poultry products. According to the
testimony given by Dr. Dan Engeljohn on October 15, 2008, the lack of
control over the pathogen *E. coli* O157:H7 continues to be a major
concern for FSIS:

> *The purpose of the guideline \[referring to the draft Compliance
> Guideline for Trim Sampling of Escherichia coli O157:H7\] was to first
> of all address the adverse events which are related to E. coli O157:H7
> in both calendar years 2007 and through today in calendar year 2008.
> We had identified that the controls for O157:H7 are not adequate to
> protect public health and that we need to put in place additional
> control measures to reduce risk.*
>
> *Part of those adverse related activities are associated with
> outbreaks for which there's human health associated with raw beef
> products in both years. Prior to calendar year 2007, there were no
> reported human-related illnesses associated with the beef products for
> which we had a recall. But last year there were a record number in
> terms of those directly associated, and then we've had some as well
> this year.*
>
> *In addition, we do track the percent positive rate in the
> verification testing results that we get from year to year. The
> testing results have been on the increase. Last year, at the end of
> the fiscal year, we were at .20, which was the level that we had been
> maintaining in ground beef for the prior couple of years, and by the
> end of the calendar year though, we were up at .37, nearly .4 by end
> of the calendar year.*
>
> *So far this year though, in comparison, for ground beef where we had
> .20 at this time last year, this year we have .40 in terms of our
> percent positive rate. And we heard some information yesterday that it
> may be our testing methodology that may be contributing to this. The
> Agency does not believe that to be the case, but it obviously is an
> issue for which we need to further assess whether or not the
> methodology does have an impact in terms of the percent positive
> rate.*
>
> *For beef trim, we started this program in March of 2007. Our positive
> rate at this time last year was .42 in beef manufacturing trim versus
> today it\'s .71 in terms of the calendar year through October 7th. So
> we believe that there\'s an increase in terms of the indicators that
> we have for positive product getting through the slaughter operation,
> through the trim on fabrication operation and into the grinding
> operations.* [^4]

Obviously, USDA/FSIS believes that controlling *E. coli* O157:H7
continues to be a challenge. Based on this assessment, FSIS feels that
it needs to find a better approach, one which will provide greater
assurances that this deadly pathogen is under control. Therefore, during
2008, the Agency drafted a *Compliance Guideline for Sampling Beef
Trimmings for Escherichia coli O157:H7,* which focusing on statistical
process control (SPC) as a way to reduce the incidence of *E. coli*
O157:H7 in FSIS' federally inspected beef producing establishments.

***[General Comments]{.underline}***

On October 14-15, 2008, USDA's Food Safety & Inspection Service held a
public meeting in Washington, D.C., to solicit input from food safety
stakeholders regarding:

1.  the development of uniform and consistent microbiological sampling
    and testing methodologies for *E. coli* O157:H7 in beef
    manufacturing trimmings;

2.  laboratory protocols for *E. coli* O157:H7 testing;

3.  FSIS' Draft *Compliance Guideline for Sampling Beef Trimmings for E.
    coli O157:H7*;

4.  the use of labels bearing *E. coli* O157:H7 testing claims on
    pre-retail beef manufacturing trimmings;

5.  guidelines for employee training on proper sampling procedures for
    *E. coli* O157:H7.

CFI applauds the Agency for recognizing the important role that sampling
and testing methodologies play in building a robust food inspection
system, especially since *E. coli* O157:H7 continues to be a public
health threat of national importance. CFI is particularly pleased with
the overall direction of the Draft *Compliance Guideline for Sampling
Beef Trimmings for Escherichia coli O157:H7*. CFI, however, recognizes
that improvements could be made to this document and encourages FSIS to
adopt a policy that will make all of its proposals available to the
public in a transparent and timely fashion.

***[The Role of Microbiological Testing in Beef Manufacturing
Trimmings]{.underline}***

The effectiveness of any meat and poultry regulatory program is
dependent on its ability to protect public health. Regulatory agencies
must set public health standards and ensure that process controls
designed to achieve those standards are effectively implemented.
Microbiological testing programs provide a useful tool for regulatory
agencies to use in developing science-based public policies that protect
public health. These same standards also serve as a mechanism for
assessing process control and determining if public health standards are
being met. However, microbiological testing cannot replace effective
prevention strategies and process control, which are the keys to
controlling microbiological contamination.

