[Federal Register: April 9, 2009 (Volume 74, Number 67)]
[Page 16176-16178]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food Safety and Inspection Service

[Docket No. FSIS-2009-0003]

Draft FSIS Comparative Risk Assessment for Listeria Monocytogenes 
in Ready-To-Eat Meat and Poultry Deli Meats

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of request for comment.


SUMMARY: The Food Safety and Inspection Service (FSIS) is requesting 
public comment on a draft quantitative food safety risk assessment for 
Listeria monocytogenes (L. monocytogenes) that compares the risk of 
listeriosis from consumption of prepackaged ready-to-eat (RTE) deli 
meat versus RTE deli meat that is sliced and packaged at retail. The 
risk assessment analyzes the comparative risk of listeriosis from 
prepackaged RTE deli meat versus RTE deli meat that is sliced and 
packaged at retail using data from a study by the National Alliance for 
Food Safety and Security (NAFSS) and new consumer survey data from 
Research Triangle Institute (RTI) International, Tennessee State 
University, and Kansas State University.

DATES: Submit written comments by June 8, 2009.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by either of the following methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://
www.regulations.gov. Follow the online instructions at that site for 
submitting comments.
     Mail, Including Floppy Disks or CD-ROMs, and Hand- or 
Courier-Delivered Items: Send to Docket Clerk, U.S. Department of 
Agriculture, FSIS, 1400 Independence Avenue, SW., Room 2534, South 
Agriculture Building, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2009-0003. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any

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personal information, to http://www.regulations.gov.
    For access to background documents or comments received, go to the 
FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 
p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Dare Akingbade, Office of Public 
Health Science, FSIS, 1400 Independence Avenue, SW., Aerospace Center, 
Washington, DC. 20250-3700; Telephone: (202) 690-6462; Fax: (202) 690-
6337; Electronic mail: dare.akingbade@fsis.usda.gov.


I. Background

    L. monocytogenes is estimated to cause approximately 2,500 
illnesses, 2,300 hospitalizations, and 500 deaths each year in the 
United States (Mead et al., 1999). L. monocytogenes is ubiquitous in 
nature. It is commonly found in the intestines of animals and humans 
without causing illness. It can survive for long periods of time in 
soil, leaf litter, sewage, silage dust, vegetation, and water. The 
organism has been found in many domestic and wild animals, fish, birds, 
insects, and snails. L. monocytogenes has been isolated from a variety 
of products, including raw milk, cheese made from unpasteurized milk, 
soft cheese, meat and poultry and their products, cole slaw, and 
cabbage. L. monocytogenes is found in the food-processing environment 
and can form biofilms on solid surfaces in food processing plants. L. 
monocytogenes can also survive adverse conditions on apparently smooth 
surfaces (http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://
    Consumption of food contaminated with L. monocytogenes can cause 
listeriosis, a disease that results in high fever, severe headache, 
neck stiffness, and nausea. Listeriosis can also cause miscarriages and 
stillbirths, as well as fatal infections in those with weakened immune 
systems, such as infants, the elderly, and persons with HIV infection 
or undergoing chemotherapy (http://www.fsis.usda.gov/News_&_Events/
    To better understand the sources of foodborne L. monocytogenes 
infection, the Food and Drug Administration (FDA) and FSIS developed a 
quantitative risk assessment that compared the risk of listeriosis 
among 23 categories of RTE foods. The results of the risk assessment, 
completed in 2003, indicated deli meats pose the greatest risk for 
listeriosis, accounting for approximately 1,600 illnesses per year 
    Because of these findings, FDA and FSIS conducted a preliminary 
analysis using the deli meat model component of the 2003 FDA and FSIS 
Listeria monocytogenes risk assessment. This analysis estimated the 
relative risk of illness from Listeria monocytogenes on deli meat 
sliced and packaged at Federally inspected processing establishments 
compared to deli meat sliced at retail facilities. The results of the 
preliminary analysis indicated that approximately 80% of listeriosis 
cases related to deli meats were associated with those sliced at 
retail. However, because these results were based on a retail survey 
not specifically designed to collect contamination data on deli meats 
(Gombas et al. 2003), FSIS sought to gather targeted contamination data 
for prepackaged and retail-sliced deli meats to further examine the 
relative risk of listeriosis.
    In the risk assessment released today--the Comparative Risk 
Assessment for Listeria monocytogenes in Ready-To-Eat Meat and Poultry 
Deli Meats--FSIS reanalyzes the relative risk of illness from Listeria 
monocytogenes on deli meat sliced and packaged at Federally inspected 
processing establishments compared to deli meat sliced at retail 
facilities based on new data.

