[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19311-19313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8360]
[[Page 19311]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2010-0035]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0092]
Update of the 2003 Interagency Quantitative Assessment of the
Relative Risk to Public Health From Foodborne Listeria Monocytogenes
Among Selected Categories of Ready-to-Eat Foods; Request for Comments,
Scientific Data and Information
AGENCY: Food Safety and Inspection Service, USDA; Food and Drug
Administration, HHS.
ACTION: Notice; request for comments and for scientific data and
information.
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SUMMARY: The Food Safety and Inspection Service (FSIS) and the Food and
Drug Administration (FDA) are requesting comments and scientific data
and information that would assist the agencies in their plan to update
a risk assessment on the relationship between foodborne Listeria
monocytogenes in selected categories of ready-to-eat (RTE) foods and
human health. The purpose of the risk assessment is to incorporate
newly available scientific data and information into the risk
assessment in order to update estimates of the relative risk of illness
and death associated with the consumption of different types of RTE
foods that may be contaminated with L. monocytogenes and to evaluate
the relative effectiveness of strategies to reduce or prevent exposure
to L. monocytogenes from the consumption of RTE foods, including, for
example, the impact of changing refrigerated time and temperature
storage prior to consumption.
DATES: Submit electronic or written comments and scientific data and
information by July 6, 2011.
ADDRESSES: FSIS: Submit electronic comments and scientific data and
information to http://www.regulations.gov. Submit written comments and
scientific data and information to the Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, George Washington
Carver Center, 5601 Sunnyside Ave., Mailstop 5474, Beltsville, MD
20705-5464. All submissions must include the Agency name and docket
number FSIS-2010-0035.
FDA: Submit electronic comments and scientific data and information
to http://www.regulations.gov. Submit written comments and scientific
data and information to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. All submissions must include the Agency name and docket
number FDA-2011-N-0092.
FOR FURTHER INFORMATION CONTACT: FSIS: Janell Kause, Office of Public
Health Science, Food Safety and Inspection Service, United States
Department of Agriculture, 1400 Independence Ave., Aerospace Maildrop
344, Washington, DC 20250, 202-690-0286; or
FDA: Sherri Dennis, Center for Food Safety and Applied Nutrition
(HFS-06), Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, 301-436-1914.
SUPPLEMENTARY INFORMATION:
I. Background
Listeria monocytogenes is a bacterium that is commonly found in the
human environment, including food processing environments. After
ingesting L. monocytogenes, humans can develop listeriosis, a severe
foodborne disease with a high case-fatality rate. Listeriosis occurs
predominantly in high-risk population subgroups, including pregnant
women and their fetuses or neonates, immune-compromised individuals,
and the elderly population (defined for the purpose of the risk
assessment discussed in this notice as individuals who are 60 years of
age or older). Due to the high proportion of serious illnesses and the
high case-fatality rate associated with listeriosis, the ``Healthy
People 2010'' goals for national disease prevention and health
promotion specified a reduction in the prevalence of foodborne
listeriosis by 50 percent as an important objective (Ref. 1).
(``Healthy People'' is a national health promotion and disease
prevention initiative that brings together national, State, and local
government agencies; nonprofit, voluntary, and professional
organizations; and businesses, communities, and individuals to improve
the health and quality of life of all Americans, eliminate disparities
in health, and promote good health and quality of life across all life
stages (Ref. 2).) However, despite considerable efforts to reduce the
number of listeriosis cases during the past decade, the listeriosis
prevalence still exceeds the ``Healthy People 2010'' target of 0.25
cases per 100,000 population (Ref. 3). (Note that then President
Clinton's Council on Food Safety, established by Executive Order 13100,
August 25, 1998, developed a strategic plan that set public health
goals including, by 2005, reducing foodborne illness by 25 percent for
some pathogens and for others to the quantitative targets established
in ``Healthy People 2010.'' In 2005, FoodNet data showed 0.30 L.
monocytogenes cases per 100,000 population; the ``Healthy People 2005''
target was 0.25 L. monocytogenes cases per 100,000 population.) In
2009, the prevalence of listeriosis had decreased by only 26 percent
compared to the baseline period (1996 to 1998) rate, and reducing the
prevalence of listeriosis was retained in the ``Healthy People 2020''
objectives, with a target of 0.2 cases per 100,000 population (Refs. 3
and 4).
In 2003, FDA and FSIS published a quantitative assessment of the
relative risk to public health from foodborne L. monocytogenes among 23
selected categories of RTE foods (the 2003 risk assessment) (Ref. 5).