Statistical Process Control (SPC), which is at the heart of PR/HACCP, is
the application of statistical tools to the improvement of quality and
productivity. It is based on the premise that there are two types of
variation: 1) those inherent in the process and 2) uncontrolled
variation. By using statistical techniques, the variation in any process
can be measured and analyzed, which will, in turn, help control the
process and identify when the process is out of control. Over time, the
process will be improved, thereby increasing quality and productivity.
This continuous assessment is commonly referred to as the
"Plan-Do-Check-Act" cycle, as presented by Timothy Beila during the
FSIS' October meeting. It is important to note, however, that SPC cannot
correct a poorly designed process.

FSIS, in the draft *Compliance Guideline*, states that microbiological
testing can be used to assess process control by verifying "that the
slaughter and dressing procedures that are designed to prevent
contamination are effective." However, historically, microbiological
verification testing programs have [not]{.underline} been designed to
assess process control. Rather, they were designed to determine if a
particular establishment was meeting PR/HACCP performance standards at a
particular point in time. The difference between these two approaches is
important.

In recent years, FSIS has allowed establishments to "test and hold"
products before releasing them to FSIS for Agency testing and
distribution into commerce. The establishments using "test and hold" are
under no obligation to inform FSIS of their test results or take
corrective action. As a result, establishments could repeatedly test
positive for *E. coli* O157:H7, indicating an ongoing process control
problem, and simply divert product rather than address the root cause.
As stated by FSIS in the draft *Compliance Guideline*, this type of
microbiological testing simply "becomes a 'test and divert' program,
which will not prevent, eliminate or reduce *E. coli* O157:H7 in raw
beef products."

In the spirit of PR/HACCP, FSIS has proposed a new approach to sampling
trim and other products being used for ground beef production. . This
approach is based on SPC and provides a mechanism for assessing the
adequacy of the process controls for *E. coli* O157:H7. By testing
products on an ongoing basis and recording the results over time,
establishments will be able to monitor the process and differentiate
between sporadic positives and those positives that indicate a lack of
process control.

Currently, all positive test results are viewed as individual,
non-related events -- in other words, sporadic. While establishments are
required to take corrective actions when a positive occurs, they are not
required to re-assess the effectiveness of their process. According to
Title 9 CFR 417.3, all meat/poultry products contaminated with *E. coli*
O157:H7 are not allowed to enter commerce, so all contaminated product
is either diverted to cooking for further processing or recalled.
Further, the current language requires that when an establishment finds
a positive for *E. coli* O157:H7, it must take steps to identify how the
deviation occurred; eliminate the cause and take proactive measures to
assure that the problem does not reoccur.

Under FSIS's new approach, statistical evidence of an increase in the
incidence of positive test results would suggest "a systemic cause or
breakdown of process controls," indicating a process that is
"out-of-control." In this situation, a positive result would implicate
not only the current production lot but other production lots as well.
FSIS would, therefore, expect "a more thorough investigation of the
contributing cause, as compared to the follow-up investigation that
occurs with the sporadic positive test result."

Microbiological testing does have important limitations that the Agency,
food industry and food safety stakeholders need to understand. It is
well accepted that bacterial pathogens are not evenly distributed within
food, increasing the risk that microbiological testing results will not
accurately characterize the microbiological safety of the product. As a
result, verification testing cannot be used to determine the presence or
absence of pathogens (i.e. acceptance sampling). As recognized by FSIS,
"negative results do not imply that tested product is not contaminated."
Therefore, FSIS states that "each positive result should be investigated
to determine its cause" and " it is critical that a full investigation
be made of the process surrounding a positive result." FSIS further
states that "regardless of whether the positive result is a sporadic
result or due to loss of process control, the establishment needs to
ensure that no product that is injurious to health or adulterated enters
commerce." Based on these statements, it is clear that FSIS intends for
this new approach to verification testing to supplement, rather than
replace, traditional microbiological testing programs and should not be
viewed as an alternative to zero tolerance.

[CFI endorses this approach to microbiological testing.]{.underline}

***[Developing Effective Microbiological Testing
Programs]{.underline}***

While it is not possible to test safety into meat and poultry products,
microbial testing does serve as a very important tool for food safety
management. According to the International Commission on Microbiological
Specifications for Food (ICMSF), "the purpose of sampling a food is to
collect a representative sample to obtain information on its
microbiological status." Sampling plans, when designed properly using
sound statistical concepts, provide a systematic means for assessing the
microbiological status of food with a high degree of confidence.
Therefore, in order to be effective in meeting public health goals,
microbiological testing programs must be based on robust sampling plans
that are designed to meet the testing program objectives and are
implemented correctly.

