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January 8, 1999
FSIS Docket Clerk
Docket #98-037N
Room 102 Cotton Annex Building
300 12th Street, SW
Washington, DC 20250-3700
Re: Comments on "Preliminary Pathways and Data for a Risk Assessment of E. coli
O157:H7 in Beef"
Dear Sir or Madam:
In response to Dr. Ruth Etzel's November 16, 1998 request, the
Food Marketing Institute is pleased to submit the following comments
on the draft report entitled, "Preliminary Pathways and Data
for a Risk Assessment of E. coli O157:H7 in Beef"
(hereinafter "Preliminary Pathways").
The Food Marketing Institute is a nonprofit association that conducts programs in research, education, industry relations and public affairs on behalf of its 1,500 members and their subsidiaries. Our membership includes food retailers and wholesalers, as well as their customers, in the United States and around the world. FMI's domestic member companies operate approximately 21,000 retail food stores with a combined annual sales volume of
$220 billion, which accounts for more than half of all grocery
store sales in the United States. FMI's retail membership is
composed of large multi-store chains, small regional firms and
independent supermarkets. Our international membership includes
200 members from 60 countries.
We were specifically asked to address the following issues: (1)
the scientific evidence acquired by the risk assessment team to
date; (2) the existing data gaps identified by the risk assessment
team; (3) the analytical framework that will be used to conduct
the intended risk assessment; and (4) the scope of the analysis.
In addition, we believe it is appropriate to consider the overall
utility of the proposed risk assessment. As discussed more fully
below, we recommend that the Agency focus its valuable resources
on demonstrating the efficacy of measures to eliminate the pathogen
from the food supply.
In general, we are encouraged by the efforts of the United States
Department of Agriculture (USDA), and particularly the Food Safety
and Inspection Service (FSIS), to apply scientific principles
to improve the safety of our meat and poultry food supply. Using
science as the foundation to formulate better and more effective
policies is a laudable goal, which is fully supported by FMI.
Moreover, the "Preliminary Pathways" document generated
as a result of FSIS's efforts is, itself, a useful tool. The
scientific evidence acquired by the risk assessment team and presented
in "Preliminary Pathways" includes a comprehensive review
of current information and numerous conclusions drawn from existing
data. More importantly, the report documents the gaps in the
presently available data set.
As noted above, however, our primary concern lies with the overall
utility of conducting the proposed risk assessment. The application
of formal risk assessment techniques to the fields of microbiology
and food safety is a relatively new approach. In this case, the
risk assessment analysis is further complicated by the numerous
and significant gaps in the data (as identified in "Preliminary
Pathways"), as well as the multitude of assumptions upon
which the risk assessment must necessarily be predicated as a
result of the data gaps.
Even if thsee methodological issues can be addressed, the data
that will result from the proposed study are likely to be of only
limited use in improving the safety of the food supply for several
reasons.
First, the analysis focuses on a single food product (i.e.,
hamburger), rather than on the pathogen itself. As the source
and infection mechanism of the pathogen are not well-understood,
the more effective and useful approach would be to conduct a study
to clarify the ecology of E. coli O157:H7.
Second, with respect to the Production Module, the stated purpose
of the analysis is "to simulate the number of cattle presented
for slaughter that are E. coli O157:H7 affected."
Preliminary Pathways at 2-1. Rather than quantifying the number
of cattle that might be affected, FSIS should devote its resources
to assessing the risks associated with on-farm practices or to
evaluating measures prior to slaughter that might be used to reduce
the incidence of E. coli O157:H7 in beef. Despite the
stated intention to "reflect a full range of current practices
and behaviors from farm to fork," the risk assessment is
virtually devoid of any on-farm assessment, such as the risk assessment
reduction or avoidance techniques used by producers and their
utility in reducing E. coli O157:H7.
Third, to the extent that the Preparation Module of the risk assessment
is intended to generate data that enumerate and predict the number
of E. coli O157:H7 illnesses that have or will occur, the
study will duplicate efforts currently performed by the Foodborne
Diseases Active Surveillance Network (FoodNet) and others. See
Preliminary Pathways at 1-13 - 1-15. That is, the results
will either confirm the data generated by FoodNet that indicate
that E. coli O157:H7 is a significant cause of foodborne
disease in the United States or the data will differ. In the
former case, the data are redundant and, in the latter case, the
significance of the conflicting data will be difficult to evaluate,
particularly in view of the inherent uncertainty associated with
a risk assessment based on as many unknown variables as have been
identified in "Preliminary Pathways." Moreover, even
if the data indicate that the risk to the general population is
relatively small, the results should not alter the Agency's resolve
to minimize the risk from the pathogen. These comments also apply
to the Public Health Module.
In contrast, we note that the stated goal of the Slaughter Module
is to determine those practices that are most likely to reduce
the risk of contamination with E. coli O157:H7. Preliminary
Pathways at 3-1. Along these lines, we note that the beef industry
has been adopting and implementing practices that have been scientifically
proven to reduce the incidence of E. coli O157:H7 in beef
over the past several years. As a result, the data provided in
"Preliminary Pathways" indicate that the number and
percentage of illnesses attributed to ground beef has been steadily
declining from a high of 55 percent in the period from 1982 to
1993 to 4 percent or 6 percent in the past two years. Accordingly,
consistent with the reduction in illnesses resulting from the
implementation of procedures to reduce the occurrence of the pathogen
in food, we urge the Agency to adopt the approach outlined in
the Slaughter Module from which data proving the efficacy of additional,
practical techniques may be derived.
In conclusion, FMI supports FSIS's goal to use sound, scientific
research as a basis for augmenting the safety of our food supply.
However, we recommend that the Agency redirect its resources
from those aspects of the risk assessment study that are based
on substantial data gaps and that are intended to quantify a known
problem, and instead utilize these resources to determine the
sources of E. coli O157:H7 and to establish the effectiveness
of controls and interventions that will reduce the pathogen before
it enters the food supply.
Thank you for your consideration. We look forward to continuing
to work with you on increasing the safety of our food supply and
we would be pleased to discuss our comments with you in more depth.
Sincerely,
Tim Hammonds
President and Chief Executive Officer