This 2003 risk assessment provided estimates for the median number of
listeriosis cases attributable to each of 23 RTE food categories on a
per-annum and per-serving basis. This allowed for a relative ranking of
the 23 food categories based on the associated public health risk and
permitted the evaluation of the likely impact of several ``what-if''
mitigation scenarios.
Since publication of the 2003 risk assessment, the food industry
has changed some practices, including by adding growth inhibitors to
RTE products. L. monocytogenes prevalence in some RTE foods has
decreased over the past decade, and a substantial amount of new
scientific data has become available for potential inclusion in risk
assessments (Refs. 6, 7, and 8). These changes could potentially affect
the outcomes of the risk assessment and alter the relative risk
rankings of the RTE food categories evaluated in the 2003 risk
assessment.
Risk assessments can be used to evaluate potential risk mitigation
strategies and can guide, support, and enhance an Agency's risk
management policies, outreach efforts, data collection initiatives, and
research priorities. To help ensure that risk mitigation strategies,
risk management policies, outreach efforts, data collection
initiatives, and research priorities aimed at controlling L.
monocytogenes in RTE foods are directed to those RTE foods that pose
the greatest risk, FDA and FSIS have initiated an update to the 2003
risk assessment. The purpose of updating the risk assessment is to
incorporate newly available scientific
[[Page 19312]]
data and information that reflect changes in L. monocytogenes
prevalence and industry practices into the risk assessment in order to:
(1) Update estimates of the relative risk of listeriosis associated
with the consumption of different types of RTE foods that may be
contaminated with L. monocytogenes and (2) evaluate the relative
effectiveness of strategies to reduce or prevent exposure to L.
monocytogenes from the consumption of RTE foods, including by modeling
the effect of changing refrigerated storage times and temperatures. To
fill critical data gaps, FDA and FSIS have initiated collaborative
efforts with the USDA Agricultural Research Service, academic partners,
and private laboratories to survey the presence and quantity of L.
monocytogenes in selected categories of RTE foods. RTE foods chosen for
this survey include: Leafy green vegetables, low-acid cut fruits,
smoked seafood, seafood and deli-type salads, soft ripened and semi-
soft cheeses, sandwiches, raw milk, deli meats, hot dogs,
p[acirc]t[eacute], and meat spreads. Estimates for other RTE foods to
be included in the risk assessment will be updated using scientific
data newly available in the literature (if applicable) and information
provided in response to this notice.
II. Request for Comments and Scientific Data and Information
FSIS and FDA are requesting technical comments on the approach
outlined previously for updating the 2003 risk assessment. FDA and FSIS
are also requesting the submission of new data and information relevant
to this risk assessment that was not available for inclusion in the
previous risk assessment and that may reflect changes in L.
monocytogenes prevalence and industry practices that have occurred
since the previous risk assessment.
The agencies specifically request new data and information
concerning, but not limited to, the following factors that may affect
the relative risk of listeriosis associated with consumption of the
types of RTE foods that were considered in the 2003 risk assessment:
1. L. monocytogenes contamination in different RTE foods sampled at
retail or in the processing plant, including:
The frequency of detecting the presence of L.
monocytogenes in RTE foods (including sample size, number of positives,
total number tested for a specified time period, and test method); and
The number of L. monocytogenes cells present per amount
(unit volume or weight) of contaminated RTE food (including method
used).
2. L. monocytogenes survival and growth dynamics in RTE foods,
including:
Data or models on survival and growth of L. monocytogenes
in specific RTE food matrices, including the potential effects of
commensal microflora;
Data or models on survival and growth of L. monocytogenes
in the presence or absence of substances that inhibit or retard growth;
and
Data or models on survival and growth of L. monocytogenes
at different storage temperatures and over different storage times.
3. The relationship between the dose of L. monocytogenes ingested
with food and the frequency of listeriosis, including:
The effect of age, health status, or other characteristics
of the consumer on the dose-response relationship;
The effect of food matrix and product formulation on the
dose-response relationship;
The effect of genetic characteristics of the L.
monocytogenes strain on the dose-response relationship; and
Any other data pertinent to L. monocytogenes dose-response
relationships.
4. Current food consumption practices in the United States,
including:
The frequency with which different RTE foods (e.g., deli
meats or cheeses manufactured with growth inhibitors) are consumed by
population subgroups (e.g., general adult population, pregnant women,
the elderly); and
Serving sizes for different RTE foods.