The development and implementation of any microbiological testing
program must address:

1.  The objectives of microbiological testing, which are driven by
    public health goals, should be clearly identified.

2.  A robust sampling plan that is designed to meet the microbiological
    testing objectives with a high degree of confidence must be
    developed.

3.  The adequacy of the sampling plan must be evaluated and
    certified/approved by an independent third party.

4.  In order to ensure the generalizability and interpretability of
    microbiological testing results, the sampling plan must be
    implemented correctly. As a result, FSIS needs to establish
    mechanisms for verifying that industry and government sampling plans
    are implemented correctly. Further, when presenting microbiological
    testing results, FSIS and industry must specify the power of the
    results in order to verify that the testing program's objectives
    were met. This will allow the public to evaluate the reliability of
    the results.

5.  Based on the results of microbiological testing, actions will be
    taken. FSIS needs to clearly define the actions that will be taken
    as well the circumstances that will trigger the actions.

Developing and implementing robust and effective microbiological testing
programs will require FSIS and industry to invest significant additional
resources compared to what is currently being expended. Given the number
of recalls in recent years and the trends seen in FoodNet data, this
investment is warranted and will provide significant public health
value.

***[Designing Sampling Plans for Verifying Control of E. coli
O157:H7]{.underline}***

The key to an effective microbiological testing program is the sampling
plan. Since it is not possible to conduct 100% testing, one must use a
sample to draw inferences about the entire population. As indicated in
the draft *Compliance Guideline*, the sampling plan should be designed
to provide a high probability of finding *E. coli* O157:H7, if it is
present, and identifying a process that is out of control.

There are several factors that will affect the design of the sampling
plan. In the draft *Compliance Guidance*, FSIS outlines the key elements
that should be addressed in a sampling plan used to verify process
controls, including what constitutes a sample, the number of samples to
be collected, how samples will be collected, the number of samples it
will collect, the frequency of sample collection, the procedures used to
analyze samples and the criteria for signaling an out-of-control
process. CFI further recommends that the sampling plan be designed
to: 1) ensure that the samples collected are representative of the
entire population, 2) minimize bias, 3) address potential statistical
problems, such as confounding, collinearity and interactions, and 4)
ensure that the sample size is sufficient to provide the desired level
of confidence. Further, it is important that the sampling plan address
the fact that foodborne pathogens are heterogeneously distributed
throughout food products. In addition, there is significant variability
in prevalence rates over time (seasonal variation). Both of these
factors can decrease the likelihood of correctly identifying
contaminated products. Other factors that may affect the design of a
sampling plan, and these factors also need to be considered.

As indicated by FSIS, the first and most critical step in developing a
sampling plan is defining the population of interest which, in
microbiological testing, is the production lot. The size of the
production lot will have ramifications on the rest of the sampling plan
as well as the interpretation of positive results. In order to maintain
the same level of confidence in detecting *E. coli* O157:H7 (if it
exists), a large production lot size will require more samples than a
small production lot size. CFI concurs with FSIS that the production lot
should be defined before sampling begins and should not be redefined
during testing or after the results are known. Further, CFI concurs with
FSIS that production lots should be defined so that they are independent
of each other. The draft *Compliance Guideline* suggests ways for
ensuring independence, such as limiting production lots to a single
supplier, and strongly discourages the use of sub-lots. Clearly defining
the production lot and maintaining independence will minimize bias,
improve data integrity and provide markers that can delineate sporadic
events or an "out of control" process. [Therefore, CFI recommends that
FSIS provide clear and strong guidelines on defining production lots and
what constitutes independence.]{.underline}

Once the population of interest has been defined, the next steps in
developing the sampling plan is to define the sampling unit, determine
how the sample will be collected and determine the number of samples to
be collected. Representative samples, which should reflect the
composition of the population of interest, are critical to the
interpretability and generalizability of any results. However, as
acknowledged by FSIS, there is seasonal variation in the prevalence of
pathogens, and it is well established that pathogens are not evenly
distributed in meat and poultry products. As a result, there is a risk
that microbiological test results may not accurately reflect the
microbiological status of the product. CFI concurs with FSIS that, to
account for seasonal variation and the heterogeneous distribution of
pathogens, the testing frequency should be further increased during high
prevalence months and product should be sampled at different sites
within the production lot or at different times. CFI further recommends
that a stratified and random sampling collection procedure be employed
to collect samples at uniform intervals throughout the entire time that
product moves past a sampling point. In fact, since the objective is to
verify process control, product should be sampled on an ongoing basis,
as acknowledged by FSIS. [Therefore, CFI strongly recommends continuous
monitoring of meat and poultry products, using microbiological testing,
to verify process control.]{.underline}

Continuous sampling has frequently been rejected due to cost constraints
and usually only one sample is selected per production lot. It should be
noted that reducing the frequency of sampling and/or the size of the
sample unit has important consequences, particularly on the level of
confidence and power associated with the sampling plan. Such trade-offs
should be weighed carefully, in particular with regard to their effect
on public health.

