[Federal Register: April 9, 2009 (Volume 74, Number 67)]
[Notices]
[Page 16176-16178]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap09-27]
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DEPARTMENT OF AGRICULTURE
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.
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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.
SUPPLEMENTARY INFORMATION:
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://
www.fsis.usda.gov/oa/topics/lmguide.htm).
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/
Recall_051_2008_Release/index.asp).
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
(http://www.foodsafety.gov/~dms/lmr2-toc.html).
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://
www.fsis.usda.gov/Science/Risk_Assessments/index.asp#RTE).
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]
BILLING CODE 3410-DM-P