[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Pages 3617-3619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-938]



Food and Drug Administration

[Docket No. FDA-2008-N-0658]

Risk Assessment of the Public Health Impact From Foodborne 
Listeria monocytogenes in Some Ready-to-Eat Foods Sliced, Prepared, 
and/or Packaged in Retail Facilities; Request for Comments and for 
Scientific Data and Information

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice; request for comments and for scientific data and 


SUMMARY: The Food and Drug Administration (FDA) is requesting

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comments and scientific data and information that would assist the 
agency in its plans to conduct a risk assessment of the public health 
impact of foodborne Listeria monocytogenes in some ready-to-eat foods 
sliced, prepared, and/or packaged in retail facilities. The purpose of 
the risk assessment is to ascertain the impact on public health of 
current practices and potential interventions that reduce or prevent L. 
monocytogenes contamination in ready-to-eat food.

DATES: Submit comments and scientific data and information by April 21, 

ADDRESSES:  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. 
Submit electronic comments, scientific data, and information to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Sherri Dennis, Center for Food Safety 
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 
Paint Branch Pkwy, College Park, MD 20740, 301-436-2355, e-mail: 
[email protected].


I. Background

    The Department of Health and Human Services' Healthy People 2010 is 
a comprehensive set of disease prevention and health promotion 
objectives for the Nation to achieve over the first decade of the new 
century. Created by scientists both inside and outside of government, 
it identifies a wide range of public health priorities and specific, 
measurable objectives. One of these objectives calls on Federal food 
safety agencies to reduce foodborne listeriosis (Ref. 1). In support of 
this goal, in 2003, FDA and the Food Safety and Inspection Service 
(FSIS) of the U.S. Department of Agriculture (USDA) issued an 
assessment of the relative risk to public health from foodborne 
Listeria monocytogenes among selected categories of ready-to-eat (RTE) 
foods (Listeria risk assessment, Ref. 2). The Listeria risk assessment 
formed the basis of the 2003 FDA and Centers for Disease Control and 
Prevention (CDC) Listeria Action Plan (Ref. 3), which identifies 
prevention and control activities that FDA and CDC will take to reduce 
the incidence of foodborne listeriosis in the United States.
    The 2003 Listeria risk assessment provided the first quantitative 
estimate of the relative risk of listeriosis from consumption of a 
variety of RTE foods. Among the RTE foods evaluated in the 2003 risk 
assessment, deli meats (e.g., luncheon meats) were considered to 
present the highest risk per serving and the highest risk per annum. 
This rank was the result of a moderate contamination frequency, a high 
number of servings consumed and high growth rates of L. monocytogenes. 
Additional data obtained in California and Maryland showed that L. 
monocytogenes prevalence and levels in luncheon meats, deli-style 
salads, and seafood salads were higher for in-store-packaged than for 
manufacturer-packaged foods (Ref. 4). This observation was confirmed 
for meat and poultry products in a study by the National Alliance for 
Food Safety and Security performed in northern California, Georgia, 
Minnesota, and Tennessee in 2008 (Ref. 5). Using these latter results, 
it was estimated that most of the listeriosis cases attributed to 
ready-to-eat meat and poultry deli meats are from products sliced and 
packaged at retail (FSIS/USDA, unpublished results).
    Little is known about how Listeria contamination occurs in retail 
facilities. Retail practices may result in either cross-contamination 
from one product to another or through contamination from the retail 
environment. There is thus a need to identify potential sources and 
practices that may increase L. monocytogenes contamination in retail 
settings and practices or interventions that could reduce or eliminate 
L. monocytogenes contamination of food products (sold to consumers at 
the retail level) and resulting human illness.
    FDA is engaged in a risk assessment that will evaluate the dynamics 
of L. monocytogenes contamination in retail facilities contributing to 
listeriosis. It will evaluate how specific practices could affect the 
overall level and frequency of contamination, and the relative 
effectiveness of various process changes and intervention strategies 
intended to reduce human illness. The project will address FDA and USDA 
regulated RTE foods. It will focus on RTE foods that are sliced, 
prepared, and/or packaged for the consumer in the retail environment 
and consumed in the home. Cheeses, deli meats, and deli-type salads (as 
defined in Ref. 2) will be studied as representative examples.
    This risk assessment of the public health impact of L. 
monocytogenes in RTE foods sliced, prepared, and/or packaged in retail 
facilities supports the agency's commitment to fulfilling the Listeria 
Action Plan (Ref. 3).