The confidence level and power associated with a sampling plan provide a
mechanism for evaluating the effectiveness of the sampling plan's
ability to address the microbiological testing program objectives. The
confidence level and power are one minus the probability of a Type I and
Type II error, respectively. The Type I error is the probability of a
false positive and is usually set at 0.05. The Type II error is the
probability of a false negative and is usually set at 0.10 or 0.20.
Obviously, diverting product that is truly not contaminated (Type I
error) is a problem but has much less impact on public health than
distributing contaminated product into commerce (Type II error).
Therefore, in the context of public health, power is more important than
the confidence level in evaluating the effectiveness of microbiological
sampling plans. While the importance of the level of confidence and
power is touched upon in the draft *Compliance Guideline*, [CFI
recommends that FSIS be transparent about the power of the sampling
plans used by the Agency and industry and require that it be disclosed,
along with the justification for choosing a particular sampling
plan.]{.underline}

Due to the complexity of designing a sampling plan, it is highly
recommended that a statistician or someone with equivalent training is
involved in the development of the sampling plan. However, some plants
may not have such resources and CFI has previously recommended that FSIS
provide plants with the necessary technical assistance, including
statistical consulting services, to develop a robust sampling plan. FSIS
acknowledges this in the draft *Compliance Guidance*, noting that
establishments can seek guidance from state Extension Specialists on how
to design a sampling plan using the compliance guideline. However, CFI
is concerned that, due to funding cuts, Extension Specialists may not
have the appropriate expertise or resources to adequately help plants
develop robust sampling plans. [Therefore, CFI recommends that FSIS seek
adequate funding in order to provide technical assistance and
statistical support to any establishment under their jurisdiction that
requests it.]{.underline}

***N60 Sampling***

In the draft *Compliance Guideline*, FSIS has recommended that
establishments collect one 375 gram sample per production lot using N60
sampling methods. N60 sampling refers to the number of portions that are
used in constructing a composite sample and has been accepted by the
Joint Food and Agriculture Organization/World Health Organization
(FAO/WHO), as well as the Food Hygiene Committee of the Codex
Alimentarius Commission. The power of this sampling plan is dependent on
the number of portions used to construct the composite sample and the
prevalence of *E. coli* O157:H7 in beef manufacturing trim.

In 1974, ICMSF developed a sampling plan to detect severe or direct
health hazards. Basically, the ICMSF plan employs "two limits -- '*m*,'
a number below which there is no concern, and '*M*,' a number above
which serious questions arise about the quality and/or safety of the
food."[^5] Further, in this plan, ICMSF classifies "foods into fifteen
hazard categories, called cases, on the basis of the combined effects of
two factors: 1) the type of organism; and 2) the future conditions to
which the food will usually be exposed. For each case, a sampling plan
can be devised to match the degree of concern. The stringency of the
plan increases as the hazard increases, with a plan of n = 5, c = 3 for
Case 1, and n = 60, c = 0 for Case 15."[^6] While ICMSF's sampling plan
*cannot* ensure 100% product safety (no plan can do that), it does take
into account "both the non-homogeneity within a lot and the large
differences in numbers of microorganisms normally associated with
various foods."[^7]

As stated earlier, continuous sampling is ideal. However, N60 sampling
is an improvement over current sampling methods, which usually consist
of the infrequent collection of one single 375 gram sample (N1
sampling). Increasing the number of portions used to construct a
composite sample will increase the probability of detecting pathogens,
if they are present. While the power provided by N60 sampling is higher
than that of N1 sampling, it is still well below the 80% to 90% power
that is typically expected in order to protect public health.
[Therefore, CFI recommends that N-60 be the minimum standard for all
federal and federal-state inspected establishments, whether they are
large, small or very small, until such time that a better sampling plan
is developed.]{.underline}

