[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19311-19313]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8360]



[[Page 19311]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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