II. Request for Comments and for Scientific Data and Information

    FDA requests comments on the risk assessment goals outlined in this 
document and the submission of scientific data and information relevant 
to the risk assessment. Specifically, we request data and information 
about the following:
    1. Characteristics of ready-to-eat food markets in the United 
States, including:
    a. Volumes of cheeses and deli meats sliced by manufacturers and 
the volumes sliced in retail facilities,
    b. Volumes of deli-type salads prepared by manufacturers and the 
volumes prepared in retail facilities, and
    c. Volumes of ready-to-eat food sold in delicatessen departments of 
major grocery chains (i.e., large supermarket facilities) and the 
volumes sold in other groceries (i.e., multipurpose independent small 
or local facilities).
    2. Characteristics of deli departments in groceries, including the 
proportion of separated seafood/meat/dairy deli departments in 
    3. Product contamination data, including:
    a. L. monocytogenes levels and/or frequencies in wholesale products 
(deli meats (chubs), cheeses, fresh produce, seafood) arriving at 
retail facilities; and
    b. L. monocytogenes levels and/or frequencies in cheeses, deli 
meats, and deli-type salads sold by retail facilities.
    4. Factors that influence the growth of L. monocytogenes in 
cheeses, deli meats, and deli-type salads, including:
    a. Growth rates of L. monocytogenes in cheeses, deli meats, and 
deli-type salads and the effects of different ingredients in and 
compositions of those products;
    b. Chemical characteristics of cheeses, deli meats, and deli-type 
salads that could influence L. monocytogenes, including pH and water 
    c. Proportions of deli meats treated with growth inhibitors, the 
inhibitors used, the level of growth inhibitors, and their efficiency;
    d. Data on the temperatures to which cheeses, deli meats, and deli-
type salads are exposed at retail, including time and temperature for 
walk-in coolers or refrigerators, display cabinets, and ambient 
displays; and
    e. Data on the use of advisory ``use-by'' or ``best by'' labels for 
ready-to-eat food sold by retail facilities.
    5. Environmental contamination data, including:
    a. Data and information on the prevalence and levels of L. 
monocytogenes in the retail environment including, e.g., drains, 
countertops, walls, and equipment; and

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    b. Data on the growth of L. monocytogenes on non-food surfaces 
including environmental biofilm growth.
    6. Factors that influence the environmental contamination and the 
cross-contamination of food by L. monocytogenes in retail facilities, 
    a. Data and information on the potential transfer of L. 
monocytogenes to food from the retail environment, e.g., experimental 
studies on the transfer to food from drains, slicers, food contact 
surfaces, and non-food contact surfaces; and
    b. Data and information on food handlers' activities, e.g., 
observations of food handlers' practices and monitoring of specific 
food safety actions in retail facilities (e.g., glove usage, hand 
hygiene practices, and cleaning practices).
    7. Identity and effectiveness of control measures or interventions 
intended to reduce levels and frequency of L. monocytogenes in the 
retail environment, including:
    a. Environmental sanitation procedures including the sanitizers and 
protocols used, frequency of application, and efficiency; and
    b. Worker sanitation procedures including frequencies, protocols, 
and efficiency.
    8. Any other data related to the occurrence, growth, and control of 
L. monocytogenes in retail facilities.
    As the project progresses, additional data needs may be identified.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. 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. (FDA has verified the 
Web site addresses, but FDA is not responsible for any subsequent 
changes to the Web sites after this document publishes in the Federal 
    1. U.S. Department of Health and Human Services, Healthy People 
2010, v. 1. Washington, DC, 2000, http://healthypeople.gov.
    2. 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 Listeria monocytogenes Among Selected Categories of Ready-
to-Eat Foods,'' September 2003, http://www.foodsafety.gov/~dms/lmr2-
    3. U.S. Department of Health and Human Services, Food and Drug 
Administration/Centers for Disease Control and Prevention, 
``Reducing the Risk of Listeria monocytogenes FDA/CDC 2003 Update of 
the Listeria Action Plan,'' November 2003, http://www.cfsan.fda.gov/
    4. Gombas, D.E., Chen, Y., Clavero, R.S., and Scott, V.N. 
(2003). Survey of Listeria monocytogenes in ready-to-eat foods. 
Journal of Food Protection, 66(4), 559-569.
    5. Draughon, A.F. (2006). A collaborative analysis/risk 
assessment of Listeria monocytogenes in ready-to-eat processed meat 
and poultry collected in four FoodNet states. Symposium S-16: 
Contamination of ready-to-eat foods: transfer and risk: Listeria 
monocytogenes and other microorganisms. International Association 
for Food Protection 93rd Annual Meeting, Calgary, Alberta. August 

    Dated: January 12, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-938 Filed 1-16-09; 8:45 am]