As stated previously, the true prevalence of *E. coli* O157:H7 in beef
trim will also affect the power of the sampling plan. According to the
draft *Compliance Guidance*, FSIS conducted a Microbiological Baseline
Survey in beef trim and found 0.68% of samples were positive for E. coli
O157:H7. However, the samples in this study were collected from lots
already pre-tested by establishments and found to be negative. Industry
has anecdotally reported the prevalence rate to be between 1% and 2%. As
a result, FSIS is assuming that the prevalence rate is 1.5%. Based on
this prevalence rate, two positives out of 24 would be needed to
identify a process that is out of control. If plants collect samples
bimonthly or monthly, as recommended by FSIS, it would take one and two
years, respectively, to identify a process control problem. In order to
protect public health, it is critical that out-of-control processes are
identified and corrected in a timely manner. [Therefore, CFI recommends
that FSIS:]{.underline}

1.  [estimate the prevalence of E. coli O157:H7 in beef trim using an
    appropriately designed study;]{.underline}

2.  [recommend more frequent testing, and]{.underline}

3.  [be transparent about the power and confidence level associated with
    any sampling program.]{.underline}

***[Labeling of Beef Manufacturing Trimmings Regarding E. coli O157:H7
Claims]{.underline}***

CFI believes that labels bearing *E. coli* O157:H7 testing claims could
be useful for receiving establishments, in particular small and very
small plants, in making purchasing decisions. CFI agrees with FSIS'
assessment that Certificates of Analysis (COAs) do not always accompany
product as it moves through distributors. CFI also agrees that this type
of labeling would need to be carefully reviewed by FSIS before it was
applied. CFI is hopeful that this type of labeling would provide all
receiving establishments with timely and accurate information about the
product that they have brought into their facilities for further
processing.

***[Other Concerns]{.underline}***

Microbiological testing alone is not sufficient to ensure process
control and protect public health. As stated above and throughout USDA's
*Draft Compliance Guideline*, other factors, such as scientifically
documented interventions and timely reporting practices need to be
implemented to assure that public health goals are being met. Hand in
hand with these functions, is the need to develop and implement a
mandatory product tracing system that can identify product all the way
from its growth source to the point at which contamination was found. In
order to put this type of system in place, all overseeing food agencies
and food industries must put aside the status quo and investigate
innovative technologies that can provide rapid and accurate product
identification.

***1. Product Tracing***

Product tracing is an essential element to any system aimed at
protecting public health.

When a positive is found, identifying the supplier is critical and must
be done as quickly as possible to ensure that process control problems
are corrected and contaminated product is not distributed.

In FSIS's draft *Compliance Document*, FSIS states that establishments
may "find it useful to record the producer or supplier of source
materials that test positive" to establish "a pattern of positive
results associated with a particular supplier." However, the Agency has
not followed its own advice in the collection of samples for FSIS
microbiological testing programs. Historically, FSIS inspectors have
been directed to [not record]{.underline} the supplier(s) when
collecting a microbiological sample. Instead, they were directed to wait
until there was a presumptive or confirmed positive and then go back to
the establishment to determine the supplier(s) of the product. Not
surprisingly, this strategy makes retrieving contaminated product more
difficult and less timely.

Shortly after the 2002 ConAgra and 2007 TOPPS recall, FSIS did require
its inspectors to record the name of the supplier(s) when they collected
a sample for microbial testing purposes. However, CFI was disappointed
to learn that FSIS has again relaxed this requirement and FSIS
inspectors have been directed to return to their previous practices. It
is unclear why the Agency is reluctant to heed its own advice to keep
accurate and timely records, especially since this type of
record-keeping is easy to perform and can have significant impact on
public health goals.

CFI believes that FSIS, in order to achieve its public health
objectives, must improve its ability to trace pathogenic contamination
to its source. Total transparency in reporting, along with the
development of regulations requiring establishments and federal
employees to use timely record-keeping practices, are changes that need
to be implemented quickly. [CFI strongly recommends to FSIS that they
hold a public meeting to determine the gaps in reporting practices and
to explore new approaches for developing a reliable and efficient
product tracing system.]{.underline}

***2. Research***

Research is the process of looking for a specific answer to a specific
question in an organized, objective and reliable way. In essence,
research expands knowledge by providing accurate, relevant, timely and
credible data from which informed decisions can be made. Objective
research and analysis are critical to the formulation of sound public
polices and the development of successful strategies and programs.