5. Food production practices in the United States that may impact
L. monocytogenes prevalence, concentration, survival, or growth in RTE
foods, including:
The absolute or relative frequency of manufacturing
different RTE foods with substances that inhibit the growth of L.
monocytogenes and the types and concentrations of growth inhibitor
used;
The absolute or relative amount of specific types of RTE
foods that are prepared, sliced, cut, or repackaged in retail
operations as opposed to being sold pre-sliced/pre-cut;
The absolute or relative amount of different RTE foods
manufactured without growth inhibitors that are prepared, sliced, or
repackaged at retail;
The average shelf life of foods that were identified in
the 2003 risk assessment (Ref. 4) as supporting L. monocytogenes
growth;
The average shelf life of RTE foods that were not
explicitly identified in the 2003 risk assessment but that may
conceivably support L. monocytogenes growth;
The ability of current production practices to prevent or
reduce L. monocytogenes contamination in finished product;
The ability of current operational practices in retail
operations to prevent or reduce L. monocytogenes contamination in the
final product at the time of sale; and
The ability of current post-processing practices to
prevent L. monocytogenes cross-contamination after processing.
6. Storage times and temperatures that may affect L. monocytogenes
growth during transport and storage of foods in the consumer's home.
7. Other comments, including the RTE food categories that should be
evaluated in the risk assessment.
III. Request for Comments, Scientific Data and Information
FSIS: Interested persons may submit to FSIS's Docket Clerk (see
ADDRESSES) either electronic or written comments regarding this
document. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the FSIS
Docket Room between 8:30 a.m. and 4:30 p.m., Monday through Friday.
FDA: Interested persons may submit to FDA's Division of Dockets
Management (see ADDRESSES) either electronic or written comments
regarding this document. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday. We have verified all
addresses, but we are not responsible for any subsequent changes to the
Web sites after this document publishes in the Federal Register.
1. U.S. Department of Health and Human Services, ``Healthy People
2010,'' Chapter 10, Food Safety, Washington, DC, 2000, http://www.healthypeople.gov/2010/Document/pdf/Volume1/10Food.pdf.
2. U.S. Department of Health and Human Services, ``Healthy People
2020,'' HP 2020 Framework, Washington, DC, 2010, available at http://
www.healthy
[[Page 19313]]
people.gov/2020/Consortium/HP2020Framework.pdf.
3. Anonymous, 2010, ``Preliminary FoodNet Data on the Incidence of
Infection With Pathogens Transmitted Commonly Through Food--10 States,
2009,'' Morbidity and Mortality Weekly Report, 59: 418-422, available
at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5914a2.htm.
4. U.S. Department of Health and Human Services, ``Healthy People
2020,'' HP 2020 FS-1.3, Washington, DC, 2010, available at http://www.healthypeople.gov/2020/topicsobjectives2020/pdfs/HP2020objectives.pdf.
5. U.S. Department of Health and Human Services and U.S. Department
of Agriculture/Food Safety and Inspection Service, ``Quantitative
Assessment of Relative Risk to Public Health From Foodborne L.
monocytogenes Among Selected Categories of RTE Foods,'' September 2003,
available in Docket No. FDA-1999-N-0134 (formerly Docket No. 1999N-
1168), vols. 23 through 28, available at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/ucm183966.htm.
6. Endrikat, S., D. Gallagher, R. Pouillot, H. Hicks Quesenberry,
D. Labarre, C. M. Schroeder, and J. Kause, ``A Comparative Risk
Assessment for L. monocytogenes in Prepackaged Versus Retail-Sliced
Deli Meat,'' Journal of Food Protection, 73:612-9.
7. U.S. Department of Agriculture, Food Safety and Inspection
Service, 2003, 9 CFR part 430, ``Control of Listeria monocytogenes in
Ready-to-Eat Meat and Poultry Products,'' final rule. Federal Register,
68 FR 34208 to 34254.
8. U.S. Department of Agriculture/Food Safety and Inspection
Service, ``The FSIS Microbiological Testing Program for Ready-to-Eat
(RTE) Meat and Poultry Products, 1990-2009,'' September 2010, available
at http://www.fsis.usda.gov/Science/Micro_Testing_RTE/index.asp.
Dated: March 25, 2011.
Alfred V. Almanza,
Administrator, FSIS.
Dated: March 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8360 Filed 4-6-11; 8:45 am]
BILLING CODE 4160-01-P