II. The Draft Risk Assessment

    The Comparative Listeria Monocytogenes in Ready-to-Eat Meat and 
Poultry Deli Meats risk assessment has undergone an independent 
external peer review consistent with the requirements in the Office of 
Management and Budget's ``Final Information Quality Bulletin for Peer 
Review'' and review by various government agencies. This quantitative 
risk assessment provides a science-based, analytical approach to 
collate and incorporate available data into a mathematical model. It 
provides risk managers with a decision-support tool to understand and 
evaluate the relative risk of slicing and packaging deli meat in retail 
facilities versus slicing and packaging deli meat in federally 
inspected processing establishments.
    The deli meat pathway model of the draft risk assessment consists 
of four distinct stages: (1) A retail stage that determines the level 
of L. monocytogenes in prepackaged deli meats and those deli meats 
sliced at retail; (2) a growth stage that uses an exponential growth 
rate function to model the growth of L. monocytogenes in deli meat 
between purchase at retail and consumption; (3) a consumption stage 
that uses information about deli meat serving sizes and the number of 
servings consumed to estimate consumer exposure to the pathogen of 
concern; and (4) a dose-response stage that predicts the probability of 
death from consuming L. monocytogenes.
    To update the deli meat pathway model of the 2003 risk assessment 
discussed above, FSIS obtained retail contamination data from the NAFSS 
study (Draughon, 2006) and used it in conjunction with new consumer 
survey data obtained by RTI International, Tennessee State University, 
and Kansas State University (Cates et al., 2006).
    The results from this comparative Lm risk assessment model indicate 
that approximately 83% of listeriosis cases and deaths attributed to 
deli meat consumption are from deli meat sliced and packaged at retail.
    As part of an evaluation of the draft comparative L. monocytogenes 
risk assessment, FSIS seeks comments about:
    (1) The assumptions made,
    (2) The modeling techniques,
    (3) The data used, and
    (4) The clarity of the draft risk assessment document.
    FSIS will review and evaluate all public comments on this draft 
comparative risk assessment and make modifications to the assessment 
based on comments, as appropriate. The draft risk assessment is 
available electronically on the FSIS Web site (http://

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that the 
public and in particular minorities, women, and persons with 
disabilities, are aware of this notice, FSIS will announce it on-line 
through the FSIS Web page located at http://www.fsis.usda.gov/
regulations/2009_Notices_Index/. FSIS also will make copies of this 
Federal Register publication available through the FSIS Constituent 
Update, which is used to provide information regarding FSIS policies, 
procedures, regulations, Federal Register notices, FSIS public 
meetings, and other types of information that could affect or would be 
of interest to our constituents and stakeholders. The Update is 
communicated via Listserv, a free e-mail subscription service 
consisting of industry, trade, and farm groups, consumer interest 
groups, allied health professionals, scientific professionals, and 
other individuals who have requested to be included. The

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Update also is available on the FSIS Web page. Through Listserv and the 
Web page, FSIS is able to provide information to a much broader, more 
diverse audience.
    In addition, FSIS offers an e-mail subscription service which 
provides automatic and customized access to selected food safety news 
and information. This service is available at http://www.fsis.usda.gov/
news_and_events/email_subscription/. Options range from recalls, 
export information, regulations, directives, and notices. Customers can 
add or delete subscriptions themselves, and have the option to password 
protect their accounts.

    Done at Washington, DC, on April 3, 2009.
Carol Maczka,
Assistant Administrator, ODIFP.
[FR Doc. E9-8056 Filed 4-8-09; 8:45 am]