Unfortunately, FSIS is not allowed to conduct its own research on
foodborne pathogens and must rely on other agencies, such as USDA's
Agricultural Research Services (ARS) or CDC, to meet its research needs.
FSIS needs to develop a comprehensive research agenda that would allow a
steady and progressive growth in the Agency's knowledge about the
sources, trends, health outcomes or preventive strategies for foodborne
disease. Such research efforts would also lead the Agency into building
a public health-driven, risk-based inspection system. In fact, it could
be argued that FSIS microbiological testing programs are research.

[FSIS' lack of research capability needs to be reviewed by Congress,
especially if food oversight agencies are expected to provide leadership
on food safety in the 21^st^ century.]{.underline}

***[Conclusion]{.underline}***

On November 6, 2008, the Government Accountability Office (GAO) issued a
statement to President-elect Obama and the 111^th^ Congress saying that
the federal oversight of food was one of the nation's 13 "Urgent
Issues." In addition, the earlier 2007 GAO Report listed food safety as
a high risk area and said the following about *Transforming Federal
Oversight of Food Safety*: "Legislation is likely to be necessary, as a
supplement to actions by the executive branch, in order to effectively
address this high risk area." CFI concurs with these GAO assessments.

After reviewing the materials from the October 14-15 USDA public
meeting, CFI believes the following:

1)  Due to the heterogeneous distribution of pathogens in meat and
    poultry products, microbiological testing cannot guarantee that
    product is free of contamination and should not be used for product
    acceptance.

2)  Microbiological testing should be used to verify process control and
    should occur on an ongoing basis as part of the "Plan-Do-Check-Act"
    cycle.

3)  Consistent and uniform sampling and testing methodologies for
    microbiological testing of beef manufacturing trimmings should be
    developed and implemented with the primary objective of protecting
    public health.

4)  Sound statistical sampling plans for microbiological testing
    programs should be designed to assess process control and maximize
    the probability of detecting contamination, if it exists. The power
    and confidence level associated with the sampling plan should be
    considered and disclosed, along with the justification for the
    design of the sampling plan.

5)  N60 sampling should be the minimum sampling protocol for beef
    manufacturing trimmings in all federally inspected meat and poultry
    establishments.

6)  Labeling bearing *E. coli* O157:H7 testing claims on beef
    manufacturing trimmings will provide down-line processors valuable
    information needed in making purchasing decisions. Guidelines for
    labeling must be outlined and enforced. Misrepresentation should
    carry stiff penalties.

7)  FSIS and industry employees need to be trained on proper procedures
    for sampling beef manufacturing trimmings for *E. coli* O157:H7.

8)  Given the continued problems with pathogenic contamination of the
    U.S. food supply, FSIS needs to hold a public meeting on product
    tracing and animal identification.

9)  FSIS should have research capabilities.

Finally, these recommendations will require additional investments by
both the government and industry. However, these investments are
warranted since they have public health value. FSIS should secure
additional funding to protect public health through improved
microbiological testing. FSIS should also provide the public with a
report on its progress in implementing these recommendations in six
months.

CFI is committed to working with USDA and FSIS to minimize foodborne
illness through more effective food safety management, including the
development of appropriate regulation. We appreciate this opportunity to
comment on the October 14-15, 2008, USDA public meeting, and we look
forward to continuing our dialog with the Agency on important food
safety issues.

Respectfully submitted,

Patricia Buck

Executive Director

Center for Foodborne Illness Research & Prevention

Barbara Kowalcyk

Director for Food Safety

Center for Foodborne Illness Research & Prevention

[^1]: Mead, Paul, et al. *Food-Related Illness and Death in the United
    States*. [Emerging Infectious Diseases]{.underline}, Vol. 5, No. 5,
    September-October, 1999.

[^2]: Tauxe, Robert. Power point presentation, slide 2, April 9, 2008.

[^3]: HUS is a serious disease. According to the National Kidney
    Foundation, HUS caused by shiga toxin-producing pathogens like *E.
    coli* O157:H7 is the leading cause of acute kidney failure in young
    children in the United States. HUS can result in long-term
    gastrointestinal complications, hypertension, diabetes, seizures or
    chronic cognitive and/or emotional problems.

[^4]: Engeljohn, Daniel. Transcript from the USDA public meeting
    entitled *Addressing Sampling and Testing Methodologies, Compliance
    Guidelines, and N60 Labeling,* Washington, D.C., October 15, 2008,
    pp. 218-220.

[^5]: American Public Health Association. *Protection of the Public
    Against Foods and Beverages That Are Unfit for Human Consumption.*
    Public Policy Number: 7925 (PP). Policy Date: 01/01/1979, p. 3.

[^6]: Ibid., p. 4.

[^7]: Ibid., p. 4.